Five-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer: pooled analysis of the ONO-4538-05 and ONO-4538-06 studies. (6th October 2020)

• Record Type: Journal Article
• Authors: Saka, Hideo; Nishio, Makoto; Hida, Toyoaki; Nakagawa, Kazuhiko; Sakai, Hiroshi; Nogami, Naoyuki; Atagi, Shinji; Takahashi, Toshiaki; Horinouchi, Hidehito; Takenoyama, Mitsuhiro; Katakami, Nobuyuki; Tanaka, Hiroshi; Takeda, Koji; Satouchi, Miyako; Isobe, Hiroshi; Maemondo, Makoto; Goto, Koichi; Hirashima, Tomonori; Minato, Koichi; Yada, Nobumichi; Tamura, Tomohide
• Is Part Of: Japanese journal of clinical oncology. Volume 51:Number 1(2021)
• Page Start: 106
• Page End: 113
• Publication Date: 2020-10-06
• Subjects: nivolumab -- survival -- non-small cell lung cancer -- safety; Oncology -- Periodicals; Cancer -- Periodicals; 616.994005
• DOI: 10.1093/jjco/hyaa157
• Languages: English
• ISSNs: 0368-2811

Abstract

Abstract: Background: Two phase II studies in Japan examined the efficacy and safety of nivolumab, a programmed cell death 1 receptor inhibitor, in patients with advanced squamous and non-squamous non-small cell lung cancer (ONO-4538-05 and ONO-4538-06). We examined the long-term efficacy and safety of nivolumab in these patients treated for up to 5 years. Methods: Patients with squamous ( N = 35) or non-squamous ( N = 76) non-small cell lung cancer received nivolumab (3 mg/kg every 2 weeks) until disease progression/death. Overall survival and progression-free survival were assessed at 5 years after starting treatment in separate and pooled analyses. Safety was evaluated in terms of treatment-related adverse events. Results: A total of 17 patients were alive at the database lock (26 July 2019). The median overall survival (95% confidence interval) and 5-year survival rate were 16.3 (12.4–25.2) months and 14.3% in squamous patients, 17.1 (13.3–23.0) months and 19.4% in non-squamous patients and 17.1 (14.2–20.6) months and 17.8% in the pooled analysis, respectively. Programmed death ligand-1 expression tended to be greater among 5-year survivors than in non-survivors ( P = 0.0703). Overall survival prolonged with increasing programmed death ligand-1 expression, with 5-year survival rates of 11.8, 21.8 and 41.7% in patients with programmed death ligand-1 expression of <1, ≥1–<50 and ≥50%, respectively. Treatment-related adverse events in ≥10% of patients (pooled analysis) included rash (15.3%), malaise (14.4%), decreased appetite (14.4%), pyrexia (14.4%) and nausea (10.8%). Conclusions: Long-term survival with nivolumab was observed in patients with squamous or non-squamous non-small cell lung cancer. No new safety signals were reported after ≥5 years of follow-up. Abstract : This long-term follow-up demonstrated ongoing efficacy and safety of nivolumab over ≥5 years in patients with squamous or non-squamous non-small cell lung cancer in Japan.