Merck announces long-term OS data from pivotal Phase 3 KEYNOTE-006 trial

Merck announced long-term overall survival data from the pivotal Phase 3 KEYNOTE-006 trial, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with advanced melanoma. Based on 10 years of follow-up, the data showed sustained improved survival outcomes for patients receiving KEYTRUDA as a single agent compared to ipilimumab in patients with advanced melanoma. These late-breaking data will be presented for the first time during a mini oral session at the European Society for Medical Oncology Congress 2024 and published in the Annals of Oncology. For patients with advanced melanoma, these long-term follow-up data showed the 10-year OS rate for KEYTRUDA was 34.0% versus 23.6% for ipilimumab. KEYTRUDA demonstrated a sustained OS benefit, reducing the risk of death by 29% . At 10 years, KEYTRUDA more than doubled the median OS compared to ipilimumab. To date, KEYTRUDA has demonstrated sustained survival benefits of five years or more across multiple types of cancer, including certain types of melanoma, non-small cell lung cancer, head and neck cancer and bladder cancer. Based on the results from KEYNOTE-006 in December 2015, the U.S. Food and Drug Administration approved KEYTRUDA for the treatment of patients with unresectable or metastatic melanoma.