Merck's Keytruda Becomes First Adjuvant Therapy to Show Statistically Significant Overall Survival Benefit in High-Risk Renal Cell Carcinoma Patients Post-Nephrectomy

▎WuXi

Edited by Kant Content Team

MSD announced today that its Phase 3 clinical trial, KEYNOTE-564, has successfully achieved the critical secondary endpoint of overall survival (OS). The trial evaluates the efficacy and safety of its key PD-1 inhibitor, Keytruda, as an adjuvant therapy for patients with renal cell carcinoma (RCC) who have an intermediate-high or high risk of recurrence after undergoing nephrectomy or nephrectomy combined with metastasectomy.According to the press release, Keytruda is the first adjuvant therapy to demonstrate a statistically significant improvement in OS for patients with RCC at high risk of recurrence after nephrectomy.

The pre-specified interim analysis by the Independent Data Monitoring Committee showed,Compared with placebo, Keytruda demonstrated a statistically significant and clinically relevant improvement in OS.This analysis result is consistent with the previously published clinical results. An early interim analysis with a median follow-up period of 23.9 months found that KEYNOTE-564 achieved its primary endpoint of disease-free survival (DFS).Compared with placebo, Keytruda reduced the risk of disease recurrence or death by 32% (HR=0.68, 95% CI: 0.53-0.87, p=0.0010).

The safety profile of Keytruda was consistent with previous trials, showing no new safety concerns. The newly released OS data further reinforce the significant disease-free survival benefit observed in the earlier KEYNOTE-564 trial.

Keytruda is a humanized anti-PD-1 monoclonal antibody that blocks the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby activating T lymphocytes.This effect may enhance the ability of the immune system in the body to detect and resist tumor cells. In September 2014, Keytruda was first approved by the FDA for the treatment of advanced melanoma, and was subsequently approved as a first-line therapy for patients with metastatic NSCLC. In China, Keytruda has also been approved for multiple indications, covering melanoma, NSCLC, head and neck squamous cell carcinoma, colorectal cancer, esophageal cancer, liver cancer, etc.