Advantages of dosage and half-life over Tabrecta… Differentiation of liquid biopsy data
[Newsmp] Merck Biopharma Korea has come to be the second company in Korea to launch a treatment for non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations, Tepmetko.
The company explained that it has various advantages such as dosage and duration of efficacy, as well as data on liquid biopsy in the genetic mutation test, compared to Novartis’ product released in the first half.
Tepmetko was approved by the U.S. Food and Drug Administration in February 2021 and the Korean Ministry of Food and Drug Safety last November for a lung cancer treatment for patients with metastatic NSCLC MET exon 14 skipping alterations.
The approval was based on the VISION clinical trial, which was the largest clinical trial conducted on NSCLC patients with MET exon 14 skipping mutations.
According to the most recently published clinical results, the median progression-free survival (PFS) was 15.3 months, and the objective response rate (ORR) was 56.8 percent.
The median duration of response (DoR) was 46.4 months, and the median overall survival (OS) was 25.9 months, showing long-term and continuous antitumor activity.
Considering that the OS of MET exon 14 skipping mutation positive NSCLS is known to not exceed one year, it is said that it indicated a life prolonged effect.
In this regard, Merck Biopharma Korea held a press release at Lotte Hotel in Seoul to celebrate the launch of Tepmetko.
At this conference, Seo Beom-jun, Manager of Merck Biopharma Korea’s medical division, said that Tepmetko has various advantages compared to Tabrecta (Novartis, ingredient: capmartinib), which was released in April.
Seo said that Tepmetko has a half-life of 30 hours, which is longer than Tabrecta’s six to seven hours, and fewer tablets to be taken once a day, which leads to patient adherence to the medication advantage.
In addition, there is no difference in efficacy between patients diagnosed with liquid biopsy and those diagnosed with tissue biopsy, so it is evaluated that it can provide more opportunities to patients.
However, Myung-joo Ahn, a professor of the department of hemato-oncology at Samsung Medical Center, who introduced the major clinical results of Tepmetko, stressed that there is not a significant difference in the effectiveness of the two drugs.
She pointed out that it is unreasonable to compare the safety and efficacy of the two drugs while there is an absence of direct comparative study results, as various differences may occur in clinical studies.
Nevertheless, as the results of the liquid biopsy can be confirmed faster at the clinical site, Ahn believed the results of the study that there is no significant difference from the biopsy are meaningful.
Moreover, the safety and efficacy of Tepmetko were similar in Asians, who account for 30% of the total 152 patients participating in the VISION study, including 20 Korean participants.
Professor Ahn added that Tepmetko’s drug resistance was excellent not only in clinical results but also in actual clinical sites.
