FDA approves Keytruda regimen for patients with advanced biliary tract cancer
Click Here to Manage Email Alerts
The FDA approved pembrolizumab in combination with gemcitabine and cisplatin chemotherapy for adults with locally advanced unresectable or metastatic biliary tract cancer.
The approval marks the sixth gastrontstinal cancer indication for pembrolizumab (Keytruda, Merck), anti-PD1 humanized monoclonal antibody.
The agency based the new indication on results of the double-blind phase 3 KEYNOTE-966 trial, which included 1,069 patients with locally advanced unresectable or metastatic biliary tract cancer who had not received prior systemic therapy in the advanced disease setting.
Investigators randomly assigned study participants to receive 1,000 mg/m2 gemcitabine and 25 mg/m2 cisplatin on day 1 and day 8 every 3 weeks plus either 200 mg pembrolizumab (n = 533) or placebo (n = 536) on day 1 via IV infusion, with treatment continuing until unacceptable toxicity or disease progression.
Researchers observed a statistically significant improvement in OS — the study’s primary endpoint — as use of pembrolizumab reduced the risk for death by 17% (HR = 0.83; 95% CI, 0.72-0.95) compared with chemotherapy alone.
Additionally, researchers noted median OS of 12.7 months (95% CI, 11.5-13.6) for pembrolizumab plus chemotherapy vs. 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.
“Cancers of the biliary tract can be highly aggressive tumors, underscoring the need for additional treatment options for the growing number of patients facing this challenging disease,” Robin Kate Kelley, MD, professor of clinical medicine in the division of hematology/oncology at University of California, San Francisco, said in a Merck-issued press release. “[This] approval of pembrolizumab in combination with chemotherapy offers patients with locally advanced unresectable or metastatic biliary tract cancer a new immunotherapy regimen that has demonstrated the potential to help these patients live longer.”
Researchers also noted a median PFS of 6.5 months (95% CI, 5.7-6.9) for the investigational arm and 5.6 months (95% CI, 5.1-6.6) for chemotherapy alone; however, such a result did not reach statistical significance.
Safety results showed no clinically meaningful differences in incidence of grade 3 or 4 toxicity between the two study arms.
Click Here to Manage Email Alerts