DREAM3R: DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma: A Phase 3 Randomised Trial

Abstract

<b>Purpose/Objective(s):</b> • Platinum-based chemotherapy with pemetrexed is an appropriate first line treatment option for unresectable malignant pleural mesothelioma (MPM) • The DREAM¹ and PrE0505² Phase II trials combined durvalumab (PD-L1 inhibitor) with a platinum and pemetrexed both exceeding pre-specified response with acceptable toxicity • CheckMate 7433 recently reported an overall survival benefit with ipilimumab plus nivolumab vs. chemotherapy (HR 0.74, 95% CI 0.50 to 0.91). However, this benefit was less apparent in the 75% of patients with epithelioid histology (HR 0.86, 95% CI 0.69 to 1.08) • Clinical trials to further explore optimal first line treatment for MPM with immunotherapy are needed <h3>Materials/Methods</h3> International, open label, randomised (2:1), multi-centre, phase 3 trial • 480 patients (320 durvalumab and chemotherapy, 160 chemotherapy) to be recruited over 27 months and followed for another 24 months • This provides over 85% power if the true hazard ratio for overall survival is 0.70 with 2-sided alpha of 0.05, assuming a median survival of 15 months in the chemotherapy group, 21.4 months in the durvalumab and chemotherapy group, with an allowance for crossover <h3>Results</h3> TBD <h3>Conclusion</h3> TBD