KRAS inhibitors: Phase 2 clinical results positive for pancreatic and gastrointestinal cancers
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KRAS inhibitors: Phase 2 clinical results positive for pancreatic and gastrointestinal cancers.
100% disease control rate in patients with pancreatic and gastrointestinal cancers with positive Phase 2 results for KRAS inhibitor
Mirati Therapeutics announced today that its KRAS G12C inhibitor adagrasib has achieved positive results in a Phase 2 clinical trial called KRYSTAL-1.
In a cohort of previously treated patients with pancreatic ductal adenocarcinoma and other gastrointestinal (GI) cancers harboring a KRAS G12C mutation, adagrasib demonstrated significant clinical activity and broad disease control.
Adagrasib is a highly specific and potent oral KRAS G12C inhibitor optimized for durable target inhibition. Adagrasib has a half-life of up to 24 hours, broad tissue distribution, and its ability to cross the blood-brain barrier, helping to maximize drug efficacy.
In June last year, the U.S. Food and Drug Administration granted it breakthrough therapy designation for the treatment of previously treated non-small cell lung cancer patients with the KRAS G12C mutation.
▲Design features of Adagrasib (Image source: Mirati’s official website)
The test results show:
As of September 10, 2021, the objective response rate (ORR) among evaluable patients (n=27) was 41%, and the disease control rate (DCR) was 100%.
Among evaluable pancreatic cancer patients (n=10), response rate (RR) was 50%, including 1 unconfirmed partial response (PR); median duration of response (mDOR) was 7.0 months, median Follow-up time was 8.1 months.
Among patients with other GI tumors (n=17), the RR was 35% and there were 2 unconfirmed PRs; these patients had an mDOR of 7.9 months and a median follow-up of 6.3 months.
Median progression-free survival (mPFS) was 6.6 months (95% CI: 1.0-9.7) for patients with pancreatic cancer and 7.9 months (95% CI 6.90-11.30) for patients with other GI tumors.
Adagrasib was well tolerated and had a manageable safety profile. Grade 3/4 treatment-related adverse events (TRAEs) were observed in 27% of patients treated with adagrasib, no TRAEs leading to treatment discontinuation, and no grade 5 TRAEs were observed.
References:
[1] Mirati Therapeutics Presents Positive Clinical Data with Investigational Adagrasib in Patients with KRASG12C-Mutated Gastrointestinal Cancers. Retrieved January 21, 2022, from https://www.prnewswire.com/news-releases/mirati-therapeutics-presents-positive- clinical-data-with-investigational-adagrasib-in-patients-with-krasg12c-mutated-gastrointestinal-cancers-301465506.html
KRAS inhibitors: Phase 2 clinical results positive for pancreatic and gastrointestinal cancers
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