Pembrolizumab versus ipilimumab for advanced melanoma: Final overall survival analysis of KEYNOTE-006.
2016; Lippincott Williams & Wilkins; Volume: 34; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2016.34.15_suppl.9504
ISSN1527-7755
AutoresJacob Schachter, Antoni Ribas, Georgina V. Long, Ana Arance, Jean‐Jacques Grob, Laurent Mortier, Adil Daud, Matteo S. Carlino, Catriona M. McNeil, Michal Lotem, James Larkin, Paul Lorigan, Bart Neyns, Christian U. Blank, Teresa M. Petrella, Omid Hamid, Haiyu Zhou, Scot Ebbinghaus, Nageatte Ibrahim, Caroline Robert,
Tópico(s)Immunotherapy and Immune Responses
Resumo9504 Background: In the phase III KEYNOTE-006 study (NCT01866319), pembro (anti–PD-1) provided superior OS and PFS and a lower incidence of grade 3-5 treatment-related AEs compared with ipi (anti–CTLA-4) in patients (pts) with advanced melanoma and ≤ 1 prior therapy. Here, we present the final OS analysis. Methods: 834 pts were randomized 1:1:1 to 24 mo of pembro 10 mg/kg Q3W or Q2W or to 4 doses of ipi 3 mg/kg Q3W. Clinically stable pts with radiologic progression could receive treatment until confirmed progression. Response was assessed per RECIST v1.1 by central review at wk 12, every 6 wk until wk 48, then every 12 wk thereafter. Survival follow-up was every 12 wk. Final OS analysis occurred after all pts were followed for ≥ 21 mo. Differences in OS were assessed in the intention-to-treat population using the stratified log-rank test with the Hochberg procedure. Results: As of Dec 3, 2015, median follow-up duration was 22.9 mo and 383 pts had died. Pembro continued to provide superior OS, PFS, and ORR over ipi, with no difference between pembro schedules (Table). Median OS was not reached for pembro vs 16.0 mo with ipi; estimated 24-mo OS rates were 55% and 43%, respectively. The PFS KM curves appeared to flatten after ~20 mo for all arms, with estimated 24-mo rates of ~30% for pembro and 14% for ipi. KM estimates suggest ~70% of responding pts have a response lasting ≥ 72 wk. There was 1 treatment-related death (sepsis in the pembro Q2W arm). The safety profile was consistent with that previously reported. Conclusions: With an additional 9 mo of follow-up, median OS was not reached for pembro, and the superiority of pembro over ipi for advanced melanoma was confirmed. Coupled with the durability of response and manageable safety profile, these data support pembro as a standard of care for advanced melanoma. Clinical trial information: NCT01866319. Pembro 10 Q2W N = 279 Pembro 10 Q3W N = 277 Ipi N = 278 OS, median, mo Median, mo NR NR 16.0 24-mo rate, % 55.1 55.3 43.0 HRa (95% CI) 0.68 (0.53-0.87) P = .0008 0.68 (0.53-0.86) P = .0008 — PFS, median, mo Median, mo 5.6 4.1 2.8 24-mo rate, % 31.2 27.8 13.5 HRa (95% CI) 0.61 (0.50-0.75) P < .0001b 0.61 (0.50-0.75) P < .0001b — ORR, % 36.9 P < .0001a,b 36.1 P < .0001a,b 13.3 Responders without further progression, % 72.8 69.0 75.7 aVersus ipi; bNominal.
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