The FDA approved Merck & Co Inc's MRK Keytruda, in combination with gemcitabine and cisplatin, for locally advanced unresectable or metastatic biliary tract cancer (BTC).
The approval was based on results from the Phase 3 KEYNOTE-966 trial, in which Keytruda plus chemotherapy demonstrated a statistically significant improvement in the study's primary endpoint of overall survival (OS), reducing the risk of death by 17% compared to chemotherapy alone at the trial's pre-specified final analysis for OS.
Median OS was 12.7 months for Keytruda plus chemotherapy versus 10.9 months for chemotherapy alone.
This approval marks the sixth indication for Keytruda in gastrointestinal cancers.
Merck also released data from the Phase 3 KEYNOTE-564 trial evaluating Keytruda versus placebo as adjuvant therapy for certain patients with renal cell carcinoma (RCC) following nephrectomy (surgical removal of a kidney).
The study met its key secondary endpoint of overall survival (OS).
At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, Keytruda demonstrated a statistically significant and clinically meaningful improvement in OS compared to placebo.
As previously reported, at an earlier pre-specified interim analysis with a median follow-up of 23.9 months, KEYNOTE-564 met its primary endpoint of disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% compared to placebo.
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