^
Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Biliary Tract Cancer |
| Drug: | Imfinzi (durvalumab) (PD-L1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Imfinzi plus chemotherapy approved in China as first immunotherapy regimen for patients with locally advanced or metastatic biliary tract cancer
Published date:
11/14/2023
Excerpt:
AstraZeneca’s Imfinzi (durvalumab) has been approved in China for the 1st-line treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine and cisplatin)....The approval by China’s National Medical Products Administration (NMPA) was based on the primary results from the TOPAZ-1 Phase III...
Secondary therapy:
cisplatin + gemcitabine
Source:
Title:
AstraZeneca’s Imfinzi plus chemotherapy approved by MHRA for biliary tract cancer
Published date:
02/03/2023
Excerpt:
AstraZeneca's (AZ) Imfinzi (durvalumab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat biliary tract cancer (BTC) in combination with chemotherapy, the company announced.
Secondary therapy:
Chemotherapy
Source:
Title:
Imfinzi plus Imjudo approved in Japan for advanced liver and non-small cell lung cancers, and Imfinzi approved for unresectable biliary tract and liver cancers
Published date:
12/28/2022
Excerpt:
AstraZeneca’s immunotherapies Imfinzi (durvalumab) and Imjudo (tremelimumab) have been approved in Japan for the treatment of three cancer types: advanced liver, biliary tract and lung….The approvals authorise Imfinzi in combination with Imjudo for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC) and for the treatment of adult patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) in combination with chemotherapy. Imfinzi was also authorised for the treatment of adult patients with unresectable HCC as monotherapy and for the treatment of adult patients with curatively unresectable biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).
Secondary therapy:
cisplatin + gemcitabine
Source:
Title:
Imfinzi plus chemotherapy approved in the EU as first immunotherapy regimen for patients with advanced biliary tract cancer
Published date:
12/21/2022
Excerpt:
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).
Secondary therapy:
cisplatin + gemcitabine
Source:
Title:
Regulator recognizes Imfinzi’s indication for biliary tract cancer
Published date:
11/10/2022
Excerpt:
...the Ministry of Food and Drug Safety approved the combination therapy of Imfinzi (durvalumab) and Gemcitabine/Cisplatin (GemCis) as the primary treatment of adults with locally progressive or metastatic biliary tract cancer.
Secondary therapy:
cisplatin + gemcitabine
Source:
Published date:
09/02/2022
Excerpt:
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:...in combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
Secondary therapy:
cisplatin + gemcitabine
Source:
Published date:
03/29/2022
Excerpt:
Biliary Tract Cancers...Other Recommended Regimens: Durvalumab added as a Category 2A recommendation.
Secondary therapy:
cisplatin + gemcitabine
Source:
Title:
Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer
Published date:
11/14/2022
Excerpt:
AstraZeneca’s Imfinzi (durvalumab) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin)....The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on the primary results from the TOPAZ-1 Phase III trial...
Secondary therapy:
cisplatin + gemcitabine
Source:
Title:
Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer
Published date:
06/01/2022
Excerpt:
In this double-blind, placebo-controlled, phase 3 study, we randomly assigned patients with previously untreated unresectable or metastatic biliary tract cancer or with recurrent disease 1:1 to receive durvalumab or placebo in combination with gemcitabine plus cisplatin...Durvalumab plus chemotherapy significantly improved overall survival versus placebo plus chemotherapy and showed improvements versus placebo plus chemotherapy in prespecified secondary end points including progression-free survival and objective response rate.
Secondary therapy:
cisplatin + gemcitabine
DOI:
https://doi.org/10.1056/EVIDoa2200015
Trial ID:
Source:
Title:
Patient-reported outcomes for the phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer.
Published date:
05/26/2022
Excerpt:
Compliance rates for PROs were high at baseline (>81%) and remained high (majority >70% over 28 cycles) for both treatment groups. Baseline scores were comparable between treatment groups. Addition of D was well tolerated, with no significant difference in TTD in D + GC versus PBO + GC for pt-reported symptoms or functioning using either C30 or BIL21 (Table), or Global Health Status/QoL (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.69–1.12; p=0.279).Addition of D to GC improved OS (Oh D-Y, et al. J Clin Oncol 2022;40(suppl 4). Abs 378) and was well tolerated with no difference in TTD of QoL for pts, supporting D + GC as a new treatment option for pts with BTC.
Secondary therapy:
cisplatin + gemcitabine
DOI:
10.1200/JCO.2022.40.16_suppl.4070
Trial ID:
Source:
Title:
Imfinzi plus chemotherapy granted Priority Review in the US for patients with locally advanced or metastatic biliary tract cancer based on TOPAZ-1 Phase III trial
Published date:
05/04/2022
Excerpt:
AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, has been accepted and granted Priority Review in the US for patients with locally advanced or metastatic biliary tract cancer (BTC)....The sBLA was based on results from an interim analysis of the TOPAZ-1 Phase III trial....The data showed Imfinzi plus chemotherapy (gemcitabine plus cisplatin) reduced the risk of death by 20% versus chemotherapy alone (based on a hazard ratio [HR] of 0.80; 95% confidence interval [CI], 0.66-0.97; 2-sided p=0.021).
Secondary therapy:
cisplatin + gemcitabine
