Safety and efficacy of nivolumab plus recombinant human endostatin in previously treated advanced non-small-cell lung cancer

Weize Lv; Xiaofeng Pei; Wenhua Zhao; Yunyan Cong; Yajun Wei; Ting Li; Hongyu Zhang; Zhong Lin; Yuichi Saito; Jae Jun Kim; Zibin Liang; Beilong Zhong; Zhihui Wang

doi:10.21037/tlcr-22-49

Safety and efficacy of nivolumab plus recombinant human endostatin in previously treated advanced non-small-cell lung cancer

Transl Lung Cancer Res. 2022 Feb;11(2):201-212. doi: 10.21037/tlcr-22-49.

Authors

Weize Lv^#^{1

2}, Xiaofeng Pei^#^{2

3}, Wenhua Zhao^#⁴, Yunyan Cong^{2

3}, Yajun Wei^{1

2}, Ting Li^{2

3}, Hongyu Zhang^{2

5}, Zhong Lin^{2

3}, Yuichi Saito⁶, Jae Jun Kim⁷, Zibin Liang^{2

3}, Beilong Zhong^{2

8}, Zhihui Wang^{2

3}

Affiliations

¹ Department of Interventional Medicine, The Fifth Affiliated Hospital Sun Yat-sen University, Zhuhai, China.
² Guangdong Provincial Key Laboratory of Biomedical Imaging, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.
³ Department of Thoracic Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.
⁴ Medical Oncology of Respiratory, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China.
⁵ Department of Abdominal Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.
⁶ Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan.
⁷ Department of Thoracic and Cardiovascular Surgery, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea.
⁸ Department of Cardiothoracic Surgery, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.

^# Contributed equally.

Abstract

Background: Evidence of the efficacy of immune checkpoint inhibitors (ICIs) plus antiangiogenic drugs in previously treated patients with advanced non-small-cell lung cancer (NSCLC) is still insufficient, so we investigated the safety and efﬁcacy of nivolumab plus recombinant human (rh)-endostatin in such patients.

Methods: Patients without epithelial growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) targetable mutations in advanced NSCLC who did not respond to previous treatment were enrolled. Eligible patients received nivolumab (3 mg/kg, i.v. drip, day 1) every 2 weeks and rh-endostatin (210 mg, continuous i.v. infusion for 168 h) every 4 weeks until disease progression or discontinuation. The primary endpoint was the objective response rate (ORR). The secondary endpoints included disease control rate (DCR), duration of response (DOR), clinical benefit response rate (CBR), progression-free survival (PFS), overall survival (OS) and safety.

Results: A total of 34 patients received a median of 4 cycles of therapy. In all, 14 patients achieved conﬁrmed partial response (PR) with an ORR of 41.2% [14/34; 95% confidence interval (CI): 23.7-58.6%], DCR of 64.7% (22/34; 95% CI: 47.8-81.6%), CBR of 44.1% (95% CI: 26.5-61.7%), and a DOR of 6.9 (95% CI: 4.4-9.4) months. Median follow-up was 12.2 (range, 2.3-18.1) months. Median PFS (mPFS) was 6.8 (95% CI: 1.1-12.1) months, median OS (mOS) was 17.1 (95% CI: 6.6-27.6) months, and 12-month survival rate of 64.4% (95% CI: 46.2-82.6%). In all, 18 (18/34, 52.9%) patients experienced at least one treatment-related adverse event (TRAE), and Grade 3 TRAEs occurred in 4 (4/34, 11.8%) of them.

Conclusions: This study is first to assess nivolumab plus rh-endostatin in previously treated patients with advanced NSCLC. In view of its favorable efﬁcacy and safety proﬁle, this combination represents a promising treatment regimen in this patient population.

Keywords: Anti-angiogenesis; Endostar; immune checkpoint inhibitors (ICIs); nivolumab; non-small-cell lung cancer (NSCLC).