New Phase 3 Data Show Jakafi® (ruxolitinib) is Superior to Best Available Therapy in Patients with PV

  • 62 percent of PV patients treated with Jakafi achieved hematocrit control without phlebotomy, compared to 18 percent of patients treated with best available therapy
  • RESPONSE-2 data complements previous findings from RESPONSE, reinforcing Jakafi is effective in PV patients with or without an enlarged spleen

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq: INCY) today announced new 28-week data from the Phase 3 RESPONSE-2 study of Jakafi® (ruxolitinib). The data show that Jakafi was superior to best available therapy (BAT) in maintaining hematocrit control (62.2% vs. 18.7%, respectively; P<0.0001)1 without the need for phlebotomy in patients with inadequately controlled polycythemia vera (PV) resistant to or intolerant of hydroxyurea (HU) who did not have an enlarged spleen. The safety profile of Jakafi was consistent with previous studies. These findings were presented at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark.

Novartis presents data showing Jakavi® superior to best available therapy in patients with less advanced PV

  • Three times as many patients with inadequately controlled PV without enlarged spleen had hematocrit control without phlebotomy on Jakavi® (ruxolitinib) vs BAT[1]
  • RESPONSE-2 complements data from pivotal RESPONSE study, showing that Jakavi is effective in certain PV patients with and without an enlarged spleen[1,2]
  • Myelofibrosis data suggest patients on Jakavi lived longer with 5-year survival showing a 31% reduced risk of death compared to those randomized to placebo[3]

Basel, June 10, 2016 Novartis today announced Phase III data from RESPONSE-2 showing that Jakavi® (ruxolitinib) helped patients with polycythemia vera (PV), who did not have an enlarged spleen and were resistant to or intolerant of hydroxyurea, achieve superior hematocrit control compared to best available therapy (BAT) at 28 weeks (62.2% vs 18.7%, respectively; p<0.0001)[1]. The findings were presented for the first time at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark.

Polycythemia vera is a rare and incurable blood cancer associated with an overproduction of blood cells that can cause serious cardiovascular complications, such as blood clots, stroke and heart attack[4]. As the disease progresses, the spleen can become enlarged as it works to clear a greater number of blood cells than normal[5]. In this study, patients did not have an enlarged spleen as assessed by physical examination at baseline (spleen palpation) and a majority (approximately 70%) were previously treated with hydroxyurea only, therefore considered less advanced. The remaining patients were treated with multiple lines of therapy (approximately 30%)[1].

Watch our interview with Dr. Marie Huong Nguyen, University of Michigan, MPN Researcher/Clinician

Watch the full interview here

 



 

 Watch Ann Brazeau, CEO- MPN Advocacy and Education International
And Dr. Ruben Mesa, MD- Mayo Clinic discuss:

The Journey from Diagnosis to Treatment and a Healthier Lifestyle

 

image2Watch full interview here

Summary and Future events. Click here.

What is MF ET PV? Click here.

Proper Diagnosis and Treatment. Click here.

Are These Blood Cancers? Click here.

Older and Younger Patient. Click here.

Fatigue and Lifestyle Choices. Click here.

Environmental Issues. Click here.

American Society of Hematology Conference Highlights. Click here.

Novel Therapies Likely To Change Role of Stem Cell Transplants In Blood Cancers

 

Stem cell transplantation was rightly hailed as a breakthrough treatment for people with many blood-based cancers when pioneering hematologists began using them regularly in the 1970s. Their popularity grew slowly but steadily throughout the 1980s and then took off in the 1990s as multiple studies demonstrated their efficacy and new techniques made them safer. Total annual US transplantation figures grew from less than 2000 in 1990 to more than 19,000 in 2013, according to the Center for International Blood & Marrow Transplant Research (CIBMTR).1 –

Click here to read more.

Clinical Trial IMbark Now Enrolling Patients for Phase 2 Study of Imetelstat

Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants With Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With Janus Kinase (JAK) Inhibitor.

Janssen Research & Development, LLC is currently recruiting patients for the Phase 2 clinical trial IMbark with the study drug Imetelstat, a first-in-class telomerase inhibitor. With its novel mechanism of action, Imetelstat may provide clinical benefit to myelofibrosis (MF) patients. Imetelstat is administered as a 2-hour intravenous infusion every 21 days.

IMbark is a study for people with intermediate 2 and high risk MF who no longer benefit from treatment with JAK inhibitor therapy. This study is being conducted at multiple hospitals and institutions around the world, approximately 95 centers globally.

You may qualify for this study if you

• Are age 18 years or older
• Have been diagnosed with MF
• Have Intermediate-2 or high risk MF by the Dynamic International Prognostic Scoring System (DIPSS)which is a standard prognostic tool
• Your doctor does not think that JAK inhibitor treatment (like ruxolitinib for example) will further help you

Click here to view the details for this clinical trial.

Thank you to all who attended this wonderful event.

Do you have Myelofibrosis, Essential Thrombocythemia, or Polycythemia Vera?

If so, please join us in Honolulu, Hawaii for an

MPN Educational Symposium on April 23, 2015

Guest Speakers:

Dr. Ruben Mesa, M.D.

Mayo Clinic-Scottsdale, AZ

Dr. Laura Michaelis, M.D.

Medical College of Wisconsin, WI

Additional MPN Experts to be Announced

————————————————————————————————————————

This program is offered free of charge however you must

pre-register.

Continental Breakfast and Lunch

provided

For a free MPN patient brochure visit our website at

http://mpnadvocacy.com

Location:

Waikiki Beach Marriott Resort and Spa

2552 Kalakawa Avenue

Honolulu, Oahu, HI

Time:

Registration: 8:00 am

Program: 9:00 am – 4:00 pm

To Register Please Contact Ann Brazeau, abrazeau@mpnadvocacy.com,  517.899.6889

Incyte 2014 MPN Heroes program

Incyte Corporation, who distributes ruxolitinib (trade name Jakafi) is publicizing a “MPN Heroes” program for 2014 to recognize organizations and individuals who significantly contribute to the betterment of the MPN community.  MPN “Heroes” will be publicly recognized and individual awardees will be granted the right to direct a monetary award to an MPN-related charitable organization of her or his choice. More information:   Nomination Form Disclaimer: Incyte Corporation is an industry partner and sponsor of MPN Advocacy and Education International.

San Mateo Symposium Speakers

At the Bay Area Patient Symposium on May 22, 2014, several speakers addressed issues of importance to MPN patients and caregivers.

Ann Brazeau, CEO, MPN Advocacy & Education International

Dr. David Snyder, City of Hope, Duarte, California – Transplants and Imetelstat

Dr. Jason Gotlib, Stanford University School of Medicine – Mutation/Biology: New Data on CALR

Dr. Ruben Mesa, Mayo Clinic-Scottsdale, AZ – Unmet Needs in MPNs and Current Clinical Trials

Dr. Catriona Jamison, UCSD – New Diagnostic and Therapeutic Targets in MPNs

Patient Story 1

Patient Story 2

Updates