Amgen, Inc. ( AMGN Quick Quote AMGN - Free Report) submitted a marketing authorization application (MAA), seeking approval of its investigational KRAS inhibitor, sotorasib in Europe for previously treated locally advanced/metastatic non-small-cell lung cancer (“NSCLC”) in patients with KRAS G12C mutation.
Amgen filed a new drug application (NDA) to the FDA for sotorasib last week. The NDA and MAA filings were based on positive data from the phase II CodeBreaK 100 study, which evaluated sotorasib in patients with advanced NSCLC whose disease progressed despite prior treatment with chemotherapy and/or immunotherapy. Data from the study showed that treatment with sotorasib led to deep and durable anticancer activity with a positive benefit-risk profile in the given patient population.
Notably, tumors characterized by KRAS mutations are commonly associated with poor prognosis and resistance to therapy.
Per the company, KRAS G12C mutations are present in approximately 13% of NSCLC adenocarcinomas. There is a high unmet medical need for the given indication as NSCLC patients with KRAS G12C mutation who have failed first-line treatment have limited treatment options available. Annually, approximately 33,000 new patients in the EU are diagnosed with KRAS G12C-mutated NSCLC. If successfully developed and approved, sotorasib will be the first approved targeted therapy for this patient population.
Amgen’s stock has declined 8.3% this year so far against an increase of 10.1% for the
Sotorasib is also being evaluated in a phase II monotherapy study in advanced colorectal cancer patients whose top-line data are expected to be released next year. Amgen is also conducting phase Ib combination studies on sotorasib with PD-1, MEK and other targeted therapies.
We note that many companies have KRAS G12C inhibitors in their pipelines being developed for various cancer indications. Apart from Amgen,
Eli Lilly ( LLY Quick Quote LLY - Free Report) and J&J ( JNJ Quick Quote JNJ - Free Report) have KRAS G12C inhibitor candidates in their pipelines. Small biotech, Mirati Therapeutics ( MRTX Quick Quote MRTX - Free Report) has adagrasib, a KRAS G12C inhibitor, in its pipeline.
In a separate press release Amgen announced that it is out-licensing rights to AMG 634, an investigational therapy for tuberculosis and leprosy, to Medicines Development for Global Health (MDGH), a non-profit biotech. Amgen had acquired AMG 634 as part of the Otezla deal from Celgene in 2019. MDGH will now take care of AMG 634’s development/commercialization.
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