On April 27, 2022 Mirati Therapeutics, Inc. (Nasdaq: MRTX), a clinical-stage targeted oncology company reported the presentation of new clinical research showcasing the potential of its investigational KRASG12C inhibitor, adagrasib, in a study of patients with KRASG12C-mutated non-small cell lung cancer (NSCLC) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3 to 7, 2022 in Chicago, IL (Press release, Mirati, APR 27, 2022, View Source [SID1234613076]).
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"Mirati continues to develop adagrasib with the goal of having a meaningful impact on patients with lung cancer," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "Our data at this year’s ASCO (Free ASCO Whitepaper) congress includes important insights into adagrasib’s clinical profile in patients with NSCLC who harbor a KRASG12C mutation, including those with active and untreated CNS metastases, which is a serious and potentially fatal complication for these patients. We believe adagrasib has the potential to transform the lives of those with KRAS-mutated cancers including lung, colorectal, pancreatic and other tumors that carry the KRASG12C mutation."
The adagrasib New Drug Application (NDA) is currently being reviewed by the U.S. Food and Drug Administration (FDA) for Accelerated Approval (Subpart H) as a treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy. The application is being 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. Adagrasib has also 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.
Mirati presentations at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting include:
Presentation Title: KRYSTAL-1: Activity and Safety of Adagrasib (MRTX849) in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring a KRASG12C Mutation
Author: Alexander I. Spira
Abstract Number: 9002
Session: Lung Cancer—Non-Small Cell Metastatic
Presentation Date/Time: Friday, June 3, 2022 at 2:24 to 2:36 PM ET/1:24 to 1:36 PM CT
Presentation Title: Activity of Adagrasib (MRTX849) in Patients with KRASG12C-Mutated NSCLC and Active, Untreated CNS Metastases in the KRYSTAL-1 Trial
Author: Joshua K Sabari
Abstract Number: LBA9009
Session: Clinical Science Symposium/Including the Excluded: Advancing Care for All Patients With Lung Cancer
Presentation Date/Time: June 6, 2022 at 5:30 to 5:42 PM ET/4:30 to 4:42 PM CT
Mirati will also host an exhibit at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting at booth number 2097.
Virtual Investor Event
Mirati Therapeutics will host an Investor Event on Monday, June 6, 2022 at 8:00 PM ET / 7:00 PM CT.
Investors and the general public are invited to register and listen to a live webcast of the event through the "Investors and Media" section on Mirati.com. A replay of the event will be available shortly after the conclusion of the event.
About Adagrasib (MRTX849)
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. Adagrasib is a being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.
Mirati has an Expanded Access Program (EAP) for investigational adagrasib for the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, in the U.S. Learn more about the EAP at Mirati.com/expanded-access-policy.