CHICAGO–The safety profile of MEDI4736 in patients with squamous cell carcinoma of the head and neck is manageable and consistent with previous studies and MEDI4736 produces durable responses, according to a study presented at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting in Chicago, IL.
For the study, researchers enrolled 62 patients with recurrent/metastatic squamous cell carcinoma of the head and neck who had not received prior treatment with an anti-PD-1/PD-L1. All patients received MEDI4736, a human IgG1 monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80 with high affinity and selectivity, at a dose of 10 mg/kg intravenously every 2 weeks for 12 months.
Results showed 61% of patients experienced drug-related adverse events with the most common being fatigue, diarrhea, and nausea. Grade 3 or higher adverse events included rash, increased GGT, fatigue, oncologic complication, dyspnea, and abnormal hepatic function. No patients discontinued treatment due to drug-related adverse events and no colitis or grade 3 or higher pneumonitis was observed.
In regard to efficacy, “objective response rate was higher in patients with PD-L1-postive patients versus PD-L1-negative patients,” said Neil H. Segal, MD, PhD, lead author and medical oncologist from Memorial Sloan Kettering Cancer Center in New York, NY. Specifically, 18% (95% CI: 5.2,40.3) of PD-L1-positive patients achieved a response compared with 8% (95% CI: 1.7,21.9) of PD-L1-negative patients.
“PD-L1 status may correlate with response rate,” Dr. Segal said.
Response rates were also higher among HPV-negative patients and never smokers compared with HPV-positive patients and former or current smokers, respectively.
Of note, three patients have maintained a response beyond 1 year.
Researchers are conducting further trials in patients with squamous cell carcinoma of the head and neck to evaluate MEDI4736 alone and in combination with tremelimumab.
- Segal NH, Ou S-H I, Balmanoukian AS, et al. Safety and efficacy of MEDI4736, an anti-PD-L1 antibody, in patients from a squamous cell carcinoma of the head and neck (SCCHN) expansion cohort. J Clin Oncol. 2015:33;(suppl; abstr 3011).