Idecabtagene vicleucel

The cell and gene therapy sectors are rapidly advancing, with updates on PepGen's PGN-EDO51 IND hold, innovative payment models for high-cost treatments, Janssen and Legend Biotech's Carvykti showing higher MRD negativity rates, Bristol Myers Squibb and 2seventy bio's Abecma responses in CNS-affected MM patients, Editas Medicine discontinuing EDIT-301 development, and SpliceBio's SB-007 receiving IND clearance for Stargardt disease treatment.

Idecabtagene vicleucel (Ide-cel) shows similar safety and efficacy in older and younger multiple myeloma patients, despite geriatric factors like comorbidities and organ dysfunction. Older patients had an 86.7% overall response rate, comparable to younger patients, suggesting clinical trial criteria should be more inclusive for older patients.

Belantamab mafodotin's comeback, FDA approvals for subcutaneous daratumumab-hyaluronidase and expanded CAR T-cell products, and isatuximab-based quadruplet emerging as new standard for transplant-ineligible newly diagnosed multiple myeloma patients.

Poseida Therapeutics' P-BCMA-ALLO1, an allogeneic BCMA-directed CAR-T therapy, showed 91% ORR in a phase 1/1b trial for r/r MM, with no graft versus host disease and low CRS risk. Enhanced lymphodepletion improved in vivo expansion and persistence, addressing unmet needs for patients failing other therapies.

Aumolertinib improved progression-free survival in unresectable stage III NSCLC, with increased AEs in the experimental arm. New endocrine therapies and BCL-2 inhibitors are advancing treatment options, while ivonescimab showed efficacy over pembrolizumab in advanced NSCLC.

Shaji Kumar, MD, reviews data from cohort C of CARTITUDE-2 and a real-world study on ide-cel in relapsed/refractory multiple myeloma.

Bristol Myers Squibb won dismissal of a $6.4 billion lawsuit claiming it delayed FDA approval for Breyanzi and two other drugs, as Judge Jesse Furman ruled UMB Bank was not properly appointed trustee for Celgene shareholders' contingent value rights (CVR).