2017 ASCO Annual Meeting!
Session: Melanoma/Skin Cancers
Type: Oral Abstract Session
Time: Sunday June 4, 8:00 AM to 11:00 AM
Location: Arie Crown Theater
Long-term outcomes in patients (pts) with ipilimumab (ipi)-naive advanced melanoma in the phase 3 KEYNOTE-006 study who completed pembrolizumab (pembro) treatment.
2017 ASCO Annual Meeting
J Clin Oncol 35, 2017 (suppl; abstr 9504)
Author(s): Caroline Robert, Georgina V. Long, Jacob Schachter, Ana 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, Honghong Zhou, Blanca Homet Moreno, Nageatte Ibrahim, Antoni Ribas; Gustave Roussy, Villejuif, France; Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, Australia; Sheba Medical Center, Tel Hashomer, Israel; Hospital Clínic de Barcelona, Barcelona, Spain; Aix Marseille University, Hôpital de la Timone, Marseille, France; Universite Lille, Centre Hospitalier Regional Universitaire de Lille, Lille, France; University of California, San Francisco, San Francisco, CA; Westmead and Blacktown Hospitals and Melanoma Institute Australia, Sydney, Australia; Chris O’Brien Lifehouse, Camperdown, Australia; Sharett Institute of Oncology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel; 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; Sunnybrook Health Sciences Centre, Toronto, ON, Canada; The Angeles Clinic and Research Institute, Los Angeles, CA; Merck & Co., Inc., Kenilworth, NJ; University of California, Los Angeles, Los Angeles, CA
Background: Pembro demonstrated superior PFS and OS vs ipi in ipi-naive pts with advanced melanoma in the phase 3 KEYNOTE-006 study (NCT01866319). Here, we present long-term outcomes for all pts and in those pts who completed pembro therapy. Methods: Eligible pts (N = 834) were randomized 1:1:1 to pembro 10 mg/kg Q2W, pembro 10 mg/kg Q3W, or ipi 3 mg/kg Q3W for 4 doses. Treatment was continued for 2 yr (pembro only) or until disease progression, intolerable toxicity, or pt/investigator decision to discontinue. Per protocol, pts could interrupt pembro for ≤12 wk before discontinuation was required. Tumor imaging was performed at wk 12, then every 6 wk up to wk 48 and every 12 wk thereafter. After the prespecified final analysis, response assessments were per immune-related response criteria (irRC) by investigator review. Results: As of the data cutoff (Nov 3, 2016), median follow-up in the total population was 33.9 mo (range, 32.1-37.6). 33-mo OS rates were 50% in the pooled pembro arms (n = 556) and 39% in the ipi arm (n = 278); 33-mo PFS rates were 31% and 14%. ORR was 42% and 16%. Median duration of response was not reached for pembro (range 1.0+ to 33.8+ mo) or ipi (1.1+ to 34.8+ mo); 46 (68%) pembro-treated pts and 7 (58%) ipi-treated pts had a response lasting ≥30 mo. Among the 104/556 (19%) pts who completed pembro, median exposure to pembro was 24.0 mo (range 22.1-25.9). After a median follow-up of 9.0 mo after completion of pembro, 102 (98%) pts were alive. Responses were durable in pts who completed pembro; 9.7 mo after completion of pembro, estimated PFS (95% CI) was 91% (80-96) in all 104 pts, 95% (69-99) in pts with complete response (n = 24), 91% (74-97) in pts with partial response (n = 68), and 83% (48-96) in pts with stable disease (n = 12). Conclusions: Pembro provides durable efficacy after stopping the protocol-specified duration of treatment in pts with ipi-naive advanced melanoma in KEYNOTE-006. The estimated risk for progression or death nearly 10 mo after completing pembro is 9% and does not appear to differ by best response to pembro. Clinical trial information: NCT01866319
2. REGN2810: A fully human anti-PD-1 monoclonal antibody, for patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC)—Initial safety and efficacy from expansion cohorts (ECs) of phase I study.