The time patients with resected melanoma, a type of skin cancer, lived without their disease spreading to distant organs improved drastically after treatment with Keytruda.
The immunotherapy agent Keytruda (pembrolizumab) significantly improved the length of time patients lived without distant metastases — known as distant metastasis-free survival — over placebo in patients with resected stage 2B or 2C melanoma, according to recently announced data from the phase 3 KEYNOTE-716 trial.
The multi-center trial includes 976 patients aged 12 years and above who have stage 2B or 2C melanoma that has been resected (surgically removed).
“Patients with melanoma that has spread to distant sites have a significantly worse prognosis and the goal of adjuvant therapy is to delay disease recurrence, especially distant metastases,” said Dr. Scot Ebbinghaus, vice president of clinical research at Merck Research Laboratories, in a statement.
The interim analysis showed not only an improvement in distant metastasis-free survival, but also in recurrence-free survival (time a patient lives without their disease coming back), which is the study’s main goal. According to Merck, the manufacturer of Keytruda, the recurrence rate for patients with stage 2B or 2C melanoma is about 32 to 46%.
“In KEYNOTE-716, adjuvant treatment with Keytruda first showed a significant improvement in recurrence-free survival and has now demonstrated a significant improvement in the time until the first diagnosis of a distant metastasis compared to placebo. The distant metastasis-free survival data from KEYNOTE-716 reinforce the evidence for Keytruda as adjuvant therapy in stage 2B and 2C melanoma,” Ebbinghaus said.
The recurrence-free survival outcomes of KEYNOTE-716 led to the Food and Drug Administration’s approval of Keytruda for fully resected stage 2B, 2C or 3 in December 2021.
Additionally, side effect data from KEYNOTE-716 showed no new safety signals — meaning that there were no additional side effects from Keytruda that were not previously observed in other studies.
Like other checkpoint inhibitor immunotherapy agents, Keytruda works by making tumors more visible to the immune system, which then, in turn, will find and kill the cancer cells. Sparking this immunotherapy response can lead to inflammation throughout the body — including organs such as the pancreas and adrenal gland. This is something that patients and their providers should discuss before starting Keytruda treatment, especially in younger populations, one expert urged.
Findings will be presented at an upcoming medical meeting, according to Merck.
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