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Amgen's (AMGN) KRAS Inhibitor Gets CHMP Nod for Lung Cancer

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Amgen Inc. AMGN announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and has recommended conditional marketing authorization to its KRAS inhibitor, Lumykras (sotorasib), for the treatment of adult patients with KRAS G12C mutated advanced non-small-cell lung cancer (“NSCLC”) whose disease has progressed after at least one prior line of systemic therapy.

The opinion will now be reviewed by the European Commission with a decision expected by mid-January 2022. If approved, Lumykras will become the first targeted therapy to be available for the KRAS G12C mutation in the European Union.

The positive CHMP opinion was based on data from the phase II CodeBreaK 100 study that evaluated patients with the KRAS G12C mutation. Data from the same showed that treatment with once-daily Lumykras (960 mg) led to an objective response rate of 37.1% and a median duration of response of 11.1 months. 80.6% patients treated with Lumakras achieved disease control while the median overall survival was 12.5 months.

Per the company, KRAS G12C mutations are present in approximately 13-15% of non-squamous NSCLC patients. Lumykras has the potential to be the new standard of care for NSCLC patients with this mutation in the EU.

Shares of Amgen have declined 8% so far this year compared with the industry’s decrease of 13.9%.

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Zacks Investment Research

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We note that Lumykras is marketed under the trade name Lumakras in the United States. The FDA approved Lumakras for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, following at least one prior systemic therapy in May this year. Lumakras generated sales worth $36 million in the third quarter of 2021.

Please note that tumors characterized by KRAS, a common cancer mutation, are commonly associated with poor prognosis and resistance to therapy.

Amgen is conducting a phase II monotherapy study on sotorasib in second-line plus NSCLC and in advanced colorectal cancer (“CRC”) patients. A phase II monotherapy study in patients with KRAS G12C-mutated solid tumors, other than those suffering from NSCLC and CRC, is ongoing. A phase II study in first-line NSCLC (in patients who are either PD-L1 negative or carrying STK11 mutations) was initiated in the third quarter of 2021 while a phase III study on Lumakras + Vectibix in third-line CRC is expected to begin enrollment in the fourth quarter of 2021. Amgen is also conducting phase Ib combination studies with PD-1, MEK, EGFR and other targeted therapies with some initial data expected in first half of 2022.

We note that many companies have KRAS G12C inhibitors in their pipelines being developed for various cancer indications. Small biotech, Mirati Therapeutics MRTX has adagrasib, a KRAS G12C inhibitor, in its pipeline. Earlier this month, Mirati initiated the submission of the new drug application (NDA) for adagrasib to treat patients with previously treated KRAS G12C-mutated NSCLC under the Real-Time Oncology Review pilot program.

Mirati is also developing adagrasib for other cancer indications.

Zacks Rank & Stocks to Consider

Amgen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Galera Therapeutics, Inc. GRTX and Editas Medicine, Inc. EDIT, 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.

Galera Therapeutics’ loss per share estimates have narrowed 19.5% for 2021 and 32.3% for 2022, over the past 60 days.

Earnings of Galera Therapeutics have surpassed estimates in only one of the trailing four quarters, and missed the same on the other three occasions.

Editas Medicine’s loss per share estimates have narrowed 11.9% for 2021 and 4.1% for 2022, over the past 60 days.

Editas Medicine’s earnings have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.

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