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Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial

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Lu, Shun, Wang, Jie, Yu, Yan, Yu, Xinmin, Hu, Yanping, Ai, Xinghao, Ma, Zhiyong, Li, Xingya, Zhuang, Wu, Liu, Yunpeng, Li, Weidong, Cui, Jiuwei, Wang, Dong, Liao, Wangjun, Zhou, Jianying, Wang, Zhehai, Sun, Yuping, Qiu, Xiusong, Gao, Jie, Bao, Yuanyuan, Liang, Liang, Wang, Mengzhao·2021·Journal of Thoracic Oncology

DOI 10.1016/j.jtho.2021.05.005

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Abstract

INTRODUCTION: Tislelizumab, an anti-programmed cell death protein-1 antibody, was specifically engineered to minimize FcɣR macrophage binding to abrogate antibody-dependent phagocytosis. Compared with chemotherapy alone, tislelizumab plus chemotherapy may improve clinical outcomes in patients with advanced nonsquamous NSCLC (nsq-NSCLC). METHODS: In this open-label phase 3 trial (RATIONALE 304; NCT03663205), patients with histologically confirmed stage IIIB or IV nsq-NSCLC were randomized (2:1) to receive either arm A: tislelizumab plus platinum (carboplatin or cisplatin) and pemetrexed every 3 weeks (Q3Ws) or arm B: platinum and pemetrexed alone Q3W during induction treatment, followed by intravenous maintenance pemetrexed Q3W. The primary end point was progression-free survival (PFS) assessed by an independent review committee; clinical response and safety and tolerability were secondary end points. RESULTS: Overall, 332 patients (n = 222 [A]; n = 110 [B]) received treatment. With a median study follow-up of 9.8 months, PFS was significantly longer with tislelizumab plus chemotherapy compared with chemotherapy alone (median PFS: 9.7 versus 7.6 mo; hazard ratio = 0.645 [95% confidence interval: 0.462-0.902], p = 0.0044). In addition, response rates were higher and response duration was longer with combination therapy versus chemotherapy alone. Hematologic adverse events (AEs) were common in both treatment arms; the most reported AEs were grades 1 to 2 in severity. The most common grade greater than or equal to 3 AEs were associated with chemotherapy and included neutropenia (44.6% [A]; 35.5% [B]) and leukopenia (21.6% [A]; 14.5% [B]). CONCLUSIONS: Addition of tislelizumab to chemotherapy resulted in significantly prolonged PFS, higher response rates, and longer response duration compared with chemotherapy alone, identifying a new potential option for first-line treatment of advanced nsq-NSCLC irrespective of disease stage.

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Authors: Lu, S., Wang, J., Yu, Y., Yu, X., Hu, Y., Ai, X., Ma, Z., Li, X., Zhuang, W., Liu, Y., Li, W., Cui, J., Wang, D., Liao, W., Zhou, J., Wang, Z., Sun, Y., Qiu, X., Gao, J., Bao, Y., Liang, L., & Wang, M.
Affiliations: Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
Third Affiliated Hospital of Harbin Medical University (CN)
Zhejiang Cancer Hospital (CN)
Hubei Cancer Hospital (CN)
Shanghai Chest Hospital (CN)
Zhengzhou University (CN)
First Affiliated Hospital of Zhengzhou University (CN)
Fujian Provincial Cancer Hospital (CN)
First Hospital of China Medical University (CN)
Guangzhou Medical University Cancer Hospital (CN)
First Hospital of Jilin University (CN)
Army Medical University (CN)
Nanfang Hospital (CN)
First Affiliated Hospital Zhejiang University (CN)
Shandong Tumor Hospital (CN)
Jinan Central Hospital (CN)
BeiGene (China) (CN)
Peking Union Medical College Hospital (CN)
ORCID: Lu, Shun
Wang, Jie
Yu, Yan
Hu, Yanping
Ma, Zhiyong
Li, Xingya
Zhuang, Wu
Liu, Yunpeng
Li, Weidong
Cui, Jiuwei
Wang, Dong
Liao, Wangjun
Zhou, Jianying
Wang, Zhehai
Gao, Jie
Liang, Liang
Wang, Mengzhao
Venue: Journal of Thoracic Oncology
Publisher: Elsevier BV
Published: 2021-09
Volume: 16
Issue: 9
Pages: 1512-1522
ISSN: 1556-0864 (ISSN-L)
DOI: 10.1016/j.jtho.2021.05.005
OpenAlex: W3164993995
Cited by: 284
References: 22
Citations by year: 2026: 41 · 2025: 59 · 2024: 57 · 2023: 62 · 2022: 54 · 2021: 11
FWCI: 29.83
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Locations: Journal of Thoracic Oncology (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Funders: Roche
Boehringer Ingelheim
AstraZeneca
BeiGene
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: tislelizumab, non-squamous non-small cell lung cancer, first-line therapy, anti-PD-1 therapy, progression-free survival, Fcγ receptor binding, antibody-dependent phagocytosis, locally advanced or metastatic NSCLC, neutropenia, leukopenia
MeSH terms: Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Antibodies, Monoclonal, Humanized

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Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial

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