Tepmetko targets rare lung cancer target with reimbursement

After 3 attempts, the drug for patients with MET-mutated non-small cell lung cancer is covered by national health insurance

In the VISION study, the ORR for Asian patients, including Koreans, was 64%, and PFS was 16.5 months

Targeted therapy is expected to be effective in elderly patients with low response rates to immune-oncology drugs

Merck is seeking to increase the market influence of Tepmetko (tepotinib), which was granted reimbursement 3 years after its approval, by improving treatment access.

 

Although the MET mutation is a rare mutation that occurs in 1.8-3.1% of non-small cell lung cancer patients in Korea, it is evaluated that the drug’s reimbursement will have a significant effect as it increases the success rate when early diagnosis and appropriate treatment are carried out.

 

Ji-Youn Han, professor of Hemato-Oncology at the National Cancer Center,

On the 15th, Merck Biopharma Korea held a press conference to shed light on the implications brought by Tepmetko’s reimbursement, a treatment for non-small cell lung cancer with MET exon 14 deletion mutation.

 

In Korea, MET mutations in non-small cell lung cancer are known to cause resistance to other anticancer treatments and have a high rate of metastasis to bones, the brain, etc., which is associated with poor patient prognosis.

 

In addition, most patients are elderly, which lowers the response rate to immuno-oncology drugs, and most patients relapse within 5 months.

 

“MET-mutated non-small cell lung cancer has a poor prognosis, and brings threefold increased risk of death compared to those without mutations,” said Ji-Youn Han, a professor of Hemato-Oncology at the National Cancer Center, who presented at the press conference.

 

”Most patients are elderly, have a low response rate to immuno-oncology drugs, and have difficulty tolerating strong side effects, so there was a high unmet need for MET-mutation targeted therapies.” Tepmetko’s reimbursement was based on the Phase II VISION study in patients with MET-mutated NSCLC.

 

In the 32.6-month follow-up of 313 patients diagnosed by liquid biopsy or tissue biopsy, Tepmetko showed an objective response rate (ORR) of 58.6%, median progression-free survival (PFS) of 15.9 months, median overall survival (OS) of 29.7 months, and median duration of response (DoR) of 46.4 months in patients diagnosed by tissue biopsy and with no previous treatment experience.

 

These results were consistent regardless of treatment line, biopsy method, etc., and showed consistent efficacy in Asian patients, including Koreans.

 

In a subgroup analysis of 106 Asian patients, the ORR of patients who were initially treated with Tepmetko was 64%, with a median PFS of 16.5 months, a median OS of 32.7 months, and a median DoR of 20.7.

 

“The importance of personalized treatment based on MET mutations is being emphasized in the non-small cell lung cancer setting.

 

Tepmetko has demonstrated consistent effects regardless of the treatment line in Asians,” said Professor Han.

 

Although Tepmetko has demonstrated its effect through clinical results, the company had to jump over high hurdles to be included in the reimbursement list.

 

After failing to set the reimbursement criteria twice, including during the Health Insurance Review and Assessment Service's Cancer Disease Review Committee meeting, the company voluntarily withdrew its reimbursement application, and submitted a new application in July last year, which led to the current result.

 

As a result, Tepmetko became the first treatment option in the same class to be listed for reimbursement, ahead of Tabrecta (capmatinib), an anticancer drug that was approved in Korea at the same time in 2021.

 

Currently, Tepmetko is expected to quickly settle into the prescription environment as it has passed the Drug Committees (DCs) of more than 30 medical institutions nationwide, including the Big 5 tertiary hospitals such as Samsung Medical Center and Seoul National University Hospital.

 

“From the perspective of a doctor treating patients in the clinical setting, we need more treatment options to keep patients alive and improve their quality of life,” said Professor Han.

 

”I think this coverage of Tepmetko is a positive step because it means patients can use it without financial burden.” “We hope that this reimbursement of Tepmetko will play an important role in the future treatment environment in Korea,” said Christoph Hamann, General Manager of Merck BioPharma Korea.

 

”Merck will continue to endeavor to drive innovation at the forefront in the field of cancer treatment and will continue to strive to improve the intractable cancer treatment environment.”