Jason Luke, MD, FACP, discusses the final analysis of distant metastasis–free survival in the phase 3 KEYNOTE-716 trial of pembrolizumab vs placebo as adjuvant therapy in patients with stage IIB or IIC melanoma.
Jason Luke, MD, FACP, associate professor of medicine, Division of Hematology/Oncology, director, Cancer Immunotherapeutic Center, Immunology and Immunotherapy Program, UPMC Hillman Cancer Center, discusses the final analysis of distant metastasis–free survival (DMFS) in the phase 3 KEYNOTE-716 trial (NCT03553836) of pembrolizumab (Keytruda) vs placebo as adjuvant therapy in patients with stage IIB or IIC melanoma.
At the 2023 ASCO Annual Meeting, Luke shared final updates to the protocol-specified DMFS analysis from the phase 3 trial. Findings showed that patients treated with pembrolizumab experienced a 41% reduction in the risk of distant metastases compared with those treated with placebo (HR, 0.59; 95% CI, 0.44-0.79). At a median follow-up of 39.4 months, the median DMFS was not reached in both arms. However, patients in the pembrolizumab arm achieved a 36-month DMFS rate of 84.4% compared with 74.7% in the placebo arm. In patients with stage IIB disease, the 36-month DMFS rate was 86.7% for pembrolizumab and 78.9% for placebo. For those with stage IIC melanoma, the 36-month DMFS rates were 80.9% and 68.1% for pembrolizumab and placebo, respectively.
These data now serve as a benchmark as a new standard of care for patients with stage IIB or IIC melanoma, Luke says. He emphasizes that patients with IIB or IIC disease are at a high risk of recurrence, and this can be mitigated with pembrolizumab. These data that will help inform future treatment approaches, such as combination therapies, and the findings will also help guide the management of patients who are presently seen in the clinic, Luke notes.
With longer-term follow-up of KEYNOTE-716, no new safety signals were reported for pembrolizumab, Luke says. The tradeoff between safety and efficacy is always a consideration when selecting treatment in the adjuvant setting, Luke continues. Pembrolizumab is associated with an infrequent incidence of high-grade, immune-related toxicities that can be irreversible, Luke explains, adding that this is at the crux of the decision-making process for a patient in the adjuvant setting. Although adjuvant immunotherapy has demonstrated the ability to reduce the risk of recurrence and distant metastases, serious adverse effects could accompany treatment, which should be discussed with patients when making a treatment decision, Luke concludes.