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Revolution looks earlier in pancreatic cancer

In its quarterly results release Revolution Medicines noted plans to complete enrolment into the phase 3 Rasolute-302 trial of its lead project, the pan-KRAS inhibitor daraxonrasib, this year. If it stays on track, this paves the way for readout of the study, in second-line pancreatic cancer, in 2026, as previously hoped. Investors might be more interested in an update in earlier pancreatic cancer. Revolution first revealed plans for a pivotal first-line pancreatic ductal adenocarcinoma (PDAC) trial in mid-2024, and it has now emerged that this will test daraxonrasib (previously known as RMC-6236) with or without chemo, versus chemo alone. The company previously flagged median overall survival benchmarks of 8.5-11.1 months with approved chemotherapies. Meanwhile, Revolution added that it would also start a pivotal trial in adjuvant PDAC this year – although it didn’t give any further details. The group estimates that around 15% of newly diagnosed PDAC patients have resectable disease, meaning that the adjuvant market isn’t to be sniffed at. Pancreatic cancer isn’t the only target for daraxonrasib: the Rasolve-301 trial in second-line RAS-mutated NSCLC has begun, Revolution announced, although the study doesn’t appear to be listed yet on clinicaltrials.gov.

 

Revolution’s phase 3 trials of daraxonrasib 

TrialSettingRegimenPrimary endpointsStatus
Rasolute-3022nd-line PDAC (RASm & RASwt)Daraxonrasib 300mg/day, vs investigator’s choice chemoPFS & OS in G12Xm ptsExpects “substantially completing” enrolment in 2025; data due 2026
Rasolve-3012nd-line RASm NSCLCDaraxonrasib 200mg/day, vs docetaxelPFS & OS in G12X-Cm ptsActivating study sites
Unnamed1st-line PDACDaraxonrasib +/- chemo, vs chemoTBCTo start H2 2025
UnnamedAdjuvant PDACTBCTBCTo start H2 2025

Notes: *NSCLC=non-small cell lung cancer; PDAC=pancreatic ductal adenocarcinoma. Source: OncologyPipeline, clinicaltrials.com & company releases.

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Molecular Drug Targets