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Mirati (MRTX) to Begin Clinical Study in MTAP-Deleted Cancers

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Mirati Therapeutics, Inc. MRTX announced that it has submitted an investigational new drug application to the FDA to begin clinical studies on its investigational PRMT5 inhibitor, MRTX1719, for the treatment of methylthioadenosine phosphoylase (“MTAP”)-deleted cancers.

Pending clearance from the regulatory body, the company plans to begin a phase I/II study on MRTX1719 in the first quarter of 2022.

Per the company, the phase I/II study for MRTX1719 is designed to set up a phase II dose and evaluate the safety, pharmacokinetics and initial clinical activity of MRTX1719 in treating MTAP-deleted cancers.

Shares of Mirati have plunged 36.9% so far this year compared with the industry’s decrease of 14.4%.

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We note that Mirati’s clinical pipeline consists of two key candidates: adagrasib (MRTX849), a KRAS G12C inhibitor, and sitravatinib, a multi-kinase inhibitor.

Earlier this month, the company initiated the submission of the new drug application for adagrasib to treat patients with previously treated KRAS G12C-mutated non-small cell lung cancer (“NSCLC”) under the Real-Time Oncology Review pilot program.

The company is evaluating adagrasib in multiple cohorts of an early-stage study in combination with other therapies. These include a combination of adagrasib with Merck’s MRK Keytruda in first-line NSCLC, a combination of adagrasib plus Gilotrif (afatinib) in advanced NSCLC and adagrasib combined with Lilly’s Erbitux in second-line colorectal cancer.

Preliminary data from the adagrasib plus Keytruda cohort demonstrated that the combination achieved 100% disease control rate as of Oct 21, 2021. We note that, Keytruda is Merck's biggest revenue driver and is already approved for treating several types of cancers globally.

Last month, Mirati entered into a non-exclusive clinical collaboration agreement with Sanofi SNY to evaluate the combination of adagrasib with the latter's investigational SHP2 inhibitor SAR442720 (also known as RMC-4630) in a phase I/II dose escalation and expansion study in previously treated NSCLC patients with KRAS G12C mutations.

Per the agreement terms, Sanofi will be responsible for sponsoring and operating the study.

Sitravatinib has been designed to selectively target a spectrum of tyrosine kinases involved in both tumor growth and the suppression of immune responses to tumors. The candidate is being evaluated in combination with immune checkpoint inhibitors like Bristol-Myers BMY and BeiGene’s anti-PD-1 checkpoint inhibitors, Opdivo and tislelizumab, respectively.

Sitravatinib is being evaluated in a pivotal phase III study (SAPPHIRE) in combination with Bristol-Myers’ Opdivo for second-line or third-line non-squamous NSCLC. Data from the study is expected in the second half of 2022. It is also being evaluated in phase II studies in combination with Opdivo for NSCLC and advanced/metastatic urothelial carcinoma.

Zacks Rank

Mirati currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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