Mirati Therapeutics, Inc. announced positive data from a cohort of the phase I/II KRYSTAL–1 study evaluating its leading KRAS inhibitor adagrasib in patients with heavily pretreated colorectal cancer (“CRC”).
The cohort from the study evaluated adagrasib (600mg BID) in two arms, as a monotherapy and in a combination with Eli Lilly’s (LLY - Free Report) Erbitux (cetuximab). In both arms of the study, adagrasib achieved significant clinical activity and broad disease control in patients with KRAS G12C-Mutated CRC.
In the year so far, Mirati’s stock price has plunged 20.7% against the industry’s 0.9% rise.
In the monotherapy arm, the investigator-assessed response rate (“RR”) was 22% and disease control rate (“DCR”) was 87% (as of May 25, 2021). In the combination arm, the investigator-assessed RR was 43% and DCR was 100% (as of Jul 9, 2021).
Data from the KRYSTAL–1 study also demonstrated that the therapy was well tolerated among the participants in both arms of the cohort. The data were presented at the European Society for Medical Oncology Congress (ESMO) 2021.
Mirati has completed enrolment in a phase II potentially registration-enabling monotherapy cohort of adagrasib for treating patients with at least second-line non-small cell lung cancer (“NSCLC”) with KRAS G12C mutation. Mirati anticipates filing a new drug application for the accelerated approval of adagrasib in fourth-quarter 2021 to treat the given indication.
Enrolment is also ongoing in other key cohorts of the above study, which is evaluating adagrasib plus Merck’s (MRK - Free Report) Keytruda for first-line NSCLC and adagrasib plus Erbitux for second-line CRC.
Mirati is also conducting the phase III KRYSTAL-10 study, which is evaluating adagrasib plus Erbitux with a standard of care chemotherapy in patients with second-line CRC.
Please note that tumors characterized by KRAS mutations are commonly associated with poor prognosis and resistance to therapy. KRAS mutations are extremely difficult to directly inhibit. Adagrasib is designed to directly inhibit KRAS G12C mutations and if approved, it can open a market with significant unmet needs.
Amgen’s (AMGN - Free Report) Lumakras, a KRAS inhibitor, is also being evaluated in a phase II monotherapy study in advanced CRC patients. In May 2021, Lumakras became the first KRAS inhibitor to be approved in the United States for treating KRAS G12C-mutated locally advanced or metastatic NSCLC.
Zacks Rank
Mirati currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Mirati Therapeutics, Inc. announced positive data from a cohort of the phase I/II KRYSTAL–1 study evaluating its leading KRAS inhibitor adagrasib in patients with heavily pretreated colorectal cancer (“CRC”).
The cohort from the study evaluated adagrasib (600mg BID) in two arms, as a monotherapy and in a combination with Eli Lilly’s (LLY - Free Report) Erbitux (cetuximab). In both arms of the study, adagrasib achieved significant clinical activity and broad disease control in patients with KRAS G12C-Mutated CRC.
In the year so far, Mirati’s stock price has plunged 20.7% against the industry’s 0.9% rise.
In the monotherapy arm, the investigator-assessed response rate (“RR”) was 22% and disease control rate (“DCR”) was 87% (as of May 25, 2021). In the combination arm, the investigator-assessed RR was 43% and DCR was 100% (as of Jul 9, 2021).
Data from the KRYSTAL–1 study also demonstrated that the therapy was well tolerated among the participants in both arms of the cohort. The data were presented at the European Society for Medical Oncology Congress (ESMO) 2021.
Mirati has completed enrolment in a phase II potentially registration-enabling monotherapy cohort of adagrasib for treating patients with at least second-line non-small cell lung cancer (“NSCLC”) with KRAS G12C mutation. Mirati anticipates filing a new drug application for the accelerated approval of adagrasib in fourth-quarter 2021 to treat the given indication.
Enrolment is also ongoing in other key cohorts of the above study, which is evaluating adagrasib plus Merck’s (MRK - Free Report) Keytruda for first-line NSCLC and adagrasib plus Erbitux for second-line CRC.
Mirati is also conducting the phase III KRYSTAL-10 study, which is evaluating adagrasib plus Erbitux with a standard of care chemotherapy in patients with second-line CRC.
Please note that tumors characterized by KRAS mutations are commonly associated with poor prognosis and resistance to therapy. KRAS mutations are extremely difficult to directly inhibit. Adagrasib is designed to directly inhibit KRAS G12C mutations and if approved, it can open a market with significant unmet needs.
Amgen’s (AMGN - Free Report) Lumakras, a KRAS inhibitor, is also being evaluated in a phase II monotherapy study in advanced CRC patients. In May 2021, Lumakras became the first KRAS inhibitor to be approved in the United States for treating KRAS G12C-mutated locally advanced or metastatic NSCLC.
Zacks Rank
Mirati currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Buy 5 Stocks BEFORE Election Day
Biden or Trump? Zacks is releasing a FREE Special Report, Profit from the 2024 Presidential Election (no matter who wins).
Since 1950, presidential election years have been strong for the market. This report names 5 timely stocks to ride the wave of electoral excitement.
They include a medical manufacturer that gained +11,000% in the last 15 years… a rental company absolutely crushing its sector… an energy powerhouse planning to grow its already large dividend by 25%... an aerospace and defense standout that just landed a potentially $80 billion contract… and a giant chipmaker building huge plants in the U.S.
Don’t Wait. Download FREE >>
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