FDA’S ODAC to Discuss PD-L1 Levels for ICIs in Gastric and Esophageal Cancers

Microscopic image of gastric tumor cells - Generated with Google Gemini AI

• The FDA will hold a meeting of the Oncologic Drug Advisory Committee (ODAC) on September 26, 2024.
• The topic of the meeting is to discuss risks and benefits of PD-L1 expression level cutoffs for immune checkpoint inhibitors in gastric, gastroesophageal junction (GEJ), and esophageal cancers.
• The Committee will also discuss the biologics license application (BLA) of tislelizumab (Tevimbra) and supplemental BLAs (sBLAs) of nivolumab (Opdivo), pembrolizumab (Keytruda), and ipilimumab (Yervoy).

On September 26, 2024, the FDA’s ODAC will convene to conduct risk-benefit assessments of PD-L1 expression level cutoffs for immune checkpoint inhibitor treatment for patients with gastric, gastroesophageal, and esophageal cancers.¹

In the morning session, the Committee will discuss the use of immune checkpoint inhibitors in unresectable or metastatic gastric and GEJ cancers. The FDA is looking for the Committee’s opinion on the adequacy of PD-L1 expression as a predictive biomarker, risks and benefits of PD-L1 expression analysis in different subgroups, and the adequacy of data to restrict the approval of immune checkpoint inhibitors based on PD-L1 expression. Here, the sBLAs of nivolumab and pembrolizumab and the BLA of tislelizumab for these indications will be discussed.

In the afternoon session, the Committee will consider immune checkpoint inhibitors in patients with metastatic or unresectable esophageal squamous cell carcinoma (ESCC), with the same considerations as the morning session. The Committee will discuss the sBLAs for pembrolizumab, nivolumab, and ipilimumab and the BLA for tislelizumab for this indication.

“With proven survival benefits, [nivolumab]-based regimens have changed the outlook for patients with [gastric cancer], GEJ [cancer], [esophageal adenocarcinoma] and ESCC regardless of PD-L1 status,” Ian M. Waxman, MD, vice president, senior global program lead, late development, oncology, Bristol Myers Squibb, said in a press release.² “We look forward to the opportunity to discuss the importance of [nivolumab]-based regimens as treatment options for appropriate gastric and esophageal cancer patients more in depth with the Committee.”Bristol Myers Squibb is the sponsor of the sBLAs of nivolumab and ipilimumab.

During the meeting, the ODAC will hear from Bristol Myers Squibb, Merck, and BeiGene, sponsors of these sBLAs and BLAs.

Currently, the BLA of tislelizumab has a Prescription Drug User Fee Act target action date of December 1, 2024.³ Nivolumab, pembrolizumab, and ipilimumab are already approved for these indications.¹

REFERENCES:

1. September 26, 2024: Meeting of the Oncologic Drugs Advisory Committee meeting announcement. FDA. August 23, 2024. Accessed August 26, 2024. https://tinyurl.com/mst9ffud

2. Bristol Myers Squibb statement on Oncologic Drugs Advisory Committee (ODAC) meeting to discuss PD-L1 expression levels in gastric and esophageal cancers. News release. Bristol Myers Squibb. August 22, 2024. Accessed August 26, 2024. https://tinyurl.com/2va7jb97

3. BeiGene’s biologics license application for TEVIMBRA® (tislelizumab) for first-line gastric or gastroesophageal junction cancers accepted by FDA. News release. BeiGene, Ltd. February 27, 2024. Accessed August 26, 2024. https://tinyurl.com/2bfxky4j