melanoma

Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial

In the November 20, 2020 edition of Journal of Clinical Oncology, Alexander M. M and colleagues report on the EORTC 1325-MG/KEYNOTE-054 Trial

PURPOSE

The phase III double-blind EORTC 1325/KEYNOTE-054 trial was organized to evaluate pembrolizumab versus placebo in patients with resected high-risk stage III melanoma and this publication reviewed a 3-year relapse free survival.

PATIENTS AND METHODS

A total of 1,019 melanoma patients who completed lymph node dissection, with stage IIIA (by definition they had at least one lymph node metastasis > 1 mm), IIIB, or IIIC (without evidence of in-transit metastasis) cutaneous melanoma were randomized to receive pembrolizumab at a flat dose of 200 mg (n = 514) or placebo (n = 505) every 3 weeks for 12 months or until disease recurrence or unacceptable toxicity. The two coprimary end points were relapse free survival in the overall population and in those with PD-L1 positive tumors.

RESULTS

There were 190 RFS events in the pembrolizumab arm compared with 283 RFS events in the placebo arm which resulted in prolonged RFS in the overall population (3-year RFS rate, 63.7% v 44.1% for pembrolizumab v placebo, respectively; HR, 0.56; 95% CI, 0.47 -o 0.68) and in the PD-L1+ subgroup (HR, 0.57; 99% CI, 0.43 – 0.74). The impact of pembrolizumab on RFS was not different in subgroups, both for AJCC staging and and BRAF mutation status (HR, 0.51 [99% CI, 0.36 – 0.73] v 0.66 [99% CI, 0.46 – 0.95] for V600E/K v wild type).

The authors concluded “In resected high-risk stage III melanoma, pembrolizumab adjuvant therapy provided a sustained and clinically meaningful improvement in RFS at 3-year median follow-up. This improvement was consistent across subgroups.”

Reference:

Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial

https://ascopubs.org/doi/full/10.1200/JCO.20.02110

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