Merck & Co. Inc. said two follow-up studies showed Keytruda's long-term benefit in patients with advanced skin cancer.
The company presented long-term effectiveness data from its phase 3 study, named Keynote-006, and phase 1b trial, dubbed Keynote-001, evaluating its cancer immunotherapy Keytruda in advanced melanoma.
Keynote-006 compared the safety and efficacy of Keytruda with Bristol-Myers Squibb Co.'s Yervoy in patients with stage III or IV melanoma, which could not be removed via surgery, who had either not been treated previously or had received a prior targeted therapy for BRAF-mutation-positive melanoma.
In a new analysis of the Keynote-006 data, 86% of the patients who completed their Keytruda treatment remained alive without the disease worsening after a median follow-up period of 20.3 months. In addition, 41.7% of the patients in the Keytruda treatment arm remained alive for four years, compared to 34.1% for the Yervoy treatment group.
Among the patients who did not receive any prior treatment, 44.3% of the patients who received Keytruda were alive for four years versus 36.4% for those treated with Yervoy. Among both groups of patients who had not been treated previously or had received prior therapy, 47% saw their tumors shrink on Keytruda, versus 17% seeing a reduction in tumors with Yervoy.
The Keynote-001 evaluated Keytruda in patients with various advanced cancers, including 655 patients with advanced melanoma. The study found that 41% of patients on Keytruda saw a reduction in the size of their tumors, while 52% of the patients who had not received prior treatment saw their tumors shrink.
Results from this study also showed that 34% of the patients who received Keytruda and 41% of patients who did not receive any prior treatment lived for five years.
"Looking across the findings for both Keynote-006 and Keynote-001 we are seeing further validation that Keytruda is significantly extending the survival of first-line metastatic melanoma patients, regardless of tumor BRAF-mutation status," said Scot Ebbinghaus, the vice president of clinical research at Merck Research Laboratories.
The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on-site and an additional 3,350 abstracts to be published online.
