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.

• DOI: 10.1200/jco.2015.33.15_suppl.3011
• Publication Date: 2019-03-07T22:17:57Z
• Authors: Neil Howard Segal; Sai-Hong Ignatius Ou; Ani Sarkis Balman...; Matthew G. Fury; Erminia Massarelli; Julie R. Brahmer; Jared Weiss; Patrick Schoffski; Scott Joseph Antonia; Christophe Massard; Dan Paul Zandberg; Samir Khleif; Xia Li; Marlon Rebelatto; Keith Steele; Paul B. Robbins; John A. Blake-Has...; Marcus O. Butler
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

3011 Background: Outcomes are poor for patients (pts) with recurrent/metastatic (R/M) SCCHN, and new treatments needed. An ongoing phase I/II, multicenter, open-label study (NCT01693562) is evaluating the safety efficacy of MEDI4736 (M), a human IgG1 mAb that blocks PD-L1 binding to PD-1 CD80 high affinity selectivity, in multiple solid tumor types including SCCHN. expressed SCCHN tumors may be associated response anti-PD-L1 treatment. Methods: Pts R/M an ECOG 0 or 1, without prior anti-PD-1/PD-L1 exposure eligible. M administered IV every 2 weeks at 10 mg/kg 12 months. Retreatment permitted upon progression after expression assessed by IHC using Ventana SP263 clone. Prior documented HPV status collected entry. Response based on investigator assessment per RECIST v1.1. Data included represent larger population more mature follow up than previously reported (Fury M, et al. Poster presented ESMO 2014, 988PD). Results: As 31 Oct 62 pts (mean age 58 years [range 24–96]; 86% male; 64% current/prior smokers; 0/1: 38%/62%; pos/neg/unk: 40%/39%/21%), median 3 systemic (1–10), received 6 doses (1–26). Drug-related AEs were observed 60% pts; most frequent fatigue (11%), diarrhea, (8%), nausea (7%). Grade ≥ related 7% pts: rash (2 pts), increased GGT, fatigue, inflammation (1 pt each). No drug-related led discontinuation death. colitis grade pneumonitis was observed. Overall, 51 evaluable 24 up; ORR 12% (25% PD-L1+ DCR 16% pts). Responses 5/6 responding pts, durations ranging from 4+ 43+ weeks. Median duration has not been reached. Conclusions: With up, profile manageable consistent previous reports. durable; higher pts. A registration program underway alone combination tremelimumab. Clinical trial information: NCT01693562.