key papersKey paper

NCI9673: nivolumab for previously treated unresectable metastatic anal cancer

In the first completed immunotherapy trial for anal cancer, the PD-1 antibody nivolumab shrank tumours in a quarter of heavily pretreated patients with few side effects.

Multicentre single-arm phase 2 trial: 37 patients with previously treated metastatic squamous cell carcinoma of the anal canal received nivolumab 3 mg/kg every two weeks.

Nine patients (24 percent, 95% CI 15 to 33) responded, two completely and seven partially. Grade 3 adverse events were anaemia (2), fatigue, rash and hypothyroidism (1 each); there were no serious adverse events.

Observational studyChanged practice37 participants

Authors

Morris VK, Salem ME, Nimeiri H, et al.

Published

The Lancet Oncology, 2017

Full text

doi:10.1016/S1470-2045(17)30104-3 PubMed 28223062

Findings

Objective response 24 percent (95% CI 15 to 33): 2 complete and 7 partial responses in 37 patients.
Grade 3 adverse events in 5 patients; no serious adverse events.

What it means

PD-1 blockade is an option for metastatic anal cancer after chemotherapy, and the basis for later immunotherapy combinations in the disease.

Caveats

Single-arm design with 37 patients.

Connected

5top

cancers

Anal cancer (squamous cell carcinoma)Metastatic and recurrent anal squamous cell carcinoma

drugs

ApprovedMonoclonal antibody (anti-PD-1)

Nivolumab · Opdivo / Opdivo Qvantig (SC)

trials

NCI9673

journals

The Lancet Oncology