Will RVMD report that RASolve 301 (NSCLC Phase III) has completed enrollment by December 31, 2026?

RASolve 301 is enrolling globally in 2L+ NSCLC, but the timeline is uncertain. NSCLC has existing KRAS G12C treatments (sotorasib, adagrasib), making patient recruitment potentially slower than in PDAC where no alternatives exist. Daraxonrasib's multi-selective mechanism covers more KRAS mutations than G12C-only therapies, broadening the eligible patient pool. However, global Phase III enrollment in NSCLC typically takes 12-24 months from initiation. Without knowing when enrollment started, completing by December 2026 is uncertain. Estimate 30% — possible if enrollment is well advanced but unconfirmed.

The analysis states RASolve 301 is 'enrolling globally' but provides no enrollment milestones, site counts, or timeline targets. Global Phase III trials in NSCLC typically require 300-600 patients and 18-24 months. If initiation was in H2 2025, completion by December 2026 (12-18 months) would require above-average enrollment velocity. The competition for NSCLC KRAS patients from sotorasib and adagrasib may slow recruitment. Without concrete enrollment data, probability is below 30%.

If RVMD's 251 open positions and heavy R&D staffing are partly dedicated to trial infrastructure, enrollment could proceed faster than industry average. The company has demonstrated ability to complete enrollment in RASolute 302, suggesting institutional capability. A positive RASolute 302 readout in H1 2026 could generate physician enthusiasm and accelerate RASolve 301 enrollment. However, this is speculative without concrete enrollment data.

Too many unknowns: enrollment start date, target enrollment, current enrollment status, site count. Global NSCLC Phase III trials are large and take time. Without positive signals about enrollment velocity, the base case is that enrollment extends into 2027. Approximately 28% chance of completing by year-end 2026.

The question is about reporting enrollment completion, not just completing it. RVMD may complete enrollment but not disclose until the next earnings call or press release, potentially pushing the report date past December 2026 even if enrollment finishes earlier. That said, positive RASolute 302 data would increase investor interest in the NSCLC program, incentivizing timely disclosure. Probability around 32%.

The NSCLC competitive landscape is more crowded than PDAC. Sotorasib and adagrasib are approved options, making investigators less compelled to enroll patients in a trial of an unapproved agent. This dynamic typically slows enrollment. Without knowing if enrollment is on track or struggling, lean toward the lower end. 25% seems appropriate given the uncertainty.

Too much uncertainty about enrollment timeline. Global Phase III NSCLC trials typically take 18-24 months. Without concrete enrollment progress data, below 30%.

RVMD has demonstrated enrollment capability with RASolute 302 completion. If RASolve 301 started in early 2025 and enrollment is on track, completion by December 2026 is possible. But competition from approved KRAS therapies may slow it. Around 28%.

The combination of unknowns (start date, progress, competitive dynamics) makes this difficult to assess. Default to below 25% given the typical Phase III timeline and lack of positive enrollment signals.