KEYNOTE-716: Immunotherapy May Be Introduced Earlier in the Melanoma Patient’s Journey

A pivotal randomized Phase 3 clinical trial involving stage II melanoma evidenced a 35% reduction in the risk of recurrence with adjuvant pembrolizumab compared with placebo. Presented at the European Society for Medical Oncology (ESMO) Congress 2021, the late-breaking KEYNOTE-716 trial reveals that patients with IIB and IIC melanoma present a deep or ulcerated primary tumor and comparable risk of recurrence and death as do patients with stage IIIA and IIIB melanoma. While the patients in the former group face the same risk as the latter group, the standard of care differs—the former receives the standard of care while the latter adjuvant therapy. The findings could lead to the U.S. Food and Drug Administration’s (FDA) decision to introduce immunotherapy earlier in the patient journey. This could reduce recurrence and metastases in melanoma patients.

The Study Results Thus Far

The KEYNOTE-716 study (NCT03553836) evaluates the safety and efficacy of pembrolizumab (Keytruda) compared to placebo in participants with surgically resected high-risk Stage II melanoma. 

According to ESMO’s recent press release, the study randomly allocated to 976 patients with complete resection ...

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