On June 20, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported that the Journal of Clinical Oncology published clinical results from the KRYSTAL-1 study of adagrasib, a potent and selective KRASG12C inhibitor, demonstrating durable IC activity in patients living with KRASG12C-mutated NSCLC with untreated CNS metastases (Press release, Mirati, JUN 20, 2023, View Source [SID1234632804]). This result is clinically meaningful as CNS metastases are present in 27%-42% of patients living with KRASG12C-mutated NSCLC at diagnosis and are linked to worse prognosis and higher rates of disease progression in the CNS. Read the publication, here.

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Data with adagrasib from KRYSTAL-1 demonstrating the first prospective evaluation of a KRASG12C inhibitor in untreated CNS metastases were based on 25 enrolled patients (19 radiographically evaluable per CNS RECIST v1.1) who had received a median of 1 prior systemic therapy. Results showed an IC objective response rate (ORR) of 42% and IC disease control rate of 90%. High concordance between IC and systemic activity was observed. The median IC progression-free survival was 5.4 months and median overall survival 11.4 months. Notably, findings demonstrate a manageable safety profile consistent with previous reports of adagrasib with few CNS-specific adverse events. The publication of this data follows the recent inclusion of adagrasib in the NCCN guidelines for CNS Cancers.

"We are pleased that JCO, the NCCN, and the oncology community has recognized the importance and potential impact of adagrasib’s strong clinical results in patients living with KRASG12C-mutated NSCLC with untreated CNS metastases. This is a patient population with a high unmet need for which few treatment options exist," said Alan Sandler, M.D., chief medical officer, Mirati Therapeutics, Inc. "This practice-informing publication reinforces the potential of adagrasib as a best-in-class KRASG12C inhibitor and underscores its ability to drive meaningful clinical activity in the CNS. We look forward to the continued development of adagrasib for the potential benefit of patients living with cancer."

About KRAZATI (adagrasib)
In the U.S., KRAZATI was approved by the FDA for Accelerated Approval (Subpart H), which allows for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on surrogate endpoints. KRAZATI was reviewed under the FDA Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Mirati submitted a Marketing Authorization Application (MAA) in the EU in May 2022. In 2021, adagrasib achieved Breakthrough Therapy Designation in the U.S. as a potential treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy. For Prescribing Information, visit Mirati.com/KRAZATI_USPI

Adagrasib continues to be evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC, colorectal cancer, and pancreatic cancer. For more information, visit Mirati.com/science.

KRAZATI (adagrasib) U.S. Indication
KRAZATI is indicated for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).