First KRAS inhibitor (Lumakras) disappointed
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First KRAS inhibitor (Lumakras) disappointed.
Amgen’s novel KRAS inhibitor Lumakras (sotorasib) is in the spotlight ahead of approval.
However, the commercial performance in non-small cell lung cancer after FDA approval for marketing on May 28, 2021 has been disappointing.
Recent U.S. prescription trends don’t bode well for Lumakras , analysts at Silicon Valley Bank (SVB) Securities said in a recent report.
The team has lowered its second-quarter U.S. sales forecast for Lumakras by 8% to $ 55 million, below the consensus Wall Street estimate of $ 62.4 million.
Back in the first quarter of 2022 , Lumakras had $ 48 million in U.S. sales.
But quarterly growth over the past three months was just 8% , a sharp slowdown from the 27% sequential increase in the first quarter and well below industry expectations, IQVIA data showed.
For the full year, SVB also lowered its global sales forecast for Lumakras to $ 326 million, compared with Wall Street’s forecast of $ 347 million.
Lumakras was previously expected to be Amgen’s next big growth driver.
Some of the company’s other key products, such as TNF blocker Enbrel , inflammatory disease treatment Otezla and CGRP migraine drug Aimovig , face stiff competition in related fields.
Meanwhile, Lumakras could soon face its most direct rival, Mirati Therapeutics ‘ adagrasib.
So far, Lumakras and adagrasib have released several rounds of clinical data, with each drug having a corresponding victory or draw, which is close.
If adagrasib is approved before the FDA target decision date ( Dec. 14 ), there is a good chance that it will steal some market share from Lumakras .
Amgen will present key drug combination data for Lumakras at the upcoming World Conference on Lung Cancer , which will detail the early stage of Lumakras with Merck’s Keytruda or Roche’s Tecentriq and Sanofi /Revolution Medicines ‘ SHP2 inhibitor RMC-4630 in NSCLC data.
PD-1/L1 inhibitors are widely used as a joint basis in the oncology field, and Mirati has previously shared early data based on an immuno-oncology strategy.
Amgen also said that SHP2 inhibition may be one of the most suitable combinations with KRAS inhibitors.
However, with data from the CodeBreaK200 confirmatory trial for accelerated approval of Lumakras now more in focus , industry watchers will be closely watching how the drug’s tumor response rate, duration of response and median time to tumor progression or death compare to previous early results .
First KRAS inhibitor (Lumakras) disappointed
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