AstraZeneca Korea, headed by CEO Kim Sang-pyo, has announced that its anti-PD-L1 immuno-oncology drug, ‘Imfinzi (Dervalumab),’ has received approval from the Ministry of Food and Drug Safety for an additional indication as a first-line treatment option for advanced or unresectable hepatocellular carcinoma. This approval was granted based on the findings from the phase 3 HIMALAYA study, which compared the efficacy of Imfinzi in combination with the anti Imudo (Tremelimumab) to Sorafenib monotherapy in 1,171 treatment-naïve or unresectable advanced hepatocellular carcinoma patients.
The HIMALAYA study revealed promising results, indicating that the Imfinzi-Imudo combination therapy group experienced a 22% reduction in the risk of death compared to the Sorafenib monotherapy group. The study’s primary endpoint, overall survival (OS), also showed improvement, with the Imfinzi-Imudo combination therapy group exhibiting a 31% overall survival rate at 3 years, compared to 20% for the Sorafenib monotherapy group. Additionally, the median overall survival for the Imfinzi-Imudo combination therapy group was 16.4 months, compared to 13.8 months for the Sorafenib monotherapy group.
Secondary endpoints, such as the objective response rate, further supported the efficacy of the Imfinzi-Imudo combination therapy. The combination therapy group showed an objective response rate of 20.1%, approximately four times higher than the rate of 5.1% observed in the Sorafenib monotherapy group. Moreover, the complete response rate was 3.1% in the Imfinzi-Imudo combination therapy group, while the Sorafenib monotherapy group had no complete responses.
In terms of safety, the incidence of grade 3 or higher side effects was lower in the Imfinzi-Imudo combination therapy group (25.8%) compared to the Sorafenib monotherapy group (36.9%).
The Imfinzi-Imudo combination therapy works by enhancing the activation of T cells, which are immune cells, through the administration of Imfinzi followed by periodic doses to reduce the PD-L1 protein on cancer cells’ surface. This selective inhibition of T cell activation has demonstrated a significant therapeutic effect.
The National Comprehensive Cancer Network (NCCN) oncology treatment guidelines recommend the Imfinzi-Imudo combination therapy as the standard first-line systemic treatment for advanced or unresectable hepatocellular carcinoma.
Yang Mi-sun, executive director of AstraZeneca’s anti-cancer division, emphasized the importance of this breakthrough, stating, “Hepatocellular carcinoma has a dismal prognosis, accounting for approximately 75.1% of liver cancer cases and presenting a relative 5-year survival rate of just 38.7% among major carcinomas in Korea. The introduction of this dual immuno-oncology therapy as a first-line treatment option for hepatocellular carcinoma is expected to significantly improve treatment outcomes by maximizing the benefits of immuno-oncology.”
AstraZeneca Korea’s anti-cancer division plans to continue their efforts in improving the survival and quality of life for cancer patients. They aim to expand access to Imfinzi for the treatment of lung cancer, biliary tract cancer, and hepatocellular carcinoma.
AstraZeneca’s ‘Imfinzi’ has added an indication for the first-line treatment of hepatocellular carcinoma patients as combination therapy with Imudo. The photo is an image of an Impinji product. © AstraZeneca Korea
AstraZeneca Korea (CEO Kim Sang-pyo) announced that its anti-PD-L1 immuno-oncology drug ‘Imfinzi (Dervalumab)’ was approved by the Ministry of Food and Drug Safety on the 30th of last month as a therapy combination with the anti Imudo (Tremelimumab), an immuno-oncology-CTLA-4 drug, announced on the 4th that it has received additional indications for the first-line treatment of patients with advanced or unresectable hepatocellular carcinoma.
The approval for the expansion of this indication was based on the phase 3 HIMALAYA study, which evaluated the efficacy of the treatment between Imfinzi-Imudo combination therapy and Sorafenib monotherapy in 1,171 patients with treatment-naïve or unresectable advanced hepatocellular carcinoma.
As a result of the HIMALAYA study, the Imfinzi-Imudo combination therapy group improved the risk of death by 22% compared to the sorafenib monotherapy group, and showed an improvement in overall survival (OS), the primary endpoint. At 3 years, the overall survival rate of the Imfinzi-Imudo combination therapy group was 31% and the Sorafenib monotherapy group was 20%, and the median overall survival of the Imfinzi-Imudo combination therapy group was 16.4 months and the Sorafenib monotherapy group was 13.8 months.
In the case of the objective response rate among the secondary endpoints, the Imfinzi-Imudo combination therapy group was confirmed to be 20.1%, approximately 4 times higher than the 5.1% of the sorafenib monotherapy group. In addition, the complete response (CR) was 3.1% in the Imfinzi-Imudo combination therapy group, but only 0% in the sorafenib monotherapy group.
The median length of response in the Imfinzi-Imudo combination therapy group was 22.3 months, and in the Sorafenib monotherapy group, 18.4 months. In the fenib monotherapy group, it was confirmed to be 3.8 months.
In terms of safety, the incidence of grade 3 or higher grade 3 or higher side effects in the Imfinzi-Imudo combination therapy group was 25.8% and in the Sorafenib monotherapy group 36.9%.
Imfinzi-Imudo combination therapy increases the activation of T cells, which are immune cells, by first administering Imfinzi, which inhibits CTLA-4 cells, and then periodically administering Imfinzi to reduce the protein PD-L1 on the surface of cancer cells. selectively inhibiting T cell activation, it shows a significant therapeutic effect. The National Comprehensive Cancer Network (NCCN) oncology treatment guidelines also recommend Imfinzi-Imudo combination therapy as the standard treatment for first-line systemic treatment for advanced or unresectable hepatocellular carcinoma.
“Hepatocellular carcinoma has a poor prognosis, accounting for about 75.1% of liver cancer cases with a relative 5-year survival rate of only 38.7% among major carcinomas in Korea,” said Yang Mi-sun, executive director of the anti – AstraZeneca cancer. The combination therapy is the first dual immuno-oncology therapy introduced in the first-line treatment of hepatocellular carcinoma, and is expected to contribute to improving the treatment outcomes of hepatocellular carcinoma in Korea by maximizing the benefits of immuno-oncology.”
“In the future, AstraZeneca Korea’s anti-cancer division will do its best to improve the survival and quality of life of cancer patients by increasing access to treatment for lung cancer, biliary tract cancer, and hepatocellular carcinoma through Imfinzi,” he added.
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