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Amgen's (AMGN) Lumakras Meets Goal in New Lung Cancer Study
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Amgen Inc. (AMGN - Free Report) announced top-line data from the phase III CodeBreaK 200 study, which evaluated its KRAS inhibitor, Lumakras (sotorasib), for the treatment of non-small cell lung cancer (NSCLC).
The CodeBreak 200 study assessed the safety and efficacy of once-daily oral, Lumakras, in previously-treated patients with KRAS G12C-mutated NSCLC who had already received at minimum prior platinum-based doublet chemotherapy and checkpoint inhibitor therapy.
The study compared Lumakras to docetaxel — the standard of care chemotherapy — in the given patient population.
Data from the same showed that treatment with Lumakras demonstrated statistical significance and superiority over intravenous docetaxel, the primary endpoint of progression-free survival.
Secondary endpoints of the CodeBreak 200 study include overall survival, objective response rate and patient-reported outcomes.
Shares of Amgen have rallied 8% this year so far against the industry’s decline of 24.3%.
Image Source: Zacks Investment Research
Lumakras was approved for advanced or metastatic NSCLC in the United States in May 2021 and the EU (marketed as Lumykras) in January 2022.
The drug is now approved in more than 40 countries. Lumakras 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.
Lumakras is also in phase I and phase II development for the treatment of NSCLC as a monotherapy and in combination with other therapies.
Lumakras is being investigated in previously treated KRAS G12C-mutated colorectal cancer (CRC) as a monotherapy and in combination with other therapies. The phase II study in CRC is fully enrolled.
Amgen is evaluating Lumakras both as a monotherapy and in combination therapy in multiple phase Ib studies (CodeBreaK 101) for treating various types of advanced solid tumors. Amgen also plans to soon initiate a phase III study of Lumakras plus chemotherapy in first-line advanced or metastatic NSCLC.
Another company that has a KRAS inhibitor in its pipeline is Mirati Therapeutics .
Mirati submitted a new drug application or NDA to the FDA seeking approval for adagrasib, monotherapy, to treat patients with at least second-line NSCLC with KRAS G12C mutation. The FDA accepted the NDA in February 2022 and a decision is expected later in 2022.
MRTX is also evaluating adagrasib — both as monotherapy and combinations — in a mid-stage study across multiple solid tumors that carry KRAS G12C mutations.
Achilles Therapeutics’ loss per share estimates narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 31.8% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.
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Amgen's (AMGN) Lumakras Meets Goal in New Lung Cancer Study
Amgen Inc. (AMGN - Free Report) announced top-line data from the phase III CodeBreaK 200 study, which evaluated its KRAS inhibitor, Lumakras (sotorasib), for the treatment of non-small cell lung cancer (NSCLC).
The CodeBreak 200 study assessed the safety and efficacy of once-daily oral, Lumakras, in previously-treated patients with KRAS G12C-mutated NSCLC who had already received at minimum prior platinum-based doublet chemotherapy and checkpoint inhibitor therapy.
The study compared Lumakras to docetaxel — the standard of care chemotherapy — in the given patient population.
Data from the same showed that treatment with Lumakras demonstrated statistical significance and superiority over intravenous docetaxel, the primary endpoint of progression-free survival.
Secondary endpoints of the CodeBreak 200 study include overall survival, objective response rate and patient-reported outcomes.
Shares of Amgen have rallied 8% this year so far against the industry’s decline of 24.3%.
Image Source: Zacks Investment Research
Lumakras was approved for advanced or metastatic NSCLC in the United States in May 2021 and the EU (marketed as Lumykras) in January 2022.
The drug is now approved in more than 40 countries. Lumakras 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.
Lumakras is also in phase I and phase II development for the treatment of NSCLC as a monotherapy and in combination with other therapies.
Lumakras is being investigated in previously treated KRAS G12C-mutated colorectal cancer (CRC) as a monotherapy and in combination with other therapies. The phase II study in CRC is fully enrolled.
Amgen is evaluating Lumakras both as a monotherapy and in combination therapy in multiple phase Ib studies (CodeBreaK 101) for treating various types of advanced solid tumors. Amgen also plans to soon initiate a phase III study of Lumakras plus chemotherapy in first-line advanced or metastatic NSCLC.
Another company that has a KRAS inhibitor in its pipeline is Mirati Therapeutics .
Mirati submitted a new drug application or NDA to the FDA seeking approval for adagrasib, monotherapy, to treat patients with at least second-line NSCLC with KRAS G12C mutation. The FDA accepted the NDA in February 2022 and a decision is expected later in 2022.
MRTX is also evaluating adagrasib — both as monotherapy and combinations — in a mid-stage study across multiple solid tumors that carry KRAS G12C mutations.
Zacks Rank & Stocks to Consider
Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Achilles Therapeutics plc (ACHL - Free Report) and Atara Biotherapeutics, Inc. (ATRA - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Achilles Therapeutics’ loss per share estimates narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 31.8% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.