Novartis pulls plug on KRAS drug amid growing treatment options

2024-05-30

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Novartis has decided to discontinue development of its experimental KRAS G12C inhibitor KRAS G12C inhibitor opnurasib (JDQ443) across all studies following a strategic review, including halting the Phase III KontRASt-02 trial evaluating the drug in non-small-cell lung cancer (NSCLC).

"This decision was made in light of the increasing options available to patients with KRAS G12C-driven cancers," Novartis told FirstWord in a statement. "It was not driven by clinical data and no new safety signals have been observed." The company added that it is continuing to "[explore] multiple modalities in our early pipeline" to treat lung cancer.

The KontRASt-02 trial, which started in 2022, was comparing JDQ443 monotherapy to docetaxel chemotherapy in an estimated 360 previously treated patients with locally advanced or metastatic KRAS G12C-mutant NSCLC. It was expected to complete in 2025.

Earlier-stage results for JDQ443 unveiled in 2022 had shown a remission rate of 57% at the recommended dose of 200mg twice daily. At the time, Novartis said the Phase Ib/II KontRASt-01 data pointed to "high systemic exposure" and a "favourable" safety profile at this dose.

Another study that got underway last month, dubbed STRIDER, was evaluating the intracranial efficacy of JDQ443 in NSCLC patients with KRAS G12C mutations and asymptomatic, untreated or treated brain metastases.

If it had reached the market, JDQ443 would have had to compete against two commercial KRAS inhibitors KRAS inhibitors – Amgen's Lumakras/Lumykras (sotorasib) and Bristol Myers Squibb's Krazati (adagrasib). Other KRAS contenders in development include Eli Lilly's second-generation KRAS inhibitor olomorasib (LY3537982), currently in Phase III for NSCLC, and Roche's Phase I asset divarasib (GDC-6036) in testing for solid tumours.

For related analysis, see KOL Views Q&A: LY3537982's safety profile may be make or break for Eli Lilly in oral KRAS tussle.

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