Mirati Announces Latest Results of KRAS Inhibitor for Non-Small Cell Lung Cancer

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Mirati Announces Latest Results of KRAS Inhibitor for Non-Small Cell Lung Cancer

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Mirati Announces Latest Results of KRAS Inhibitor for the Treatment of Non-Small Cell Lung Cancer.

Mirati Therapeutics announced positive results from a Phase 2 clinical trial of its KRAS G12C inhibitor adagrasib in previously treated non-small cell lung cancer patients with KRAS G12C mutations.

Currently adagrasib is under review by the US FDA. 

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.

As of October 15, 2021, among 112 evaluable patients, the objective response rate was 43% and the disease control rate was 80%.

The median duration of response was 8.5 months (95% CI, 6.2-13.8), and the median progression-free survival was 6.5 months. As of January 15, 2022, the median overall survival was 12.6 months.

The company also published results from a retrospective exploratory analysis of a subset of patients with stable, previously treated central nervous system (CNS) metastases in the Phase 2 clinical trial.

In this subgroup of patients, adagrasib demonstrated a 33% intracranial objective response rate and an 85% intracranial disease control rate.

In terms of safety, the safety profile of adagrasib in this study was similar to previous reports, and no new safety signals were identified.

The most common treatment-related adverse events (TRAEs) were gastrointestinal events and exhaustion. The majority were grades 1-2 (53%), with grades 3-4 TRAEs occurring in 43% of patients and grade 5 TRAEs in 2 patients.

TRAE led to discontinuation of treatment in 7% of patients.

References:

[1] Investigational Adagrasib Delivers Positive Results in Registration-Enabling Study of Patients with KRASG12C-Mutated Advanced Non-Small Cell Lung Cancer. Retrieved May 26, 2022, from https://ir.mirati.com/press-releases/press- release-details/2022/Investigational-Adagrasib-Delivers-Positive-Results-in-Registration-Enabling-Study-of-Patients-with-KRASG12C-Mutated-Advanced-Non-Small-Cell-Lung-Cancer/default.aspx

(source:internet, reference only)

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