On Monday, Revolution Medicines, Inc. (NASDAQ:RVMD) stock declined 10% following an update on clinical data. The company, focused on developing therapies for RAS-addicted cancers, shared updates from its RAS(ON) inhibitor portfolio during an investor webcast.
The presentation included data from the Phase 1 RMC-6236 monotherapy study in pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). Additionally, new data from combination studies involving RMC-6236 with pembrolizumab, RMC-6291 with pembrolizumab, and a RAS(ON) inhibitor doublet of RMC-6291 and RMC-6236 were discussed.
In the PDAC cohort, RMC-6236 demonstrated a favorable safety profile and showed promising antitumor activity, particularly in patients with a KRAS G12X mutation. The median progression-free survival (PFS) for this group was 8.8 months, with a 100% survival rate six months after starting treatment. The objective response rate (ORR) was 36% for patients with the KRAS G12X mutation. These results support the ongoing RASolute 302 Phase 3 trial and plans to advance RMC-6236 into earlier lines of therapy for metastatic PDAC.
For the NSCLC cohort, RMC-6236 was well tolerated at doses ranging from 120 mg to 220 mg once daily. The ORR was 38% in patients who had previously received immunotherapy and platinum chemotherapy, with a median PFS of 9.8 months. These findings endorse the initiation of the RASolve 301 Phase 3 trial, expected to begin in the first quarter of 2025, comparing RMC-6236 to docetaxel in previously treated, locally advanced or metastatic RAS mutant NSCLC.
The combination of RMC-6236 with pembrolizumab in NSCLC patients also showed a favorable initial safety profile, encouraging further evaluation in first-line NSCLC treatment. Meanwhile, the RAS(ON) inhibitor doublet of RMC-6291 and RMC-6236 in colorectal cancer patients who had previously been treated with a KRAS(OFF) G12C inhibitor showed an ORR of 25% and a disease control rate (DCR) of 92%, suggesting potential for this treatment strategy.
Revolution Medicines aims to continue developing RAS(ON) doublets in various tumor types and earlier lines of therapy. The company also plans to investigate the triplet combination of RMC-6291 and RMC-6236 with pembrolizumab as a chemotherapy-sparing option for first-line NSCLC patients.
TD Cowen reiterated its Buy rating on Revolution Medicines, highlighting the potential for RMC-6236 to become the standard of care in PDAC and NSCLC, and noting the significant upside as the drug moves into earlier lines of PDAC treatment. The analyst anticipates that RMC-6236 will likely receive approval in second-line lung cancer and has a clear path forward in first-line treatment settings.
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