Amgen drops to six-month low amid latest challenges to pipeline
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Amgen (NASDAQ:AMGN) shares reached the lowest level since March on Tuesday as Wall Street reacted to the company's latest update on KRAS inhibitor Lumakras, while Bristol Myers (BMY) introduced a new rival against its blockbuster psoriasis treatment Otezla.
Based on data for overall response rate (ORR) and duration of response (DOR), the FDA has already greenlighted Lumakras to treat adults with KRAS G12C-mutated non-small cell lung cancer (NSCLC) as a second-line option.
The company, which launched the once-daily oral therapy at a list price of $17.9K a month last year after winning the FDA nod under its accelerated approval pathway, is required to show the drug's benefit in confirmatory trials for continued approval.
Announcing detailed results from a global CodeBreaK 200 Phase 3 trial on Sunday ahead of a presentation at the ESMO 2022 Congress in Paris, AMGN said that patients who took the drug went without their cancer getting worse for 5.6 months compared to 4.5 months in those who received chemotherapy docetaxel.
However, the data indicated no clear benefit in terms of overall survival (OS), a key secondary endpoint of the trial and the gold standard to measure the efficacy of cancer treatment.
While the trial was not powered to measure OS, the patients survived a median of 10.6 months, compared to 11.3 months in the chemotherapy arm. The company said the difference between the treatment arms was not statistically significant and noted that the OS data were too early "but appears promising."
However, the 345-patient trial showed a favorable safety profile for Lumakras, with only 11% of those who received the treatment reporting serious adverse events compared to 23% in the chemotherapy arm.
Noting that the data could be adequate for Amgen (AMGN) to secure full approval for the treatment, Baird analyst Brian Skorney raised concerns over its potential uptake, given the high price tag and limited data on overall survival.
"Payers could say, 'Why should we pay hundreds of thousands of dollars more for a drug that does not provide a survival benefit?'" Skorney said.
Meanwhile, Bristol Myers (BMY) dealt another setback for AMGN on Friday following FDA approval of its oral psoriasis therapy Sotyktu without a black box warning.
AMGN's Otezla, approved in the U.S. for psoriasis with an FDA warning for toxicity, added $2.2B in product sales for the company in 2021 with ~2% YoY growth.