Ph 3 KEYNOTE-756 Trial Met Primary Endpoint of pCR Rate in Patients With High-Risk, Early-Stage ER+/HER2- Breast Cancer
“This is the first positive Phase 3 study evaluating an immunotherapy-based regimen for patients with high-risk, early-stage ER-positive, HER2-negative breast cancer, and an important milestone in our efforts to advance research in early-stage breast cancer,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We look forward to sharing the detailed results with the medical community and thank the patients and investigators for their important contributions to this study.”
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“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.