Calreticulin and JAK2V617F Driver Mutations Induce Distinct Mitotic Defects in Myeloproliferative Neoplasms

Kristin Holl, Nicolas Chatain, Susanne Krapp, Anja Scheufen, Nathalie Brock, Steffen Koschmieder, Daniel Moreno-Andrés

Abstract
Myeloproliferative neoplasms (MPNs) encompass a diverse group of hematologic disorders driven by mutations in JAK2, CALR, or MPL. The prevailing working model explaining how these driver mutations induce different disease phenotypes is based on the decisive influence of the cellular microenvironment and the acquisition of additional mutations. Here, we report increased levels of chromatin segregation errors in hematopoietic cells stably expressing CALRdel52 or JAK2V617F mutations. Our investigations employing murine 32D MPL and human erythroleukemic TF-1MPL cells demonstrate a link between CALRdel52 or JAK2V617F expression and a compromised spindle assembly checkpoint (SAC), a phenomenon contributing to error-prone mitosis. This defective SAC is associated with imbalances in the recruitment of SAC factors to mitotic kinetochores upon CALRdel52 or JAK2V617F expression. We show that JAK2 mutant CD34 + MPN patient-derived cells exhibit reduced expression of the master mitotic regulators PLK1, aurora kinase B and PP2A catalytic subunit. Furthermore, the expression profile of mitotic regulators in CD34 + patient-derived cells allows to faithfully distinguish patients from healthy controls, as well as to differentiate primary and secondary myelofibrosis from essential thrombocythemia and polycythemia vera. Altogether, our data suggest alterations in mitotic regulation as a potential driver in the pathogenesis in MPN.

Introduction
Philadelphia chromosome-negative myeloproliferative neoplasms (Ph-neg. MPNs) are a heterogeneous group of clonal hematopoietic disorders clinically subdivided into polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF) [1]. The mutations in the genes of the Janus kinase 2 (JAK2), calreticulin (CALR), or the thrombopoietin receptor (TPOR/MPL) are driver mutations of these diseases [2, 3]. Their occurrence and variant allele frequency, together with specific bystander mutations, determine the clinical features, disease severity, and whether these disease evolve with dismal prognosis and decreased survival[3–6], towards secondary myelofibrosis (SMF), secondary acute myeloid leukemia and/or secondary solid tumors [7, 8]. The main pathogenic molecular signaling event of Ph-neg. MPNs is the constitutive activation of JAK2- STAT-dependent signaling pathways by mutations in CALR, JAK2 or the MPL receptor [2, 3]. Yet, noncanonical mechanisms of mutant JAK2[9], and CALR[10] have been recently linked to aspects of the disease pathology. However, the molecular mechanisms of the phase transition towards acute disease states are poorly defined [2, 5].

In contrast to other myeloid neoplasms such as primary acute myeloid leukemia (AML) [11, 12], myelodysplastic syndromes [13, 14] or chronic myeloid leukemia [15, 16], the cytology and molecular status of mitosis in Ph-neg. MPNs has not been studied in detail. However, karyotype abnormalities likely caused by chromatin segregation defects due to defective mitosis are present in up to 5% of ET, 20% of
PV, and 57% of PMF cases at the time of diagnosis [4, 17, 18] and accumulate over time, especially at blast-phase transformation[19–22] and frequently are associated with unfavorable prognosis and decreased survival[23–25]. Therefore, mitotic defects induced by driver Ph-neg. MPN mutations could play a role in the pathological mechanisms and contribute to the phase transition. Mitosis is tightly regulated by the crosstalk between the kinases Aurora B, CDK1 (cyclic dependent kinase 1)-Cyclin B1, and Polo-Like Kinase 1 (PLK1), and the protein phosphatase PP2A, as well as by the spindle assembly checkpoint (SAC) [26, 27]. The latter constitutes a protein network recruited to chromosome kinetochores to ensure proper chromosome-spindle attachments and accurate chromatin segregation. It includes several evolutionarily conserved proteins, like BubR1, Aurora B, MAD1, MAD2, MPS1, CDC20 and kinesin motor proteins, such as CENP-E, which are required for precise SAC function [26, 28]. Precise maintenance of the molecular equilibrium in gene expression and accurate subcellular positioning of these mitotic regulators play a critical role in preserving chromosome integrity and ensuring the stability of the karyotype [16, 28–30]. Consequently, defects in mitotic regulation promote chromosome instability (CIN), acquisition and evolution of heterogeneous karyotypes, inflammation, and epigenetic dysregulation. All these pathological mechanisms are linked to the malignant transformation in many solid cancers [31–33]. Similarly, hematological malignancies [16] such as AML [11, 12] and myelodysplastic syndromes [13, 14], show defects or dysregulation in crucial mitotic factors linked to CIN and heterogeneous karyotypes. Here, we have analyzed the mitotic cytology in murine and human cells stably expressing CALRdel52 or JAK2V617F and found error-prone mitosis. The examination of the molecular status of key mitotic regulators suggests defective SAC function. Also, CD34 + Ph-neg. MPN patient cells display differential expression profiles of a subset of important mitotic regulators, including the SAC components BUB1, MAD2L1, INCENP, CDC20, CDK1, PLK1 and Aurora A/B.

Results
CALRdel52 and JAK2V617F 32D MPL cells have a stresssensitive and error-prone mitosis To investigate chromatin segregation and the duration of mitosis, we performed long term live-cell imaging of murine 32D MPL cells (Fig. 1A) for a duration of 20 h followed by image analysis. In comparison with control 32D MPL (EV) cells, 32D MPL cells transduced with CALRdel52 or JAK2V617F showed a slight and non-significant increase in the numbers of chromatin bridges and lagging chromosomes (Fig. 1B). In contrast, the percentage of telophase micronuclei is significantly increased in the JAK2V617F mutant cell (p < 0.008, Fisher´s exact test). The occurrence of all three kinds of chromatin segregation errors further increases significantly in comparison to EV when DNA damage is induced with the chemotherapeutic agent doxorubicin [34] (p < 0.05, Fisher´s exact test), or SAC malfunction with the antimitotic drug NMS-P715 [35] (p < 0.02, Fisher´s exact test), which inhibits the checkpoint kinase MPS1 (Fig. 1B). The average mitotic timing in untreated cells or upon treatment with doxorubicin or MPS1 inhibitor is similar between mutants and control (EV) transfected cells (Supplementary Fig. S1). As expected, treatment the SAC inhibitor NMS-P715 reduced the mitotic timing with respect to untreated samples (Supplementary Fig. S1). These data suggest that mitosis in CALRdel52 and JAK2V617F mutant 32D MPL cells is stress sensitive. A weakened SAC contributes to error-prone mitosis in murine 32D
MPL CALRdel52 and JAK2V617F cells JAK2V617F [9, 36] and CALRdel52 [37] mutations have been linked to increased ROS production. In
addition, JAK2V617F is also linked to replication stress[38], and to lower p53 levels, a factor which is critical for the DNA damage response[39]. Replication stress and DNA damage signalling pathways, together with mitotic dysregulation, are well-known sources of karyotype aberrations such as aneuploidy, CIN, and genomic instability [40]. Therefore, we investigated whether the observed error-prone mitosis in CALRdel52 and JAK2V617F cells after doxorubicin treatment could be due to an altered response to DNA damage or replication stress.

First, we tested whether CALRdel52 or JAK2V617F transduced 32D MPL cells show increased levels of double-strand breaks during entry into mitosis as compared to control (EV) cells by immunofluorescence staining of γ-H2AX (H2AX S139ph) a well-described marker for DNA damage [41]. Visual inspection of γH2AX foci in untreated prometaphase EV and mutant cells revealed similar low levels of DNA damage. As
expected, the number of γ-H2AX foci increased to a similar extent in control (EV) and mutant cells after doxorubicin treatment (Supplementary Fig. S2A). In agreement with the literature [39], p53 basal levels in untreated JAK2V617F cells were much lower than in control EV cells or CALRdel52 (Supplementary Fig. S2B, Supplementary Figure S8). After doxorubicin treatment, p53 levels increased more than four-fold in all the cell lines. These results indicate that DNA damage is similarly induced by doxorubicin in control (EV) and mutant cells during mitotic entry and all cells showed a comparable functional stabilization of p53 after genotoxic stress. To test whether defects in SAC could contribute to the observed increase of chromatin segregation errors in CALRdel52 and JAK2V617F mutant cells, we challenged them with the spindle poison nocodazole. Cells with a weakened or defective SAC escape faster from the nocodazole induced mitotic arrest [29, 42]. Nocodazole treatment induced mitotic arrest in all three cell lines, but compared to control (EV) cells (257 ± 45 min), CALRdel52 (210 ± 36 min, p < 0.02 one-way ANOVA) or JAK2V617F (186 ± 35 min, p < 0.0001) transduced 32D MPL cells showed significantly shorter mitotic arrest and faster mitotic exit (Fig. 2A, B). The outcomes of mitotic arrest induced with microtubule inhibitors are diverse among cancer and normal cell lines due to the different pathways they induce [43, 44]. The current ‘competing networks-threshold’ model proposes that cell fate determination of – either cell death or extended survival – hinges on which of the two thresholds is reached first: either the activation of pro-apoptotic caspases or the degradation of cyclin B1 leading to mitotic slippage [43, 45]. To discriminate between these two options, we directly analyzed the fate of individual cells under mitotic arrest. The fraction of cells with mitotic death after mitotic arrest upon nocodazole treatment is very low (< 10%) and without significant differences between control (EV), CALRdel52, and JAK2V617F cells (two-way ANOVA with Dunnet post test) (Fig. 2C). In all conditions the arrested cells mostly escaped mitotic arrest by mitotic slippage without significant differences between the different cell types (two-way ANOVA with Dunnet post test) (Fig. 2C).

It has been proposed that murine cells are naturally more resistant than human cells to mitotic poisons due to the presence of clearance systems [46]. Therefore, we determined whether cyclin B1 accumulation was different between control (EV) and CALRdel52 or JAK2V617F cells after 3 hours of nocodazole treatment, which is the lower average time the cells (JAK2V617F cells, Fig. 2A) spend in mitotic arrest
before they undergo slippage. Cyclin B1 accumulated similarly in all three cell lines (Fig. 3A). Once accumulated, cyclin B1 was degraded faster in cells expressing CALRdel52 and JAK2V617F mutations (Fig. 3B; Supplementary Fig. S3; Supplementary Fig. S6) suggesting that a weakened SAC contributes to the error-prone mitosis in these cells.

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Incyte To Spotlight More Than 40 Hematology And Oncology Abstracts Including A Plenary Presentation At The ASH Annual Meeting

November 2, 2023

– Sixteen oral presentations, as well as a plenary session and poster presentations, highlight new advances across eight of the Company’s medicines

– Plenary Scientific Session will feature the full data from AGAVE-201 evaluating axatilimab, an anti-CSFR-1R monoclonal antibody, in patients with chronic graft-versus-host disease (GVHD)

– Incyte to host an in-person analyst and investor event on Monday, December 11, 2023 from 12:00-1:30 p.m. PT to discuss key data presentations at ASH

WILMINGTON, Del.–(BUSINESS WIRE)–Nov. 2, 2023– Incyte (Nasdaq:INCY) today announced that more than 40 abstracts highlighting data from eight of its hematology and oncology products will be presented at the upcoming 65th American Society of Hematology Annual Meeting 2023 (ASH 2023), held December 9-12, 2023, in San Diego and virtually.

“We have continued to make significant progress in advancing our hematology and oncology pipeline with the goal to deliver better medicines for a range of diseases that have limited treatment options, including myeloproliferative neoplasms (MPNs) and chronic graft-versus-host disease (GVHD),” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “We are excited to showcase the depth of our portfolio and clinical progress at this year’s ASH congress. In particular, we look forward to the presentation of the axatilimab AGAVE-201 trial results in patients with chronic GVHD at the Plenary Scientific Session, as well as the numerous oral and poster presentations including new data for our mutant CALR, BET, ALK2 and CK0804 programs in MPNs. Additionally, we are proud that the first presentation of data for INCB160058, our new potentially disease modifying JAK2V617F therapy for patients with MPNs, will be at this year’s meeting.”

Select key abstract presentations from Incyte-developed and partnered programs include:

Plenary Scientific Session

Axatilimab

Safety and Efficacy of Axatilimab at 3 Different Doses in Patients with Chronic Graft-Versus-Host Disease (AGAVE-201)1 (Abstract #1. Plenary Scientific Session. Sunday, December 10, 5:00 p.m. – 7:00 p.m. ET)

Oral Presentations

Ruxolitinib (MPN)

A Real-World Evaluation of Risk Factors for Disease Progression in Patients with Polycythemia Vera (PV) Enrolled in REVEAL (Abstract #385. Session: 906. Outcomes Research – Myeloid Malignancies: Risk Factors and Health Disparities. Saturday, December 9, 7:00 p.m. ET)

Phase 1/2 Study of the Activin Receptor-Like Kinase-2 Inhibitor Zilurgisertib (INCB000928, LIMBER-104) as Monotherapy or with Ruxolitinib in Patients with Anemia Due to Myelofibrosis (Abstract #624. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Charting The Future Of MPN Therapies. Sunday, December 10, 8:45 p.m. ET)

Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 (LIMBER-103) in Patients with Relapsed or Refractory Myelofibrosis (R/R MF) and Other Advanced Myeloid Neoplasms: A Phase 1 Study (Abstract #750. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Treatment and Outcomes in MPNs. Monday, December 11, 2:45 p.m. ET)

Ruxolitinib (GVHD)

Ruxolitinib in Patients with Chronic Graft-Versus-Host Disease: Three-Year Final Analysis of Efficacy and Safety of the Phase 3 REACH3 Study2 (Abstract #654. Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Innovative Approaches to GVHD Prevention and Treatment. Sunday, December 10, 8:45 p.m. ET)

Tafasitamab

Tafasitamab for the Treatment of Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) in the U.S. Real-World Setting (Abstract #265. Session: 905. Outcomes Research – Lymphoid Malignancies: Outcomes Research in Lymphoma/CLL: Biomarkers, Dosing Strategies, and Big-Data. Saturday, December 9, 5:00 p.m. ET)

Itacitinib

Itacitinib for the Prevention of Immune Effector Cell Therapy-Associated Cytokine Release Syndrome: Results from the Phase 2 INCB 39110-211 Placebo-Controlled, Randomized Cohort (Abstract #356. Session: 705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Prediction and Management of CAR-T Cell Related Toxicity. Saturday, December 9, 7:15 p.m. ET)

INCB160058

Preclinical Evaluation of INCB160058 – A Novel and Potentially Disease-Modifying Therapy for JAK2V617F Mutant Myeloproliferative Neoplasms (Abstract #860. Session: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Lineage Tracing and Novel Target Discovery. Monday, December 11, 6:00 p.m. ET)

Poster Presentations

Ruxolitinib (MPN)

Effect of New or Worsening Anemia on Clinical Outcomes in 2,233 Patients with Myelofibrosis (MF) Treated with Ruxolitinib in the Expanded-Access JUMP Study (Abstract #5174. Session: 906. Outcomes Research—Myeloid Malignancies: Poster III. Monday, December 11, 9:00 p.m. – 11:00 p.m. ET)

Ruxolitinib Treatment in Polycythemia Vera Results in Reduction in JAK2 Allele Burden in Addition to Improvement in Hematocrit Control and Symptom Burden (Abstract #4553. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Monday, December 11, 9:00 p.m. – 11:00 p.m. ET)

High Rate of Disease Progression in Patients with Low-Risk Myelofibrosis (MF) Enrolled in the Prospective, Real-World, MOST Study Abstract #3803. Session: 906. Outcomes Research—Myeloid Malignancies: Poster II. Sunday, December 10, 9:00 p.m. – 11:00 p.m. ET)

Progression to Myelofibrosis in Patients with Essential Thrombocythemia: A Real-World Analysis from the Prospective MOST Study (Abstract #2433. Session: 906. Outcomes Research—Myeloid Malignancies: Poster I. Saturday, December 9, 8:30 p.m. – 10:30 p.m. ET)

Clinical and Disease Characteristics of Patients With Myelofibrosis and Essential Thrombocythemia that Harbor a Calreticulin (CALR) Gene Mutation: Subanalysis of the MOST Study (Abstract #3812. Session: 906. Outcomes Research—Myeloid Malignancies: Poster II. Sunday, December 10, 9:00 p.m. – 11:00 p.m. ET)

Comparison of the Enzymatic and Cellular Profiles of Clinical JAK2 Inhibitors for the Treatment of Myelofibrosis (Abstract #4532. Session: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster III. Monday, December 11, 9:00 p.m. – 11:00 p.m. ET)

ALK2 and JAK2 Inhibition for Improved Treatment of Anemia in Myelofibrosis Patients: Preclinical Profile of an ALK2 Inhibitor Zilurgisertib in Combination with Ruxolitinib (Abstract #1789. Session: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster I. Saturday, December 9, 8:30 p.m. – 10:30 p.m. ET)

The Association between Blood Cell Counts and Thrombotic Events in Japanese Patients with Polycythemia Vera: A Retrospective Database Study2 (Abstract #3191. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II. Sunday, December 10, 9:00 p.m. – 11:00 p.m. ET)

Tafasitamab

Real-World Use of Tafasitamab (tafa) for Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) Among Racial and Ethnic Minorities in the United States (Abstract #2415. Session: 905. Outcomes Research – Lymphoid Malignancies: Poster I. Saturday, December 9, 8:30 – 10:30 p.m. ET)

Tafasitamab in Combination with a CD20xCD3 Bispecific T-cell Engager Significantly Prolongs Survival in Preclinical Lymphoma Models3 (Abstract #2813. Session: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II. Sunday, December 10, 9:00 – 11:00 p.m. ET)

Pemigatinib

Deep and Durable Cytogenetic and Molecular Responses with Pemigatinib in Myeloid/Lymphoid Neoplasms with Fibroblast Growth Factor Receptor 1 Rearrangement: The FIGHT-203 Study (Abstract #4551. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Monday, December 11, 9:00 p.m. – 11:00 p.m. ET)

Ponatinib

Long-term Results From the OPTIC Trial: A Dose-Optimization Study of 3 Starting Doses of Ponatinib4 (Abstract #3164. Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster II. Sunday, December 10, 9:00 – 11:00 p.m. ET)

Ponatinib Versus Imatinib in Patients with Newly Diagnosed Ph+ ALL: Subgroup Analysis of the Phase 3 PhALLCON Study4 (Abstract #2871. 614. Acute Lymphoblastic Leukemias: Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II. Sunday, December 10, 9:00 – 11:00 p.m. ET)

Itacitinib

Janus Kinase (JAK) 1 Inhibition Results in Significant Changes in Serum Proteins and Peripheral T-Cell Populations that Correlated with Clinical Scores in Chronic Graft-Versus-Host Disease (GVHD) Patients (an Analysis from GRAVITAS-309) (Abstract #2197. Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster I. Saturday, December 9, 8:30 – 10:30 p.m. ET)

Axatilimab

Axatilimab Ameliorates Inflammation and Fibrosis by Targeting the Macrophages in a Preclinical Model of Chronic GVHD (Abstract #2540. Session: 201. Granulocytes, Monocytes, and Macrophages: Poster II. Sunday, December 10, 9:00 – 11:00 p.m. ET)

CK0804

A Phase 1b, Open-Label Study of Add on Therapy with CK0804 in Participants with Myelofibrosis and Suboptimal Response to Ruxolitinib5 (Abstract #1813. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. Saturday, December 9, 8:30 – 10:30 p.m. ET)

More information regarding the congress is available on the ASH website: https://www.hematology.org/meetings/annual-meeting. This in-person event will be broadcast virtually and access to the meeting’s virtual platform is included with registration.

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FDA Approval of Momelotinib May Establish New SOC for Myelofibrosis With Anemia

November 2, 2023

Courtney Flaherty

The JAK1/JAK2 and ACVR1 inhibitor momelotinib (Ojjaara) not only provides spleen volume and constitutional symptom benefits in patients with anemic symptomatic myelofibrosis that is noninferior to that achieved with available JAK inhibitors, but may meaningfully reduce disease-related anemia symptoms that standard-of-care agents or danazol do not address, according to Andrew T. Kuykendall, MD. He added that the agent’s recent approval in this population requires re-evaluation of current approaches for managing these aspects of the disease.

On September 15, 2023, the FDA approved momelotinib for the treatment of patients with intermediate- or high-risk myelofibrosis, including primary or secondary myelofibrosis, and disease-related anemia.1,2 Findings from the phase 3 MOMENTUM trial (NCT04173494), as well as data from a subpopulation of adult patients with anemia from the phase 3 SIMPLIFY-1 trial (NCT01969838), supported the regulatory decision.

Twenty-five percent of patients with symptomatic and anemic myelofibrosis who were previously exposed to a JAK inhibitor experienced at least a 50% reduction in tumor symptom score (TSS) with momelotinib vs 9% of patients treated with danazol, which translated to a treatment difference of 16% (95% CI, 6%-26%; P < .01). Additionally, 30% of patients in the momelotinib arm achieved transfusion independence (TI) vs 20% of those in the danazol arm, which translated to a noninferiority treatment difference of 14% (95% CI, 2%-25%; = .023). Spleen volume reduction and a decrease in anemia-related symptoms were also observed with momelotinib.3

“[With momelotinib], we’re extending the benefits of JAK inhibition to more people and we’re potentially helping [to ameliorate] anemia, which has been an area of unmet need for a long time for patients with myelofibrosis,” said Kuykendall, who is an assistant member of the Department of Malignant Hematology at Moffitt Cancer Center in Tampa, Florida.

In an interview with OncLive®, Kuykendall discussed the importance of this approval for treating patients with anemic symptomatic myelofibrosis in clinical practice, key efficacy and safety data from the MOMENTUM trial that supported the decision, and unanswered questions regarding the agent’s potential role in other subsets within this population.

OncLive: What is the significance of the recent FDA approval of momelotinib for patients with myelofibrosis and anemia?

Kuykendall: This decision represents our further advancement in the perpetual story of [managing patients with] myelofibrosis [over] the past decade. On one hand, [we’re] trying to bring JAK inhibition to as many patients with myelofibrosis as possible. Ruxolitinib [Jakafi] really changed the game in myelofibrosis by allowing patients to [experience] profound improvement of splenomegaly and disease-related symptoms; it is also associated with a modest survival benefit. However, we continue to run into issues with patients who have anemia, which is most patients with myelofibrosis. [These patients, as well as those] who have low platelets, can’t experience the full benefit of JAK inhibition. The accelerated approval of pacritinib [Vonjo] helped with some aspects of that.

Now, momelotinib [provides] a full dose of a potent JAK inhibitor for patients who are anemic and may even be able to help with that anemia, as well. On the flip side, it looks like it can help with patients [who have] low platelets, as well. [The MOMENTUM trial] enrolled [patients] [with a] platelet count [of more than 25 x 109 cells/L].

What is unique about the mechanism of action of momelotinib compared with other JAK inhibitors?

All of the main approved agents in myelofibrosis are JAK2 inhibitors. However, their kinase inhibition profiles serve as differentiating factors. Momelotinib is a bit different in the sense that, like ruxolitinib, it [targets] JAK1 and JAK2. Pacritinib, and to a lesser extent, fedratinib [Inrebic], are more selective for JAK2. [Momelotinib] also inhibits ACVR1, which we believe plays a key role in modulating hepcidin and improving anemia. This potentially distinguishes momelotinib from ruxolitinib.

Now, instead of worsening anemia, which we often see happen with ruxolitinib or fedratinib, we’re able to get those symptom and spleen benefits [that come with] JAK1/JAK2 inhibition, and at the very least, mitigate some of the anemia we saw with ruxolitinib. [Momelotinib could] potentially lead to an overall improvement in anemia and fewer transfusions for patients.

Could you expand on the design of the MOMENTUM trial, and the patient population enrolled?

The MOMENTUM trial was the third phase 3 trial of momelotinib. Ultimately, the trial enrolled patients who had previously been exposed to ruxolitinib, were anemic, had some degree of myelofibrosis-related symptoms, and had splenomegaly. Patients didn’t have to be [treated with] ruxolitinib for a long time. They could have been on it for just about a month, [during which] they had some anemia. Those patients were randomly assigned 2:1 to either momelotinib or danazol, which we know is a control. This means that we use the agent for patients who are anemic.

What key efficacy findings were reported?

The primary end point of the trial was symptom improvement and aimed for a 50% reduction in TSS. Overall, we expected to see improvement with momelotinib over danazol, [However], we know that symptoms can be related not just to inflammatory cytokines or to splenomegaly but can also occur due to anemia. We expected danazol to help with some of those [symptoms]. Some key secondary end points [included] some improvement in splenomegaly reduction compared with danazol. Although the results didn’t meet the criteria for superiority, TI rate [with momelotinib] was nominally better than the rate [observed with danazol]. More patients on the momelotinib arm were TI after 24 weeks vs [those in] the danazol arm with essentially an equal number [transfusion dependent between groups] at baseline.

Spleen response rates [with momelotinib] are similar to what you might expect to see with ruxolitinib or another JAK inhibitor. However, momelotinib has been directly compared with ruxolitinib in the SIMPLIFY-1 trial, where treatment-naive patients were randomly assigned to momelotinib or ruxolitinib. In that trial, momelotinib was noninferior to ruxolitinib in terms of spleen responses. Therefore, we know it is a potent JAK inhibitor in terms of inducing spleen responses. It was exciting to see results play out like that in this pivotal trial.

What should be known about the safety profile of momelotinib?

[The toxicities associated with momelotinib] are relatively benign. When we think about JAK inhibitors, we consider the safety profiles. In general, these are palliative medications that we’re using to make people feel better and improve quality of life and functionality. If our ultimate goal is for people to feel better, we need these agents to be well tolerated. When one of our key findings is symptoms improving, you can see that these are well-tolerated medications. In the short term, patients are reporting that they feel better than they did previously after going on these medications.

In terms of things to watch out for, there’s a mild increase in gastrointestinal [GI] toxicity vs what was seen with danazol. Still, these rates are relatively low for those experiencing nausea, which is also usually low grade. This is probably lower than what we have seen in other trials with pacritinib and fedratinib that inhibit FLT3, as anything that inhibits FLT3 is associated with some degree of GI toxicity.

In previous trials, there was some concern for peripheral neuropathy, which wasn’t really seen in the MOMENTUM study. There were relatively low rates of anemia and thrombocytopenia. In fact, this agent is likely to improve, or at least stabilize, anemia and was leveraged safely in patients with a quite low platelet count. Overall, there’s not too much to be concerned about [regarding] hematologic adverse effects. [Additionally,] momelotinib actually had fewer adverse effects on the kidneys than danazol did.

With this approval, where do you see momelotinib fitting into the treatment paradigm in myelofibrosis?

The clearest answer is [that it will be used for] patients who are quite anemic and have struggled to continue treatment with ruxolitinib at adequate doses without needing transfusions or developing symptomatic anemia. That’s the ideal population. Certainly, you could think about using it outside of those bounds, as well. Anyone with anemia and some degree of splenomegaly symptoms could be afforded momelotinib as an option, given the concern that ruxolitinib or fedratinib treatment might drop hemoglobin [levels], pushing people into transfusion dependency.

In that anemic population, there are outstanding questions: What about patients who don’t have symptomatic splenomegaly and don’t have a ton of disease-related symptoms, but are anemic? Is this now going to be our treatment of choice for this cytopenic population? Momelotinib was nominally better than danazol [at reducing transfusion dependence], so are we going to now choose this over danazol in a patient without too many splenic symptoms? That’s tough to say right now, but you could make an argument for momelotinib in that space.

In patients who are not anemic and are being treated with ruxolitinib but need to move to a second-line agent, is [momelotinib an option] that you’re going to leverage, knowing that anemia is part of the natural history of this disease over time and that it may be reasonable to start this type of an agent earlier rather than later? There are many different areas where this could be a beneficial agent, but [its potential role in] the anemic population is very clear.

What is your main message for colleagues regarding this approval?

Momelotinib is another tool in the toolbox. [It’s approval] is another reason to differentiate and understand when and why you would use different JAK inhibitors since we now have 4 [available]. You have to understand why and when to use one agent over the other, when you’re going to switch from one to the other, when you’re going to dose modify, and which agents are best [for each case]. This is a good time to think about those questions and have a clear plan in mind. It’s great to have different options for patients, but knowing when to use them is going to ensure that we’re using them in the right way.

References

  1. Ojjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anaemia. News release. GlaxoSmithKline. September 15, 2023. Accessed October 4, 2023. https://www.gsk.com/en-gb/media/press-releases/ojjaara-momelotinib-approved-in-the-us-as-the-first-and-only-treatment-indicated-for-myelofibrosis-patients-with-anaemia
  2. Momelotinib (Ojjaara) Prescribing information. GlaxoSmithKline; 2023. Accessed November 2, 2023. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Ojjaara/pdf/OJJAARA-PI-PIL.PDF
  3. Verstovsek S, Gerds AT, Vannuchi AM, et al. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study. Lancet. 2023;401(10373):269-280. doi:10.1016/S0140-6736(22)02036-0

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EXCEED-ET Study Evaluates Ropeginterferon alfa-2b-njf in ET

November 2, 2023

Lucia Masarova, MD

Lucia Masarova, MD, PhD, assistant professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the rationale of the EXCEED-ET study (NCT05482971) of ropeginterferon alfa-2b-njf (Besremi) for patients with essential thrombocytopenia (ET).

Transcription:

0:10 | The EXCEED-ET study is getting the ropeginterferon, which is the novel interferon into the space of ET. It is phase 1/2 study that gets the novel ropeginterferon in patients in North America. The patients are hydroxyurea-refractory or hydroxyurea-naive. Patients that have ET platelets over 450,000 need the therapy with some symptoms, and do not have a contraindication for interferons, which also had to be mentioned that the drugs could not be used in patients that have previous autoimmune disease, psychiatric diseases, or neurological because it could aggravate their symptoms.

0:51 | But those patients, if they would be eligible, they could be getting the full access to the drug. Also, with patients with ET, the escalation is going to be a lot faster to 250 micrograms, every other week, 350, and then 500 is the maximum dose that has been explored. However, I have to say the approval of ropeginterferon for PV had even higher dose, and the maximum-tolerated dose was not reached. This is a perfectly safe dose that we have patients on. We’re going to see how it’s going to do in ET patients.

1:25 | There is a core treatment period, which continues after the 4 weeks of escalation of up to 56 weeks. The patients will be dosed every other week with a tolerable dose. We will be monitoring the primary end points of durability of control, hematologic control, platelets less than 450, white cells less than 10. That will basically sustain 80% of 36 consecutive weeks. Then, the key secondary end points are going to include all important end points in ET patients, such as complete hematologic response, composite hematologic response, that includes control of spleen, control of symptoms, absence of disease progression, and absence of thromboembolic events. Then, it’s going to also have this exciting end point, which is basically a decline or allele burden. We’ll be checking the allo burden, what we call the molecular response, and then bone marrow morphology response.

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Presentation at MPN Congress and ASH Annual Meeting Reinforce Clinical Role of ropeginterferon alfa-2b-njft

November 2, 2023

BURLINGTON, Mass., November 02, 2023–(BUSINESS WIRE)–PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that new abstracts on ropeginterferon alfa-2b-njft will be presented during the 15th International Congress on Myeloproliferative Neoplasms (MPN Congress) in Brooklyn, NY on November 2-3, 2023, and during the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, CA on December 9-12, 2023.

Key highlights from the accepted abstracts include:

  • AI-based Discovery: Application of AI technology to identify a potentially important association between myeloproliferative neoplasms (MPNs) and neurodegenerative diseases that may reflect common disease mechanisms and shared targets, including inhibitory immunoreceptors. The analysis suggests that dysregulation of specific immune checkpoints may promote chronic inflammation and thrombosis in MPNs and targeting these pathways may represent a novel approach to restoring immune and vascular homeostasis in these diseases.
  • Patient Survey: A qualitative analysis of responses to a survey distributed to MPN patients in partnership with two MPN advocacy organizations was conducted to help understand the patient experience on ropeginterferon alfa-2b-njft. In the interim analysis, themes that emerged from MPN patient responses ranged from satisfaction of observed outcomes with ropeginterferon alfa-2b-njft, management of safety concerns and comments on the ease of the injection.
  • Clinical Trial in Progress: Study design details of the Phase 2b clinical study EXCEED-ET evaluating ropeginterferon alfa-2b-njft for the investigational treatment of adults with essential thrombocythemia (ET) in the U.S. and Canada will be shared.
  • Medical Chart Review: A description of the study details for a quantitative, retrospective review of medical charts to assess the longitudinal clinical and economic burden of illness in patients with polycythemia vera (PV).
  • Investigator-led Korean study: Interim results from an independent, single-arm, open-label, multicenter study showed that with ropeginterferon alfa-2b-njft therapy and an accelerated dose titration at 12 months, 63% of participants achieved a complete hematological response, 61% achieved molecular response, as well as an overall reduction in JAK2 allele burden. The treatment was well tolerated in evaluated patients with PV.

“PharmaEssentia strives to be an essential partner to the MPN community, and these findings are a testament to the breadth and depth of the current and planned clinical and real-world evidence supporting the safety and efficacy of ropeginterferon alfa-2b-njft as a therapeutic option,” said Raymond Urbanski, M.D., Ph.D., Senior Vice President and U.S. Head of Clinical Development and Medical Affairs at PharmaEssentia. “We believe these encouraging data will help healthcare providers advance important discussions around improving care and outcomes for people living with MPNs who continue to face challenges managing their rare blood cancers.”

MPN Congress Abstract Details

  • Causal AI dissection of RNAseq datasets pinpoints connections between MPNs and neurodegenerative diseases
    • Abstract 127 – Thursday, November 2, 2023, 5:15 – 7 PM ET
  • Sharing the treatment experience of ropeginterferon alfa-2b-njft: A qualitative analysis of patient responses
    • Abstract 141 – Thursday, November 2, 2023, 5:15 – 7 PM ET
  • The clinical and economic burden of illness in patients with polycythemia vera: A retrospective medical chart audit study
    • Abstract 133 – Thursday, November 2, 2023, 5:15 – 7 PM ET
  • EXCEED-ET: A single-arm multicenter study to assess the efficacy, safety, and tolerability of ropeginterferon alfa-2b-njft (P1101) in North American adults with essential thrombocythemia
    • Abstract 137 – Thursday, November 2, 2023, 5:15 – 7 PM ET
  • A single-arm, open-label, multicenter study to assess molecular response of P1101 therapy in patients with polycythemia vera and elevated hematocrit
    • Abstract 116 – Thursday, November 2, 2023, 5:15 – 7 PM ET

ASH Abstract Details

  • A single-arm, open-label, multicenter study to assess molecular response of P1101 therapy in patients with polycythemia vera and elevated hematocrit: results from 12-month core study (New Data)
    • Abstract 4575 – Monday, December 11, 2023, 6 – 8 PM PT

Follow PharmaEssentia USA on Twitter and LinkedIn for news and updates at the meetings.

About Polycythemia Vera (PV)

Polycythemia vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.1

About Essential Thrombocythemia (ET)

Essential thrombocythemia (ET) is a myeloproliferative neoplasm (MPN) characterized by an overproduction of platelets in the blood that results from a genetic mutation; data indicates a JAK2 gene mutation is present in approximately half of diagnosed patients. ET is estimated to affect up to 57 per 100,000 people in the U.S. The disease is most commonly diagnosed through routine blood work and is most common in people over the age of 50, with women 1.5 times more likely to be diagnosed than men. As a chronic, progressive disease, ET requires regular monitoring and appropriate treatment. Over time, the disease may progress into more deadly conditions such as myelofibrosis or acute leukemia.2,3

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Pelabresib Generates Excitement in Myelofibrosis

November 3,  2023

Jordyn Sava

Multiple studies are evaluating pelabresib (CPI-0610) for the treatment of patients with myeloproliferative neoplasms (MPNs). With more data on the agent expected to be released from trials in this space toward the end of the year, Joseph M. Scandura, MD, PhD, reflected on its potential role for patients with myelofibrosis and studies evaluating the agent.

Pelabresib is an oral, small-molecule, investigational BET inhibitor. The agent works by downregulating NF-κB and signals other relevant genes involved in myelofibrosis disease pathways.

In the ongoing, global, nonrandomized, multicohort, open-label, phase 2 MANIFEST study (NCT02158858), investigators are assessing pelabresib as a monotherapy and in combination with ruxolitinib (Jakafi) in patients with myelofibrosis.1

The study is evaluating the efficacy of the JAK inhibitor combination therapy vs pelabresib alone for treatment-naïve or pretreated patient populations, and involved 4 separate cohorts. Patients with JAK inhibitor-pretreated myelofibrosis were given pelabresib, patients with ruxolitinib-pretreated myelofibrosis were given pelabresib plus ruxolitinib, patients with JAK inhibitor naïve myelofibrosis were given pelabresib plus ruxolitinib, and patients with essential thrombocythemia were given pelabresib alone.

According to data from the trial presented at the 2023 EHA Congress, by the data cutoff of July 29, 2022, 7 of the 20 patients enrolled in the study were treated for at least 6 months. Fourteen patients continued to receive pelabresib. Findings showed that pelabresib plus ruxolitinib demonstrated durable improvements in spleen volume and total symptom score among those enrolled. The confirmed complete response rate was 40% and the partial hematologic response rate was 20%, respectively.

Another study evaluating pelabresib is the ongoing, randomized, double-blind, phase 3 MANIFEST-2 trial (NCT04603495).Here, patients with JAK inhibitor-naïve myelofibrosis are being randomized 1:1 and treated with upfront pelabresib plus ruxolitinib vs ruxolitinib alone.

Patient enrollment in this study was completed in May 2023. Topline findings are expected to be released in late 2023.

In an interview with Targeted OncologyTM, Scandura, Weill Cornell Medicine, discussed research on pelabresib for the treatment of patients with MPNs.

Targeted Oncology: Can you discuss pelabresib and its mechanism of action?

Scandura: Pelabresib is a first-in-class oral inhibitor of BET proteins, primarily those containing the BD1 and BD2 domains. It’s being developed currently in myelofibrosis. It has been tested in other diseases, but it has shown significant activity in myelofibrosis. I believe that it’s going forward in that area and represents the first of what is potentially multiple drugs hitting these same epigenetic pathways.

What sets it apart from other agents for patients with MPNs?

Well, it’s the first drug that hits the BET inhibitors. It’s among the first epigenetic modifiers, and these are pathways that affect how genes are packaged and expressed, turned on, and turned off. In all myeloid malignancies, in fact in all cancers, epigenetic abnormalities are much more common than genetic abnormalities and exactly how to target them has been a challenge. This particular pathway has been shown to be kind of hyperactivated in myelofibrosis. This inhibitor has shown some activity, both in terms of single-agent use and in combination with standard JAK inhibitor therapy.

Can you explain some of the recent research on pelabresib?

John Mascarenhas, MD, [presented] an update of the long-term follow-up of patients treated with the combination of ruxolitinib with pelabresib–ruxolitinib being a first-in-class and standard-of-care JAK inhibitor. What he’s showing are the remarkable early responses that have been observed and are being maintained through the most recent follow-up. Then, Claire Harrison, MD, FRCP, FRCP, [presented] data on another arm of the phase 2 study where in pelabresib was added to ruxolitinib in people who are not achieving an adequate response.

I have presented an update on the translational work related to pelabresib trying to understand what some of these markers are, and these changes were observed in the bone marrow. From that standpoint, I think that’s where the excitement was generated with pelabresib. It’s 1 of the first agents that has been able to reverse fibrosis in the marrow in a sizable percentage of patients. Of course, this disease is myelofibrosis, so the idea of reducing fibrosis is appealing.

The reality of it is we don’t know, besides that kind of intuitive appeal, what it means when patients respond and have reversion of fibrosis in terms of long-term outcomes or in terms of what that goes along with our patients feeling better. [Those are] some of the other measures of response correlating with the marrow response.

What are some key takeaways regarding pelabresib and its development?

The first one is that we need to wait for the data to mature. My personal bias is all of these biomarkers are invaluable until we know outcomes such as survival or time to treatment failure or event-free survival. Until we know that, we are just kind of stuck in this circular loop of what should be, what we hope will be, what our intuitive beliefs are, but we do not really know what any of these things mean until we have those outcomes. That just takes time.

The nice thing is there are a number of phase 3 studies, randomized trials, collaborative studies. MANIFEST-2 is a randomized phase 3 study, and that will allow us to address and follow up on some of these findings, and hopefully get to those answers about whether or not these changes that we’re observing in the short-term are predicting these long-term beneficial outcomes. It just takes time for that data to mature.

REFERENCES:
Passamonti F, Patriarca A, Knapper S, et al. Pelabresib (CPI-0610) monotherapy in patients with high-risk essential thrombocythemia refractory or intolerant to hydroxyurea: preliminary results from MANIFEST study. Presented at: 2023 EHA Congress; June 8-11,2023;Frankfurt,Germany. Abstract S168.
Harrison CN, Gupta VK, Gerds AT, et al. Phase III MANIFEST-2: pelabresib + ruxolitinib vs placebo + ruxolitinib in JAK inhibitor treatment-naive myelofibrosis. Future Oncol. 2022;18(27):2987-2997. doi:10.2217/fon-2022-0484

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Patients on Medicaid Disproportionately Affected by Drug Shortage

November 2, 2023

Brielle Benyon

A new survey conducted by the American Cancer Society Cancer Action Network (ASC CAN) found that many patients in active cancer treatment reported being affected by the ongoing drug shortage, with patients insured by Medicaid being disproportionately affected.

“One of the most salient insights that we received here is that this is not affecting everybody equally,” Mark Fleury, policy principal for the ACS CAN said in an interview with CURE®.

A higher percentage of patients on Medicaid were affected by the cancer drug shortage than those who were insured by their employer.

The survey, which was conducted in September 2023, included survey responses from 1,222 patients and survivors of cancer who have been diagnosed with or treated for cancer within the last seven years. The findings showed that while 10% of overall patients in active treatment were affected by the chemotherapy shortage, patients insured by Medicaid were more impacted by it, with 18% stating that they were affected.

“We have a very tight supply chain. There’s really no buffer there, so every vial that’s made has to be distributed,” Fleury explained. “There are (cancer treatment) sites that are large enough to have someone keep an eye on shortages, but not every institution has that. … It seems that institutions that are maybe smaller or have fewer resources or personnel to be chasing down these drugs are the ones that are the most impacted. And institutions with less resources oftentimes are serving patients with less resources as well.”

Fleury mentioned that cancer drug shortages put unnecessary stress on patients and their families during an already stressful time, and patient-provider communication is key.

“Patients (should have) individual conversations with their providers about how to move forward, and obviously every patient and every cancer type is different. Some have appropriate solutions, and some don’t.”

Regardless of insurance type, the most common way people were affected by the drug shortage included:

  • Delayed or missed treatment (reported by 45% of respondents who were affected, including 38% of this population who faced delays of one month or longer)
  • Using an alternate drug (23%; with 68% reporting that they and their medical teams were not able to find an effective substitute)
  • Faced difficulty using their insurance to fill a prescription related to the shortage, such as delays in covering an alternative drug (35%)
  • Continued the medication with a dose change (6%)

The survey, which was published in October, also included quotes from patients who participated. One individual said, “My doctor’s office only gets enough for one patient a month. I’m currently set to get mine in over six months.” Another person said, “(The shortage) has extended my treatment, which adds to the stress level and horrible side effects.”

However, some individuals — approximately 40% of those surveyed — said that their issues related to cancer drug shortages have since been resolved and their drug is now available to them.

“I think we may be slowly moving away from reducing the number of patients who aren’t able to get the drugs that they need. But I think we’re just going up to that slightly better level where the system is still super fragile. And any additional disruptions … could bring us back and patients not getting them,” Fleury said, mentioning that the ACS CAN is investigating solutions that can fix this problem in a more robust way.

“There (are) short term fixes (for) people who need (cancer drugs) today. … It took us years and even decades to get here. It’s going to take us years to get us out. So we’re looking at both short, shorter and long-term solutions to try and get us away from the brink where we’ve been living, frankly, for quite a while.”

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Early to Bed, Early to Rise

By Natalie Giocondo

“Early to bed, early to rise, makes a man healthy, wealthy, and wise.” -Benjamin Franklin.

As the last few leaves of autumn fall, and we barrel headlong into the busyness of the holidays, let’s take a moment to welcome the shortening of days and changing seasons. Flowing from a time of harvest to a time of suspension Winter presents us with the opportunity to pause. Just as the animals hibernate and the plants go dormant, we too are invited by the late sunrises and early sunsets to tuck in for some deep relaxation and sleep.

Getting a good night’s rest promotes physical health and overall well-being; unfortunately, it can be a challenge and maybe particularly challenging for MPN patients. According to the National Institutes of Health (NIH), sleep affects every system in the body, and lack of sleep correlates with several issues of interest to the MPN community, including high blood pressure and cardiovascular disease. The NIH also suggests that insomnia is an unmet need in communities with chronic hematological cancers. In 2017, a study conducted by Dr. Krisstina Gowin echoed that unmet need when 52.1 % of her MPN participants reported trouble staying asleep, and another 33.7% said they had difficulty falling asleep, while 31.2% mentioned having insomnia. 

Here are some tried and true healthy sleep habits:

  • Stay on a sleep schedule. Go to bed and rise at the same time each day. I, for one, begin heading to bed earlier once the cold sets in and the roosters are crowing a little later in the morning. 
  • Create an environment for sleep. Dark, quiet, cool, and without electronics works best. 
  • Get enough exercise during the day. If you don’t already have an exercise routine, I highly recommend Justin Grinnell’s Moderate-Impact webinar to get you started. 
  • Avoid stimulation. This could be anything from caffeine to nicotine to watching the news or engaging in heated conversations too close to bedtime. 
  • Eat early. This point cannot be understated! Some patients with MPNs report digestive issues that interfere with sleep. Giving your body plenty of time to process before heading to bed may be worth a try.

Yoga Nidra

A less well-known practice to encourage deep rest and cultivate sleep is yoga nidra. The words yoga nidra mean yoga (to yoke) and nidra (to sleep). It brings up images of a little yogi cowboy lassoing sleep, or a sleep herder. This practice was brought to the US in the 1960s by Swami Satchidadnanda and popularized by practitioners like Nischala Joy Devi (Deep Relaxation), and Dr. Richard Miller (iRest Yoga Nidra).

The practice requires the practitioner to lie in a comfortable resting position while a guide verbally takes them on a gentle journey through 6 phases of meditation: preparation, intention, rotation of consciousness, breath awareness, sensation awareness, visualization, and dropped mind awareness.

While not studied in the MPN population, studies on yoga nidra have suggested benefits such as reduced perceptions of pain, positive effects on blood pressure, pulse, and respiration rates, reduction in erythrocyte sedimentation (which detects the level of inflammation in the body), and has cured chronic insomnia in some people. 

If you are curious about yoga nidra and would like a little taste, please join me on Thursday, November 16th at noon ET, when we will host a 30-minute guided yoga nidra practice. 

 

Supporting the Patient’s Psychosocial Needs Throughout MPN Treatment

October 31, 2o23

Rebecca Testi, MSN, APN, APN-G

Patients with myeloproliferative neoplasms (MPNs) — a rare form of blood cancer — may lack specific met needs when it comes to psychological care. Providers and caregivers can start by validating patients with MPN to help diminish psychosocial needs, according to Rebecca Testi, MSN, APN, APN-G, Hackensack Meridian Health.

“I think education is really key with the patients, you as the nurse or nurse practitioner clinician really need to be able to tell patients, the depression is a side effect of the disease itself. Not you necessarily being sick, but truly like an underlying disease process. So I think it all starts with really good education, about disease process, treatment, support options, things like that,” explained Testi.

With patients who have MPNs, psychosocial help can be rare, causing patients to lack proper resources. Getting patients to normalize utilizing help can go unmanaged.

“I think we as providers could definitely be better about addressing it, explained Testi, who added that although its normal for patients to feel this way, it is important to find ways to help patients manage it so they can live a more normal life.

“Most cancer centers have really good social workers on staff that are designated to that particular division,” she said. “Where I work, we have dedicated social work for all liquid tumor patients, and most institutions will be able to connect you with a peer-to-peer support group. If patients agree, we’ll often connect one MPN patient with another who’s willing to have their information shared so that they can talk to each other share their feelings.”

Testi also highlighted the importance of caregiver support groups.

“Another thing that’s really important is caregiver support groups,” she said. “Their families can interact and share how having a loved one with this defeat disease affects them. It is often just as hard on the family members and caregivers as it is on the patient.”

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DISC-0974 by Disc Medicine for Myelofibrosis: Likelihood of Approval

October 28, 2023

DISC-0974 is under clinical development by Disc Medicine and currently in Phase II for Myelofibrosis. According to GlobalData, Phase II drugs for Myelofibrosis have a 40% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how DISC-0974’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Smarter leaders trust GlobalData

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

DISC-0974 overview

DISC-0974 is under development for the treatment of chronic inflammation and hematological disorders such as anemia of chronic disease, anemia in chronic kidney disease, Iron refractory iron deficiency anemia (IRIDA), myelofibrosis, chronic idiopathic myelofibrosis (primary myelofibrosis), post-essential thrombocythemia myelofibrosis (post-et mf), post-polycythemia vera myelofibrosis (ppv-mf) and myeloproliferative disorders. The drug candidate acts by targeting hemojuvelin. It is administered through intravenous and subcutaneous routes.

Disc Medicine overview

Disc Medicine, formerly Gemini Therapeutics Inc, is a clinical-stage biopharmaceutical company that specialises in the discovery, development and commercialization of novel treatments for patients with severe hematologic disorders. The company pipeline includes bitopertin for the treatment of erythropoietic porphyrias, including erythropoietic protoporphyria and X-linked protoporphyria and Diamond-Blackfan Anaemia, or DBA; DISC-0974 for the treatment of anaemia of myelofibrosis and anaemia of chronic kidney disease, or CKD; and MWTX-003 for the treatment of polycythemia vera, or PV, and other hematologic disorders. The company’s preclinical programmes consist of DISC-0998, which is used to treat anaemia brought on by inflammatory disorders. Disc Medicine is headquartered in Cambridge, Massachusetts, the US.

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