Regulatory Decision Summary for Keytruda

Authorization of Keytruda was based on one international, multicenter, randomized, open-label, Phase 3 study to assess the efficacy and safety of Keytruda (pembrolizumab) monotherapy. Participants (n = 307) were randomized 1:1 to receive Keytruda (200 mg Q3W) (n = 153) or investigator’s choice of standard of care (SOC) therapies for CRC (bevacizumab or cetuximab in combination with mFOLFOX6 or FOLFIRI) (n = 154). The co-primary endpoints were progression-free survival (PFS) per RECIST 1.1 and overall survival (OS).

A statistically significant and clinically meaningful improvement in PFS was observed in the pembrolizumab arm compared to the SOC arm. Median PFS in the pembrolizumab arm was double the median PFS in the SOC arm (16.5 months vs. 8.2 months). Median OS was not reached in the pembrolizumab arm, compared to 34.8 months in the SOC arm.

In general, the AEs observed in both treatment arms were consistent with those associated with the disease, and with the known safety profiles of pembrolizumab monotherapy and SOC therapies. The duration of exposure was about twice as long for the pembrolizumab arm than the SOC arm (11.1 months vs. 5.7 months) but incidence rates of many AEs were lower in the pembrolizumab arm than in the SOC arm such as diarrhea, fatigue, nausea, neutropenia, and decreased neutrophil count. The most commonly reported AEs that showed a higher rate in the pembrolizumab arm were arthralgia, hypothyroidism, and increased blood alkaline phosphatase. Overall, pembrolizumab treatment was well-tolerated and no new safety concerns were identified in this study. Compared to SOC treatment, pembrolizumab has a favourable safety profile.

The recommended dose of Keytruda is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months or 35 doses, whichever is longer, in patients without disease progression. View the Keytruda Product Monograph for details.