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May 22, 2026
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.
May 20, 2026
Phase 3 BREAKWATER found encorafenib plus cetuximab plus FOLFIRI improved PFS and response in first-line BRAF V600E-mutant metastatic colorectal cancer. OS data remain immature.
May 20, 2026
A phase I trial and a preclinical study found viral immunotherapy triggered T cell responses in glioblastoma. The clinical study enrolled 41 patients; the mouse study showed prolonged survival and immunologic memory.
May 19, 2026
The FDA has accepted the New Drug Application for giredestrant plus everolimus in ESR1-mutated, ER-positive, HER2-negative advanced breast cancer. The filing is based on Phase III evERA data showing reduced risk of disease progression or death versus standard-of-care endocrine therapy plus everolimus.
May 19, 2026
MSD said sacituzumab tirumotecan improved overall survival and progression-free survival in the Phase III TroFuse-005 trial in endometrial cancer. The study also met its objective response rate endpoint.
May 19, 2026
An interim phase 3 analysis showed mezigdomide plus carfilzomib and dexamethasone reduced the risk of progression or death in relapsed/refractory multiple myeloma. The SUCCESSOR-2 study remains ongoing and will assess overall survival and safety.
May 18, 2026
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.
May 11, 2026
The FDA has accepted for review a supplemental application for taletrectinib in advanced ROS1-positive NSCLC, with a PDUFA date of January 4, 2027. Updated TRUST-I and TRUST-2 data showed high response rates, durable responses and no new safety signals.
May 11, 2026
Sino Biopharmaceutical won Chinese approval for a new indication for benmelstobart as maintenance therapy in unresectable stage III NSCLC after chemoradiotherapy. Phase III R-ALPS data showed significantly prolonged progression-free survival versus placebo and a manageable safety profile.
May 07, 2026
Sensei Biotherapeutics dosed the first patient in a Phase 1b/2 trial of PIKTOR (sapanisertib + serabelisib) in HR+/HER2- advanced breast cancer. The multi-node PI3K/AKT/mTOR inhibitor previously showed a 47% overall response rate in a Phase 1b trial.
May 05, 2026
The FDA granted Breakthrough Therapy Designation to bezuclastinib plus sunitinib for previously treated GIST. The PEAK trial showed median progression-free survival of 16.5 months versus 9.2 months for sunitinib alone.
May 05, 2026
Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
May 02, 2026
Phase 3 trial data show daratumumab reduced relapse risk by 74% in NMOSD. Separately, the FDA accepted an NDA for iberdomide plus daratumumab/dexamethasone in relapsed/refractory multiple myeloma, with a PDUFA date of August 17, 2026.
May 02, 2026
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
May 01, 2026
FDA's ODAC voted 6-3 against AstraZeneca's camizestrant for HR+/HER2- metastatic breast cancer, citing uncertain clinical benefit from the SERENA-6 trial design. The FDA raised concerns about the early-switch treatment paradigm and long-term outcomes.
May 01, 2026
Crescent Biopharma dosed the first patient in its ASCEND Phase 1/2 trial of CR-001, a PD-1 x VEGF bispecific antibody for solid tumors. The company also reported Q1 2026 results and outlined pipeline milestones including ADC combination trials expected in the second half of 2026.
Apr 30, 2026
Two studies show liquid biopsy can predict immunotherapy response in HER2-negative breast cancer and identify which patients with relapsed germ cell tumors may benefit from high-dose chemotherapy, advancing precision oncology.
Apr 29, 2026
Immunome submitted an NDA to the FDA for varegacestat in desmoid tumors after the Phase 3 RINGSIDE trial showed an 84% reduction in progression risk (HR=0.16) and a 56% objective response rate. The company plans to file in Q2 2026.
Apr 29, 2026
Single-cell RNA sequencing of nearly 92,000 cells from the DESTINY-Gastric06 trial reveals distinct primary and acquired resistance mechanisms to trastuzumab deruxtecan in HER2-positive gastric cancer, including MUC3A and CST3 as key drivers.
Apr 28, 2026
Compass Therapeutics reported mixed Phase 2/3 data for tovecimig in biliary tract cancer and plans to meet with the FDA for a BLA discussion. The study met its primary ORR endpoint (17% vs 5%), while PFS and OS data are due late this quarter.
