On May 22, 2017 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported multiple presentations discussing clinical and non-clinical studies relating to their oral rigosertib plus azacitidine combination therapy for which a Phase 3 trial is being designed (Press release, Onconova, MAY 22, 2017, View Source [SID1234519256]). In addition, SymBio, Onconova’s partner in Japan and Korea, will present Phase 1 data evaluating intravenous rigosertib in Japanese patients with recurrent/relapsed or refractory Myelodysplastic Syndromes. Schedule your 30 min Free 1stOncology Demo! DETAILS OF THE PRESENTATIONS:
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Combination Therapy with Rigosertib Plus Azacitidine
Oral Rigosertib Combined With Azacitidine in Patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS): Effects in Treatment of Naive and Relapsed/Refractory Patients
Format: Oral presentation
Date: June 24, 2017
Presenter: Shyamala Navada, M.D., Assistant Professor, Mount Sinai School of Medicine
Abstract: S488
Rigosertib Combined with Azacitidine Epigenetically Modulates Chromatin and Hematopoietic Stem Cell Populations in the Myelodysplastic Syndromes (MDS)
Author: Pratima Chaurasia, Ph.D., Assistant Clinical Professor, Mount Sinai School of Medicine
Shyamala C. Navada, M.D., Assistant Professor, Mount Sinai School of Medicine
Abstract: E1170
Oral Rigosertib as a Single Agent
A Multicenter, Open-label, Phase 1 Cinical Study: Safety, Efficacy, and Pharmacokinetics of Oral Rigosertib in Japanese Patients with Recurrent/Relapsed or Refractory Myelodysplastic Syndromes
Format: E Poster Presentation
Author: Kenichi Ishizawa, M.D., Ph.D.
Abstract: E1199
Another abstract of Phase 1 Data Demonstrating Intravenous Rigosertib as a Single Agent from SymBio collaborators will be published as an abstract only:
Safety, Efficacy and Pharmacokinetics of Intravenous Rigosertib in Japanese Patients with Recurrent/Relapsed or Refractory Myelodysplastic Syndromes (MDS): A Multicenter, Open-label, Phase 1 Study
Format: Publication only
Author: Michinori Ogura, M.D., Ph.D.
Abstract: PB1919
About IV Rigosertib
The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trials involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 international INSPIRE trial for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is intended for patients with advanced disease, provides long duration of exposure, and ensures dosing under a controlled setting.
About INSPIRE
The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial. INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first 9 months or nine cycles over the course of one year after initiation of HMA treatment. This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).
About Oral Rigosertib
The oral form of rigosertib was developed to provide more convenient dosing for use where the duration of treatment may extend to multiple years. This dosage form also supports many combination therapy modalities. To date, 368 patients have been treated with the oral formulation of rigosertib. Initial studies with single-agent oral rigosertib were conducted in hematological malignancies, lower-risk MDS, and solid tumors. Combination therapy of oral rigosertib with azacitidine and chemoradiotherapy has also been explored. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy. A Phase 2 trial of the combination therapy has been fully enrolled and the preliminary results were presented in 2016. This novel combination is the subject of an issued US patent with earliest expiration in 2028.