Rivoceranib

Treatment with camrelizumab, rivoceranib, and chemotherapy (SOXRC) showed better pre- and postsurgical responses in advanced gastric cancer compared to chemotherapy alone (SOX). The phase 3 DRAGON IV/CAP 05 study reported pathologic complete response rates of 18.3% vs. 5% and major pathologic response rates of 51.1% vs. 37.8% in the SOXRC and SOX groups, respectively. The study suggests an early signal of efficacy for combined PD-1/VEGFR inhibition plus chemotherapy, though not yet ready for routine use.

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Richard Kim, MD, discusses the positive phase 3 CARES-310 trial evaluating rivoceranib plus camrelizumab for first-line HCC treatment, with updated data showing improved survival vs sorafenib. The FDA accepted the NDA resubmission in 2024, anticipating approval once manufacturing issues are resolved, potentially offering a new first-line option for HCC next year.

A phase III multicenter, randomized, open-label study in China (Jan 2021-Jun 2022) evaluated DEB-TACE alone vs. DEB-TACE + apatinib for uHCC. Eligibility criteria included BCLC stage B-C, age 18-75, ECOG PS 0-1, and liver tumor <60% of total liver volume. DEB-TACE was standardized, with apatinib administered orally post-TACE. Treatment efficacy was assessed via mRECIST criteria, with PFS and OS as primary endpoints. Sample size estimation required 233 participants, with statistical analysis using Cox Frailty models to account for center effects.

Gastric cancer affects 26,890 people annually in the US, with 10,880 expected deaths in 2024. Risk factors include smoking, age, diet, and stomach inflammation. Cell therapy, particularly CAR-T, is a focus for new treatments. CARsgen completed patient enrollment for its CLDN18.2-targeting CAR-T therapy satri-cel in China. The first patient with refractory gastroesophageal cancer was dosed in a phase 2 trial combining iNKT cell therapy agenT-797 with immune checkpoint inhibitors. Triumvira’s TAC01-CLDN18.2 is set for a phase 1/2 trial for solid tumors. Biosyngen’s TCR-T therapy BRL03 received FDA clearance for trials in lung and gastric cancers.

October 2024 saw significant FDA actions in oncology, including priority reviews for T-DXd in HER2-low/ultra-low breast cancer, acalabrutinib for frontline mantle cell lymphoma, and approvals for nivolumab plus chemotherapy in operable NSCLC, Cologuard Plus for CRC screening, and zolbetuximab for HER2-negative gastric cancer. Other notable actions included fast track designations, orphan drug designations, and expanded approvals for various cancer treatments.

Elevar Therapeutics' COO Seong H. Jang discussed evolving U.S. FDA regulations at KIC 2024, focusing on accelerated approval and oncology drug dose optimization. Jang clarified that Elevar's rivoceranib+camrelizumab combination review is C2, requiring only a production site re-inspection, not additional clinical trials.

Articles discuss various treatments for hepatocellular carcinoma, including immunotherapies, stereotactic body radiotherapy, and combinations with checkpoint inhibitors. Topics include global cancer statistics, management of portal vein tumor thrombosis, and guidelines for diagnosis and treatment. Key studies highlight the efficacy and safety of different therapies, such as atezolizumab plus bevacizumab, and the potential synergies between radiotherapy and immunotherapy.

FDA accepts NDA resubmission for rivoceranib/camrelizumab combo in unresectable HCC; acalabrutinib plus venetoclax/rituximab yields 100% ORR in treatment-naive mantle cell lymphoma; FDA approves companion diagnostic for zolbetuximab in CLDN18.2+ gastric/GEJ cancer; first-in-class bicycle toxin conjugate targeting nectin-4 generates excitement in urothelial carcinoma; pembrolizumab earns EU approval in 2 new indications for endometrial and cervical cancer.