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Mirati (MRTX), Verastem to Study Cancer Drugs for NSCLC

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Mirati Therapeutics (MRTX - Free Report) announced a non-exclusive deal with Verastem Oncology (VSTM - Free Report) to conduct a clinical study on a combination of adagrasib, Mirati’s leading KRAS inhibitor candidate, and VS-6766, Verastem’s RAF/MEK inhibitor in KRAS G12C mutant non-small cell lung cancer (NSCLC).

The phase I/II study will determine the maximum tolerated dose and recommend the dose for a phase II study and also study the safety, tolerability and efficacy of the combination in patients who have progressed on a KRAS G12C inhibitor. Mirati and Verastem will jointly oversee the study.

In the year so far, the stock price of Mirati has declined 35.8% compared with the industry’s decline of 15.8%.

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Mirati has initiated the submission of a new drug application (NDA) for adagrasib to treat patients with at least second-line NSCLC with KRAS G12C mutation, following prior systemic therapy. The company expects to complete the NDA submission by 2021-end.

The KRYSTAL-1 study is evaluating adagrasib in multiple cohorts in combination with other therapies. These include a combination of adagrasib with Merck’s (MRK - Free Report) Keytruda for first-line NSCLC, a combination of adagrasib plus Boehringer Ingelheim’s Gilotrif (afatinib) for advanced NSCLC and adagrasib combined with Lilly/Bristol-Myers’ (BMY - Free Report) Erbitux for second-line colorectal cancer (“CRC”).

Preliminary data from the adagrasib plus Merck’s Keytruda cohort demonstrated that the combination achieved 100% disease control rate with all seven patients exhibiting tumor regression ranging from 37% to 92% as of Oct 21, 2021.

In September 2021, the company reported top-line data from a cohort of the study, which demonstrated that both adagrasib monotherapy and adagrasib+ Lilly/Bristol-Myers’s Erbitux achieved significant clinical activity and broad disease control in patients with KRAS G12C mutated CRC.

A phase I/II combination study of adagrasib with Novartis' SHP2 inhibitor TNO-155 for advanced NSCLC and CRC is also currently ongoing.

Several pipeline data readouts are expected in 2022, which could be catalysts for the stock.

With regard to Verastem’s VS-6766, phase II studies are ongoing to evaluate VS-6766 in combination with defactinib in patients with recurrent low-grade serous ovarian cancer and patients with recurrent KRAS-G12V mutant NSCLC 

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