2018 ASCO Annual Meeting!
Session: Melanoma/Skin Cancers
Type: Oral Abstract Session
Time: Monday June 4, 8:00 AM to 11:00 AM
Location: Arie Crown Theater
4-year survival and outcomes after cessation of pembrolizumab (pembro) after 2-years in patients (pts) with ipilimumab (ipi)-naive advanced melanoma in KEYNOTE-006.
2018 ASCO Annual Meeting
J Clin Oncol 36, 2018 (suppl; abstr 9503)
Author(s): Georgina V. Long, Jacob Schachter, Antoni Ribas, Ana M. Arance, Jean-Jacques Grob, Laurent Mortier, Adil Daud, Matteo S. Carlino, Catriona M. McNeil, Michal Lotem, James M. G. Larkin, Paul Lorigan, Bart Neyns, Christian U. Blank, Teresa M. Petrella, Omid Hamid, James Anderson, Clemens Krepler, Nageatte Ibrahim, Caroline Robert; Melanoma Institute Australia, The University of Sydney, Mater Hospital, and Royal North Shore Hospital, Sydney, Australia; Sheba Medical Center at Tel Hashomer, Ramat Gan, Israel; University of California, Los Angeles, Los Angeles, CA; Hospital Clínic de Barcelona, Barcelona, Spain; Aix-Marseille University, Hopital de la Timone, Marseille, France; Université Lille, Centre Hospitalier Régional Universitaire de Lille, Lille, France; University of California, San Francisco, San Francisco, CA; Westmead and Blacktown Hospitals, Melanoma Institute Australia, and The University of Sydney, Sydney, Australia; Chris O'Brien Lifehouse, Camperdown, Australia; Sharett Institute of Oncology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel; The Royal Marsden Hospital, London, United Kingdom; University of Manchester and the Christie NHS Foundation Trust, Manchester, United Kingdom; Universitair Ziekenhuis Brussel, Brussels, Belgium; Netherlands Cancer Institute, Amsterdam, Netherlands; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; The Angeles Clinic and Research Institute, Los Angeles, CA; Merck & Co., Inc., Kenilworth, NJ; Merck & Co., Inc., Kenilworth, NJ, US; Merck & Co, Inc., Kenilworth, NJ; Gustave Roussy Institute, Paris, France
Background: KEYNOTE-006 (NCT01866319) established superiority of pembro over ipi in advanced melanoma. We provide 4-y outcomes, long-term data for pts who completed 2 y pembro, and data for second course. Methods: Eligible pts (N = 834) were randomly assigned 1:1:1 to receive pembro 10 mg/kg Q2W, pembro 10 mg/kg Q3W, or ipi 3 mg/kg Q3W for 4 doses. Treatment was continued for 2 y (pembro only; completed defined as ≥94 weeks of pembro and discontinued with at least SD) or until disease progression, intolerable toxicity, or pt/investigator decision to discontinue. End points were OS and ORR per irRC by investigator review. Upon PD, eligible pts could receive an additional 1 y pembro. Results: At data cutoff (Dec 4, 2017), median follow-up was 45.9 mo (range, 0.3-50.0). 4-y OS rate was 42% in the pooled pembro arms (n = 556) and 34% in the ipi arm (n = 278); ORR was 42% and 17%. Median DOR was NR for pembro (range, 1.0+ to 46.1+ mo) or ipi (1.1+ to 45.6+ mo); 62% pembro- and 59% ipi-treated pts had a response lasting ≥42 mo. In treatment-naive pts, 4-y OS rates were 44% in the pooled pembro arms (n = 368) and 36% in the ipi arm (n = 181); ORR was 47% and 17%. Median DOR was NR for pembro (range, 1.6+ to 46.0+ mo) or ipi (1.1+ to 42.2+ mo); 65% pembro- and 68% ipi-treated pts had a response lasting ≥42 mo. Of 556 pts, 103 (19%) completed the protocol-specified 2-y pembro (28 CR, 65 PR, 10 SD). Median follow-up was 20.3 mo after pembro completion; 89 (86%) pts did not progress and 14 pts had PD (prior response 2 CR, 9 PR, 3 SD). Eight pts (prior response 3 CR [including 1 pt who discontinued early with CR and then progressed], 4 PR, and 1 SD) received second-course pembro but 3 discontinued (1 each due to PD, interstitial pneumonia, and infection). Median duration of second-course pembro was 9.7 mo; BOR was 1 CR, 1 PR, 5 SD, and 1 PD. 1 pt with SD had subsequent PD. 5 pts had a TRAE during second-course pembro; there were no grade 3/4 TRAEs or deaths. Conclusions: Pembro provides durable antitumor activity in treatment-naive or -experienced pts with advanced melanoma. Of pts who completed 2 y pembro, 86% were progression free at 20 mo. Pembro is safe and provides additional antitumor activity as second-course treatment. Clinical trial information: NCT01866319