-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
On October 25th, AstraZeneca announced that its PD-L1 monoclonal antibody duvalizumab (Imfinzi) combined with chemotherapy for the first-line treatment of advanced biliary tract cancer (BTC) in Phase III clinical TOPAZ-1 achieved overall survival in the interim analysis The primary end point of the period (OS)
.
This is the first immunotherapy with positive results in global Phase III clinical trials for first-line biliary tract cancer
.
In December 2020, Imfinzi has been granted orphan drug designation by the FDA for the treatment of BTC
This is the first immunotherapy with positive results in global Phase III clinical trials for first-line biliary tract cancer
From: AstraZeneca official website
TOPAZ-1 is a randomized, double-blind, placebo-controlled global multicenter phase III clinical trial that evaluates Imfinzi combined with chemotherapy (gemcitabine + cisplatin) compared with placebo combined with chemotherapy for first-line treatment of unresectable advanced or metastatic BTC patients The efficacy and safety
.
The trial enrolled 685 patients worldwide.
TOPAZ-1
In a pre-determined interim analysis, Imfinzi combination therapy showed statistically significant and clinically significant overall survival (OS) benefits compared with chemotherapy alone, reaching the primary endpoint; at the same time, PFS and ORR were also significantly improved
.
In terms of safety, Imfinzi combined with chemotherapy is well tolerated and has similar safety compared with the control group.
AstraZeneca said that specific clinical data will be announced in subsequent medical conferences and communicated with regulatory agencies
.
BTC is a rare and aggressive cancer that occurs in the bile ducts and gallbladder.
Around 210,000 people are diagnosed with BTC every year worldwide
.
Most of these patients have advanced to the advanced stage when they are diagnosed, and the prognosis is poor.
However, the FDA has only approved 3 targeted drugs for biliary tract cancer, and no immunotherapy has been approved
.
These three treatments for cholangiocarcinoma have only just been approved in 2020 and 2021.
However, currently the FDA has only approved 3 targeted drugs for biliary tract cancer, and no immunotherapy has been approved
Recently, Imfinzi has made breakthroughs in key clinical trials beyond biliary tract cancer
.
On October 15, AstraZeneca just announced that it had reached the primary endpoint of OS in the first-line liver cancer phase III clinical HIMALAYA study
Recently, Imfinzi has made breakthroughs in key clinical trials beyond biliary tract cancer
Susan Galbraith, vice president of oncology research and development at AstraZeneca, said that the HIMALAYA study is the first time that dual immunotherapy has improved overall survival (OS) in the first-line treatment of patients with unresectable liver cancer
.
.
According to AstraZeneca's semi-annual report, Imfinzi will receive 1.
2 billion U.
S.
dollars in revenue in 2021H1, an increase of 18%
.
At present, the approved indications for the drug include unresectable stage III NSCLC, extensive-stage small cell lung cancer and bladder cancer.
With the expansion of indications, it is bound to gain a stronger growth driver
.
From: AstraZeneca Semi-Annual Report PPT
At the same time, in 2021H2, AstraZeneca will also submit Imfinzi combined with CTLA-4 for the first-line treatment of NSCLC sBLA; 2022H1 is expected to submit two indications of sBLA, for stage III NSCLC and combined with CTLA-4 for the treatment of hepatocellular carcinoma; 2022H2 is expected to submit 1L NSCLC SBLA of cervical cancer and biliary tract cancer
.
From: AstraZeneca Semi-Annual Report PPT
