Kras opinions diverge

A day after Novartis suggested that Kras inhibition only made sense in combinations, and two days after sales of the first marketed Kras inhibitor, Amgen’s Lumakras, flatlined, Roche confirmed the progression of its Kras contender into phase 3. Roche’s GDC-6036 has been added to the B-Fast study, in a new cohort comparing monotherapy against docetaxel in second-line, Kras G12C-mutant disease, the approved setting for Lumakras and Mirati’s Krazati. But Novartis seems to have put the brakes on JDQ443 – even though this, too, is already in a pivotal monotherapy NSCLC trial. While stressing that phase 3 was continuing, Novartis said it was “critical” to demonstrate efficacy in a combination. “That would really give us more confidence that [JDQ443] could be a very significant medicine.” For Roche a more immediate catalyst is overall survival data from the Skyscraper-01 trial of the anti-Tigit MAb tiragolumab, but there is no news yet: interim analysis is still scheduled for February, and “the most likely scenario is that the study will continue until final readout in the second half”, Roche said. It promises to communicate any negative result immediately, but “if you don’t hear back in February you know [Skyscraper-01] is continuing to final readout”.

Studies of four Kras inhibitors in unapproved settings
Project Company Trial Setting
Lumakras Amgen Codebreak-101 Includes Keytruda combo in Kras G12Cm NSCLC (various lines)
Krazati Mirati Krystal-7 1L Kras G12Cm NSCLC, Keytruda combo, vs Keytruda + chemo
RG6330/ GDC-6036 Roche B-Fast Includes monotherapy in 2L Kras G12C NSCLC, vs docetaxel
JDQ443  Novartis Kontrast-02 Monotherapy in 2/3L Kras G12C NSCLC, vs docetaxel

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