Novartis will stop developing a KRAS lung cancer drug that had made it to Phase 3 testing, a spokesperson confirmed to Endpoints News on Thursday.
The experimental medicine, known as JDQ443 or opnurasib, was still listed in Novartis’ pipeline as recently as its first-quarter update on April 23. At the time, Novartis projected an approval submission for the oral tablet no earlier than 2027, a timeline that was pushed back from prior estimations of a 2024 filing.
“This decision was made in light of the increasing options available to patients with KRAS G12C-driven cancers,” the spokesperson said in an emailed statement. “It was not driven by clinical data and no new safety signals have been observed.”
Amgen opened up the KRAS field in May 2021 with an FDA accelerated approval of Lumakras, but the medicine was denied full approval last December. Mirati Therapeutics, which Bristol Myers Squibb recently bought for $4.8 billion, followed Amgen with an FDA accelerated nod for Krazati in December 2022. Both Amgen and Bristol Myers are looking to expand the landscape of the medicines, as are other KRAS drug developers.
Novartis’ move was made following a “strategic review,” the spokesperson said, noting the pharma giant is working with trial investigators on “specific plans for each opnurasib study and current participants will continue as per protocol.”
The discontinuation was disclosed in a Wednesday update to a Phase 2 trial looking at JDQ443 for certain forms of non-small cell lung cancer and brain metastases. The investigational medicine is in various human studies for NSCLC and solid tumors, according to the US federal clinical trials database.
The spokesperson said the cull will be included in the Swiss drugmaker’s upcoming second-quarter presentation.