Ph 2/3 TEBE-AM trial converted into registrational Ph 3 trial of KIMMTRAK for previously treated advanced cutaneous melanoma
Mark Moyer, SVP, Regulatory Affairs, Immunocore said: “The decision to launch a registrational trial in cutaneous melanoma was based on KIMMTRAK’s overall survival benefit in uveal melanoma, and promising clinical activity as monotherapy and in combination with immune checkpoint therapy in Phase 1 cutaneous melanoma trials. To allow robust testing of two KIMMTRAK regimens and to accelerate the time to primary analysis, we decided, in consultation with the FDA, to amend the protocol into a single Phase 3 registrational study.”
Share:
More News
“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel
“The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer,” said Ben Hickey, President of RayzeBio. “The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated
“We believe these results mark a potentially important step forward in the treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer,” said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. “To address the unmet medical needs of patients and their families, we will continue working closely with
“Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies that may limit the utility in earlier lines