Mirati Therapeutics to Present New Research at the 2022 ASCO Annual Meeting Showcasing Clinical Advances of Treating KRASG12C-Mutated Lung Cancer with Investigational Adagrasib

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Mirati Therapeutics (Nasdaq: MRTX) announced exciting new data regarding its investigational KRAS^G12C inhibitor, adagrasib, at the 2022 ASCO Annual Meeting. The results focus on patients with pre-treated non-small cell lung cancer (NSCLC) harboring the KRAS^G12C mutation, including those with untreated central nervous system (CNS) metastases. Mirati also revealed that the NDA for adagrasib is under FDA review for Accelerated Approval. An upcoming virtual investor event will be held on June 6, 2022, to discuss these findings in detail.

• Full results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib in patients with pre-treated non-small cell lung cancer (NSCLC) harboring a KRAS^G12C mutation
• Late-breaking data on adagrasib in patients with KRAS^G12C-mutated NSCLC with active and untreated central nervous system (CNS) metastases
• Company to host Virtual Investor Event on Monday, June 6, 2022 at 8 PM ET/7 PM CT to discuss highlights from ASCO 2022

SAN DIEGO, April 27, 2022 /PRNewswire/ -- Mirati Therapeutics, Inc. (Nasdaq: MRTX), a clinical-stage targeted oncology company today announced the presentation of new clinical research showcasing the potential of its investigational KRAS^G12C inhibitor, adagrasib, in a study of patients with KRAS^G12C-mutated non-small cell lung cancer (NSCLC) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3 to 7, 2022 in Chicago, IL.

"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 congress includes important insights into adagrasib's clinical profile in patients with NSCLC who harbor a KRAS^G12C 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 KRAS^G12C 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 KRAS^G12C 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 KRAS^G12C mutation who have received at least one prior systemic therapy.

Mirati presentations at the 2022 ASCO 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 KRAS^G12C 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 KRAS^G12C-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 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 KRAS^G12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRAS^G12C-mutated cancers, as the KRAS^G12C 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 KRAS^G12C-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 KRAS^G12C-mutated cancers, regardless of tumor type, in the U.S. Learn more about the EAP at Mirati.com/expanded-access-policy.

About Mirati Therapeutics, Inc.  

Mirati Therapeutics, Inc. is a clinical-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet medical need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.  For more information about Mirati, visit us at Mirati.com or follow us on Twitter, LinkedIn and Facebook.

Forward Looking Statements

This press release contains certain forward-looking statements regarding the business of Mirati Therapeutics, Inc. ("Mirati"). Any statement describing Mirati's goals, expectations, financial or other projections, intentions or beliefs, development plans and the commercial potential of Mirati's drug development pipeline, including without limitation adagrasib (MRTX849), sitravatinib, MRTX1133, MRTX1719 and MRTX0902 is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to risks and uncertainties, particularly those challenges inherent in the process of discovering, developing and commercialization of new drug products that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.

Mirati's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Mirati's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Mirati. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Mirati's programs are described in additional detail in Mirati's quarterly reports on Form 10-Q and annual reports on Form 10-K, which are on file with the U.S. Securities and Exchange Commission (the "SEC") available at the SEC's Internet site (www.sec.gov). Mirati assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

Mirati Contacts:

Investor Relations: ir@mirati.com

Media Relations: media@mirati.com 

 

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SOURCE Mirati Therapeutics, Inc.

FAQ

What were the key findings about adagrasib presented by Mirati Therapeutics at ASCO 2022?

Mirati presented data showing the effectiveness of adagrasib in pre-treated patients with KRAS^G12C-mutated non-small cell lung cancer, particularly those with untreated CNS metastases.

When is the virtual investor event for Mirati Therapeutics scheduled?

The virtual investor event is scheduled for June 6, 2022, at 8 PM ET.

What is the significance of the NDA submission for adagrasib by Mirati?

The NDA for adagrasib is under review by the FDA for Accelerated Approval, which indicates a potential early access to this treatment for eligible patients.

What is the KRYSTAL-1 study related to adagrasib?

The KRYSTAL-1 study evaluates the activity and safety of adagrasib in patients with advanced KRAS^G12C mutated non-small cell lung cancer.

What sessions will Mirati Therapeutics present at ASCO 2022?

Mirati will present two sessions focusing on the activity of adagrasib in KRAS^G12C-mutated NSCLC and in patients with active untreated CNS metastases.