MET inhibitor Tepmetko enters last stage to reimb in KOR

Agenda passed DREC review in December last year and has started drug pricing negotiations with the NHIS

Achievement made 3 years after domestic approval, the emergence of the first treatment option in sight

MET-targeted anticancer drug ‘Tepmetko’ has entered the final gateway to insurance reimbursement nearly 3 years after its domestic approval.

 

According to industry sources, Merck Korea has recently started negotiating drug prices with the National Health Insurance Service for its Tepmetko (tepotinib), a treatment for locally advanced or metastatic non-small cell lung cancer with a confirmed MET exon 14 skipping mutation.

 

The drug passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in December last year.

 

Tepmetko obtained domestic approval and went through the reimbursement process in 2021 at the same time as the same mechanism drug Tabrecta (capmatinib).

 

However, no MET cancer drug has been listed for reimbursement in Korea yet.

 

Therefore, it remains to be seen whether Tepmetko will complete the reimbursement process.

 

The drug has failed to meet the criteria for insurance reimbursement twice, including failing review by the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee in March.

 

It then voluntarily suspended the coverage process and submitted another application for coverage in July, and this time, it passed the committee.

 

This achievement was made 3 years after its domestic approval.

 

Non-small cell lung cancer accounts for 80% of all lung cancer diagnoses.

 

MET exon 14 skipping mutation is a rare type of cancer that is present in approximately 3-4% of these patients.

 

In Korea, of the 1,020 NSCLC patients in Korea, 1.9% of the NSCLC patients were confirmed to have MET exon 14 deletion.

 

Tepmetko’s efficacy was demonstrated through the VISION study, which enrolled the largest number of NSCLC patients with MET exon 14 skipping mutations.

 

The results showed a significant life extension effect, with a median progression-free survival (PFS) of 15.3 months and an objective response rate (ORR) of 56.8 percent.

 

The median duration of response (DoR) was 46.4 months, and the median overall survival (OS) was 25.9 months, showing continuous antitumor activity in the long term.

 

Also, according to a presentation by Ji-Youn Han, Professor of Oncology at the Center for Lung Cancer at the National Cancer Center, which was at the Korean Association for Lung Cancer International Conference last year after analyzing 79 Asian patients that participated in the VISION study, the ORR was quite high at 66.7%, and 48.1% in the second-line treatment group.

 

Meanwhile, Tepmetko also showed significant results in a follow-up analysis of Asian patients enrolled in the pivotal Phase III VISION study.

 

In this analysis, Tepmetko demonstrated an objective response rate of 56.6%, a median duration of response of 18.5 months, a median progression-free survival of 13.8 months, and a median overall survival of 25.5 months.

 

The objective response rate was 64.0% in treatment-naïve Asian patients, confirming previous findings that the first dose was more effective.

 

No new safety information was identified, with 39.6% of patients experiencing grade 3 or higher adverse events.

 

In addition, Tepmetko has now passed the Drug Committees (DCs) of more than 30 medical institutions nationwide, including the Big 5 tertiary hospitals - Samsung Medical Center, Seoul National University Hospital, and Seoul St.

 

Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital.