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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
Open accessAbstract
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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“Later in 2021, the NMPA approved camrelizumab plus gemcitabine and cisplatin (for advanced nasopharyngeal carcinoma) and tislelizumab plus chemotherapy (for NSCLC) [62–64].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [64]
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“Later in 2021, the NMPA approved camrelizumab plus gemcitabine and cisplatin (for advanced nasopharyngeal carcinoma) and tislelizumab plus chemotherapy (for NSCLC) [62–64].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [64]
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Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer
Gandhi, L., Rodríguez-Abreu, D., Gadgeel, S., Esteban, E., Felip, E., De Angelis, F., Domine, M., Clingan, P., Hochmair, M. J., Powell, S. F., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1801005 · Cited by 6,607
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Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC
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Self-citationMok, T. S. K., Wu, Y.-L. L. C., Kudaba, I., Kowalski, D. M., Cho, B. C., Turna, H. Z., de Castro, G., Srimuninnimit, V., Лактионов, К. К., Bondarenko, I., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(18)32409-7 · Cited by 3,357
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FcγRs Modulate the Anti-tumor Activity of Antibodies Targeting the PD-1/PD-L1 Axis
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Metadata
- 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
- Venue
- Journal of Thoracic Oncology
- Publisher
- Elsevier BV
- Published
- 2021-09
- Volume
- 16
- Issue
- 9
- Pages
- 1512-1522
- ISSN
- 1556-0864 (ISSN-L)
- 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
- 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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