On November 29, 2023 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, reported that the target patient enrollment outside of mainland China in the ongoing Phase 3 REGAL trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) who have achieved complete remission following second-line salvage therapy has been reached (Press release, Sellas Life Sciences, NOV 29, 2023, View Source [SID1234638046]).

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"Reaching target enrollment ex-mainland China in this important study represents a significant milestone for SELLAS, the GPS development program, and the AML patient community," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We are extremely grateful to the participating patients and investigators who have helped achieve this critical milestone and we look forward to sharing the interim analysis which we expect to occur by the end of this year or early next year based upon our statistical assumptions. We are also looking forward to the upcoming IDMC meeting later this month. REGAL is the most comprehensive study conducted by a biotech company to date in this orphan disease setting. With a strong scientific rationale and supportive clinical data in previously conducted Phase 1 and Phase 2 studies in the AML maintenance setting, we believe GPS holds significant promise as a potential new treatment for AML patients. Furthermore, the positive outcome from the recently completed FDA Type C meeting and FDA’s guidance on the advancement of our CMC plans for a BLA filing, assuming positive results from the REGAL study, further strengthens our overall GPS program."

The Phase 3 open-label REGAL trial was designed with formal input from the United States Food and Drug Administration. Over 100 patients have been enrolled in the United States, Europe and Asia in the study which compares GPS monotherapy in the maintenance setting to investigators’ choice of best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is overall survival (OS) from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples.

Based upon the Company’s statistical assumptions, the interim analysis (after 60 events) is expected to occur in late 2023 or early 2024 and the final analysis (after 80 events) is on track to occur by the end of 2024. Because these analyses are event driven, they may occur at a different time than currently expected.

GPS has received Fast Track Designation in the United States and Orphan Drug Designation in both the United States and the European Union for AML.

For more information on the REGAL Phase 3 trial of GPS for the treatment of AML, please visit ClinicalTrials.gov and reference Identifier NCT04229979.