Clinical activity and biomarkers of MEDI4736, an anti-PD-L1 antibody, in patients with NSCLC.

• DOI: 10.1200/jco.2014.32.15_suppl.8021
• Publication Date: 2019-01-03T17:36:36Z
• Authors: Julie R. Brahmer; Naiyer A. Rizvi; Jose Lutzky; Samir Khleif; Andy Blake-Haskins; Xia Li; Paul B. Robbins; Jim Vasselli; Ramy A. Ibrahim; Scott Joseph Antonia
• Keywords: Discontinuation; Pneumonitis

8021^ Background: Lung cancer is the leading cause of death in both men and women. PD-L1 upregulated NSCLC may be associated with a poor prognosis. MEDI4736 human IgG1 antibody which binds specifically to preventing binding PD-1 CD80. Methods: An ongoing phase 1, multicenter, open-label study (NCT01693562) evaluating safety efficacy administered IV every 2 wks (q2w) or 3 (q3w) using 3+3 dose escalation followed by expansion cohorts. pts were assigned cohorts histology line therapy (including treatment- naïve pts). Retreatment was permitted for progression after 12 mos therapy. Response assessed immune-related response criteria (irRC) RECIST v1.1 expansion. Results: As Jan 17, 2014, 13 (median age 65 yrs; 40-76), all PS 0-1, median 4 prior treatments, received 7 doses (1-25) across 6 (0.1 – 10 mg/kg q2w; 15 q3w). Treatment-related AEs occurred 43% pts, Grade 1-2; none led discontinuation drug. No pneumonitis colitis reported escalation. Of PRs observed, additional achieving tumor shrinkage not meeting PR per irRC (46% 48% decreases). Tumor as early first assessment (6 wks) benefit durable; 4/13 remain on (10+, 10+, 11.1+, 14.9+ mos) data cutoff. Expansion opened Sep 2013; 43 treatment-naïve pts) have been dosed, opportunity enroll > 300 total. Preliminary clinical activity has observed acceptable safety, no ≥ grade pneumonitis, apparent differences toxicity between vs pretreated pts. Assessment expression, underlying mutation, smoking history, patient-reported outcomes ongoing. Conclusions: The preliminary durable profile supports continued development; are manageable, even highly Recruitment continues development monotherapy combination Clinical trial information: NCT01693562.