Enhertu's petition subcommittee is announced

discussion next week

With the consent of 50,000 people, the Welfare Committee was presented in February

The 'answer' to the national petition urging insurance coverage for the next-generation ADC anti-cancer drug Enhertu is expected to come out soon.

 

According to the related industry, Daiichi Sankyo Korea and AstraZeneca Korea's HER2-positive breast cancer treatment, Antibody-drug conjugate (ADC) Enhertu, will be submitted to the Petition Review Subcommittee next week.

 

As a result, attention is paid to how it will affect the Enhertu benefit listing process.

 

The drug was referred to the Health and Welfare Committee of the National Assembly last month after a petition urging health insurance approval at the beginning of this year gained the consent of 50,000 people.

 

Enhertu, based on the DESTINY-Breast01 and DESTINY-Gastric01 clinical studies from the Ministry of Food and Drug Safety in September of last year, Enhertu is ▲unresectable or metastatic HER2-positive breast cancer who have previously received two or more anti-HER2-based therapies and ▲previously anti-HER2 anti-HER2 approved for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more therapies, including treatment.

 

Also, in December, based on the DESTINY-Breast03 clinical trial, it received approval for an expanded indication for the treatment of patients with unresectable or metastatic HER2-positive breast cancer who had previously received one or more anti-HER2-based therapies.

 

Enhertu is an antibody-drug conjugate.

 

The antibody-drug conjugate uses the selectivity for the target and the killing activity of the drug to selectively act only on cancer cells, thereby increasing the therapeutic effect and minimizing side effects.

 

Ra Seon-young, a professor of oncology at Yonsei Cancer Hospital, said, "Enhertu is the first and only HER2-targeted therapy that has demonstrated a survival period of more than one year as a treatment for advanced gastric cancer after treatment with Trastuzumab.

 

"Considering the small number of patients, we hope that the reimbursement will be applied as soon as possible," she said.

 

In the Enhertu DESTINY-Breast03 study, a head-to-head treatment with T-DM1 showed a significant improvement in PFS in patients with unresectable or metastatic HER2-positive breast cancer who had previously received one or more anti-HER2 therapies.

 

In the interim analysis updated in 2022, mPFS was 28.8 months in the Enhertu group, 22 months longer than 6.8 months in the T-DM1 group, and overall survival (OS), a major secondary endpoint, was higher in the Enhertu group than in the T-DM1 group It showed a statistically significant result that reduced the risk of death by 36% compared to Enhertu's DESTINY-Breast01 trial confirmed sustained antitumor effects in patients with unresectable or metastatic HER2-positive breast cancer who had previously received two or more anti-HER2 therapies including T-DM1, Trastuzumab, and Pertuzumab.

 

As a result of the study, Enhertu showed a confirmed ORR of 60.9%) and mPFS of 16.4 months.

 

The mDOR was 14.8 months, showing a sustained antitumor effect even in severely ill patients with a median number of previous anticancer drugs reaching 6 (range 2-27).