Pembrolizumab Demonstrates Improvement in IIB, IIC Melanoma

Merck, a pharmaceutical company, announcedthe results of a phase 3 KEYNOTE-716 trial (NCT03553836) investigating pembrolizumab (Keytruda, Merck), a humanized monoclonal antibody that blocks the interaction between an anti-programmed death receptor (PD)-1 and its ligands, PD-L1 and PD-L2, thus activating T-lymphocytes, which may affect both tumor and healthy cells.KEYNOTE-716 is a randomized, 2-part, phase 3 trial evaluating the adjuvant treatment of patients with completely resected high-risk stage II melanoma.

The trial examined the treatment as adjuvant treatment for patients with resected stage IIB and IIC melanoma. It met its key secondary endpoint of distant metastasis-free survival (DMFS) at a pre-specified interim analysis, according to the press release. In the trial, pembrolizumab as an adjuvant treatment demonstrated a statistically significant improvement in the endpoint of DMFS compared to placebo andno new safety signals were observed. Currently, the analysis shows that treatment with pembrolizumab also continued to show an improvement in recurrence-free survival (RFS) compared to placebo. The full results from this analysis of KEYNOTE-716 will be presented at an upcoming medical meeting, according to the release.

“Patients with melanoma that has spread to distant sites have a significantly worse prognosis and the goal of adjuvant therapy is to delay disease recurrence, especially distant metastases,” said Scot Ebbinghaus, MD, vice president, clinical research, Merck Research Laboratories. “In KEYNOTE-716, adjuvant treatment with [pembrolizumab] first showed a significant improvement in recurrence-free survival and has now demonstrated a significant improvement in the time until the first diagnosis of a distant metastasis compared to placebo. The distant metastasis-free survival data from KEYNOTE-716 reinforce the evidence for [pembrolizumab] as adjuvant therapy in stage IIB and IIC melanoma.”

To date, pembrolizumab has shown significant improvements in RFS and DMFS compared to placebo across resected stage IIB and stage IIC (KEYNOTE-716) and stage III melanoma (EORTC1325/KEYNOTE-054: RFS HR=0.57 [95% CI, 0.46, 0.70] p<0.001; DMFS HR=0.60 [95% CI, 0.49-0.73]; p<0.001).In the US, pembrolizumab is approved for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC or III melanoma following complete resection.

Reference:

1. Merck’s KEYTRUDA (Pembrolizumab) demonstrated significant improvement in distant metastasis-free survival (DMFS) compared to placebo as adjuvant therapy for patients with resected stage IIb and IIc melanoma in phase 3 keynote-716 trial. Merck. Published March 8, 2022. Accessed March 7, 2022. https://www.merck.com/news/mercks-keytruda-pembrolizumab-demonstrated-significant-improvement-in-distant-metastasis-free-survival-dmfs-compared-to-placebo-as-adjuvant-therapy-for-patients-with-resected-stage/