Phase I CARLYSLE trial data show CAR-T therapy obe-cel induces remission in severe refractory lupus with a favorable safety profile. Separate case report documents two successful pregnancies after dual-target CAR-T therapy with no transmission to infants.
Swissmedic has authorized three orphan drugs for rare diseases: Breyanzi for mantle cell lymphoma, Alhemo for haemophilia A and B, and Ekterly for hereditary angioedema. The decisions include a new indication extension for Breyanzi, an expanded indication for Alhemo, and the initial authorization of Ekterly as part of a joint international regulatory initiative.
China has approved the world's first CAR-T cell therapy for solid tumors, specifically for stomach cancer, developed by CARsgen Therapeutics. Meanwhile, the WVU Cancer Institute has conducted the first-ever use of a subcutaneous formulation of blinatumomab to achieve remission in a patient with ultra-rare mixed phenotype acute leukemia.
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.
The phase III frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP chemotherapy reduced the risk of progression by 25% in patients with high-risk B-cell lymphomas. The 3-year progression-free survival was 67.3% with the combination versus 60.7% with R-CHOP alone. A dual-targeted CD19/CD20 immunotherapy regimen has also been approved in Australia for relapsed follicular lymphoma.
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.
CRISPR Therapeutics said CASGEVY launch momentum is building and multiple pipeline assets could generate data in the next 12 to 18 months. The company also highlighted zugo-cel progress in oncology and autoimmune disease.
Eli Lilly and Company has agreed to acquire Orna Therapeutics for up to $2.4 billion in cash. The deal includes ORN-252, a clinical-trial-ready CD19-targeting in vivo CAR-T therapy for B cell-driven autoimmune diseases.
