Tepmetko granted reimb for METex14+ NSCLC

Merck Korea’s Tepmetko is granted reimbursement for treating adult patients with locally advanced unresectable or metastatic NSCLC harboring METex14skipping alterations

Confirmed continued efficacy from VISION study's long-term follow-up results

Pic of Tepmetko

On the 31st, Merck Korea announced that its Tepmetko (ingredient name: tepotinib), a treatment for MET-ex14 deletion-mutated non-small cell lung cancer, will be reimbursed as of the 1st of next month.

 

Accordingly, Tepmetko is now covered by reimbursement for patients with locally advanced or metastatic non-small cell lung cancer with MET exon 14 deletion, regardless of the treatment line (first or later line).

 

As a result, patients with MET exon 14 deletions may now use Tepmetko as a first-line treatment and receive reimbursement.

 

MET mutations, which occur in 1.8-3.1% of NSCLC patients in Korea, are very rare.

 

They cause resistance to other anticancer treatments and have a high rate of metastasis to bones and the brain, which leads to poor patient prognosis.

 

In addition, most patients are elderly and have a low response rate to immune checkpoint inhibitors, and most patients relapse within 5 months.

 

Tepmetko’s reimbursement is 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.

 

“Patients with MET mutations have a poor prognosis, with many being elderly patients dying within a year, and there are limitations to existing reimbursement options such as chemotherapy or immunotherapy, so domestic and international guidelines recommend first using TKIs that target the right mutations,” explained Jin Seok Ahn, Professor of Hematology-Oncology at Samsung Medical Center.

 

“Tepmetko is a useful treatment that can prevent disease progression compared to the current standard of care in the first line,” said Professor Ahn.

 

”With the reimbursement approval greatly improving access to treatment, we should actively utilize next-generation sequencing that has a short average test time to provide effective treatment options for patients with MET mutations and provide personalized treatment for patients with MET mutations.”