Imfinzi expands biliary cancer indication

Standard Treatment Improvement in 10 Years

Imfinzi acquired the first biliary tract cancer indication in November last year

Research begins with a proposal from domestic medical staff, and the results of the expansion of indications are achieved

AstraZeneca Korea held a press conference on the 31st to commemorate the approval of its immuno-cancer drug Impinzi

"Although there are few clinical patients, effectiveness improvement and safety performance" A new option for immuno-cancer drugs has been born in biliary tract cancer, where chemotherapy has long been the standard treatment.

 

The medical staff said, "We improved the treatment of biliary tract cancer, which has not progressed for more than 10 years." Imfinzi's biliary tract cancer indication is the first immuno-cancer drug.

 

In particular, it is significant in that the beginning of the clinical trial of researchers, which became the basis for permission for biliary tract cancer indications, is Korea.

 

The study could begin after Oh Do-yeon, a professor of oncology at Seoul National University Hospital, actively persuaded pharmaceutical companies.

 

Biliary tract cancer is a rare and aggressive gastrointestinal cancer consisting of cancer cells from the bile duct, gallbladder, or papilla.

 

Early biliary tract cancer has no clear symptoms, and it is not well established who has a high risk of biliary tract cancer.

 

Early diagnosis is difficult due to the lack of effective screening programs.

 

When diagnosed with biliary tract cancer, most of them have limited treatment options and poor prognoses.

 

Biliary tract cancer does not have a high prevalence like lung cancer or stomach cancer, and the incidence is lower in the West, so there have been relatively few new drug studies.

 

There have been attempts to combine some targeted anticancer drugs, but clinical trials have repeatedly failed.

 

This is why Gemcitabine + Cisplatin, chemotherapy, has still existed as a standard therapy for more than a decade.

 

Professor Oh found out that immuno-cancer drugs responded relatively high in biliary tract cancer about 10 years ago, and persuaded AstraZeneca to conduct a researcher clinical trial.

 

The possibility was confirmed here, leading to the third phase of the global market.

 

Professor Oh designed the clinical design after a long discussion as a PI.

 

The TOPAZ-1 study results were successful.

 

The Impinzi group improved the overall survival rate (OS) by 20% compared to the placebo group (placebo+ Gemcitabine + Cisplatin).

 

At the time of 2 years, the OS of the Impinzi group was 25%, which was more than twice that of the placebo group.

 

mPFS was 7.2 months in the Impinzi group, an improvement of 25% compared to 5.7 months in the placebo group.

 

In terms of safety, the safety profile was similar to that of the placebo group.

 

Professor Oh, who attended the meeting, said, "I was very happy to see the safety profile as well as the effectiveness of phase 3 clinical results." "Even though we added Impinzi, the adverse reaction was similar to that of the placebo group," he said.

 

"The rate of discontinuing treatment with drugs was rather less than that of the placebo group." The U.S.

 

Food and Drug Administration (FDA) approved Imfinzi biliary tract cancer indications based on Professor Oh's clinical and TOPAZ-1 results.

 

Furthermore, NCCN recommended Impinzi as the standard treatment (Category 1) in the primary treatment of progressive and metastatic biliary tract cancer.

 

For the first time, immuno-cancer drugs were listed as the first standard treatment option, which had only chemotherapy.

 

It is a very unusual case that the clinical trial of researchers initiated by Korean medical staff led to global approval and standard treatment.

 

Professor Oh said, "The TOPAZ-1 clinical trial is drawing attention in that it has proven improved results in efficacy and safety despite the relatively small number of participating patients at 685, and its interest has been confirmed at a recent academic conference."