By Angus Liu | Feb 11, 2020 11:48am
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.
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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