Regulatory Decision Summary for Keytruda

Authorization was based on the pre-defined second interim analysis results from a Phase III, international, multi-centre, randomized, double-blind, placebo-controlled with active treatment trial. Adult metastatic squamous NSCLC patients (n = 559) with no prior systemic chemotherapy treatment for metastatic NSCLC received either Keytruda in combination with carboplatin and paclitaxel (or nab-paclitaxel) (n = 278) or platinum-based doublet chemotherapy, carboplatin and paclitaxel (or nab-paclitaxel) (n = 281) once every 3 weeks for 4 cycles followed by Keytruda or platinum-based chemotherapy alone once every 3 weeks for up to 35 cycles.

The primary efficacy endpoints were Overall Survival (OS) and Progression-Free Survival (PFS). The addition of Keytruda to the current standard of care platinum-based doublet chemotherapy of carboplatin and either paclitaxel or nab-paclitaxel provided statistically significant and clinically meaningful improvements in both primary efficacy endpoints of OS and PFS, with 36% reduction in risk of death and 44% reduction in the risk of disease progression or death compare to chemotherapy alone.

The most common drug-related adverse effects reported in at least 30% of patients in both treatment groups were alopecia, anemia, neutropenia, and nausea, which can be effectively managed by standard clinical practice. The overall safety profile of Keytruda in combination with carboplatin and paclitaxel (or nab-paclitaxel) is consistent with the established safety profiles of Keytruda monotherapy and platinum-based chemotherapy, with no new safety issues identified.

The recommended dose for Keytruda is 200 mg fixed dose administered as an intravenous infusion over 30 minutes every 3 weeks.

Efficacy and safety results from this submission are considered sufficient to establish an overall favorable benefit-risk profile in the sought indication for the treatment of patients with metastatic squamous NSCLC in combination with carboplatin and either paclitaxel or nab-paclitaxel, in adults with no prior systemic chemotherapy treatment for metastatic NSCLC.