Long-Lasting Responses Achieved with Keytruda® in Advanced Head and Neck Cancer

Treatment with the immune-stimulating agent, Keytruda® (pembrolizumab), provides impressive long-term outcomes for some patients with metastatic or recurrent head and neck cancer. These results were recently presented at the 2016 annual meeting of the American Society of Clinical Oncology (ASCO).

Globally, head and neck cancer comprises the seventh most common type of cancer with an estimated 400,000-600,000 diagnoses every year. Head and neck squamous cell cancer (HNSCC) refers to head and neck cancer that originates in certain cells called squamous cells.

Metastatic or stage IV head and neck cancer refers to cancer that has spread from its site of origin to distant sites in the body. Overall survival at 5 years for patients diagnosed with metastatic head and neck cancer has remained at less than 4%, indicating a significant need in improved treatment for patients with this disease. Recurrent head and neck cancer refers to cancer that has recurred or progressed despite prior therapy.

Pembrolizumab belong 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.

Pembrolizumab, and another new PD-1 inhibitor, Opdivo® (nivolumab), work by blocking PD-1 and have demonstrated impressive activity in the treatment of melanoma, kidney, and lung cancers. These PD-1 inhibitors both appear to represent a significant advancement in the treatment of head and neck cancers. Pembrolizumab is currently approved by the United States Food and Drug Administration (FDA) for the treatment of certain types of lung cancers and melanoma. However, it is currently being evaluated in clinical trials for several different types of cancers.

Results from long-term follow-up of data from the KEYNOTE-012 trial were presented at this year’s ASCO. The trial evaluated the effectiveness of Keytruda in the treatment of 192 patients with metastatic or recurrent HNSCC.

  • Anti-cancer responses were achieved in 18% of patients.
  • 85% of anti-cancer responses lasted for at least 6 months, and 71% of anti-cancer responses lasted for at least one year.
  • At 6 months after initiation of treatment with pembrolizumab, 58% of patients were alive, and 25% of patients were alive with no progression of cancer.
  • At one year after initiation of treatment with pembrolizumab, 38% of patients were alive, and 17% of patients were alive with no progression of cancer.
  • Patients who achieved anti-cancer responses with pembrolizumab had been followed for a median time of 12.5 months at the time of data collection. The median duration of time that anti-cancer responses continued had not yet been reached.
  • Pembrolizumab was generally well tolerated.

These results provide further evidence that treatment with pembrolizumab can provide long-lasting anti-cancer responses, while being well tolerated, among patients with metastatic and recurrent HNSCC.

Reference: Mehra R, Seiwert T, Mahipal A, et al. Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Pooled analyses after long-term follow-up in KEYNOTE-012. Proceedings from the 201 annual ASCO meeting. Abstract #6012. Available at: http://abstracts.asco.org/176/AbstView_176_168015.html. Accessed June 7, 2016.

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