Mirati Therapeutics (MRTX), a clinical-stage targeted oncology company, has announced preliminary results from its mutant KRAS selective inhibitor programs showing promising anti-tumor activity.
The preliminary results included updated clinical data of adagrasib (MRTX849), the company’s KRAS G12C inhibitor, and initial preclinical in vivo data of MRTX1133, Mirati’s selective and potent potential first-in-class KRAS G12D inhibitor.
“The adagrasib preliminary data presented today showed deep and durable anti-tumor activity in non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other solid tumors, providing renewed hope for patients that harbor a KRAS G12C mutation” commented Charles M. Baum, CEO of Mirati.
Indeed, adagrasib demonstrated a 45% confirmed objective response rate as a monotherapy in advanced NSCLC. Meanwhile 70% (16/23) of responders had a best tumor response greater than 40%.
“While this data is still maturing, adagrasib also demonstrated clinically meaningful duration of treatment for NSCLC patients in the Phase 1/1b cohort,” he added.
The company also revealed that enrollment is now complete in the Phase 2 cohort of adagrasib for patients in 2nd / 3rd line NSCLC and it anticipates submitting a New Drug Application for accelerated approval in the 2H21.
“Adagrasib has been well tolerated as a monotherapy and in combination with pembrolizumab, cetuximab and TNO-155, a SHP-2 inhibitor. We are initiating additional registration-enabling global clinical studies of adagrasib as both a monotherapy and in combinations as we expand the program to earlier lines of therapy in NSCLC and CRC” the CEO said.
Median duration of treatment was >8 months with 50% of patients and 83% of responders still on treatment in the Phase 1/1b monotherapy cohort in patients with advanced NSCLC, Mirati stated.
At the same time MRTX1133 demonstrated tumor regression in multiple in vivo tumor models, including pancreatic and colorectal cancers- potentially building up to an Investigational New Drug filing in the first half of 2021.
Shares in Mirati have surged 40% year-to-date, and the stock scores a cautiously optimistic Moderate Buy Street consensus. The average analyst price target indicates marginal upside potential from current levels.
“In our view, it’s still difficult to detect clear differentiation between Amgen’s sotorasib (AMG 510) and Mirati’s adagrasib (MRTX 849) after the latter’s updated data at the Triple Conference on Sunday” noted JP Morgan analyst Cory Kasimov.
“We continue to stress that the KRAS G12C bar remains somewhat of a moving target, and we look for AMGN’s Ph2 presentation at World Lung in Jan and the registration path forward as the next catalysts for the evolving KRAS landscape in NSCLC” the analyst told investors. (See MRTX stock analysis on TipRanks)
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