A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer.

Enrollment was expanded beyond the originally planned 100 patients based on the probability of improved efficacy for time to recurrence of <0.95 and >0.70 (this range of probabilities represents a strong trend, i.e., not yet definitive) and if an estimate of increased time to recurrence and mortality exceeded 2 months during enrollment.

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For the prospectively defined and stratified R1 subgroup, there was a nonsignificant trend for improved OS with GI-4000 treatment, with an advantage in 1-year survival for GI-4000 versus placebo (72.2% vs. 55.6%, respectively), and an improvement in median OS of 80 days for GI-4000 versus placebo (523.5 vs. 443.5 days, HR = 1.06 [CI: 0.53–2.13], p = 0.872).

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