On December 10, 2024 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 pre-specified threshold of 60 events (deaths) has been reached in its ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML), triggering the interim analysis to be conducted by the Independent Data Monitoring Committee (IDMC) (Press release, Sellas Life Sciences, DEC 10, 2024, View Source [SID1234648993]).
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The IDMC will conduct a thorough review of the current REGAL data, and the interim analysis will provide an assessment of efficacy, futility as well as safety of GPS.
"This is an exciting and very important milestone in our efforts to bring forward a new potential treatment option for AML patients," said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. "Our mission at SELLAS is to develop novel therapies that prolong patients’ lives, and the outcome of the interim analysis will hopefully bring us closer to the potential of adding GPS as a powerful ally in the battle against AML. Today, we are here thanks to the unwavering support of our shareholders, dedication of our clinical investigators and the resilience of our patients and their families. The IDMC will now carefully review and analyze all the data and have scheduled a meeting in January to review results to date. We are extremely grateful to everybody who have contributed to the REGAL study, and we look forward to sharing the IDMC’s feedback and recommendations as soon as they become available."
The Company will host a call today to review the process leading up to the IDMC meeting and the potential outcomes of the REGAL interim analysis.
To access the webinar, please use the following information:
Date: Tuesday, December 10, 2024
Time: 9:00 a.m. Eastern Time
Webcast: SELLAS GPS REGAL