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

Authors :
Forde, P.
Kindler, H.
Zauderer, M.
Sun, Z.
Ramalingam, S.
Anagnostou, V.
Brahmer, J.R.
Nowak, A.K.
Kok, P.S.
Brown, C.
Yip, S.
Cook, A.
Lesterhuis, W.J.
Hughes, B.G.M.
Pavlakis, N.
Stockler, M.R.
O'Byrne, K.J.
Source :
International Journal of Radiation Oncology, Biology, Physics. Feb2022, Vol. 112 Issue 2, pe9-e10. 2p.
Publication Year :
2022

Abstract

Purpose/Objective(s): • 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 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 TBD TBD [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
03603016
Volume :
112
Issue :
2
Database :
Academic Search Index
Journal :
International Journal of Radiation Oncology, Biology, Physics
Publication Type :
Academic Journal
Accession number :
154338724
Full Text :
https://doi.org/10.1016/j.ijrobp.2021.10.177