KEYNOTE-040 Clinical Trial Confirms Keytruda Survival Advantage in Recurrent PD-1 Positive Head and Neck Cancer Patients

Immunotherapy with the checkpoint inhibitor Keytruda (pembrolizumab) improves survival for selected patients whose head and neck cancer has spread, or recurred after an initial round of chemotherapy, according to results of the Keynote-040 trial presented at the ESMO 2017 Congress in Madrid.1

Globally, head and neck cancer (HNC) comprises the seventh most common type of cancer with an estimated 400,000-600,000 diagnoses every year. 2016 saw significant advances in understanding the role of Human Papilloma Virus in head and neck cancers and breakthrough advances in treatment with precision medicines that help the immune system recognize and attack cancer.

Keytruda belongs to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to help the immune system recognize and attack cancer. PD-1 is a protein that inhibits certain types of immune responses, allowing cancer cells to evade an attack by certain immune cells. Drugs that block the PD-1 pathway enhance the ability of the immune system to fight cancer.  PD-1 inhibitors represent a significant advancement in the treatment of head and neck cancers.

The KEYNOTE-040 trial was a global, clinical trial that included patients with recurrent or metastatic head and neck squamous cell carcinoma that had failed platinum-based chemotherapy.  Patients were treated with either keytruda (n=247) or standard of care treatment (n=248), which was the investigator’s choice of chemotherapy with either methotrexate, docetaxel, or cetuximab.

Compared to the other treatments, keytruda measured up well in terms of side-effects.  Among patients with combined cancer cell PD-L1-expression of at least 50%, the average survival was 11.6 versus 7.9 months.   Survival advantage with keytruda was positive but less impressive when cancer expressed only 1% of PD-1:  8.7 months compared to 7.1 months with standard treatment. Keyturda continues to represent a significant improvement for the management of head and neck cancers.


  1. Abstract LBA45_PR ‘Pembrolizumab (pembro) vs standard of care (SOC) for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): Phase 3 KEYNOTE-040 trial’ will be presented by Dr. Cohen during Proffered Paper Session ‘Head and neck cancer’ on Monday, 11 September 2017, 15:00 to 16:20 (CEST) in Granada Auditorium.

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