Mirati Posts Adagrasib Data In KRAS-Mutated Lung Cancer, FDA Filing Now On The Cards

After data readout from KRAS drug adagrasib in colon cancer, Mirati Therapeutics Inc MRTX has announced positive topline results from a Phase II cohort of its KRYSTAL-1 study of adagrasib in non-small cell lung cancer (NSCLC).
Adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic NSCLC containing a KRAS-G12C mutation.
The Phase II monotherapy, which Mirati calls "potentially registration-enabling" adagrasib, posted an 80% disease control rate on June 15, with 98.3% of patients previously treated with immunotherapy and chemo.
Full results from the cohort will have to wait for a medical meeting early next year, Mirati said.
Additionally, Mirati reported updated findings from the Phase 1/1b KRYSTAL-1 study evaluating adagrasib 600mg BID in 19 patients enrolled with KRASG12C-mutated advanced NSCLC.
As of the June 15, 2021 data cutoff, results showed an ORR was 58%.
The median follow-up was 17.3 months. The median duration of treatment and response was 9.5 months and 12.6 months, respectively.
The median progression-free survival was 8.3 months, and the median overall survival was not reached.
Grade 3/4 treatment-related adverse events were observed in 26% of patients, with one Grade 5 event.
The Company plans to submit an FDA marketing application in Q4 of 2021.
Price Action: MRTX stock is down 2.33% at $170.00 during the premarket session on the last check Monday.