Amgen ( AMGN Quick Quote AMGN - Free Report) announced that it has received conditional marketing authorization in the European Union (EU) for Lumykras (sotorasib) to treat adults with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. Amgen will need to conduct a confirmatory study for continued approval of Lumykras in the given indication.
The approval was expected as the European Medicines Agency’s Committee for Medicinal Products for Human Use
rendered a positive opinion recommending Lumykras in the given indication in November.
The EU approval is based on data from the phase II CodeBreaK 100 study, which evaluated the drug in NSCLC patients with KRAS G12C mutation. Data from the same showed that treatment with Lumykras (960 mg), once-daily, led to an objective response rate of 37.1% and a median duration of response of 11.1 months.
Overthe past year, Amgen’s stock price has declined 4.3% compared with the
industry’s 31% fall. Image Source: Zacks Investment Research
Per Amgen, Europe accounts for approximately 400,000 cases of NSCLC each year. In fact, KRAS G12C mutations are present in approximately 13-15% of non-squamous NSCLC patients in Europe. Following approval, Lumykras became the only therapy targeting this mutation in the EU.
The drug was approved in the United States under the trade name Lumakras for advanced NSCLC in May 2021.
The launch of Lumakras in the United States is off to an excellent start, while its label expansion studies are progressing rapidly. Amgen generated $36 million from Lumakras’ sales in third-quarter 2021.
Apart from NSCLC, Amgen is also evaluating sotorasib in other indications. The company is conducting a phase II monotherapy study on sotorasib in advanced colorectal cancer patients. Amgen is also evaluating sotorasib as monotherapy as well as in combination across multiple advanced solid tumors in multiple phase Ib studies (CodeBreaK 101).
Another company that has a KRAS inhibitor in its pipeline is
Mirati Therapeutics ( MRTX Quick Quote MRTX - Free Report) . Adagrasib, Mirati’s leading KRAS inhibitor candidate, is being studied — both as a monotherapy and in combination — in a phase I/II study (KRYSTAL) to treat patients with KRAS G12C-positive tumors.
In November 2021, Mirati announced that it has initiated the submission of a new drug application to the FDA under the Real-Time Oncology Review pilot program for adagrasib to treat patients with at least second-line NSCLC with KRAS G12C mutation. The submission was based on data from a phase I/II KRYSTAL-1 potentially registration-enabling monotherapy cohort evaluating adagrasib for the given indication. Data from the study demonstrated that treatment with adagrasib achieved an objective response rate of 43% and an 80% disease control rate as of Jun 15, 2021.
Zacks Rank & Stocks to Consider
Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include
Alkermes ( ALKS Quick Quote ALKS - Free Report) and Regeneron Pharmaceuticals ( REGN Quick Quote REGN - Free Report) , each currently carrying a Zacks Rank #1 (Strong Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
Alkermes’ earnings per share estimates for 2022 have increased from $0.70 to $0.71 in the past 30 days. Shares of Alkermes have risen 11.9% in the past year.
Earnings of Alkermes beat estimates in all the last four quarters, delivering a surprise of 147%, on average.
Regeneron’s earnings per share estimates for 2022 have increased from $50.09 to $50.23 in the past 30 days. Shares of Regeneron Pharmaceuticals have risen 20% in the past year.
Earnings of Regeneron Pharmaceuticals beat estimates in all the last four quarters, delivering a surprise of 28.9%, on average.