Crossover and rechallenge with pembrolizumab in recurrent patients from the EORTC 1325-MG/Keynote-054 phase 3 trial, pembrolizumab versus placebo after complete resection of high-risk stage III melanoma.
Alexander M Eggermont, Andrey Meshcheryakov, Victoria Atkinson, Christian U Blank, Mario Mandalà, Georgina V Long, Catherine Barrow, Anna Maria Di Giacomo, Rosalie Stephens, Shahneen Kaur Sandhu, Ragini Reiney Kudchadkar, Pablo L Ortiz-Romero, Inge Marie Svane, Alexander Christopher Jonathan Van Akkooi, Clemens Krepler, Nageatte Ibrahim, Sandrine Marreaud, Michal Kicinski, Stefan Suciu, Caroline Robert
Journal of Clinical Oncology | American Society of Clinical Oncology (ASCO) | Published : 2021
9500 Background: The phase 3 double-blind EORTC 1325/KEYNOTE-054 trial evaluated pembrolizumab (pembro) vs placebo in stage III cutaneous melanoma patients (pts) with complete resection of lymph nodes. Pembro improved RFS (hazard ratio [HR] 0.57) and DMFS (HR 0.60) (Eggermont, NEJM 2018, TLO 2021). In the pembro group, the incidence of immune related AE (irAE) grade 1-5 was 37%, and of grade 3-5 was 7%. We present the safety profile, response rate and PFS for the subset of pts who had a recurrence and crossed over or were rechallenged with pembrolizumab, within protocol. Methods: Pts were randomized to receive iv. pembro 200 mg (N=514) or placebo (N=505) every 3 weeks for a total of 18 dose..View full abstract