Adjuvant pembrolizumab: durable RFS for Stage III melanoma

At a 3-years median follow-up, the randomized, phase 3 EORTC 1325/KEYNOTE-054 trial demonstrated that adjuvant pembrolizumab taken for up to 1 year in high-risk stage III melanoma patients improved recurrence-free survival (RFS), with a consistent effect across subgroups.

At a 3-years median follow-up, the randomized, phase 3 EORTC 1325/KEYNOTE-054 trial demonstrated that adjuvant pembrolizumab taken for up to 1 year in high-risk stage III melanoma patients improved recurrence-free survival (RFS), with a consistent effect across subgroups.

Prof. Alexander Eggermont (Princess Máxima Centre for Paediatric Oncology, the Netherlands) presented the study [1], whose purpose was to assess whether post-surgery therapy with pembrolizumab improves disease recurrence for high-risk participants with melanoma (Stage IIIA [> 1 mm metastasis], IIIB, and IIIC), as compared with placebo.

The EORTC 1325/KEYNOTE-054 trial included 1,019 adults with stage IIIA (15%), stage IIIB (46%), or stage IIIC (39%) resected melanoma metastatic to lymph nodes. Patients were assigned to either adjuvant pembrolizumab (200 mg every 3 weeks) for up to 1 year (n=514) or placebo (n=505) for a total of 18 doses, until disease recurrence or unacceptable toxicity. The co-primary endpoints were RFS in the intent-to-treat population as a whole, and in patients with PD-L1-positive tumors as a pre-specified subgroup analysis.

Previously, with a median follow-up of 1.25 years, the investigators reported improved RFS for pembrolizumab compared with placebo (HR 0.57). In the current presentation, results with a median follow-up of 3.05 years again showed superior RFS for the pembrolizumab group compared with the placebo group (190 vs 283 RFS events; HR 0.56; 95% CI 0.47-0.68). Among patients with PD-L1-positive tumours (n=853), 3-year RFS rates with pembrolizumab were also better than placebo (65% vs 46%; HR 0.57; 95% CI 0.43-0.74; P<0.001). Pembrolizumab was also better for the RFS of patients with BRAF-mutated tumours (n=440; 62% vs 37%; HR 0.51; 95% CI 0.36-0.73) and patients with BRAF wild-type tumours (n=448; 62% vs 47%; HR 0.66; 95% CI 0.46-0.95).

In conclusion, adjuvant pembrolizumab conferred a durable, clinically meaningful RFS benefit for patients with resected high-risk stage III melanoma. “We have shown that longer follow-up confirms a very sustained RFS benefit for pembrolizumab compared with placebo,” Prof. Eggermont said. Elaborating on the road ahead for this study, he added: “We will report on distant metastasis-free survival when they are ready in the next 6 or 7 months”.

Source:
1. Eggermont AM, et al. Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: New recurrence-free survival results from the EORTC 1325-MG/Keynote 054 double-blinded phase III trial at three-year median follow-up. ASCO Virtual Meeting, 29-31 May 2020, Abstract 10000.

Esanum is an online network for approved doctors

Esanum is the medical platform on the Internet. Here, doctors have the opportunity to get in touch with a multitude of colleagues and to share interdisciplinary experiences. Discussions include both cases and observations from practice, as well as news and developments from everyday medical practice.

Esanum ist ein Online-Netzwerk für approbierte Ärzte

Esanum ist die Ärzteplattform im Internet. Hier haben Ärzte die Möglichkeit, mit einer Vielzahl von Kollegen in Kontakt zu treten und interdisziplinär Erfahrungen auszutauschen. Diskussionen umfassen sowohl Fälle und Beobachtungen aus der Praxis, als auch Neuigkeiten und Entwicklungen aus dem medizinischen Alltag.

Esanum est un réseau en ligne pour les médecins agréés

Esanum est un réseau social pour les médecins. Rejoignez la communauté et partagez votre expérience avec vos confrères. Actualités santé, comptes-rendus d'études scientifiques et congrès médicaux : retrouvez toute l'actualité de votre spécialité médicale sur esanum.