The FDA is assembling its Oncologic Drugs Advisory Committee next month to discuss whether a biomarker should be used to select patients with certain stomach and esophageal cancers for treatment with checkpoint inhibitors.
Cumulative data suggest the expression of a protein called PD-L1 could be used to predict the benefit of checkpoint inhibitors in some patients with gastric and gastroesophageal junction cancers and esophageal squamous cell carcinoma, the FDA said in an announcement. However, blockbuster drugs such as Merck’s Keytruda and Bristol Myers Squibb’s Opdivo have been approved in broader patient populations, regardless of PD-L1 status.
Regulators also noted that “clinical trials have used different approaches to assess PD-L1 expression and different thresholds to define PD-L1 positivity.”
On Sept. 26, the FDA will ask ODAC to weigh in on the adequacy of PD-L1 as a predictive biomarker and whether the regulators should “restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression.”
The committee will discuss existing approvals for Opdivo, Keytruda and Yervoy, as well as pending applications for BeiGene’s tislelizumab, or Tevimbra.
Ian Waxman, Bristol Myers’ VP and senior global program lead in late-development oncology, said Opdivo regimens have “changed the outlook” for patients with gastric and esophageal cancers, “regardless of PD-L1 status.”
The company stressed that its CheckMate-649 trial, which supported approval for adults with gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, demonstrated a statistically significant overall survival benefit regardless of patients’ PD-L1 status.
A Merck spokesperson also highlighted Keytruda’s “important role” in advanced gastric and esophageal cancers, adding that it looks forward to a “productive conversation with the FDA’s ODAC.”
BeiGene noted that “the approvability of Tevimbra for the first-line treatment of patients with locally advanced unresectable or metastatic G/GEJ adenocarcinoma and ESCC is not under discussion for this ODAC.”
The company is seeking an all-comer label in both applications.