100% disease control rate in express pancreatic cancer and gastrointestinal cancer patients, positive phase 2 clinical results of KRAS inhibitor

▎WuXi AppTec Content Team Editor 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
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Adagrasib is a highly specific and potent oral KRAS G12C inhibitor optimized for durable target inhibition
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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
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In China, Zai Lab owns the development rights of this innovative therapy in Greater China, and the clinical trial application jointly submitted with Mirati was accepted on November 1 last year
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▲Design features of Adagrasib (Image source: Mirati's official website) The results of the trial showed that as of September 10, 2021, the objective response rate (ORR) in evaluable patients (n=27) was 41%, and the disease control rate (DCR) is 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; the mDOR for these patients was 7.
9 months, and the median follow-up was 6.
3 months
.

The 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
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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
.

"We believe adagrasib has a differentiated molecular profile, and the newly presented data further supports its 'best-in-class' potential," said Dr.
Charles M.
Baum, founder, president and head of research and development at Mirati Therapeutics.
", adagrasib monotherapy has positive clinical activity in patients with GI cancers harboring KRAS G12C mutations, especially in pancreatic cancer patients with limited treatment options
.

We will continue to evaluate adagrasib monotherapy in a broad development program and in combination with other Cancer medicines constitute a combination therapy to help more cancer patients
.

"Reference: [1] Mirati Therapeutics Presents Positive Clinical Data with Investigational Adagrasib in Patients with KRASG12C-Mutated Gastrointestinal Cancers.
Retrieved January 21, 2022, from https:// presents-positive-clinical-data-with-investigational-adagrasib-in-patients-with-krasg12c-mutated-gastrointestinal-cancers-301465506.
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