Enhertu seeks reimb for HER2-low breast cancer and NSCLC

Applies for insurance reimbursement listing… HIRA’s review underway

The ADC anticancer drug 'Enhertu' has started a new reimbursement journey in Korea.

 

According to industry sources, Daiichi Sankyo Korea submitted an application to receive reimbursement for two additional indications of its antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in December last year and recently began discussions with the Health Insurance Review and Assessment Service.

 

Specifically, the company applied for reimbursement of the following indications: ▲ the treatment of patients with unresectable or metastatic HER2-low expression (IHC 1+ or IHC 2+/ISH-) breast cancer who have previously received systemic therapy in the metastatic setting or have relapsed during, or within six months of completing adjuvant chemotherapy, in the case of hormone receptor-positive (HR+) breast cancer patients, those who have received additional endocrine therapy or are not suitable for endocrine therapy; and ▲ patients with unresectable or metastatic non-small cell lung cancer with an activating HER2 (ERBB2) mutation in the tumor who have previously received systemic therapy including platinum-based chemotherapy.

 

These indications were approved in Korea in May 2024.

 

Enhertu was first listed as a treatment for HER2-positive breast cancer in April of the same year, but there have been persistent calls for the prompt expansion of its coverage to the HER2 low-expression indication, which is currently under discussion.

 

In fact, a petition calling for the expansion of Enhertu’s reimbursement has garnered the support of more than 50,000 people.

 

Therefore, it will be interesting to see whether Enhertu will be reimbursed for breast cancer patients with low HER2 expression and the newly added lung cancer indication.

 

Meanwhile, Enhertu has confirmed its efficacy for 2 additional indications through the DESTINY-Breast04 and DESTINY-Lung02 studies.

 

DESTINY-Breast04 compared the efficacy and safety of Enhertu and a chemotherapy regimen of the physician’s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in 557 patients with unresectable or metastatic HER2-low breast cancer who had previously received first or second lines of chemotherapy.

 

Results showed that the median progression-free survival (mPFS) of the Enhertu group in the cohort of patients with hormone receptor-positive tumors was 10.1 months, demonstrating a significant improvement compared to the 5.4 months of the control group.

 

Enhertu also reduced the risk of disease progression or death by 50% compared to the control group in the overall patient cohort, which included both hormone receptor-positive and negative tumors.

 

In addition, Enhertu showed antitumor activity in the second-line treatment of HER2-mutated metastatic non-small cell lung cancer in the DESTINY-Lung02 study.

 

The study evaluated the efficacy and safety of Enhertu in patients with unresectable or metastatic non-small cell lung cancer whose disease progressed after one or more systemic therapy treatments, including platinum-based chemotherapy.

 

Results showed Enhertu recorded a confirmed objective response rate (Confirmed ORR) of 49%, complete response (CR) of 1%, and partial response (PR) of 48%, as assessed by a blinded independent central review (BICR).