Two Ph 3 Trials of Datopotamab Deruxtecan + Imfinzi Initiated in Patients Across Two Breast Cancer Subtypes
“While the addition of immune checkpoint inhibitors to chemotherapy has led to survival improvements for patients with triple negative breast cancer, the overall prognosis for these patients remains poor,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “These two phase 3 trials will evaluate whether combining datopotamab deruxtecan, a TROP2 directed antibody drug conjugate, with durvalumab may offer a more effective option for patients across different settings of breast cancer.”
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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.