Lancet: Adjuvant Pembrolizumab Has Good Efficacy and Safety in Stage II Melanoma (KEYNOTE-716)

Are there more therapeutic areas for PD-1 mAbs in melanoma? According to the survival data of AJCC 8th edition staging, the long-term survival of patients with high-risk stage IIB and IIC melanoma after surgery is worse than that of stage IIIA or IIIB patients.

The KEYNOTE-716 study aims to answer these questions

The KEYNOTE-716 study enrolled patients ≥12 years of age, surgically resectable and negative sentinel lymph node biopsy, newly diagnosed stage IIB or IIC cutaneous melanoma (AJCC 8th edition), and ECOG PS 0-1

A total of 976 patients (64% stage IIB, 34.

At a median follow-up of 14.

Drug-related AEs occurred in 79.

Adjuvant pembrolizumab in patients with resectable stage IIB or IIC melanoma reduced the risk of recurrence and metastasis by 35% compared with placebo, which was statistically significant

Based on data from the Phase 3 KEYNOTE-716 trial, U.

Original source:

Luke JJ, Rutkowski P, Queirolo P, Del Vecchio M, Mackiewicz J, Chiarion-Sileni V, de la Cruz Merino L, Khattak MA, Schadendorf D, Long GV, Ascierto PA, Mandala M, De Galitiis F, Haydon A, Dummer R, Grob JJ, Robert C, Carlino MS, Mohr P, Poklepovic A, Sondak VK, Scolyer RA, Kirkwood JM, Chen K, Diede SJ, Ahsan S, Ibrahim N, Eggermont AMM; KEYNOTE-716 Investigators.