Meeting
2020 ASCO Virtual Scientific Program
Long-term survival from pembrolizumab (pembro) completion and pembro retreatment: Phase III KEYNOTE-006 in advanced melanoma.
Authors
Georgina V. Long
Melanoma Institute Australia, The University of Sydney, Royal North Shore Hospital, Mater Hospital, Sydney, Australia
Georgina V. Long , Jacob Schachter , Ana Arance , Jean-Jacques Grob , Laurent Mortier , Adil Daud , Matteo S. Carlino , Antoni Ribas , Catriona M. McNeil , Michal Lotem , James M. G. Larkin , Paul Lorigan , Bart Neyns , Christian U. Blank , Teresa M. Petrella , Omid Hamid , Erin Jensen , Clemens Krepler , Scott J. Diede , Caroline Robert
Organizations
Melanoma Institute Australia, The University of Sydney, Royal North Shore Hospital, Mater Hospital, Sydney, Australia, Sheba Medical Center, Tel HaShomer Hospital, Tel Aviv, Israel, Hospital Clinic de Barcelona, Barcelona, Spain, Aix Marseille University, Hôpital de la Timone, Marseille, France, Université Lille, Centre Hospitalier Régional Universitaire de Lille, Lille, France, UCSF, San Francisco, CA, Melanoma Institute Australia, University of Sydney, Blacktown Hospital, and Crown Princess Mary Cancer Centre, Westmead Hospital, Sydney, Australia, David Geffen School of Medicine at UCLA, Los Angeles, CA, University of Sydney and Chris O'Brien Lifehouse, Sydney, Australia, Sharett Institute of Oncology, Hadassah-Hebrew 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, Gustave Roussy and Paris-Sud University, Villejuif, France
Research Funding
Pharmaceutical/Biotech Company
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
Background: 5-year follow-up of the phase 3 KEYNOTE-006 study (NCT01866319) showed pembro improved OS vs ipilimumab (ipi) in patients (pts) with advanced melanoma. 3-y OS rate from pembro completion for pts who completed 2 y of pembro was 93.8%. Results with 8 mo of additional follow-up are presented to inform clinical care. Methods: Eligible pts with ipi-naive advanced melanoma, ≤1 prior therapy for BRAF-mutant disease, and ECOG PS 0 or 1 were randomized to pembro 10 mg/kg Q2W or Q3W for ≤2 y or ipi 3 mg/kg Q3W for 4 doses. Pts discontinuing pembro with CR, PR, or SD after ≥94 weeks were considered pts with 2-y pembro. Pts who stopped pembro with SD, PR or CR could receive ≤12 mo of additional pembro (2nd course) upon disease progression if still eligible. ORR was assessed per immune-related response criteria by investigator review. OS was estimated using the Kaplan-Meier method. Pembro arm data were pooled. Post hoc ITT efficacy analyses are shown. Results: Median follow-up from randomization to data cutoff (Jul 31, 2019) was 66.7 mo in the pembro and 66.9 mo in the ipi arms. OS outcomes are shown in Table. For the 103 pts with 2-y pembro (30 CR, 63 PR, 10 SD), median follow-up from completion was 42.9 mo (95% CI, 39.9-46.3).Median DOR was not reached. 36-mo OS from pembro completion was 100% (95% CI, 100.0-100.0) for pts with CR, 94.8% (95% CI, 84.7-98.3) for pts with PR, and 66.7% (95% CI, 28.2-87.8) for pts with SD. 15 pts received 2nd-course pembro; BOR in 1st course was 6 CR, 6 PR, and 3 SD. Median time from end of 1st course to start of 2ndcourse was 24.5 mo (range, 4.9-41.4). Median follow-up in pts who received 2nd-course pembro was 25.3 mo (range, 3.5-39.4). Median duration of 2nd-course pembro was 8.3 mo (range, 1.4-12.6). BOR on 2ndcourse was 3 CR, 5 PR (ongoing responses, 7 pts), 3 SD (ongoing, 2 pts), and 2 PD (1 death); 2 pts pending. Conclusions: Pembro improves the long-term survival vs ipi in pts with advanced melanoma, with all pts who completed therapy in CR still alive at 5 years. Retreatment with pembro at progression in pts who stopped at SD or better can provide additional clinical benefit in a majority of pts. Clinical trial information: NCT01866319
| Deaths (additional since last data cutoff Dec 3, 2019), n | Median OS (95% CI), mo | HR | 5-Y OS rate (95% CI), % | |
|---|---|---|---|---|
| Pembro (N = 556) | 328 (4) | 32.7 (24.5-41.6) | 0.74 | 39.7 (35.5-43.8) |
| Ipi (N = 278) | 173 (1) | 15.9 (13.3-22.0) | – | 31.0 (25.3-36.9) |
| 1L pembro (n = 368) | 203 (1) | 38.7 (27.3-50.8) | 0.72 | 43.3 (38.0-48.4) |
| 1L ipi (n = 181) | 111 (1) | 17.1 (13.8-26.2) | – | 33.0 (25.8-40.3) |
| 2L pembro (n = 97) | 125 (3) | 23.5 (16.8-34.2) | 0.78 | 32.3 (25.5-39.3) |
| 2L ipi (n = 187) | 62 (0) | 13.6 (10.7-22.0) | – | 27.3 (18.3-37.0) |
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Abstract Details
Session Type
Poster Discussion Session
Session Title
Melanoma/Skin Cancers
Track
Melanoma/Skin Cancers
Sub Track
Advanced/Metastatic Disease
Clinical Trial Registration Number
NCT01866319
Citation
J Clin Oncol 38: 2020 (suppl; abstr 10013)
DOI
10.1200/JCO.2020.38.15_suppl.10013
Abstract #
10013
Poster Bd #
362
Abstract Disclosures
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