Amgen’s Lumakras gets its colorectal date
Amgen’s KRAS G12C inhibitor Lumakras recently fell behind Bristol Myers Squibb’s rival Krazati in colorectal cancer, but Amgen might catch up soon. The biotech disclosed on Tuesday during its second-quarter earnings that an FDA approval decision on Lumakras in second-line disease is expected by 17 October. And Krazati only has an accelerated nod, while Amgen is shooting for full approval of Lumakras based on the controlled Codebreak-300 trial, which tested Lumakras plus Vectibix versus investigator’s choice. However, high-dose Lumakras only produced a 26% overall response rate, while Krazati yielded a 34% ORR in its Krystal-1 trial. In addition, Codebreak-300 didn’t show a statistically significant improvement in overall survival, although the trial wasn’t powered to do so. While a battle beckons in the second-line setting Amgen might steal a march on its competitors in the front line, where the pivotal Codebreak-301 study recently began recruiting. The only other KRAS G12C player looking at first-line colorectal cancer, according to OncologyPipeline, is Roche, with divarasib in the phase 1 Intrinsic trial. Still, the Swiss group seems focused on NSCLC. Lumakras second-quarter sales totalled $85m, while Krazati brought in $32m.
KRAS G12C inhibitors in colorectal cancer
| Project | Company | Status |
|---|---|---|
| Krazati | Bristol Myers Squibb (via Mirati) | AA for 2L use in Jun 2024 based on Krystal-1; data from confirmatory 2L Krystal-10 due 2025 |
| Lumakras | Amgen | PDUFA 17 Oct 2024 based on 2L Codebreak-300; 1L Codebreak-301 + Vectibix + FOLFIRI chemo recruiting |
| Fulzerasib | GenFleet Therapeutics | Ph3 3L trial received US FDA clearance Apr 2024 |
| Glecirasib | Jacobio Pharmaceuticals | Ph3 3L China trial planned |
| Divarasib | Roche | Impressive ph1 data in late-line disease; ph1 1L Intrinsic study ongoing |
Note: AA=accelerated approval. Source: OncologyPipeline.
1231
