Merck reports long-term data from final KEYNOTE-002 analysis
Merck announced findings from the final overall survival analysis from the KEYNOTE-002 study investigating the use of Keytruda compared to investigator-choice chemotherapy with a crossover to Keytruda design, in patients with ipilimumab-refractory advanced melanoma. The results presented at the ESMO 2016 Congress include follow-up of up to 35 months for the study's co-primary endpoints of OS and progression-free survival. Data showed prolonged OS with Keytruda 2 mg/kg and 10 mg/kg, with a median OS of 13.4 months and 14.7 months and a two-year OS rate of 35.9 percent and 38.2 percent, respectively, compared to a median OS of 11.0 months and a two-year OS rate of 29.7 percent with chemotherapy. While improvements in OS between Keytruda 2 mg/kg or 10 mg/kg and chemotherapy did not meet the protocol-specified significance threshold, longer follow-up continued to show a clinically meaningful improvement in PFS, the study's co-primary endpoint, with PFS of up to 31 months in patients treated with Keytruda. Median PFS was approximately three months for each of the patient groups -- 2.8-3.8 months with Keytruda 2 mg/kg; 2.8-5.2 months with Keytruda 10 mg/kg; and 2.6-2.8 months with chemotherapy. The two-year PFS rate was 16.0 percent and 21.9 percent with Keytruda compared to 0.6 percent of patients treated with chemotherapy. ORR was 22.2 percent and 27.6 percent with Keytruda compared to 4.5 percent with chemotherapy. At the time of analysis, 50 percent and 58 percent of patients who responded to Keytruda were alive with no subsequent progression or anti-tumor therapy, compared to 12 percent of patients who responded to chemotherapy. With longer follow-up, adverse events have remained consistent with previously reported safety data.