On May 25, 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 a trial in progress poster for the Phase 3 REGAL study of galinpepimut-S (GPS) in acute myeloid leukemia (AML) will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, 2023 in Chicago (Press release, Sellas Life Sciences, MAY 25, 2023, View Source [SID1234632076]).
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"We are pleased to present an overview of our ongoing Phase 3 REGAL registrational study at the 2023 ASCO (Free ASCO Whitepaper) meeting," said Dragan Cicic, MD, Senior Vice President, Head of Clinical Development of SELLAS. "We are proud of our continued advancement of GPS as a novel treatment for patients with AML in need of better therapies. Our independent data monitoring committee will meet again in Q3, and we currently expect the interim analysis for our Phase 3 REGAL study by the end of this year or early 2024. We have agreement with the FDA on all of our study parameters, including the biostatistical design and relevant hazard ratios and assumptions, for the interim and final analyses. We are grateful to all of our dedicated research physicians, study nurses and participating patients and families in the REGAL study."
Abstract: TPS7074 Poster Bd: 203b
Abstract Title: A randomized, open-label study of the efficacy and safety of galinpepimut-S (GPS) maintenance monotherapy compared to investigator’s choice of best available therapy (BAT) in patients with acute myeloid leukemia (AML) who have achieved complete remission (CR) after second-line salvage therapy
Clinical Trial Registration Number:NCT04229979
Presenter: Omer Jamy, M.D., Principal Investigator of REGAL study at University of Alabama Birmingham
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time: Monday, June 5, 2023, 9:00 AM – 12:00 PM EST
The poster will be available on both the ASCO (Free ASCO Whitepaper) and SELLAS websites following the session.