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

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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