Bristol bids to outdo Amgen in KRAS
Krazati had once looked well behind Amgen’s rival KRAS G12C inhibitor Lumakras, but the tables could be turning. Krazati’s new owner, Bristol Myers Squibb, said on Friday that the drug’s confirmatory lung cancer trial, Krystal-12, had shown a “statistically significant and clinically meaningful benefit” on progression-free survival and overall response rate. This needs to be borne out with data, which Bristol is keeping under wraps for now. But the big pharma has a chance to capitalise after Lumakras’s recent FDA complete response letter in second-line lung cancer over questions about its confirmatory study, Codebreak-200; Lumakras looks unlikely to be pulled from the market, but Amgen will have to carry out another confirmatory trial. Codebreak-200 was notable for not showing an overall survival benefit, and Bristol investors have to hope that Krazati doesn’t suffer a similar fate, with OS data from Krystal-12 still immature. As well as narrowing the lung cancer gap, Bristol is ahead in colorectal cancer; here progress with KRAS inhibitors has been slow, but regulatory decisions are finally due this year.
The battle of the KRAS G12C inhibitors
| Krazati (Bristol Myers Squibb) | Lumakras (Amgen) | |
|---|---|---|
| NSCLC accelerated | Approved Dec 2022 based on Krystal-1 | Approved May 2021 based on Codebreak-100 |
| NSCLC confirmatory | Krystal-12, “statistically significant and clinically meaningful benefit in PFS and ORR” vs SOC | FDA identified deficiencies in Codebreak-200; CRL Dec 2023 |
| Colorectal | Filed based on Krystal-1; PDUFA 21 June 2024 | Codebreak-300 data underwhelmed, filing planned H1 2024 |
Source: OncologyPipeline.
1375
