Imfinzi nears reimb for biliary tract cancer in Korea

Expected to expand role across gastrointestinal tumors

Passes DREC review… recognized as adequate for use in combination with chemotherapy

Demonstrates efficacy in adjuvant gastric cancer and first-line liver cancer

Immunotherapy Imfinzi Inj

The immunotherapy drug Imfinzi has cleared the Drug Reimbursement Evaluation Committee review and has taken one step closer to expanding reimbursement for biliary tract cancer.

 

Beyond biliary tract cancer, Imfinzi has also shown efficacy in hepatocellular carcinoma and gastric cancer, signaling its potential across the spectrum of gastrointestinal cancers.

 

According to industry sources on the 11th, the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee recently approved the reimbursement appropriateness of AstraZeneca's ‘Imfinzi (durvalumab)’.

 

The specific indication is as a first-line treatment for patients with advanced or metastatic biliary tract cancer, in combination with gemcitabine and cisplatin.

 

Imfinzi is an immuno-oncology drug that targets PD-L1.

 

It has been approved for multiple cancer types, including non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, endometrial cancer, and bladder cancer, in addition to bile duct cancer.

 

However, except for non-small cell lung cancer, it is currently not reimbursed in Korea, limiting patient access.

 

The DREC approval is significant as it raises potential for expanding access in the treatment of gastrointestinal cancers, where treatment gaps have persisted.

 

First reimbursable new drug for biliary tract cancer to be introduced in a decade

Immunotherapy Imfinzi Inj

Biliary tract cancer has long been one of the most challenging areas in oncology drug development.

 

Although the patient population is smaller than that of other cancers, early detection is difficult, and the disease is characterized by rapid invasion and frequent recurrence, yielding a 5-year relative survival rate of only 28.9% (2017–2021) in Korea.

 

The mortality rate stands at 11.6%.

 

Another reason for the low survival rate is the limited treatment options available.

 

For locally advanced or metastatic biliary tract cancer where surgery is not feasible, and after failure of first-line therapy, there is a shortage of treatment options available as second-line therapies.

 

In this context, in 2022, Imfinzi was approved as a first-line therapy in combination with chemotherapy, demonstrating the potential for improving long-term survival in biliary tract cancer patients.

 

Imfinzi demonstrated an improved 3-year long-term survival rate compared to the control group in clinical trials, with particularly pronounced effects observed in the Korean patient cohort.

 

Notably, no new drugs for biliary tract cancer have been reimbursed in Korea over the past decade.

 

The Imfinzi combination therapy also offers the advantage of higher overall survival (OS) rates in Korean patients.

 

According to the study results at the time, the 2-year survival rate for the Korean patient group receiving the Imfinzi combination therapy was 38.5%, more than double the 14.1% survival rate in the group receiving chemotherapy alone.

 

Furthermore, the 36-month survival rate was 21.0% for the Imfinzi combination group, more than double the 8.8% in the chemotherapy group.

 

Expanding to hepatocellular carcinoma and gastric cancer...

 

‘Immunotherapy combination’ competition intensifies During the same reimbursement review, Imfinzi also demonstrated potential as a first-line therapy for hepatocellular carcinoma in combination with Imjudo (tremelimumab), a CTLA-4–targeting immuno-oncology drug.

 

The Imfinzi–Imjudo immunotherapy regimen has already entered the Korean market.

 

Imfinzi, a PD-L1-targeted immune checkpoint inhibitor, was launched domestically in May as a liver cancer treatment in combination with the CTLA-4-targeted Imjudo.

 

The Phase III HIMALAYA study demonstrated the efficacy of the Imfinzi and Imjudo combination.

 

The trial compared the efficacy and safety of the Imfinzi + Imjudo combination versus Bayer's Nexavar in 1,171 patients aged 18 years or older with previously untreated, unresectable HCC.

 

The study showed that Imfinzi + Imjudo reduced the risk of death by 22% compared to Nexavar alone.

 

Median overall survival was 16.4 months versus 13.8 months, respectively.

 

The Imfinzi–Imjudo combination is expected to face stiff competition from Roche’s Tecentriq-Avastin combination regimen.

 

Imfinzi is considered to carry a lower bleeding risk.

 

In contrast, Roche's already approved combination of the immuno-oncology drug Tecentriq and the targeted therapy Avastin is known to cause bleeding issues at a relatively high frequency due to Avastin.

 

Liver cancer patients often have impaired liver function, increasing their bleeding risk.

 

However, as the Imfinzi combination therapy carries a lower bleeding risk, it offers the advantage of enabling immediate endoscopic treatment.

 

The expansion of Imfinzi's indications for gastrointestinal cancers is extending beyond bile duct and liver cancers to include gastric cancer.

 

The final analysis of the Phase III MATTERHORN trial that was presented at the recent European Society for Medical Oncology (ESMO) Annual Congress 2025 in Berlin, Germany, confirmed that Imfinzi neoadjuvant and adjuvant therapy statistically significantly improved overall survival (OS).

 

This study is considered the first instance of an immunotherapy demonstrating a survival benefit as neoadjuvant and adjuvant therapy for gastric cancer.

 

The study enrolled patients with resectable locally advanced gastric cancer (stages II–IVA) and gastroesophageal junction cancer, and patients received Imfinzi plus FLOT combination therapy pre-surgery, followed by maintenance Imfinzi post-surgery.

 

The Imfinzi combination group reduced the risk of death by 22% compared to the control group, with consistent survival benefits observed regardless of PD-L1 expression levels.

 

Event-free survival (EFS) was also improved, reducing the risk of disease progression or recurrence by 29%.

 

The pathological complete response (pCR) rate was also more than double in the Imfinzi group (19%) compared to the control group (7%).