Merck & Co – known as MSD outside the US and Canada – has shared positive results from a late-stage study of its anti-PD-1 therapy in head and neck cancer.
The phase 3 KEYNOTE-689 trial has been evaluating Keytruda (pembrolizumab) as a perioperative treatment for patients newly diagnosed with stage 3 or 4A, resected, locally advanced head and neck squamous cell carcinoma.
The drug was given as a neoadjuvant therapy before surgery, then continued after surgery in combination with standard-of-care radiotherapy (with or without cisplatin) as an adjuvant therapy, and then as a maintenance therapy.
Results from a pre-specified interim analysis demonstrated a statistically significant and clinically meaningful improvement in event-free survival for patients receiving the Keytruda regimen, meeting the study’s primary endpoint.
A statistically significant improvement in major pathological response, a key secondary endpoint, was also shown for patients in the Keytruda arm compared with adjuvant radiotherapy alone, and the safety profile of Merck’s drug was consistent with that observed in previously reported studies.
More than 58,450 new cases of head and neck cancer, which describes a number of different tumours that develop in or around the throat, larynx, nose, sinuses and mouth, are expected to be diagnosed in the US this year.
Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumour cells, and is already approved as a monotherapy and in combination regimens for certain patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, outlined that KEYNOTE-689 “marks the first positive trial in two decades for patients with resected, locally advanced head and neck squamous cell carcinoma”.
“These statistically significant and clinically meaningful findings have the potential to be practice-changing and continue to highlight the promising role of Keytruda for certain patients with earlier stages of disease,” she said.
Beyond head and neck squamous cell carcinoma, Keytruda holds approvals to treat a wide range of cancers, including specific cases of breast cancer, cervical cancer, bladder cancer, biliary tract cancer, non-small cell lung cancer and renal cell carcinoma.