PD-L1 inhibition with durvalumab induces durable responses and is associated with encouraging overall survival rates among heavily pretreated patients with head and neck squamous cell carcinoma (HNSCC), according updated results presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1

There are limited treatment options and outcomes are poor for patients with recurrent and metastatic HNSCC. Researchers evaluated the activity and safety of anti-PD-L1 treatment with durvalumab in this patient population.

For the phase 1/2 study (ClinicalTrials.gov Identifier: NCT01693562), researchers enrolled 62 patients with recurrent and metastatic HNSCC. Of those, 63% were current or prior smokers, 40.3% were human papillomavirus (HPV)-positive, and 34% had PD-L1 overexpression. The median number of prior systemic therapies was 3.

Continue Reading

At a median follow-up of 25.0 months, results showed that 7 patients responded to durvalumab therapy, with 6 patients achieving responses lasting 12 months or longer. The longest duration of response reported thus far is 19.8 months.

RELATED: Dalantercept Monotherapy Study Misses Endpoint

Researchers found that 6-month and 12-months overall survival rates were 62% (95% CI, 48-74) and 42% (27-55), respectively. There appears to be no difference in overall survival with respect to PD-L1 status.

Investigators are also assessing the efficacy and safety of durvalumab alone and in combination with tremelimumab, a CTLA-4 inhibitor, among patients with recurrent or metastatic HNSCC in a phase 2 trial (ClinicalTrials.gov Identifier: NCT02319044).                         


  1. Segal NH, Ou SI, Balmanoukian AS, et al. Updated safety and efficacy of durvalumab (MEDI4736), an anti-PD-L1 antibody, in patients from a squamous cell carcinoma of the head and neck (SCCHN) expansion cohort. Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.