Keytruda Approved as Adjuvant Treatment for Stage IB, II, or IIIA NSCLC

The Food and Drug Administration (FDA) has approved Keytruda^® (pembrolizumab), as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).

The approval was based on data from the KEYNOTE-091 trial (ClinicalTrials.gov Identifier: NCT02504372), a randomized, triple-blind, placebo-controlled study that included 1177 patients with completely resected stage IB (T2a ≥4 cm), II, or IIIA NSCLC who had not received neoadjuvant radiotherapy or chemotherapy. Study participants were randomly assigned to receive pembrolizumab 200mg (n=506) or placebo (n=504) intravenously every 3 weeks; 86% (n=1010) received adjuvant platinum-based chemotherapy following resection.

In the overall study population, findings showed a statistically significant improvement in disease-free survival (DFS; primary endpoint) for patients treated with pembrolizumab compared with placebo (hazard ratio, 0.73; 95% CI, 0.60-0.89). Median DFS was reported to be 58.7 months (95% CI, 39.2-not reached) in the pembrolizumab arm and 34.9 months (95% CI, 28.6-not reached) in the placebo arm. Among patients who did not receive adjuvant chemotherapy (n=167), the DFS HR was 1.25 (95% CI, 0.76-2.05). Overall survival results were not mature at the time of analysis.

With the exception of hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%), adverse reactions observed in the KEYNOTE-091 study were similar to those seen in NSCLC patients treated with Keytruda as a single agent; fatal myocarditis was reported in 2 patients.

Keytruda is a programmed death receptor-1 (PD-1)-blocking antibody. This approval marks the fifth indication for Keytruda in the treatment of NSCLC.

References

1. FDA approves Keytruda^® (pembrolizumab) as adjuvant treatment following surgical resection and platinum-based chemotherapy for patients with stage IB (T2a ≥4 centimeters), II, or IIIA non-small cell lung cancer (NSCLC). News release. January 27, 2023. https://www.businesswire.com/news/home/20230127005078/en/FDA-Approves-KEYTRUDA%C2%AE-pembrolizumab-as-Adjuvant-Treatment-Following-Surgical-Resection-and-Platinum-Based-Chemotherapy-for-Patients-With-Stage-IB-T2a-%E2%89%A54-Centimeters-II-or-IIIA-Non-Small-Cell-Lung-Cancer-NSCLC
2. Keytruda. Package insert. Merck; 2023. Accessed January 27, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125514s128lbl.pdf