Novartis moves to climb up the Kras rankings

As Mirati talks up a US adagrasib filing by the end of this year, alongside a leadership overhaul, its investors have had yet another reminder that time is not standing still. Novartis’s third-quarter presentation today pointed out that this group’s rival Kras G12C inhibitor JDQ443 would start a phase 3 lung cancer study in the first half of 2022. This means that Amgen, having beaten Mirati to the punch and launched Lumakras in May, has first-mover advantage on the one hand, and that some considerable players, including Novartis, Roche and Merck & Co, are snapping at Mirati’s heels on the other. This battle should ultimately come down to clinical data, and here Mirati’s adagrasib looks better than Lumakras in colorectal cancer, albeit with important toxicities, and in line in NSCLC. Both indications will likely feature in an accelerated approval filing. Novartis moving to phase 3 in second/third-line NSCLC suggests that the Swiss firm does not see an accelerated timeline as realistic, something that plays to Mirati and Amgen’s advantage. Indeed, the planned launch year for JDQ443 is 2024, so assuming that Mirati gets a move on and executes, adagrasib should enjoy some breathing space.

Getting crowded: selected industry projects targeting Kras
Project Company Mechanism Status
Lumakras Amgen Kras G12C inhibitor Launched for 2nd-line, Kras G12C-mutant NSCLC
Adagrasib Mirati Therapeutics Kras G12C inhibitor Ph3 for Kras G12C-mutant NSCLC & colorectal cancer; filing in late 2021
JDQ443 Novartis Kras G12C inhibitor Ph1/2; starting ph3 in 2nd/3rd-line NSCLC in H1 2022
JAB-21822 Jacobio Pharmaceuticals Kras G12C inhibitor Ph1/2 in Kras G12C-mutant solid tumours
GDC-6036 Roche Kras G12C inhibitor Ph1 in Kras G12C-mutant solid tumours
JNJ-74699157 Johnson & Johnson Kras G12C inhibitor Ph1 in Kras G12C-mutant solid tumours
BI 1823911 Boehringer Ingelheim Kras G12C inhibitor Ph1 in Kras G12C-mutant solid tumours
BI 1701963 Boehringer Ingelheim Kras Sos 1 complex inhibitor Ph1 in Kras-mutant colorectal cancer
mRNA-5671 Moderna/Merck & Co Kras mRNA vaccine Ph1 +/- Keytruda in Kras-mutant tumours
ELI-002 Elicio Therapeutics Kras mRNA vaccine Phase 1 in Kras/Nras-mutant solid tumours
MK-1084 Merck & Co Kras G12C inhibitor Ph1 Keytruda combo in Kras G12C-mutant solid tumours begins Dec 2021
MRTX1133 Mirati Therapeutics Kras G12D inhibitor Preclinical
JAB-22000 Jacobio Pharmaceuticals Kras G12D inhibitor Preclinical
SBT-100 Singh Biotechnology Kras & Stat3 inhibitor Preclinical
BBP-454 Bridgebio Pharma Kras inhibitor Preclinical
SDGR5 Schrödinger Kras Sos 1 complex inhibitor Preclinical
Source: Evaluate Pharma, company information & clinicaltrials.gov.

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