Merck KGaA reports positive results for M7824, tepotinib in lung cancer studies

Merck KGaA released positive data ahead of presentation at the American Society of Clinical Oncology (ASCO) annual meeting for its two experimental drugs M7824 and tepotinib in patients with advanced non-small-cell lung cancer (NSCLC). Bernstein analyst Wimal Kapadia remarked "it is early data, but investors will struggle to ignore the potential, particularly given the lack of expectations on both assets." 

In a Phase I study, patients with advanced NSCLC who progressed following standard first-line therapy were assigned to treatment with M7824 at one of two doses. Results showed that the higher dose of M7824 was associated with an overall response rate of 40.7 percent in 27 patients with PD-L1 positive tumours, while the overall response rate was 71.4 percent in seven subjects with high PD-L1 expression.  

Commenting on the results for M7824, which is a TGF‑ß trap/anti-PD-L1 bi-functional immunotherapy fusion protein, Kapadia said "Merck will not have a problem finding a partner with this data set," noting that competing immunotherapies generally produce response rates in the range of 15 percent to 20 percent.

Meanwhile, the Phase II VISION study enrolled patients with advanced NSCLC harbouring MET exon 14 skipping mutations, with 15 subjects who received tepotinib available for evaluation. Data showed that 60 percent of patients given the c-Met inhibitor had a confirmed partial response, with 20 percent of patients exhibiting stable disease.

Last month, Merck identified tepotinib as one of a number of investigational assets for which it was holding discussions with potential partners regarding joint development. The treatment was previously awarded fast track designation for the treatment of NSCLC in patients harbouring MET exon 14 skipping mutations in Japan.

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