TY - JOUR
T1 - Three-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer
T2 - Pooled analysis of ONO-4538-05 and ONO-4538-06 studies
AU - Horinouchi, Hidehito
AU - Nishio, Makoto
AU - Hida, Toyoaki
AU - Nakagawa, Kazuhiko
AU - Sakai, Hiroshi
AU - Nogami, Naoyuki
AU - Atagi, Shinji
AU - Takahashi, Toshiaki
AU - Saka, Hideo
AU - Takenoyama, Mitsuhiro
AU - Katakami, Nobuyuki
AU - Tanaka, Hiroshi
AU - Takeda, Koji
AU - Satouchi, Miyako
AU - Isobe, Hiroshi
AU - Maemondo, Makoto
AU - Goto, Koichi
AU - Hirashima, Tomonori
AU - Minato, Koichi
AU - Sumiyoshi, Naoki
AU - Tamura, Tomohide
N1 - Publisher Copyright:
© 2019 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
PY - 2019/9/1
Y1 - 2019/9/1
N2 - Background: Nivolumab is a programmed cell death 1 (PD-1) receptor inhibitor antibody that enhances immune system antitumor activity. It is associated with longer overall survival (OS) than the standard treatment of docetaxel in patients with previously treated advanced squamous (SQ) and non-squamous (non-SQ) non-small cell lung cancer (NSCLC). We previously conducted two phase II studies of nivolumab in Japanese patients with SQ (ONO-4538-05) and non-SQ (ONO-4538-06) NSCLC, showing overall response rates (ORRs) (95% CI) of 25.7% (14.2-42.1) and 22.4% (14.5-32.9), respectively, with acceptable toxicity. In this analysis, we more precisely estimated the long-term safety and efficacy in patients with SQ and non-SQ NSCLC by pooling data from these two trials. Methods: SQ (N = 35) and non-SQ (N = 76) NSCLC patients received nivolumab (3 mg/kg, every 2 weeks) until progression or discontinuation. OS was estimated using the Kaplan–Meier method. A pooled analysis of SQ and non-SQ patients was also performed. Results: In SQ NSCLC patients, the median OS (95% CI) was 16.3 months (12.4-25.2), and the estimated 1-year, 2-year, and 3-year survival rates were 71.4% (53.4-83.5), 37.1% (21.6-52.7), and 20.0% (8.8-34.4), respectively. In non-SQ NSCLC patients, median OS was 17.1 months (13.3-23.0), and the estimated 1-, 2-, and 3-year survival rates were 68.0% (56.2-77.3), 37.4% (26.5-48.1), and 31.9% (21.7-42.5), respectively. When SQ NSCLC and non-SQ NSCLC data were pooled, the median OS was 17.1 months (14.2-20.6), and the estimated 1-, 2-, and 3-year survival rates were 69.1% (59.6-76.8), 37.3% (28.3-46.2), and 28.1% (20.0-36.7), respectively. Twenty (76.9%) of 26 responders lived for 3 or more years. Nivolumab was well tolerated and no new safety signals were found. Conclusion: Treatment with nivolumab improved long-term survival and was well tolerated in patients with SQ and non-SQ NSCLC. Trial registration: JapicCTI-132072; JapicCTI-132073.
AB - Background: Nivolumab is a programmed cell death 1 (PD-1) receptor inhibitor antibody that enhances immune system antitumor activity. It is associated with longer overall survival (OS) than the standard treatment of docetaxel in patients with previously treated advanced squamous (SQ) and non-squamous (non-SQ) non-small cell lung cancer (NSCLC). We previously conducted two phase II studies of nivolumab in Japanese patients with SQ (ONO-4538-05) and non-SQ (ONO-4538-06) NSCLC, showing overall response rates (ORRs) (95% CI) of 25.7% (14.2-42.1) and 22.4% (14.5-32.9), respectively, with acceptable toxicity. In this analysis, we more precisely estimated the long-term safety and efficacy in patients with SQ and non-SQ NSCLC by pooling data from these two trials. Methods: SQ (N = 35) and non-SQ (N = 76) NSCLC patients received nivolumab (3 mg/kg, every 2 weeks) until progression or discontinuation. OS was estimated using the Kaplan–Meier method. A pooled analysis of SQ and non-SQ patients was also performed. Results: In SQ NSCLC patients, the median OS (95% CI) was 16.3 months (12.4-25.2), and the estimated 1-year, 2-year, and 3-year survival rates were 71.4% (53.4-83.5), 37.1% (21.6-52.7), and 20.0% (8.8-34.4), respectively. In non-SQ NSCLC patients, median OS was 17.1 months (13.3-23.0), and the estimated 1-, 2-, and 3-year survival rates were 68.0% (56.2-77.3), 37.4% (26.5-48.1), and 31.9% (21.7-42.5), respectively. When SQ NSCLC and non-SQ NSCLC data were pooled, the median OS was 17.1 months (14.2-20.6), and the estimated 1-, 2-, and 3-year survival rates were 69.1% (59.6-76.8), 37.3% (28.3-46.2), and 28.1% (20.0-36.7), respectively. Twenty (76.9%) of 26 responders lived for 3 or more years. Nivolumab was well tolerated and no new safety signals were found. Conclusion: Treatment with nivolumab improved long-term survival and was well tolerated in patients with SQ and non-SQ NSCLC. Trial registration: JapicCTI-132072; JapicCTI-132073.
KW - nivolumab
KW - non-small cell lung cancer (NSCLC)
KW - phase II study
KW - programmed cell death 1 ligand 1 (PD-L1)
KW - programmed cell death 1 receptor (PD-1)
UR - https://www.scopus.com/pages/publications/85071560251
UR - https://www.scopus.com/inward/citedby.url?scp=85071560251&partnerID=8YFLogxK
U2 - 10.1002/cam4.2411
DO - 10.1002/cam4.2411
M3 - Article
C2 - 31353840
AN - SCOPUS:85071560251
SN - 2045-7634
VL - 8
SP - 5183
EP - 5193
JO - Cancer Medicine
JF - Cancer Medicine
IS - 11
ER -
