AMERICAN SOCIETY OF CLINICAL ONCOLOGY

The FDA's November 2024 approval of obecabtagene autoleucel (obe-cel) for relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL) adds to existing CAR T-cell therapies, offering a potentially safer profile. Experts discuss the differences in costimulatory domains and persistence of CAR T-cells, highlighting obe-cel's faster off-rate and reduced toxicity. Long-term survival data from ZUMA-3 and FELIX studies show promising outcomes, with obe-cel demonstrating high CR/CRi rates and manageable safety profiles. Challenges in access, AE management, and supportive care are also addressed, emphasizing the need for specialized centers and close monitoring.

ASTRO task force developed guidelines for palliative external beam radiation therapy (RT) in symptomatic bone metastases, recommending RT for pain management and spine metastases with or without spinal cord compression, with surgery and postoperative RT preferred over RT alone. Conventional RT doses include 800 cGY in 1 fraction, 2000 cGY in 5 fractions, 2400 cGY, or 3000 cGY in 10 fractions. The guidelines emphasize personalized patient assessment and multidisciplinary input, with future studies needed to optimize patient selection and standardize outcome measurements.

Kelun-Biotech received NMPA approval for sacituzumab tirumotecan (sac-TMT), the first domestically developed TROP2 ADC for treating advanced TNBC in China, based on positive phase 3 OptiTROP-Breast01 study results.

The US FDA accepted GSK's BLA for belantamab mafodotin (Blenrep) in combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for treating multiple myeloma patients who have received at least one previous therapy. The decision is based on positive results from Phase III clinical trials DREAMM-7 and DREAMM-8, which showed significant improvements in progression-free survival. Belantamab mafodotin is an antibody-drug conjugate already under review in the EU, Japan, UK, Canada, and Switzerland.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. received marketing authorization in China for the first domestically developed TROP2 ADC sacituzumab tirumotecan (sac-TMT) for treating unresectable locally advanced or metastatic TNBC. The approval is based on positive phase 3 OptiTROP-Breast01 study results, showing significant improvement in PFS and OS compared to chemotherapy. Sac-TMT targets TROP2 on tumor cells, inducing DNA damage and apoptosis, with potential for other cancer indications.

Meta-analysis of 40 RCTs (11,576 patients) shows surgical-based locoregional therapies (LRTs) for nonmetastatic hepatocellular carcinoma (HCC) yield best outcomes; embolization-based LRTs poorer. Hierarchical efficacy observed: surgery with adjuvant therapy > surgery alone > radiofrequency ablation (RFA) > microwave ablation (MWA) and radiotherapy (RT) > hepatic arterial infusion chemotherapy (HAIC) > transarterial chemoembolization (TACE) > transarterial radioembolization (TARE) and transarterial bland embolization (TAE). Findings suggest LRT remains crucial in HCC treatment, with some forms preferred over others.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced the marketing authorization of sacituzumab tirumotecan (sac-TMT), the first domestically developed TROP2 ADC for treating unresectable locally advanced or metastatic TNBC in China.