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SELLAS Life Sciences Receives FDA Fast Track Designation for SLS009 for Treatment of Relapsed/Refractory Acute Myeloid Leukemia and Provides Updated Data for Phase 2a Study of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia Patients
- Phase 2a Enrollment Completed in 45 mg Safety Cohort: Median Overall Survival (OS) Not Reached; 89% of Patients Alive with Significant Antileukemic Effect
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"- Phase 2a Enrollment Completed in 45 mg Safety Cohort: Median Overall Survival (OS) Not Reached; 89% of Patients Alive with Significant Antileukemic Effect Observed in 87.5% of Evaluable Patients - - First Enrolled Patient in Phase 2a Study Achieved Complete Remission and Continues on Study With Full Recovery and in Seventh Month of Survival; Second Enrolled Patient Continues on Study in Sixth Month of Survival; Median OS in Relapsed/Refractory (r/r) Acute Myeloid Leukemia (AML) Patients Treated with Standard of Care is Approximately 2.5 Months - - Fast Track Designation Accelerates SLS009's Path for U.S. Regulatory Submission for Treatment of r/r AML - NEW YORK, Jan. 09, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SLS009 (formerly GFH009), its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML). The Fast Track Designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need. “Receiving Fast Track Designation for SLS009 for r/r AML, following the recent Orphan Drug Designation for the same indication, underscores the potential for SLS009 and highlights the critical unmet need for patients with AML who face a poor prognosis due to the progressive nature of the disease,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The initial positive topline Phase 2a data at the 45 mg (safety) dose level demonstrate that SLS009 in combination with venetoclax and azacitidine (aza/ven) exhibits anti-leukemic effects with a favorable safety profile in AML patients resistant to venetoclax combination therapies. Importantly, as of the last follow-up, eight of the nine patients enrolled in the 45 mg cohort were alive. The first patient enrolled in the study achieved a complete response (CR) and continues on study in the seventh month with full peripheral blood recovery. The second enrolled patient is in the sixth month of treatment, further underscoring the potential benefit of adding C...