On February 1, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported the completion of enrollment in the Phase 1/2 clinical trial of the Company’s lead asset, galinpepimut-S (GPS), in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in second or third line Wilms Tumor-1 (WT1)(+) relapsed or refractory metastatic ovarian cancer (Press release, Sellas Life Sciences, FEB 1, 2022, View Source [SID1234607571]). The endpoints of the study include safety, overall response rate, progression-free survival, overall survival and immune response correlates. The clinical trial is being conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., Inc., Kenilworth, N.J. USA (known as MSD outside of the United States and Canada).
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The total expected enrolled and evaluable number of patients is 17. Data from 15 patients will be examined by mid-2022, with final data analysis for all evaluable patients expected by the end of 2022. SELLAS and Merck will jointly perform applicable analyses of the study, including survival, immune-biological and any other analyses of interest, to assess the safety and efficacy profile of the combination of GPS and pembrolizumab in this difficult-to-treat metastatic ovarian cancer indication.
"Completion of enrollment is an important milestone as we work diligently to evaluate a much-needed therapeutic treatment option for second or third line relapsed or refractory metastatic ovarian cancer patients," said Angelos Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS. "Our ability to complete enrollment timely, especially given the challenges related to COVID, is a tremendous accomplishment. We greatly appreciate the level of commitment Merck has given to this collaboration and are deeply grateful to all patients and their families, as well as investigators and study staff involved."
About Ovarian Cancer
Ovarian cancer is one of the most common gynecologic malignancies and the fifth most frequent cause of cancer death in women in the United States. Over 22,000 cases are diagnosed annually, resulting in an estimated 15,500 deaths per year. The majority of patients have widespread disease at presentation, and the five-year survival for the advanced-stage disease remains less than 30 percent. Combining GPS with the checkpoint inhibitor pembrolizumab, which beneficially and profoundly alters the tumor microenvironment (TME), is hypothesized to increase the proportion of patients who develop an immune response against their cancer and potentially improve their clinical outcome over pembrolizumab monotherapy, without the burden of additional toxicities in macroscopically measurable malignancies.