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Mirati (MRTX) Up on FDA Nod to Adagrasib for KRAS Mutated NSCLC
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Shares of Mirati Therapeutics were up 8.2% in after-hours trading on Monday after the company announced FDA’s accelerated approval for adagrasib for previously-treated KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Adagrasib will be marketed by the brand name Krazati and is the first approved drug in Mirati’s portfolio.
Krazati’s accelerated approval is based on objective response rate (ORR) and duration of response (DOR) data from the phase II registration-enabling cohort of the KRYSTAL-1 study. In the study, ORR was 43%, while the median DOR was 8.5 months in patients with KRASG12C mutated advanced NSCLC, previously treated with a platinum-based regimen and an immune checkpoint inhibitor. Final approval is contingent upon verification of a clinical benefit in a confirmatory study.
A marketing authorization application is also under review in Europe.
Tumors characterized by KRAS mutations are extremely difficult to directly inhibit and are commonly associated with poor prognosis and resistance to therapy. KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinomas patients, 3-4% of colorectal cancer (CRC) patients and smaller percentages of several other difficult-to-treat cancers. Krazati will be launched as a tablet formulation for advanced NSCLC patients who have a KRAS mutation and have progressed beyond a first-line treatment
This year so far, the stock price of Mirati has plunged 69.5% compared with the industry’s decline of 19%.
Image Source: Zacks Investment Research
Krazati will face competition from Amgen’s (AMGN - Free Report) KRAS G12C inhibitor, Lumakras/ Lumykras, which was approved for second-line NSCLC in the United States in 2021 and Europe in January 2022. It has now been launched in more than 45 countries. Amgen’s Lumakras/ Lumykras is off to an excellent start, while its label expansion studies, which have the potential to significantly expand the currently addressable patient population, are progressing rapidly. In the first nine months of 2022, Lumakras/ Lumykras generated sales of $214 million for Amgen.
Mirati is evaluating adagrasib — both as monotherapy and combinations — in multiple cohorts of phase I/II KRYSTAL-1 study across multiple solid tumors that harbor KRAS G12C mutations. These include the combination of adagrasib with Merck’s (MRK - Free Report) Keytruda in NSCLC, the combination with Boehringer Ingelheim’s Gilotrif (afatinib) in advanced NSCLC and Bristol-Myers’ (BMY - Free Report) Erbitux (cetuximab) in advanced colorectal cancer or CRC. In several other studies, adagrasib is being evaluated as a monotherapy and in combination with other anti-cancer therapies for advanced KRASG12C- mutated solid tumors, including NSCLC, colorectal cancer, and pancreatic cancer.
Mirati has also long been a takeover target. Last month, the stock was up on rumors that big cancer drugmakers may offer to buy the company.
Potential buyers could be Pfizer, Bristol-Myers, Merck or AstraZeneca, per an article on Investor's Business Daily. Mirati did not issue any press release or make any comment on the buyout speculations. Though there are currently no formal offers and a deal is not imminent, we believe Krazati’s approval makes the stock even more attractive to potentials buyers.
Image: Bigstock
Mirati (MRTX) Up on FDA Nod to Adagrasib for KRAS Mutated NSCLC
Shares of Mirati Therapeutics were up 8.2% in after-hours trading on Monday after the company announced FDA’s accelerated approval for adagrasib for previously-treated KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Adagrasib will be marketed by the brand name Krazati and is the first approved drug in Mirati’s portfolio.
Krazati’s accelerated approval is based on objective response rate (ORR) and duration of response (DOR) data from the phase II registration-enabling cohort of the KRYSTAL-1 study. In the study, ORR was 43%, while the median DOR was 8.5 months in patients with KRASG12C mutated advanced NSCLC, previously treated with a platinum-based regimen and an immune checkpoint inhibitor. Final approval is contingent upon verification of a clinical benefit in a confirmatory study.
A marketing authorization application is also under review in Europe.
Tumors characterized by KRAS mutations are extremely difficult to directly inhibit and are commonly associated with poor prognosis and resistance to therapy. KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinomas patients, 3-4% of colorectal cancer (CRC) patients and smaller percentages of several other difficult-to-treat cancers. Krazati will be launched as a tablet formulation for advanced NSCLC patients who have a KRAS mutation and have progressed beyond a first-line treatment
This year so far, the stock price of Mirati has plunged 69.5% compared with the industry’s decline of 19%.
Image Source: Zacks Investment Research
Krazati will face competition from Amgen’s (AMGN - Free Report) KRAS G12C inhibitor, Lumakras/ Lumykras, which was approved for second-line NSCLC in the United States in 2021 and Europe in January 2022. It has now been launched in more than 45 countries. Amgen’s Lumakras/ Lumykras is off to an excellent start, while its label expansion studies, which have the potential to significantly expand the currently addressable patient population, are progressing rapidly. In the first nine months of 2022, Lumakras/ Lumykras generated sales of $214 million for Amgen.
Mirati is evaluating adagrasib — both as monotherapy and combinations — in multiple cohorts of phase I/II KRYSTAL-1 study across multiple solid tumors that harbor KRAS G12C mutations. These include the combination of adagrasib with Merck’s (MRK - Free Report) Keytruda in NSCLC, the combination with Boehringer Ingelheim’s Gilotrif (afatinib) in advanced NSCLC and Bristol-Myers’ (BMY - Free Report) Erbitux (cetuximab) in advanced colorectal cancer or CRC. In several other studies, adagrasib is being evaluated as a monotherapy and in combination with other anti-cancer therapies for advanced KRASG12C- mutated solid tumors, including NSCLC, colorectal cancer, and pancreatic cancer.
Mirati has also long been a takeover target. Last month, the stock was up on rumors that big cancer drugmakers may offer to buy the company.
Potential buyers could be Pfizer, Bristol-Myers, Merck or AstraZeneca, per an article on Investor's Business Daily. Mirati did not issue any press release or make any comment on the buyout speculations. Though there are currently no formal offers and a deal is not imminent, we believe Krazati’s approval makes the stock even more attractive to potentials buyers.
Zacks Rank
Mirati currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.