|Celgene Issues Results of Phase III Study on Dexamethasone; Shares of Myriad Moves Lower as Launch of Cancer Panel|
|By Staff and Wire Reports|
|Thursday, 05 September 2013 20:47|
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), announced that updated results from MM-003, a phase III multi-center, randomized open-label study (n=455) of pomalidomide (marketed as POMALYST® in the U.S. and IMNOVID® in the E.U.) plus low-dose dexamethasone, were published online ahead of print in The Lancet Oncology.
The study compared oral pomalidomide plus low-dose dexamethasone with high-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma who have failed at least two prior therapies with both bortezomib and lenalidomide, administered alone or in combination.
At the interim analysis (ASH 2012, median follow-up 4.2 months), the study met its primary endpoint as pomalidomide plus low-dose dexamethasone demonstrated a significant improvement in progression-free survival (PFS) (3.8 months vs 1.9 months HR 0.41 p<0.0001) compared with high-dose dexamethasone. There was also a significant improvement in the key secondary endpoint of overall survival (OS) (11.9 months vs 7.8 months HR 0.53 p<0.0002) compared with high-dose dexamethasone even though 45 patients in the high-dose dexamethasone arm crossed over and received pomalidomide.
Additionally, the Data Monitoring Committee recommended that patients who had not yet progressed in the high-dose dexamethasone arm should have access to pomalidomide with or without low-dose dexamethasone.
At a median follow-up of 10.0 months, an updated PFS analysis and final OS analysis were conducted. Pomalidomide plus low-dose dexamethasone continued to demonstrate significantly longer PFS, the primary endpoint, compared with high-dose dexamethasone (4.0 months vs. 1.9 months, HR=0.48, p<0.0001). Additionally, pomalidomide plus low-dose dexamethasone demonstrated a significant improvement in OS compared with high-dose dexamethasone (12.7 months vs. 8.1 months, HR=0.74, p=0.0285). Overall response rate for patients receiving pomalidomide plus low-dose dexamethasone was 31% compared with 10% for patients receiving high-dose dexamethasone (p<0.0001).
The most common grade 3-4 hematological adverse events in the pomalidomide plus low-dose dexamethasone and high-dose dexamethasone arms, respectively, were: neutropenia (48% 143/300 vs. 16% 24/150), anemia (33% 99/300 vs. 37% 55/150) and thrombocytopenia (22% 67/300 vs. 26% 39/150). Grade 3-4 non-hematological adverse events in the pomalidomide plus low-dose dexamethasone and high-dose dexamethasone arms, respectively, included: pneumonia (13% 38/300 vs. 8% 12/150), bone pain (7% 21/300 vs. 5% 7/150) and fatigue (5% 16/300 vs. 6% 9/150). Four patients in the pomalidomide plus low-dose dexamethasone arm and one patient in the high-dose dexamethasone arm developed second primary malignancies. Of these, two patients in the pomalidomide plus low-dose dexamethasone arm had invasive solid tumor cancers and two patients in this group and the one in the high-dose dexamethasone group had non-invasive cancers (basal-cell skin cancers). Treatment-related adverse events led to treatment discontinuation in 4% of patients in the pomalidomide plus low-dose dexamethasone arm and 6% of patients in the high-dose dexamethasone arm.
Patients in the pomalidomide plus low-dose dexamethasone arm received 4 mg of oral pomalidomide on days 1-21 of each 28-day cycle. Oral dexamethasone was given at 40 mg on days 1, 8, 15, and 22); for patients older than 75 years, dexamethasone was administered at 20 mg weekly.
Patients in the comparator arm were treated with 40 mg oral high-dose dexamethasone on days 1-4, 9-12 and 17-20 of each 28-day cycle, until disease progression; patients older than 75 years received 20 mg oral dexamethasone on the same schedule.
Results of the MM-003 trial formed the basis of an August 2013 approval by the European Medicines Agency in patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.
Myriad Genetics, Inc. (Nasdaq: MYGN) announced it has launched myRisk Hereditary Cancer, a new multi-gene diagnostic test that will provide increased sensitivity by analyzing 25 genes associated with eight major cancers including: breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric and melanoma.
myRisk Hereditary Cancer is being launched in a phased approach beginning with an early-access, clinical-experience program to a limited number of medical and scientific thought leaders followed by an expanded access program later in the year. The Company will present extensive clinical validity data for myRisk Hereditary Cancer at The Collaborative Group of the Americas on Inherited Colorectal Cancer (CGA) annual meeting in October and the San Antonio Breast Cancer Symposium in December.
The new myRisk Hereditary Cancer test represents the next generation of hereditary cancer testing and will provide healthcare providers with clear and actionable information to improve patient care, regardless of whether the patient receives a positive or negative test result. Each test report will include a genetic test result, a clinical risk and healthcare management tool based on professional society guidelines.
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that executive management will participate in the Stifel Nicolaus Healthcare Conference to be held September 11-12, 2013 at the Four Seasons Hotel in Boston.
iBio, Inc. (NYSE MKT: IBIO), a leading provider of technology for both proprietary and biosimilar products for use in development and production of biologics, has been invited to present at the 2013 Gateway Conference being held on Tuesday, September 10, 2013 at the Palace Hotel in San Francisco.
The Cooper Companies, Inc. (NYSE:COO) today announced financial results for the fiscal third quarter ended July 31, 2013.
DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company focused on the commercialization of its complementary product portfolio of oncology and oncology supportive care products, announced today that it will be featured as a presenting company at the 15th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC.
Endocyte, Inc. (Nasdaq: ECYT), a biopharmaceutical company and leader in targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy in cancer and other serious diseases, and Nihon Medi-Physics (NMP), a market leader in the development, production and distribution of radiopharmaceuticals for nuclear medicine procedures in Japan, today announced that they have entered into a license and commercialization agreement.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that John McDermott, President and Chief Executive Officer, and Shelley Thunen, Chief Financial Officer, are scheduled to participate in two upcoming investor conferences in September.
Hyperion Therapeutics (Nasdaq:HPTX) announced today that the company is scheduled to present at the annual Stifel 2013 Healthcare Conference on Thursday, September 12 at 9:45 a.m. ET.
Ingen Technologies Inc. (OTC:IGNT), the holding company of two subsidiaries; a medical device manufacturing company selling its proprietary patented medical products worldwide, and a newly acquired growing telecom business providing services for major telecom companies worldwide, announced today that the Department of Homeland Security submitted a Purchase Order on August 31, 2013 to purchase Ingen's patented respiratory medical products for the US Coast Guard.
InoLife Technologies, Inc. (OTCQB: INOL), a diversified service based healthcare and environmental product developer and marketer is pleased to announce the Company has hired Mr. James W. Thomas II as Chief Financial Officer.
KaloBios Pharmaceuticals (Nasdaq: KBIO) today announced that the company will present at the Stifel Healthcare Conference 2013 on September 12 at the Four Seasons Hotel in Boston.
MAKO Surgical Corp. (Nasdaq:MAKO) announced today that Maurice R. Ferré, M.D., President and Chief Executive Officer, will present at the Morgan Stanley Global Healthcare Conference at the Grand Hyatt Hotel in New York on Wednesday, September 11, 2013 at 12:20 pm ET.
MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that Daniel P. Gold, Ph.D., President and Chief Executive Officer, will present at the Stifel Healthcare Conference on Wednesday, September 11, 2013 at 11:30 a.m. Eastern time from the Four Seasons Hotel in Boston.
MMRGlobal, Inc. (OTCQB: MMRF), through its wholly owned subsidiary, MyMedicalRecords, Inc. (collectively, "MMR"), today announced that pursuant to an order dated September 4, 2013, the Appellate Court ruled in favor of MMR officially remanding the appeal of Surgery Center Management, LLC ("SCM") back to the trial court at Los Angeles County Superior Court where MMR will pursue its claim for breach of contract, seeking as much as $30 million in damages against SCM.
Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that Mark Capone, President of Myriad Genetic Laboratories, Inc. is scheduled to present at the Morgan Stanley Global Healthcare Conference, at 2:55 p.m. Eastern on September 10, 2013 in New York City.
Plandaí Biotechnology, Inc. (OTCQB: PLPL), a producer of highly bioavailable plant extracts for industries including health, wellness, nutriceutical, and pharmaceutical, today announced that it has engaged North-West University, a leading medical research facility in Potchefstroom, South Africa, to conduct several clinical studies involving Phytofare™ Pheroid™ Topical Catechin Complex ("ph2TM"), a new topical cream based on the nano-entrapment technology developed by Prof. Anne Grobler at NWU and recently licensed to Plandaí for human and animal use.
Press Ventures Inc. (OTCQB:PVEN), is pleased to announce that the Company has established a new European Union (EU) corporate headquarters.
Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) chief executive officer Mark R. Baker will make a presentation on Thursday, September 12 at 1:30 PM EDT at the Stifel Healthcare Conference in Boston.
Sophiris Bio Inc. (NASDAQ: SPHS, TSX: SHS), a biopharmaceutical company developing a clinical stage, targeted treatment for the symptoms of benign prostatic hyperplasia (BPH or enlarged prostate), today announced that Randall E. Woods, President and Chief Executive Officer, will present a corporate overview at the Stifel Healthcare Conference 2013 at the Four Seasons Hotel in Boston, Massachusetts.