European Commission Approves KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation

Rhea-AI Summary

Mirati Therapeutics, Inc. (NASDAQ: MRTX) receives conditional marketing authorization from the European Commission for KRAZATI® (adagrasib) as a targeted treatment option for adult patients with KRASG12C-mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy. The approval is based on the positive results from the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, demonstrating an efficacious and tolerable therapeutic option for patients living with advanced KRASG12C-mutated NSCLC.

Positive

• Conditional marketing authorization granted by the European Commission expands potential treatment options for patients with advanced KRASG12C-mutated NSCLC.
• Positive results from the Phase 2 registration-enabling cohort of the KRYSTAL-1 study demonstrate an efficacious and tolerable therapeutic option for patients living with advanced KRASG12C-mutated NSCLC.

Negative

• None.

Oncology Doctor

The conditional marketing authorization of KRAZATI by the European Commission marks a significant advancement in the treatment landscape for advanced non-small cell lung cancer (NSCLC) with a specific mutation, KRASG12C. This mutation has been historically challenging to target and the introduction of adagrasib provides a new mechanism of action that may improve patient outcomes. From a clinical standpoint, the drug's efficacy, as evidenced by the primary endpoints of objective response rate (ORR) and duration of response (DOR), is promising. It indicates a potential shift in the standard of care for this patient subset, offering a new line of therapy post-platinum-based regimen and immune checkpoint inhibitor treatment.

Furthermore, the tolerability profile is crucial for patient adherence and overall quality of life. The availability of an oral administration route is a notable advantage, enhancing convenience for patients compared to intravenous treatments. It is imperative to monitor post-marketing data to assess the long-term benefits and any emerging safety concerns that could influence clinical practice.

Market Research Analyst

The authorization of KRAZATI in the European Union is a strategic milestone for Mirati Therapeutics, potentially bolstering the company's market share in the oncology segment. The decision by the European Commission not only opens up a new revenue stream for Mirati but also establishes the company as a key player in the niche market of targeted therapies for KRASG12C-mutated NSCLC. The drug's 'best-in-class' potential signifies that it could outperform existing treatments in terms of efficacy or safety, which may lead to a rapid uptake in the EU market.

Considering the high unmet medical need in this area, KRAZATI's market entry is well-timed. The drug's performance in the KRYSTAL-1 study positions it favorably for adoption by healthcare providers. Market penetration will depend on factors such as pricing, reimbursement policies and the effectiveness of the company's commercial strategy in different EU countries. Stakeholders should monitor the drug's post-launch performance closely, as it could significantly influence Mirati's financial projections and stock valuation.

Financial Analyst

The conditional marketing authorization for KRAZATI represents a pivotal event that is likely to have a substantial impact on Mirati Therapeutics' financial health. The expansion into the European market can significantly increase the total addressable market for KRAZATI, which until now has been limited to the regions where it was previously approved. The financial implications include potential revenue growth and increased market capitalization, contingent on the drug's commercial success.

Investors should consider the costs associated with the commercialization process in the EU, including marketing, sales and distribution expenses. Moreover, the conditional nature of the authorization means that continued approval may depend on future confirmatory trials and real-world evidence, which introduces an element of risk to the company's revenue forecasts. Strategic partnerships or licensing agreements within the EU could be a factor in mitigating these risks and leveraging local market expertise.

SAN DIEGO and ZUG, Switzerland, Jan. 10, 2024 /PRNewswire/ -- Mirati Therapeutics, Inc.^® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced that the European Commission (EC) granted conditional marketing authorization for KRAZATI^® (adagrasib) as a targeted treatment option for adult patients with KRAS^G12C -mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy.

KRAZATI has demonstrated a positive benefit-risk profile based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating KRAZATI 600 mg administered orally twice daily in 116 patients with KRAS^G12C-mutated advanced NSCLC who previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor. The primary efficacy endpoints were confirmed ORR and DOR as evaluated by blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST v1.1).

"KRAZATI offers an efficacious and tolerable therapeutic option for patients living with advanced KRAS^G12C -mutated NSCLC and this approval expands the potential treatment options available," Martin Reck, MD, PhD, Lung Clinic Grosshansdorf, Germany. "With it's differentiated profile, KRAZATI offers an impactful treatment option for patients living with lung cancer. This approval will assist physicians in tailoring treatment approaches for patients."

Conditional marketing authorization for KRAZATI is valid in all 27 EU member states plus Iceland, Norway and Liechtenstein. This authorization follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in November 2023.

"This is a meaningful day for patients living with this difficult-to-treat cancer in the European Union as we can now offer a differentiated and potentially best-in-class therapeutic option to this underserved population," Charles Baum, M.D., PhD, founder, president and chief executive officer, Mirati Therapeutics, Inc., "Mirati is resolute in our commitment to improve upon treatment options for these patients and looks forward to continued partnership with EU members states to create broad access for all qualified patients."

Mirati thanks the patients, physicians, investigators and site coordinators who participated in the clinical trials that led to this important approval.

Important Safety Information

The Summary of Product Characteristics (SmPC) for KRAZATI (adagrasib) will be available from the European Medicines Agency at the Union Register of medicinal products.

About KRAZATI (adagrasib)

Mirati has risen to meet one of the most challenging mutations in cancer research by developing KRAZATI, a highly selective and potent oral small-molecule inhibitor of KRAS^G12C.

Intentionally designed to meet the challenge of KRAS^G12C, adagrasib 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.¹ Adagrasib has shown clinically to be a CNS penetrant, which may be important given that CNS metastases frequently occur in NSCLC and lead to poor prognosis.^2-34

The FDA provided KRAZATI Accelerated Approval (Subpart H), allowing for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on surrogate endpoints.

Adagrasib continues to be evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRAS^G12C-mutated solid tumors, including NSCLC, colorectal cancer, and pancreatic cancer. For more information, visit Mirati.com/science.

About the KRYSTAL-1 Study

KRYSTAL-1 is an open-label Phase 1/2 multiple-expansion cohort trial evaluating adagrasib as monotherapy and in combination with other anti-cancer therapies in patients with advanced solid tumors harboring the KRAS^G12C mutation.

About KRAS^G12C in NSCLC

Lung cancer is one of the most common cancers worldwide, accounting for 2.21 million new cases and 1.8 million deaths worldwide in 2020.⁵ Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases.⁶ KRAS^G12C is the most common KRAS mutation in NSCLC, present in approximately 14% of patients with lung adenocarcinoma, and is a biomarker mutation of poor prognosis.^1,3

About Mirati Therapeutics, Inc.

Mirati Therapeutics, Inc. is a commercial 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 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 includes forward-looking statements regarding Mirati's business, financial guidance and the therapeutic and commercial potential of KRAZATI^® (adagrasib), MRTX1719 (MTA-cooperative PRMT5 inhibitor), MRTX0902 (SOS1 inhibitor), and MRTX1133 (selective KRASG12D inhibitor), Mirati's technologies and Mirati's other products in development. Any statement describing Mirati's goals, expectations, intentions or beliefs, financial or other projections, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including those related to the impact COVID-19 could have on our business, and including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines.

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 annual report on Form 10-K, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission and available at the SEC's Internet site (www.sec.gov). These forward-looking statements are made as of the date of this press release, and 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

References

¹ Hallin J, Engstrom LD, Hargis L, et al. The KRAS^G12C Inhibitor MRTX849 Provides Insight toward Therapeutic Susceptibility of KRAS-Mutant Cancers in Mouse Models and Patients. Cancer Discov. 2020;10(1):54-71.
² Sabari JK, Velcheti V, Shimizu K, et al. Activity of Adagrasib (MRTX849) in Brain Metastases: Preclinical Models and Clinical Data from Patients with KRASG12C-Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2022;28(15):3318-3328.
³ Cagney DN, Martin AM, Catalano PJ, et al. Incidence and prognosis of patients with brain metastases at diagnosis of systemic malignancy: a population-based study. Neuro Oncol. 2017;19(11):1511-1521.
⁴ Ali A, Goffin JR, Arnold A, Ellis PM. Survival of patients with non-small-cell lung cancer after a diagnosis of brain metastases. Curr Oncol. 2013;20(4):e300-6.
⁵ Lung cancer statistics. WCRF International. https://www.wcrf.org/cancer-trends/lung-cancer-statistics/. Published April 14, 2022.
⁶ Molina JR, Yang P, Cassivi SD, Schild SE, Adjei AA. Non-small cell lung cancer: epidemiology, risk factors, treatment, and survivorship. Mayo Clin Proc. 2008;83(5):584-94.

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SOURCE Mirati Therapeutics, Inc.

What is the company name and ticker symbol of the biotechnology company that received conditional marketing authorization from the European Commission?

Mirati Therapeutics, Inc. (NASDAQ: MRTX)

What is the targeted treatment option approved by the European Commission for adult patients with KRASG12C-mutated advanced non-small cell lung cancer?

KRAZATI® (adagrasib)

What study provided the basis for the approval of KRAZATI as a targeted treatment option for patients with advanced KRASG12C-mutated NSCLC?

The positive results from the Phase 2 registration-enabling cohort of the KRYSTAL-1 study.

What are the primary efficacy endpoints evaluated for KRAZATI in the Phase 2 registration-enabling cohort of the KRYSTAL-1 study?

The primary efficacy endpoints were confirmed ORR and DOR as evaluated by blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST v1.1).

What is the geographic scope of the conditional marketing authorization for KRAZATI?

The authorization is valid in all 27 EU member states plus Iceland, Norway, and Liechtenstein.