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Amgen's (AMGN) KRAS Inhibitor Gets FDA Nod for Lung Cancer
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Amgen (AMGN - Free Report) announced that the FDA granted approval to its KRAS inhibitor, Lumakras (sotorasib) for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. The approval was on an accelerated basis with continued approval contingent on verification of data from another study to confirm the drug’s benefits
The FDA approval was based on positive data from the phase II CodeBreaK 100 study, which evaluated Lumakras in patients with advanced NSCLC whose disease progressed despite prior treatment with chemotherapy and/or immunotherapy. Data from the study showed that 81% patients treated with once-daily dosing of Lumakras achieved disease control. Lumakras demonstrated an ORR of 36% in the study.
The approval came much earlier than the PDUFA date of Aug 16. A marketing authorization application (MAA) is also under review in Europe.
Amgen’s stock has risen 3.5% this year so far against a decrease of 4.1% for the industry.
Image Source: Zacks Investment Research
Notably, tumors characterized by KRAS, a common cancer mutation, are commonly associated with poor prognosis and resistance to therapy. Lumakras is the first drug to be approved to treat this cancer mutation that researchers have found extremely difficult to directly inhibit, thereby opening up a market with significantly unmet need. The drug is expected to produce blockbuster sales for Amgen. The drug is expected to be priced at $17,900 per month.
Per the company, KRAS G12C mutations are present in approximately 13% of non-squamous NSCLC patients.
A key candidate in Amgen’s pipeline, Lumakras has shown encouraging anti-tumor activity in patients with locally-advanced or metastatic KRASG12C mutant solid tumors like colorectal cancer (CRC) and appendiceal cancer other than NSCLC.
Amgen is conducting a phase II monotherapy study on Lumakras in advanced colorectal cancer patients, data from which is expected later in 2021. A phase II study in first-line NSCLC is expected to begin in the second quarter of 2021. Another phase III study comparing Lumakras to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrolment.
Amgen is also conducting phase Ib combination studies with PD-1, MEK and other targeted therapies with some initial data expected in the second half of 2021.
We note that many companies have KRAS G12C inhibitors in their pipelines being developed for various cancer indications. Small biotech, Mirati Therapeutics also has adagrasib, a KRAS G12C inhibitor, in its pipeline. Mirati anticipates to file a new drug application for the accelerated approval of adagrasib in the second half of 2021 for treating patients with at least second-line NSCLC
Apart from Amgen, Roche (RHHBY - Free Report) and Novartis (NVS - Free Report) also have KRAS G12C inhibitor candidates in their pipelines.
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Image: Bigstock
Amgen's (AMGN) KRAS Inhibitor Gets FDA Nod for Lung Cancer
Amgen (AMGN - Free Report) announced that the FDA granted approval to its KRAS inhibitor, Lumakras (sotorasib) for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. The approval was on an accelerated basis with continued approval contingent on verification of data from another study to confirm the drug’s benefits
The FDA approval was based on positive data from the phase II CodeBreaK 100 study, which evaluated Lumakras in patients with advanced NSCLC whose disease progressed despite prior treatment with chemotherapy and/or immunotherapy. Data from the study showed that 81% patients treated with once-daily dosing of Lumakras achieved disease control. Lumakras demonstrated an ORR of 36% in the study.
The approval came much earlier than the PDUFA date of Aug 16. A marketing authorization application (MAA) is also under review in Europe.
Amgen’s stock has risen 3.5% this year so far against a decrease of 4.1% for the industry.
Notably, tumors characterized by KRAS, a common cancer mutation, are commonly associated with poor prognosis and resistance to therapy. Lumakras is the first drug to be approved to treat this cancer mutation that researchers have found extremely difficult to directly inhibit, thereby opening up a market with significantly unmet need. The drug is expected to produce blockbuster sales for Amgen. The drug is expected to be priced at $17,900 per month.
Per the company, KRAS G12C mutations are present in approximately 13% of non-squamous NSCLC patients.
A key candidate in Amgen’s pipeline, Lumakras has shown encouraging anti-tumor activity in patients with locally-advanced or metastatic KRASG12C mutant solid tumors like colorectal cancer (CRC) and appendiceal cancer other than NSCLC.
Amgen is conducting a phase II monotherapy study on Lumakras in advanced colorectal cancer patients, data from which is expected later in 2021. A phase II study in first-line NSCLC is expected to begin in the second quarter of 2021. Another phase III study comparing Lumakras to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrolment.
Amgen is also conducting phase Ib combination studies with PD-1, MEK and other targeted therapies with some initial data expected in the second half of 2021.
We note that many companies have KRAS G12C inhibitors in their pipelines being developed for various cancer indications. Small biotech, Mirati Therapeutics also has adagrasib, a KRAS G12C inhibitor, in its pipeline. Mirati anticipates to file a new drug application for the accelerated approval of adagrasib in the second half of 2021 for treating patients with at least second-line NSCLC
Apart from Amgen, Roche (RHHBY - Free Report) and Novartis (NVS - Free Report) also have KRAS G12C inhibitor candidates in their pipelines.
Amgen currently has 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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In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create ""the world's first trillionaires."" Zacks' urgent special report reveals 3 AI picks investors need to know about today.
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