Check-Mate 141 Results: Nivolumab Improved OS in Patients With Recurrent or Metastatic Head and Neck Cancer

At 2 years, nivolumab — compared with investigator’s choice of therapy — improved survival among patients with recurrent or metastatic head and neck cancer, according to research presented at the 2018 American Association for Cancer Research (AACR) Annual Meeting.¹

Nivolumab, a PD-1 inhibitor, has shown promising activity in recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN). The phase 3 CheckMate-141 trial (ClinicalTrials.gov Identifier: NCT02105636) evaluated whether nivolumab yields superior outcomes to investigator’s choice of therapy (cetuximab, methotrexate, or docetaxel) in this setting.

At this year’s AACR meeting, researchers presented 2-year follow-up data from CheckMate-141. Patients were randomly assigned 2:1 to receive nivolumab (240 patients) or investigator’s choice (121 patients).

Compared with investigator’s choice, nivolumab improved overall survival (OS) in the overall population (median 7.7 months with nivolumab vs 5.1 months with investigator’s choice; hazard ratio [HR], 0.68 [95% CI, 0.54-0.86]). The 2-year OS rate was 16.9% with nivolumab vs 6% with investigator’s choice.

While OS improvement was seen regardless of PD-L1 levels and human papillomavirus (HPV) status, not all patients who received nivolumab had improved progression-free survival (PFS). Patients with PD-L1 levels lower than 1% had a median PFS of 2 months with nivolumab vs 2.7 months with investigator’s choice; HPV-negative patients had a median PFS of 2.1 vs 3.3 months, respectively.

Grade 3 to 4 treatment-related adverse events were noted in 15.3% of patients who received nivolumab vs 36.9% of patients who received investigator’s choice. Two patients in the nivolumab group and 1 patient in the investigator’s choice group died because of toxicity.

The authors concluded that nivolumab “continued to significantly improve OS and maintain a favorable safety profile vs [investigator’s choice]. [Nivolumab] is the only immunotherapy to demonstrate OS benefit irrespective of PD-L1 expression in [patients] with SCCHN.”

Read more of Cancer Therapy Advisor‘s coverage of the American Association for Cancer Research (AACR) 2018 meeting by visiting the conference page.

Reference

1. Ferris RL, Blumenschein Jr GR, Fayette J, et al. Nivolumab (Nivo) vs investigator’s choice (IC) in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): 2-yr outcomes in the overall population and PD-L1 subgroups of CheckMate 141. Oral presentation at: 2018 American Association for Cancer Research Annual Meeting; April 14-18, 2018; Chicago, IL.