Amgen’s first-in-class KRAS inhibitor Lumakras has been grabbing attention since even before its approval. Now, after closely watching the drug’s commercial performance in non-small cell lung cancer, one team of analysts is sounding an alarm ahead of key clinical trial data readouts.
Recent U.S. prescription trends don’t bode well for Lumakras, SVB Securities analysts said in a Monday note. The team has lowered their second-quarter U.S. sales estimates by 8% to $55 million, below Wall Street’s consensus projection of $62.4 million.
Back in the first quarter of 2022, Lumakras registered $48 million in U.S. sales. But IQVIA data showed quarterly scripts over the past three months only grew 8%, a major slowdown from a 27% sequential growth in the first quarter and well below the industry’s expectations, SVB noted.
In fact, the analysts would have assigned an even lower sales if it weren’t for a 3% U.S. price increase on July 1, which likely prompted some wholesalers to buy in beforehand in June.
For the full year, SVB also dialed down Lumakras’ global sales estimate to $326 million, versus the Street’s $347 million forecast.
Lumakras bears high expectations as Amgen’s next big growth driver. Some of the company’s other key products such as TNF blocker Enbrel, inflammatory disease therapy Otezla and CGRP migraine drug Aimovig face tough competition in their respective fields.
Meanwhile, Lumakras itself could soon face off a rival of its own in Mirati Therapeutics’ adagrasib. The two nemeses have published several rounds of clinical data showdowns with wins—or ties—for each medicine so far. No clear winner has emerged, which suggests adagrasib could have a good shot at stealing market share from Lumakras if it gets an approval as expected by the FDA target decision date, Dec. 14.
In the next few days, Amgen will drop important combination data for Lumakras at the upcoming World Conference on Lung Cancer. It will detail early data for Lumakras alongside either Merck’s Keytruda or Roche’s Tecentriq, and with RMC-4630, an SHP2 inhibitor by Sanofi and Revolution Medicines, in NSCLC.
PD-1/L1 inhibitors are widely used as combination backbones for sold tumors, and Mirati has previously shared early data based on the immuno-oncology strategy last year. Amgen has also touted SHP2 inhibition as potentially one of the most suitable combo partners with a KRAS inhibitor.
But those will be early clinical data. The more actionable data will come from CodeBreaK 200, the confirmatory trial for Lumakras’ current accelerated approval, the SVB team noted. The phase 3 trial pits Lumakras against the chemotherapy docetaxel in second-line NSCLC and bears a primary completion date this Friday, though the SVB analysts noted the exact readout timing hinges on how many disease progression or death cases the trial has accrued.
Industry watchers will keep a close eye on how the drug’s tumor response rate, duration of response and median time to tumor progression or death fare versus previous early-stage results.