Merck's Keytruda promising for perioperative head and neck cancer care

Merck & Co, known globally as MSD outside the US and Canada, has reported encouraging outcomes from a pivotal study of its anti-PD-1 therapy for head and neck cancer. The culminating phase 3 trial, named KEYNOTE-689, has been assessing the efficacy of Keytruda (pembrolizumab) as a perioperative treatment for recently diagnosed patients with stage 3 or 4A, resected, locally advanced head and neck squamous cell carcinoma.

In this trial, patients received Keytruda as a neoadjuvant therapy prior to surgery. Post-surgery, the treatment was continued in conjunction with standard-of-care radiotherapy, with or without cisplatin, serving as an adjuvant therapy. Additionally, Keytruda was administered as a maintenance therapy following the adjuvant treatment. The interim analysis, which was pre-specified, revealed a statistically significant and clinically relevant enhancement in event-free survival among patients treated with the Keytruda regimen, thus achieving the primary goal of the study.

Furthermore, a substantial improvement in the major pathological response, which is a crucial secondary outcome, was observed in patients receiving Keytruda compared to those who underwent only adjuvant radiotherapy. The safety profile of Keytruda was consistent with previous studies, indicating no new safety concerns.

This year, it is projected that there will be over 58,450 new cases of head and neck cancer in the US. These cancers encompass various types of tumors that manifest in or around the throat, larynx, nose, sinuses, and mouth. Keytruda enhances the capacity of the immune system to identify and combat tumor cells. It is already authorized for use as a monotherapy and in combination treatments for certain patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma.

Marjorie Green, who serves as the senior vice president and head of oncology at Merck Research Laboratories, emphasized the significance of the KEYNOTE-689 trial. She noted that it is the first successful trial in two decades for patients with resected, locally advanced head and neck squamous cell carcinoma. Green highlighted that the trial's findings are not only statistically significant but also carry the potential to alter clinical practices, underscoring the promising role of Keytruda for patients with earlier stages of the disease.

Beyond its application for head and neck squamous cell carcinoma, Keytruda has garnered approvals for the treatment of an extensive array of cancers. These include specific types of breast cancer, cervical cancer, bladder cancer, biliary tract cancer, non-small cell lung cancer, and renal cell carcinoma.