Zolbetuximab

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Targeted therapies, including KRAS, BRAF, and CLDN18.2 inhibitors, are transforming treatment for pancreatic, colorectal, lung, and gastric cancers. Experts highlight improved response rates and survival with molecular profiling-guided treatments, emphasizing the importance of biomarker expression for treatment selection and sequencing.

Immuno-oncology agents redefine gastric cancer treatment by considering individual tumor characteristics and immunity microenvironment, with biomarker studies and regionalized data expected to improve outcomes. Pembrolizumab combined with chemotherapy significantly improves overall survival in patients with PD-L1 expression, offering potential cures. Emerging therapies like Claudin 18.2 antibody and ADCs show promise. Differences in treatment response between Asian and Western patients highlight the need for tailored strategies. In cervical cancer, immuno-oncology combinations with chemoradiotherapy improve survival, especially in high-risk patients, with a focus on Asian patient data and toxicity management.

FDA approved zolbetuximab-clzb for CLDN18.2-positive, HER2-negative gastric/GEJ adenocarcinoma, in combination with chemotherapy. Dr. Marshall highlights the need for CLDN18.2 testing and the potential benefits and manageable toxicities of zolbetuximab, emphasizing ongoing challenges in GI cancer treatment.

Zolbetuximab, targeting CLDN18.2 in gastric cancer, showed improved PFS and OS in trials: FAST (OS 13.2 months, HR 0.72), SPOTLIGHT (PFS 11.0 months, OS 18.2 months, HR 0.73), and GLOW (OS 14.39 months, HR 0.771). Its manageable AEs and targeted action make it a promising therapy.

Astellas' Vyloy, a first-in-class gastric cancer treatment, faced complex development challenges, including manufacturing setbacks and the need for a companion diagnostic from Roche. Dr. Tadaaki Taniguchi, Astellas' chief medical officer, highlights the importance of biomarker identification, diagnostic development, and physician education in precision medicine. The approval of Vyloy alongside Roche's diagnostic underscores the collaborative efforts required in oncology precision medicine. Astellas aims to expand Vyloy's use to pancreatic cancer and continues to explore new treatment modalities in oncology.

Recap of November 2024 episodes of OncLive On Air, featuring discussions on toripalimab in nasopharyngeal carcinoma, emerging breast cancer treatments, relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer, zolbetuximab approval for CLDN18.2+ HER2-negative gastric/GEJ adenocarcinoma, HPV16-targeted immunotherapy in HNSCC, trastuzumab deruxtecan in HER2+ gynecologic cancer, long-term zanubrutinib data in R/R CLL, and obe-cel approval for B-cell precursor ALL.

Precision medicine in cancer treatment requires accurate companion diagnostics, but Korea's system lags, recognizing only two biomarkers (PD-L1 and ALK) for IHC tests. This hinders access to new therapies like Enhertu, Vyloy, and Elahere, which target biomarkers not yet covered by the current reimbursement system. The National Evidence-based Healthcare Collaborating Agency's (NECA) review process delays the listing of new biomarkers, creating a cycle that impedes the introduction of new treatments.

FDA approved zolbetuximab-clzb (Vylov) plus chemotherapy for HER2-negative, CLDN18.2-positive gastric/GEJ adenocarcinoma, addressing unmet need in PD-L1–low/HER2-negative patients. Routine CLDN18.2 testing is crucial for targeted therapy in previously non-targetable populations.