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 3 trial of azacitidine and chidamide plus CHOP in untreated PTCL showed a significant overall survival improvement but no significant gains in response rate or progression-free survival. The study suggests molecular profiling could guide future therapies.
Kura Oncology's ziftomenib shows 96% complete response in frontline AML and $5.8M in early commercial sales; updated FIT-001 trial data for kidney cancer to be presented at 2026 summit; analysts see significant upside with an average target of $32.45.
Two separate clinical trials have reported advances in cancer care. An oral drug combination of decitabine-cedazuridine and venetoclax showed efficacy in older patients with acute myeloid leukemia, with a 47% complete response rate in a phase 2b trial. A separate randomized controlled trial found that delaying pegfilgrastim administration to 72 hours post-chemotherapy significantly reduced bone pain in women with stage I–III breast cancer.
Updated data from the phase I CaMMouflage trial showed CB-011, the first allogeneic anti-BCMA CAR-T therapy with immune cloaking, achieved an approximately 92% overall response rate in relapsed/refractory multiple myeloma. The 2026 Tandem Meetings also highlighted advances in EB-103, KITE-753, and LV20.19 CAR-T constructs across lymphoma and CLL. Separately, NXC-201 reported a 95% complete response rate in AL amyloidosis.
Real-world studies show early complete response after CAR T-cell therapy predicts sustained remission in large B-cell lymphoma, while historical chemotherapy yields poor outcomes in high-risk patients. Data from registries highlight a significant event-free survival advantage for second-line axicabtagene ciloleucel versus standard-of-care salvage therapy.
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.
The FDA approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic therapies. In TRANSCEND FL, the CAR T therapy showed a 95.5% overall response rate and 62.1% complete response rate.
The FDA's January draft guidance proposes MRD-negative complete response as an accelerated approval end point for multiple myeloma drugs. It defines MRD negativity, sets trial design requirements, and accepts comments through March 23, 2026. Expert Nicholas Richardson discusses calibration challenges and the single-trial model.
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.
