Amgen's Lumakras/Keytruda/Tecentriq Combo Data Flags Safety Concern

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  • Amgen Inc AMGN announced new data sets from its thoracic oncology portfolio, including new combination study results, including Lumakras (sotorasib) with pembrolizumab or atezolizumab and Lumakras with RMC-4630.
  • Treatment with Lumakras alongside either Merck & Co Inc’s MRK Keytruda (pembrolizumab) or Roche Holdings AG’s RHHBY Tecentriq in KRAS G12C-mutated non-small cell lung cancer led to a marked increase in liver toxicities.
  • There was a roughly 50% rate of severe liver toxicity at grade 3 or 4. 
  • Also See: Amgen’s Q2 Sales Impacted By Lower Prices, Currency Headwind, Reaffirms FY22 Outlook.
  • The primary manifestation was increased liver enzyme levels.
  • Overall, treatment-related side effects caused about half the patients on concurrent combo dosing to discontinue either Lumakras or the immuno-oncology agent.
  • The liver safety problem for Lumakras with Keytruda or Tecentriq looked even more problematic because the combos only triggered a response in 29% of all 58 patients across the various cohorts. 
  • A separate dose exploration of the CodeBreaK 101 Phase 1b master study of Lumakras and escalating dose levels of RMC-4630 showed promising clinical activity. 
  • Of the 11 NSCLC patients enrolled, three (27%) achieved a confirmed partial response with two ongoing responses at the time of data cut-off, and seven (64%) achieved disease control. 
  • For the six KRASG12C inhibitor-naïve patients, an ORR of 50% was observed, and all patients demonstrated disease control. 
  • Price Action: AMGN shares are up 0.34% at $247.08 during the market session on the last check Monday.
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