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In today’s episode, supported by Astellas Pharma, we had the pleasure of speaking with Jaffer A. Ajani, MD, about the FDA approval of zolbetuximab-clzb (Vylov) plus chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are Claudin 18.2 (CLDN18.2) positive. Dr Ajani is a GI medical oncologist and professor in the Department of Gastrointestinal (GI) Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston.

On October 18, 2024, the FDA approved zolbetuximab plus fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative, CLDN18.2-positive gastric or GEJ adenocarcinoma. This regulatory decision was backed by findings from the phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials. In SPOTLIGHT, In SPOTLIGHT, patients who received zolbetuximab plus mFOLFOX6 (5-fluorouracil, leucovorin, and oxaliplatin) achieved a median progression-free survival (PFS) of 10.6 months (95% CI, 8.9-12.5) vs 8.7 months (95% CI, 8.2-10.3) in those who received placebo plus chemotherapy (HR, 0.750; 95% CI, 0.601-0.936; 1-sided 

 = .0053). In GLOW, zolbetuximab plus CAPOX (capecitabine and oxaliplatin) generated a median PFS of 8.2 months (95% CI, 7.5-8.8) vs 6.8 months (95% CI, 6.1-8.1) with placebo plus CAPOX (HR, 0.771; 95% CI, 0.615-0.965; 1-sided 

In our exclusive interview, Dr Ajani discussed key considerations for the clinical use of zolbetuximab, including its anticipated adverse effect profile and the introduction of CLDN18.2 as a biomarker for assessment prior to treatment initiation.

That’s all we have for today! Thank you for listening to this episode of 

, supported by Astellas Pharma. Check back on Mondays and Thursdays for exclusive interviews with leading experts in the oncology field.

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Podcasts

Dr Ajani discusses the FDA approval of frontline zolbetuximab plus chemo for unresectable or metastatic, HER2–, CLDN18.2+ gastric or GEJ adenocarcinoma. 

FDA Approval Insights: Zolbetuximab for CLDN18.2+ HER2-Negative Gastric and GEJ Adenocarcinoma

Jaffer A. Ajani, MD, a professor in the Department of Gastrointestinal Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, discusses how the FDA approvals of first-line nivolumab (Opdivo) plus chemotherapy and nivolumab plus ipilimumab (Yervoy) in advanced or metastatic esophageal squamous cell carcinoma (ESCC) will improve treatment in this setting.

the FDA approved the combination of nivolumab and

fluoropyrimidine- and platinum-containing chemotherapy

, as well as the combination of nivolumab and ipilimumab, as frontline therapy in adult patients with unresectable advanced or metastatic ESCC, irrespective of PD-L1 status. This approval was based on data from the phase 3 CheckMate 648 trial (NCT03143153), in which both combinations improved overall survival compared with chemotherapy alone in the all-randomized population and in patients with a PD-L1 expression of 1% or higher.

The CheckMate 648 trial measured PD-L1 expression with tumor proportion scores, where a score of 1 or higher was positive, and a score lower than 1 was negative, Ajani says. As a positive tumor proportion score translates to positive PD-L1 expression, tumor proportion score is an effective way to distinguish which patients may derive the most benefit from the combinations, Ajani explains.

Although the FDA has approved nivolumab plus chemotherapy and nivolumab plus ipilimumab for all patients with unresectable advanced or metastatic ESCC regardless of tumor proportion score, as both combinations are less effective in subsets with negative PD-L1 expression, increased discernment is recommended when considering these combinations for these patients, Ajani says. Overall, this approval will simplify the treatment paradigm for ESCC, Ajani concludes.

Videos

Jaffer A. Ajani, MD, discusses how the FDA approvals of first-line nivolumab plus chemotherapy and nivolumab plus ipilimumab in advanced or metastatic esophageal squamous cell carcinoma will improve treatment in this setting.

Jaffer A. Ajani, MD

Articles

FDA Approval Insights: Zolbetuximab for CLDN18.2+ HER2-Negative Gastric and GEJ Adenocarcinoma

Dr. Ajani on the FDA Approvals of Nivolumab Plus Chemotherapy and Nivolumab Plus Ipilimumab in ESCC