ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors

MAIA Biotechnology, BeiGene announce clinical supply agreement

MAIA Biotechnology Inc. and BeiGene entered into a clinical supply agreement to assess the efficacy of THIO, MAIA Biotechnology’s small molecule telomere-targeting anticancer agent, in combination with BeiGene’s immune checkpoint inhibitor tislelizumab, in three cancer indications. The single-arm pivotal phase II trials will study the drug combination in hepatocellular carcinoma, small cell lung cancer, and colorectal cancer.

January 17, 2025

Vol.51 No.02

Clinical Roundup

Physicians with the Lymphoma Research Foundation present research focused on immunotherapy, disparities at ASH 2024

Several physicians and lymphoma experts who work closely with the Lymphoma Research Foundation presented abstracts at the 66th annual ASH Annual Meeting and Exposition in San Diego, CA on Dec. 7-10, 2024.

FDA approves Tevimbra + chemo for first-line treatment of gastric and GEJ cancers

FDA approved Tevimbra (tislelizumab-jsgr) in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (≥1).

FDA approves Unloxcyt for metastatic or locally advanced cutaneous squamous cell carcinoma

FDA approved Unloxcyt (osibelimab-ipdl), a programmed death ligand-1 blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

FDA approves Opdivo and Opdivo Qvantig for subcutaneous injection

FDA approved Opdivo (nivolumab) and Opdivo Qvantig (hyaluronidase-nvhy) for subcutaneous injection across approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.