Oral Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2017

3-year overall survival for patients with advanced NSCLC treated with pembrolizumab (#2)

Matthew D. Hellmann 1 , Natasha B. Leighl 2 , Rina Hui 3 , Enric Carcereny 4 , Enriqueta Felip 5 , Myung-Ju Ahn 6 , Joseph Paul Eder 7 , Ani S. Balmanoukian 8 , Charu Aggarwal 9 , Leora Horn 10 , Amita Patnaik 11 , Matthew A. Gubens 12 , Suresh S. Ramalingam 13 , Gregory M. Lubiniecki 14 , Jin Zhang 14 , Bilal Piperdi 14 , Edward B. Garon 15
  1. Memorial Sloan Kettering Cancer Center, New York, NY, USA
  2. Princess Margaret Cancer Centre, Toronto, Ontario, Canada
  3. Westmead Hospital and the University of Sydney, Sydney, Australia
  4. Catalan Institute of Oncology Badalona, Badalona, Spain
  5. Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain
  6. Samsung Medical Center, Seoul, South Korea
  7. Yale University, New Haven, CT, USA
  8. The Angeles Clinic and Research Institute, Los Angeles, CA, USA
  9. Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA, USA
  10. Vanderbilt-Ingram Cancer Center, Nashville, TN, USA
  11. South Texas Accelerated Research Therapeutics, San Antonio, TX, USA
  12. University of California, San Francisco, San Francisco, CA, USA
  13. Winship Cancer Institute of Emory University, Atlanta, GA, USA
  14. Merck & Co., Inc., Kenilworth, NJ, USA
  15. David Geffen School of Medicine at the University of California, Los Angeles, Santa Monica, CA, USA

Aims: Pembrolizumab is approved as first-line (1L) treatment for advanced NSCLC patients with PD-L1 tumor proportion score (TPS) ≥50% and as treatment for previously treated advanced NSCLC patients with PD-L1 TPS ≥1%. We present 3-y OS results for patients enrolled in KEYNOTE-001 (NCT01295827), the first trial evaluating pembrolizumab in advanced NSCLC patients.

Methods: 550 patients received pembrolizumab 2 or 10 mg/kg Q3W or 10 mg/kg Q2W until intolerable toxicity, progression, or investigator or patient decision to withdraw. PD-L1 expression was assessed by IHC using the 22C3 antibody. Survival was assessed every 2 mo after treatment discontinuation.

Results: 550 advanced NSCLC patients enrolled; 101 were first line (1L), and 449 were previously treated. As of the Sept 1, 2016, data cutoff, median follow-up duration was 34.5 mo (range, 25.7-51.5 mo); 8 (7.9%) 1L patients and 28 (6.2%) previously treated patients were still on treatment. 3-y OS was 26.4% (95% CI, 14.3%-40.1%) in 1L patients and 19.0% (95% CI, 15.0%-23.4%) in previously treated patients. Median (95% CI) OS was 22.3 mo (17.1-31.5) in 1L patients and 10.5 mo (8.6-13.2) in previously treated patients. 3-y OS rate (95% CI) by PD-L1 status in 1L patients was TPS ≥1% (n=79): 16.4% (4.0-36.36); TPS ≥50% (n=27): 25.2% (5.0-53.1); and not available for TPS 1%-49% (n=52). In previously treated patients, 3-y OS rate (95% CI) by PD-L1 status was TPS ≥1% (n=306): 21.1% (16.1-26.6); TPS ≥50% (n=138): 29.7% (21.9-37.9); TPS 1%-49% (n=90): 13.5% (7.8-20.9); and TPS<1% (n=90): 8.5% (2.9-18.1). Additional description of long-term outcomes, including updated safety data and 3-y OS by PD-L1 status and in patient subgroups, will be presented.

Conclusions: Pembrolizumab provides promising long-term OS benefit for 1L and previously treated advanced NSCLC patients expressing PD-L1. The current data represent the longest efficacy and safety follow-up for patients with advanced NSCLC treated with pembrolizumab.