MEDI4736 Shows Consistent Safety Response in Head and Neck Squamous Cell Carcinoma
Safety profile of MEDI4736 in patients with squamous cell carcinoma of the head and neck is manageable.
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).