Merck (MSD) has reported that its Keytruda met the primary goal of recurrence-free survival (RFS) as adjuvant therapy in the Phase III KEYNOTE-716 trial for surgically resected high-risk stage II melanoma patients.
A humanised monoclonal antibody, Keytruda hinders the interaction between programmed death receptor-1 (PD-1) and its ligands, PD-L1 and PD-L2, to trigger T lymphocytes that could impact tumour cells and healthy cells.
The anti-PD-1 treatment boosts the immune system’s ability to find and fight tumour cells.
The randomised, two-part Phase III KEYNOTE-716 trial enrolled a total of 954 subjects aged 12 years and above.
RFS was the trial’s primary goal while secondary goals included distant metastasis-free survival, overall survival, safety and quality of life.
In KEYNOTE-716’s double-blind Part 1, subjects received an intravenous dose of Keytruda 200mg or placebo every three weeks for nearly one year.
Subjects in the open-label Part 2 were given the treatment for nearly two years.
Interim analysis data showed that Keytruda monotherapy provided statistically significant and clinically meaningful RFS improvement versus placebo as adjuvant treatment.
Furthermore, no new safety signals linked to the drug were noted in the trial.
Based on the latest results, the US Food and Drug Administration (FDA) accepted a new supplemental biologics licence application (sBLA) for Keytruda as adjuvant therapy for stage IIB or IIC melanoma after full resection in patients aged 12 years and above.
The application also received FDA priority review with a decision anticipated by 4 December 2021.
Merck Research Laboratories global clinical development senior vice-president and head Dr Roy Baynes said: “Many patients with stage II melanoma have a high risk of their cancer returning after surgery.
“This is an important milestone for patients, and we look forward to sharing these results with the medical community as soon as possible.”
Last month, Merck reported that its Keytruda met the primary goal of overall survival in Phase III KEYNOTE-355 trial involving patients with metastatic triple-negative breast cancer.