The FDA granted breakthrough therapy designation to subcutaneous amivantamab for recurrent or metastatic HPV-unrelated HNSCC after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The decision was supported by OrigAMI-4 cohort 1 data showing a 45% ORR and 76% clinical benefit rate.
A phase II trial of TAK-007 CAR-NK therapy in R/R B-cell NHL showed a 60.9% overall response rate. Preclinical CAR-NKT therapy eliminated endometrial tumors in models. Optimized costimulatory domains (2B4-DAP12) boosted CAR-NK tumor killing.
New antibody-based approaches demonstrate clinical benefits across multiple cancer types, including improved survival in triple-negative breast cancer, enhanced tumor detection via PET imaging, and activity in relapsed mantle cell lymphoma.
AIM ImmunoTech outlined key milestones for its Phase 2 DURIPANC trial evaluating Ampligen combined with durvalumab in metastatic pancreatic cancer, with primary endpoint evaluation expected in December 2026.
Two clinical trials demonstrate efficacy of talimogene laherparepvec (T-VEC) oncolytic virus therapy in HER2-negative breast cancer and nonmelanoma skin cancers, with favorable safety profiles and durable responses in subset of patients.
