Pembrolizumab Plus Amrubicin in Patients With Relapsed SCLC: Multi-Institutional, Single-Arm Phase 2 Study

Hiroaki Akamatsu, MD, PhD; Shunsuke Teraoka, MD; Hidetoshi Hayashi, MD, PhD; Daichi Fujimoto, MD; Atsushi Hayata, MD, PhD; Koji Haratani, MD, PhD; Yuichi Ozawa, MD, PhD; Takeshi Yoshida, MD, PhD; Tsutomu Iwasa, MD, PhD; Toshio Shimokawa, MD; Keisuke Tomii, MD, PhD; Kazuhiko Nakagawa, MD, PhD; Nobuyuki Yamamoto, MD, PhD

JTO Clinical and Research Reports (Jul 2021)

Pembrolizumab Plus Amrubicin in Patients With Relapsed SCLC: Multi-Institutional, Single-Arm Phase 2 Study

Hiroaki Akamatsu, MD, PhD,
Shunsuke Teraoka, MD,
Hidetoshi Hayashi, MD, PhD,
Daichi Fujimoto, MD,
Atsushi Hayata, MD, PhD,
Koji Haratani, MD, PhD,
Yuichi Ozawa, MD, PhD,
Takeshi Yoshida, MD, PhD,
Tsutomu Iwasa, MD, PhD,
Toshio Shimokawa, MD,
Keisuke Tomii, MD, PhD,
Kazuhiko Nakagawa, MD, PhD,
Nobuyuki Yamamoto, MD, PhD

Affiliations

Hiroaki Akamatsu, MD, PhD: Internal Medicine III, Wakayama Medical University, Wakayama City, Japan; Corresponding author Address for correspondence: Hiroaki Akamatsu, MD, PhD, Internal Medicine III, Wakayama Medical University, 811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan.
Shunsuke Teraoka, MD: Internal Medicine III, Wakayama Medical University, Wakayama City, Japan
Hidetoshi Hayashi, MD, PhD: Department of Medical Oncology, Faculty of Medicine, Kindai University, Osakasayama, Japan
Daichi Fujimoto, MD: Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe City, Japan
Atsushi Hayata, MD, PhD: Internal Medicine III, Wakayama Medical University, Wakayama City, Japan
Koji Haratani, MD, PhD: Department of Medical Oncology, Faculty of Medicine, Kindai University, Osakasayama, Japan
Yuichi Ozawa, MD, PhD: Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe City, Japan
Takeshi Yoshida, MD, PhD: Department of Medical Oncology, Faculty of Medicine, Kindai University, Osakasayama, Japan
Tsutomu Iwasa, MD, PhD: Department of Medical Oncology, Faculty of Medicine, Kindai University, Osakasayama, Japan
Toshio Shimokawa, MD: Clinical Study Support Center, Wakayama Medical University Hospital, Wakayama City, Japan
Keisuke Tomii, MD, PhD: Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe City, Japan
Kazuhiko Nakagawa, MD, PhD: Department of Medical Oncology, Faculty of Medicine, Kindai University, Osakasayama, Japan
Nobuyuki Yamamoto, MD, PhD: Internal Medicine III, Wakayama Medical University, Wakayama City, Japan

Journal volume & issue: Vol. 2, no. 7
p. 100184

Abstract

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Introduction: In patients with relapsed SCLC, amrubicin (AMR) is the current standard treatment in Japan. Nevertheless, its efficacy is not satisfactory and prognosis is poor. Preclinical study suggested that anthracycline agent might induce immunogenic cell death and work synergistically with immune checkpoint inhibitors. Methods: Patients with relapsed SCLC who relapsed after completion of platinum-containing regimen were registered. Patients were treated with pembrolizumab (200 mg, flat dose on d 1, every 3 wk for 2 y) plus AMR (40 mg/m2 on d 1–3, every 3 wk until progression). Primary end point was overall response rate (ORR). Secondary end points consisted of progression-free survival (PFS), overall survival, and safety. On the basis of the hypothesis that this treatment will improve ORR from 20% to 40% (0.1 of one-sided α and power of 0.8), 25 patients are required (trial identifier: NCT03253068). Results: Between November 2017 and October 2019, a total of 25 patients were enrolled. Most participants (88%) relapsed within 90 days after platinum-containing therapy and all patients were immune checkpoint inhibitor-naive. ORR, the primary end point, was 52.0% (95% confidence interval [CI]: 31.3%–72.2%). Median PFS was 4.0 months (95% CI: 2.8–7.0 mo), and PFS rate at 1 year was 14.4%. Median overall survival was 10.6 months (95% CI: 7.3–21.3 mo). Common adverse events greater than or equal to grade 3 were neutropenia (64%), leukopenia (40%), and febrile neutropenia (16%). No treatment-related deaths occurred. Conclusions: Among patients with relapsed SCLC, pembrolizumab plus AMR was effective and tolerable.

Published in JTO Clinical and Research Reports

ISSN: 2666-3643 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/jto-clinical-and-research-reports/

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