Regulatory update provided on the clinical development plan of Tedopi® in Ph 3 in monotherapy in advanced or mNSCLC after checkpoint inhibitor failure
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are pleased with the positive outcomes from the US Food & Drug Administration (FDA) Type C Meeting following the supportive European Medicines Agency (EMA) advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of Tedopi®. Leveraging on the positive data on efficacy, safety and quality of life from the initial phase 3 randomized trial in third line post-chemotherapy followed by an immune checkpoint inhibitor (ICI), we are committed in advancing the clinical development for Tedopi® as a potential new standard of care in monotherapy in second line for advanced or metastatic lung cancer patients in secondary resistance to ICI now used in first line. No therapeutic options have yet been approved to date in this patient population with high unmet medical needs.”
Share:
More News
“KEYTRUDA has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved,
“We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumor, yet there are still few treatment options that improve survival in this very difficult-to-treat tumor type. We are still on track to
“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look
“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The Phase 2 OVATION 2 study data are
