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. 2022 Sep 1;3(11):100404.
doi: 10.1016/j.jtocrr.2022.100404. eCollection 2022 Nov.

Real-World Data Analysis of Pembrolizumab Monotherapy for NSCLC Using Japanese Postmarketing All-Case Surveillance Data

Hideki Terai  1   2 , Kenzo Soejima  3   4 , Asanao Shimokawa  5 , Hidehito Horinouchi  6 , Junichi Shimizu  7 , Tetsunari Hase  8 , Ryota Kanemaru  9 , Kana Watanabe  10 , Kiichiro Ninomiya  11 , Naoko Aragane  12 , Noriko Yanagitani  13 , Yoshihiko Sakata  14 , Masahiro Seike  15 , Daichi Fujimoto  16 , Masashi Kasajima  17 , Akihito Kubo  18 , Sojiro Kusumoto  19 , Yoshitaka Oyamada  20 , Keiichi Fujiwara  21 , Masahide Mori  22 , Midori Hashimoto  23 , Masato Shingyoji  24 , Masahiro Kodani  25 , Jin Sakamoto  26 , Toshihiko Agatsuma  27 , Kosuke Kashiwabara  28 , Minehiko Inomata  29 , Motoko Tachihara  30 , Kazuhisa Tanaka  31 , Kenji Hayashihara  32 , Nobuyuki Koyama  33 , Kaoru Matsui  34 , Koichi Minato  35 , Daisuke Jingu  36 , Hiroyuki Sakashita  37 , Satoshi Hara  38 , Tomoyuki Naito  39 , Asuka Okada  40 , Masayuki Tanahashi  41 , Yuki Sato  42 , Koichiro Asano  43 , Takayuki Takeda  44 , Kensuke Nakazawa  45 , Toshiyuki Harada  46 , Kazuhiko Shibata  47 , Tatsuo Kato  48 , Etsuo Miyaoka  5 , Ichiro Yoshino  31 , Akihiko Gemma  15 , Tetsuya Mitsudomi  49
Affiliations

Real-World Data Analysis of Pembrolizumab Monotherapy for NSCLC Using Japanese Postmarketing All-Case Surveillance Data

Hideki Terai et al. JTO Clin Res Rep. .

Abstract

Introduction: Pembrolizumab is a programmed death-ligand 1 inhibitor that was initially indicated for monotherapy in patients with advanced lung cancer. The Japanese Lung Cancer Society conducted an observational study on pembrolizumab using confirmative data obtained through postmarketing all-case surveillance (PMACS), which was performed by a pharmaceutical company under the Japanese law in 2017.

Methods: This multicenter observational study was conducted by the Japanese Lung Cancer Society using PMACS data with the newly created central registration system regarding patients with NSCLC who received pembrolizumab monotherapy between February 1, 2017 and June 30, 2017; a new database was created by adding the clinical information regarding prognosis for 3 years after therapy to the existing data collected by PMACS.

Results: A total of 300 patients from 43 facilities were enrolled in this study. The median overall survival and progression-free survival after pembrolizumab initiation were 558 and 188 days, respectively. Moreover, the 1- and 3-year survival rates were 58.9% and 33.7%, respectively. Results of multivariate analysis revealed performance status (p < 0.0001), histology (p = 0.0118), previous chemotherapy (p = 0.0007), programmed death-ligand 1 expression status (p = 0.0195), and previous steroid use (p = 0.0460) as significant factors that affected overall survival. The toxicity profile was similar to that previously reported.

Conclusions: In this first attempt to use PMACS data, we successfully collected clinical information and found the real-world efficacy and safety of pembrolizumab.

Keywords: Immune checkpoint inhibitor; Immune-related adverse events; Pembrolizumab; Real-world data.

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Figures

Figure 1
Figure 1
Kaplan-Meier curves of OS and PFS of the patients with prognosis data. Survival curves of (A) OS and (B) PFS, with detailed data at the indicated time points (1 y, 2 y, and 3 y after pembrolizumab initiation). CI, confidence interval; OS, overall survival; PFS, progression-free survival.
Figure 2
Figure 2
Kaplan-Meier curves of survival stratified by prognostic factors identified by multivariate analysis. Survival data were stratified by (A) performance status, (B) histology, (C) number of previous chemotherapies, (D) TPS of PD-L1, and (E) steroid use before treatment. PD-L1, programmed death-ligand 1; PS, performance status; Sq, squamous; TPS, tumor proportion score.
See this image and copyright information in PMC

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