Memorial Sloan Kettering Cancer Center

I-DXd showed efficacy in heavily pretreated ES-SCLC patients, with 12 mg/kg dose achieving 54.8% ORR vs. 26.1% for 8 mg/kg. Safety profile consistent, but TEAEs more frequent at higher dose. 12 mg/kg selected as optimal for further studies.

Daiichi Sankyo and Merck's ifinatamab deruxtecan shows 54.8% ORR at 12 mg/kg in pretreated ES-SCLC patients, selected as optimal dose for IDeate-Lung01 phase 2 trial extension and IDeate-Lung02 phase 3 study.

Multiple myeloma treatments, including quadruple regimens and CAR T-cell therapy, improve PFS and MRD negativity. Debate exists on optimal timing for CAR T use, with arguments for earlier or later lines. Accessibility and patient-specific factors influence treatment decisions.

Ifinatamab deruxtecan shows promising objective response rates in pretreated extensive-stage small cell lung cancer patients in the IDeate-Lung01 phase 2 trial, with confirmed ORR of 54.8% and 26.1% in 12 mg/kg and 8 mg/kg cohorts, respectively.

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In August 2024, the FDA approved Adaptimmune Therapeutics’ afami-cel for synovial sarcoma, modified REMS for CAR-T therapies, lifted a hold on 4D Molecular Therapeutics’ Fabry disease gene therapy, provided guidance for IN8bio’s INB-100 in AML, and cleared Biosyngen’s BRG01 for a pivotal trial in EBV-positive nasopharyngeal carcinoma.

A phase 1 trial at Roswell Park evaluates a novel CD19/28z armored CAR T-cell therapy for relapsed or refractory hematologic malignancies. The therapy, developed by Roswell Park and Memorial Sloan Kettering, modifies patients' T cells to recognize and kill cancer cells and secrete cytokines for better outcomes. The trial expects to recruit 36 patients with specific hematologic malignancies, focusing on adverse effects and maximal tolerated dose of the CAR T cells.

GI Innovation and MSD collaborate on a Phase 2 trial combining GI-102 and KEYTRUDA for resistant liver cancer, melanoma, and renal cell carcinoma.

Immix Biopharma adds Cleveland Clinic, UC Davis, and Sutter Health to its U.S. AL Amyloidosis trial, NEXICART-2, expanding patient access to CAR-T NXC-201. MSKCC remains the lead site. Initial ex-U.S. trial data showed a 92% overall response rate.