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DREAM3R Durvalumab (MEDI4736) with Chemotherapy As First Line Treatment in Advanced Pleural Mesothelioma - a Phase 3 Randomised Trial

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DREAM3R Durvalumab (MEDI4736) with Chemotherapy As First Line Treatment in Advanced Pleural Mesothelioma - a Phase 3 Randomised Trial DREAM3R DuRvalumab (MEDI4736) with chEmotherapy as first line treAtment in advanced pleural Mesothelioma - A phase 3 Randomised trial DREAM3R is an investigator-initiated, academically-lead collaboration between TOGA (Thoracic Oncology Group of Australasia), PrECOG, and the NHMRC CTC, that builds on promising results with concurrent chemo-immunotherapy in independent phase 2 trials conducted by these groups: DREAM in Australia and PrE0505 in the USA. TRIAL OVERVIEW Adults with treatment-naïve advanced, pleural mesothelioma Randomised to cisplatin and pemetrexed +/- durvalumab (2:1, so 2/3 receive durvalumab) Chemotherapy for up to 6 cycles Durvalumab for up to 2 years, 3-weeky during chemotherapy, 4-weekly after chemotherapy Key inclusion criteria* Key exclusion criteria* Malignant pleural mesothelioma Prior systemic therapy for mesothelioma (primary peritoneal mesothelioma ineligible) Active autoimmune disease Measurable disease as per mRECIST 1.1 Ongoing systemic corticosteroids (i.e. pleural thickening > 7mm at some point Other malignancy requiring treatment or non-pleural measurable disease) Contraindications to cisplatin Diagnosis on biopsy (not cytology) AND tissue available for correlative studies Acceptable haematology and biochemistry (available on request) Performance status ECOG 0-1 * A full list of inclusion and exclusion criteria and participating sites can be found on ANZCTR (Ref ACTRN12620001199909) STUDY SCHEMA ARM A (n=320) Durvalumab Durvalumab 1500 mg Q3W + 1500 mg Q4W 2 Cisplatin 75 mg/m² Q3W + until PD or unacceptable Pemetrexed 500 mg/m² Q3W toxicity, up to maximum For maximum of 6 cycles total 2 years up - R Follow ARM B (n=160) Cisplatin 75 mg/m² Q3W + 1 Pemetrexed 500 mg/m² Q3W Observation For maximum of 6 cycles What do the results of CheckMate-743( ipilimumab and nivolumab first line in mesothelioma) mean for DREAM3R? CheckMate 743 interim analysis showed a hazard ratio of 0.74 (96.6% CI 0.60-0.91) for overall survival (non- epithelioid patients HR 0.46 (95% CI 0.31-0.68) for OS; epithelioid HR 0.86 (95% CI 0.69-1.08) for OS). This combination not PBS listed in Australia. The benefits observed were almost entirely confined to those with non-epithelioid mesothelioma, with little evidence of benefit in those with epithelioid mesothelioma. Cisplatin and pemetrexed remains an internationally accepted standard of care, particularly for epithelioid mesothelioma. DREAM3R will determine if concurrent chemo-immunotherapy can improve outcomes in mesothelioma, especially for the majority of patients with the epithelioid subtype. DREAM3R DuRvalumab (MEDI4736) with chEmotherapy as first line treAtment in advanced pleural Mesothelioma - A phase 3 Randomised trial Participating sites. NSW VIC QLD GenesisCare St Leonards Peter MacCallum Cancer Centre Princess Alexandra Hospital Westmead Hospital Epworth Healthcare Townsville Hospital Chris O’Brien Lifehouse Austin Hospital Prince Charles Hospital Liverpool Hospital Goulburn Valley Health Icon Cancer Centre Coffs Harbour Health Campus Monash Health Sunshine Coast University Hospital Gosford Hospital Border Medical Oncology TAS Calvary Mater Newcastle Peninsula & Southeastern HOG Royal Hobart Hospital Blacktown Hospital Sunshine Hospital Launceston General Hospital Nepean Hospital SA WA Orange Hospital Flinders Medical Centre Sir Charles Gairdner Hospital ACT The Queen Elizabeth Hospital Canberra .
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