^
Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Biliary Tract Cancer |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
Published date:
11/01/2023
Excerpt:
Merck...announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with 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...
Secondary therapy:
cisplatin + gemcitabine
Source:
Published date:
11/08/2023
Excerpt:
Biliary Tract Cancers: Preferred Regimens...Pembrolizumab + gemcitabine + cisplatin…
Source:
Title:
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as First-Line Treatment for Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
Published date:
11/10/2023
Excerpt:
Merck...announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma....The recommendation is based on results from the Phase 3 KEYNOTE-966 trial, in which KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in overall survival (OS) versus chemotherapy alone.
Secondary therapy:
cisplatin + gemcitabine
Source:
Title:
Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial
Published date:
04/16/2023
Excerpt:
Based on a statistically significant, clinically meaningful improvement in overall survival compared with gemcitabine and cisplatin without any new safety signals, pembrolizumab plus gemcitabine and cisplatin could be a new treatment option for patients with previously untreated metastatic or unresectable biliary tract cancer.
Secondary therapy:
cisplatin + gemcitabine
DOI:
https://doi.org/10.1016/S0140-6736(23)00727-4
Trial ID:
Source:
Title:
Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy in First-Line Advanced or Unresectable Biliary Tract Cancer in KEYNOTE-966 Trial
Published date:
01/25/2023
Excerpt:
Merck...announced positive results from the Phase 3 KEYNOTE-966 trial. In the final analysis of this trial, KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone for the first-line treatment of patients with advanced or unresectable biliary tract cancer (BTC).
Secondary therapy:
cisplatin + gemcitabine
Trial ID:
