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.