Nivolumab a New Standard-of-Care Option for Recurrent/Metastatic Head and Neck Cancers

Anti–PD-1 treatment with the PD-1 inhibitor nivolu­mab (Opdivo) significantly improved survival in patients with head and neck squamous-cell carcinoma that progressed after platinum-based therapy, according to data from a phase 3 clinical trial known as CheckMate-141.

Based on these data, “nivolumab therefore represents a new standard-­of-care option for patients with recurrent/metastatic head and neck cancer after platinum-based therapy,” announced lead investigator Maura L. Gillison, MD, PhD, Jen Coughlin Chair of Cancer Research, the Ohio State University Comprehensive Cancer Center, Columbus, at the 2016 American Association for Cancer Research annual meeting.

Approximately 50% of patients with head and neck squamous-cell carcinoma experience disease recurrence within 5 years of initial treatment, which includes combinations of surgery, radiation, and platinum-based chemotherapy. Patients with disease recurrence within 6 months of platinum-based therapy have an average survival of ≤6 months. Historically, no anticancer agent has been shown to improve survival in this patient population, and no new treatments have been approved in more than a decade.

CheckMate-141 Study Details

CheckMate-141 was a randomized, global, phase 3 clinical trial that was designed to compare the efficacy and safety of the PD-1 inhibitor nivolumab with that of investigator’s choice single-agent chemotherapy (docetaxel, methotrexate, or cetuximab), which is the current standard-of-care treatment for patients with recurrent or metastatic head and neck squamous-cell carcinoma. Patients in this clinical trial experienced disease progression within 6 months of receiving platinum-based chemotherapy.

“This was a very heavily pretreated population,” said Dr Gillison. “Over 90% had previously received radiation treatment, and 55% had received 2 or more prior lines of systemic chemotherapy for their cancer before enrolling in the trial.”

Of the 361 patients enrolled in this clinical trial, 240 patients received nivol­umab, and 121 patients received investigator’s choice single-agent chemotherapy.

At an interim analysis that was performed after 218 events, patients who received nivolumab had a 30% reduction in the risk for death compared with those who received investigator’s choice chemotherapy. The median overall survival was 7.5 months with nivolumab versus 5.1 months with investigator’s choice chemotherapy (P = .010).

“What we think is most important about this trial is that the proportion of patients who survived to a year doubled with nivolumab therapy in comparison to investigator’s choice,” Dr Gillison said. At 1 year, 36% of the patients who received nivolumab were alive compared with 17% of those who received investigator’s choice chemotherapy.

The effect of nivolumab on survival was evaluated via PD-1 ligand 1 (PD-L1) expression and human papilloma virus (HPV) status. A survival benefit with nivolumab was observed in patients with PD-L1 expression ≥1%, in patients with PD-L1 expression <1%, and in patients who were HPV-positive and HPV-negative.

“However, the magnitude of the reduction in risk of death was greater for patients whose tumors expressed PD-L1 ≥1% or who were HPV-­positive. In those 2 groups, the risk of death was reduced by approximately half,” said Dr Gillison.

Nivolumab “fulfills an incredible unmet need in the clinic” in patients with recurrent or metastatic head and neck squamous-cell carcinomas, said Dr Gillison.

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