Mirati Therapeutics Presents Positive Clinical Data with Investigational Adagrasib as Monotherapy and in Combination with Cetuximab in Patients with KRAS G12C-Mutated Colorectal Cancer
SAN DIEGO, Sept. 19, 2021 /PRNewswire/ --?Mirati Therapeutics, Inc.?(NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced results from a cohort of the Phase 1/2 KRYSTAL?1 study evaluating?adagrasib?at the 600mg BID dose as both monotherapy and in combination with cetuximab in patients with heavily pretreated colorectal cancer harboring a?KRASG12C?mutation. Results showed that?adagrasib?alone and with cetuximab demonstrated significant clinical activity and broad disease control in these patients. The findings (Abstract # LBA6) will be presented today at 9:47 a.m. ET as a late-breaking oral presentation during the Presidential Symposium II session at the European Society for Medical Oncology Congress (ESMO) 2021.
"Patients living with?KRAS-mutated colorectal cancer face a significant medical need for new treatment options," said Dr. Jared Weiss M.D., lead study investigator and associate professor of medicine, division of oncology at University of North Carolina-Chapel Hill. "The positive results presented today show that?adagrasib?alone or in combination with cetuximab may improve clinical outcomes in patients with colorectal cancer harboring a?KRASG12C?mutation."
Summary of Clinical Results
- As of May 25, 2021, 80% of patients enrolled in the?adagrasib?monotherapy arm (n=46) received at least two prior lines of systemic anticancer therapies, and had a median follow up of 8.9 months. Of the evaluable patients (n=45), results showed an investigator assessed response rate (RR) of 22%, including one unconfirmed partial response (PR), and a disease control rate (DCR) of 87%; the median duration of response (DOR) was 4.2 months. In all enrolled patients, the median progression free survival (PFS) was 5.6 months (95% Confidence Interval, CI: 4.1,8.3).
- As of July 9, 2021, 90% patients enrolled in the?adagrasib?plus cetuximab arm (n=32) received at least two prior lines of systemic anticancer therapies, and had a median follow up of 7 months. Of the evaluable patients (n=28), results showed an investigator assessed RR of 43%, including two unconfirmed PRs and a DCR rate of 100%. After the data cutoff date, of the two unconfirmed PRs, follow up scans showed one patient had a confirmed PR, and the second patient progressed. At the time of the analysis, 63% (20/32) of enrolled patients remained on treatment.
- Adagrasib?monotherapy and in combination with cetuximab was well-tolerated in this study, with a manageable safety profile. Grade 3/4 treatment related adverse events (TRAEs) were observed in 30% of patients treated with?adagrasib?alone, and in 16% of patients treated with the combination. Treatment related adverse events led to treatment discontinuation in 6% of patients who received combination therapy and in none (0%) of those who received?adagrasib?monotherapy. No Grade 5 TRAEs were observed in either treatment arm.
- A top-line update from the Phase 2 registrational cohort of the KRYSTAL-1 study evaluating?adagrasib?in previously-treated patients with KRASG12C-mutated non-small cell lung cancer (NSCLC)
- Findings from the CRC cohort of the Phase 1/2 KRYSTAL-1 study evaluating?adagrasib?as monotherapy and in combination with cetuximab in patients with heavily pretreated CRC harboring the?KRASG12C?mutation, as presented at the 2021 ESMO Congress
- Results from the Phase 2 MRTX-500 study evaluating?sitravatinib?combined with nivolumab in patients with non-squamous NSCLC who progressed on or after prior checkpoint inhibitor therapy, to be presented at the 2021 ESMO Congress
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