Novartis bags FDA priority review in tight lung cancer race against Merck KGaA

Novartis
With an FDA priority review, Novartis hopes its capmatinib can beat Merck KGaA’s tepotinib to become the first targeted drug specifically approved to treat MET exon 14 skipping-mutated non-small cell lung cancer. (Novartis)

At last year’s American Society of Clinical Oncology annual meeting, both Novartis and Merck KGaA rolled out data for their drugs in a specific type of lung cancer. Now, it looks like Novartis is one step ahead.

An application for Novartis’ MET inhibitor, capmatinib, has been granted FDA priority review. The targeted use is in metastatic non-small cell lung cancer harboring MET exon 14 skipping mutations, a rare type that occurs in about 3% to 4% of newly diagnosed advanced NSCLC cases.

The designation slashes the FDA review period to six months. If approved on schedule, capmatinib could beat Merck KGaA’s tepotinib to become the first drug specifically meant to treat this subtype of NSCLC.

Novartis and Merck went on a face-off at ASCO last year. In the phase 2 Geometry mono-1 study, capmatinib triggered an overall response rate of 67.9% among treatment-naïve patients and 40.6% in those who had failed one or two rounds of chemo. The response lasted for a median 11.14 months in new patients and 9.72 months in previously treated patients.

In comparison, tepotinib posted an overall response rate of around 45% to 50% in all patients, with the difference separated by whether the patients’ tumor alterations were identified by liquid biopsy or tissue biopsy.

Both capmatinib and tepotinib have previously secured FDA fast track designation.

RELATED: AACR: Chi-Med, AstraZeneca's savolitinib helps some Tagrisso-resistant EGFR lung cancer patients

Meanwhile, both drugs are aiming to expand into EGFR-mutated, cMET-amplified NSCLC that has progressed after EGFR inhibitor treatment. Novartis is testing capmatinib alongside AstraZeneca’s Iressa in that setting. For Merck, it’s pairing tepotinib with AZ’s newer, more powerful TKI Tagrisso in the Insight 2 study.

In that area though, Chi-Med’s savolitinib seems to be the most advanced player. In collaboration with AZ, the Chinese company already posted some early results from the Tatton trial at last year’s American Association for Cancer Research annual meeting. It showed that in patients who developed MET-driven resistance to Tagrisso, 28% responded to the savo-Tagrisso combo, with the median response lasting 9.7 months. In those who relapsed after first- or second-generation TKI, the combo’s response rate hit 52%.

Novartis is working with Foundation Medicine to develop companion diagnostics for capmatinib for both tumor tissue and liquid biopsies.

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