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ASCO Rehash 2016 Brian Boulmay, MD LSUHSC- New Orleans Section of Hematology & Oncology *many slides adapted from ASCO2016 vitual meeting Pembrolizumab Plus Chemotherapy as FrontLine Therapy for Advanced NSCLC: KEYNOTE021 Cohorts A-C Abstract 9016 Gadgeel S, Stevenson J, Langer C, et al. Background • Standard of care for mNSCLC without mutation is stil a platinum doublet. ▫ Pembrolizumab has efficacy for previosuly treated NSCLC ▫ The KEYNOTE- 10 trial established an improvement in overall survival when compared to docetaxel. 12.7 months v 10.4 months For tumors with >=50% PDL1 expression: 14.9 v 8.2 months ▫ Pembrolizumab is approved for use in the US in the second line after a platinum-based doublet in tumors that express PDL1 Herbst The Lancet 2016 Study Design • Phase I/II trial of pembro + platinum based doublet first line. • Key Eligibility: ▫ Age 18-75, any NSCLC histology, EGFR and ALK wild-type, no active CNS mets….and any PDL1 status. Study Schema Results: Baseline Characteristics Results: Baseline Characteristics Safety Signals • Three patients in cohort B stopped study drug due to AEs ▫ Grade III pneumonitis ▫ Grade III drug hypersensitivity ▫ Grade III colitis • No treatment related deaths Immune-Related AEs RESULTS: ORR RESULTS: ORR PFS Median: 10.3 months Median: NR Median 10.2 months Overall Survival Median: NR Median: NR Median: NR Conclusions • Chemotherapy plus pembrolizumab appears to be well tolerated ▫ Exception is bevacizumab containing regimen • Keynote 189- evaluating pem/platinum +/pembrolizumab is recruiting for Non-SqNSCLC • Keynote 407- evaluting Taxol/platinum +/pembrolizumb is recruiting for SqCCa Checkmate 032: Nivolumab Alone or in Combination with Ipilimumab for the Treatment of Recurrent Small Cell Lung Cancer Antonia S, et. al. Abstract 100 Small cell lung cancer • Trivial progress in the last three decades • Good responses, recurrence is the rule • Second line therapy basically ineffective Small cell lung cancer • Small cell lung cancer is generally felt to be a ‘cold tumor’ ▫ T-cell infiltrates are sparse • Unlike melanoma, NSCLC • In theory, immune therapy with PD1 would not be effective. ▫ No T-cells to activate Ipilimumab is not active in the tumor environment, but in the lymphoid compartment May enhance T-cell infiltrate of cold tumors Checkmate 032 Checkmate 032 Checkmate 032 • Tocixity: ▫ 79% had toxicity of any grade in the Nivo1+Ipi3 arm. ▫ Diarrhea and fatigue most common ▫ 4% pneumonitis Checkmate 032 Checkmate 032 Checkmate 032 Conclusions • Safety profile is similar to other diseases. • Durable objective response rates • Tumors responded despite low PDL1 expression • Nivo1/Ipi3 chosen for further study ▫ Checkmate 032 expanded ▫ Checkmate 451 maintenance Plug • AZ Trial to open at LSU ▫ Durvalumab plus tremelimumab first line NSCLC
