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All Comers No More? US FDA AdComm Supports PD-L1 Threshold In Esophageal, Gastric Cancer

 
• By Bridget Silverman

Maturing data supporting first-line indications for Merck’s Keytruda, Bristol’s Opdivo and BeiGene’s Tevimbra show inadequate efficacy for patients at the lowest level of PD-L1 expression in esophageal and gastric cancers.

cancer cells
ODAC members considered PD-1 risk-benefit questions in two types of cancer. • Source: Shutterstock

The US Food and Drug Administration’s Oncologic Drugs Advisory Committee overwhelmingly agreed that first-line indications for PD-1 inhibitors in HER2-negative, microsatellite-stable gastric and gastroesophageal junction (GEJ) adenocarcinoma and esophageal squamous cell carcinoma should be revised to add a threshold level of PD-L1 expression despite misgivings about the variability of biomarker measurement.

Key Takeaways

  • ODAC members decided PD-1 inhibitor labels in first-line indications for some gastric and gastroesophageal cancers should be revised.

  • Most committee members said patients with a PD-L1 expression of less than 1 did not have a favorable risk-benefit

The FDA convened the ODAC meeting on 26 September in “an attempt to bring order to a confusing situation” by seeking fresh eyes, FDA Division of Oncology 3 Director Steven Lemery said

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