Merck announces new long-term Keytruda data

Merck (MRK) announced new long-term data highlighting the sustained survival benefits of Keytruda, Merck’s anti-PD-1 therapy, in treating non-small cell lung cancer. The results are based on the exploratory five-year analyses of KEYNOTE-671 evaluating Keytruda as part of a neoadjuvant followed by adjuvant treatment regimen for patients with resectable NSCLC; and the eight-year analyses of KEYNOTE-024 and -042 and the 10-year analyses of KEYNOTE-001 and -010 evaluating Keytruda as monotherapy in certain patients with locally advanced or metastatic NSCLC. In the exploratory five-year follow-up data from the Phase 3 KEYNOTE-671 trial, Keytruda in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery continued to show clinically meaningful improvements in overall survival and event-free survival outcomes in certain patients with resectable stage II, IIIA or IIIB NSCLC, compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo alone. The hazard ratio for OS for the Keytruda regimen versus the chemotherapy-placebo regimen was 0.74. For EFS, the HR for the Keytruda regimen versus the chemotherapy-placebo regimen was 0.58. In the exploratory eight-year analyses from KEYNOTE-024 and KEYNOTE-042 and the exploratory 10-year analyses from KEYNOTE-001 and KEYNOTE-010, Keytruda continued to improve OS in patients with locally advanced or metastatic NSCLC compared to chemotherapy. In KEYNOTE-001, the median OS for patients receiving Keytruda was 13.2 months in those with any Tumor Proportion Score and a median OS of 17.3 months in those with a TPS greater than or equal to50%. KEYNOTE-001 did not compare Keytruda to another agent or placebo. In KEYNOTE-010, the median OS for patients receiving Keytruda with a TPS greater than or equal to 1% was 11.8 months versus 8.3 months for chemotherapy. For patients receiving Keytruda, with a TPS greater than or equal to 50%, the median OS was 16.6 months versus 8.2 months for chemotherapy. In KEYNOTE-024, the median OS for patients receiving Keytruda with a TPS greater than or equal to 50% was 26.3 months versus 13.4 months for chemotherapy. In KEYNOTE-042, the median OS for patients receiving Keytruda with a TPS greater than or equal to 1% was 16.4 months versus 12.1 months for chemotherapy. For patients receiving Keytruda with a TPS greater than or equal to 50%, the median OS was 20.0 months versus 12.2 months for chemotherapy. Participants from KEYNOTE-001, KEYNOTE-010, KEYNOTE-024 and KEYNOTE-042 who achieved a complete response after taking Keytruda and then had progressive disease were eligible for a subsequent anti-cancer therapy including a second course of Keytruda monotherapy.