Response characteristics of tislelizumab combined with chemotherapy in first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer.
10.3760/cma.j.cn112152-20220928-00662
- Author:
Shun LU
1
;
Xin Min YU
2
;
Yan Ping HU
3
;
Zhi Yong MA
4
;
Xing Ya LI
5
;
Wei Dong LI
6
;
Yun Peng LIU
7
;
Dong WANG
8
;
Xiu Wen WANG
9
;
Zhe Hai WANG
10
;
Jing Xun WU
11
;
Dian Sheng ZHONG
12
;
Gao Feng LI
13
;
Wan Yu HE
14
;
Yuan Yuan BAO
15
;
Yuan YUAN
15
;
Jing Hui FAN
14
Author Information
1. Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, China.
2. Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China.
3. Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan 430079, China.
4. Department of Respiratory Medicine, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou University, Zhengzhou 450003, China.
5. Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.
6. Department of Medical Oncology, Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou 510095, China.
7. Department of Medical Oncology, The First Hospital of China Medical University, Shenyang 110001, China.
8. Department of Oncology, Army Sepcialty Medical Center, Chongqing 400042, China.
9. Department of Medical Oncology, Qilu Hospital of Shandong University, Jinan 250012, China.
10. Department of Medical Oncology, Shandong Cancer Hospital, Jinan 250117, China.
11. Department of Medical Oncology, The First Affiliated Hospital of Xiamen University, Xiamen 361003, China.
12. Department of Medical Oncology, Tianjin Medical University General Hospital, Tianjin 300052, China.
13. Department of Thoracic Surgery, Yunnan Cancer Hospital, Kunming 650118, China.
14. BeiGene (Beijing) Co., Ltd., Beijing 100022, China.
15. BeiGene (Shanghai) Co., Ltd., Shanghai 200020, China.
- Publication Type:Randomized Controlled Trial
- Keywords:
Depth of response;
Immunotherapy combined with chemotherapy;
Lung neoplasms;
Non-squamous non-small cell lung cancer;
Time to response;
Tislelizumab
- MeSH:
Humans;
Antibodies, Monoclonal, Humanized/therapeutic use*;
Antineoplastic Combined Chemotherapy Protocols/adverse effects*;
Carcinoma, Non-Small-Cell Lung/pathology*;
Lung Neoplasms/pathology*;
Treatment Outcome
- From:
Chinese Journal of Oncology
2023;45(4):358-367
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To investigate the response characteristics of patients with locally advanced/metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) treated with tislelizumab in combination with chemotherapy in the first line. Methods: Patients with nsq-NSCLC who achieved complete or partial remission after treatment with tislelizumab in combination with chemotherapy or chemotherapy alone in the RATIONALE 304 study, as assessed by an independent review board, were selected to analyze the response characteristics and safety profile of the responders. Time to response (TTR) was defined as the time from randomization to the achievement of first objective response. Depth of response (DpR) was defined as the maximum percentage of tumor shrinkage compared with the sum of the baseline target lesion length diameters. Results: As of January 23, 2020, 128 patients treated with tislelizumab in combination with chemotherapy achieved objective tumor response (responders), representing 57.4%(128/223) of the intention-to-treat population, with a TTR of 5.1 to 33.3 weeks and a median TTR of 7.9 weeks. Of the responders (128), 50.8%(65) achieved first remission at the first efficacy assessment (week 6), 31.3%(40) at the second efficacy assessment (week 12), and 18.0%(23) at the third and subsequent tumor assessments. The percentages of responders who achieved a depth of tumor response of 30% to <50%, 50% to <70% and 70% to 100% were 45.3%(58/128), 28.1%(36/128) and 26.6%(34/128), respectively, with median progression-free survival (PFS) of 9.0 months (95% CI: 7.7 to 9.9 months), 11.5 months (95% CI: 7.7 months to not reached) and not reached (95% CI: 11.8 months to not estimable), respectively. Tislelizumab plus chemotherapy were generally well tolerated in responders with similar safety profile to the overall safety population. Conclusion: Among responders to tislelizumab in combination with chemotherapy for nsq-NSCLC, 82.0%(105/128) achieves response within the first two tumor assessments (12 weeks) and 18.0%(23/128) achieves response at later (18 to 33 weeks) assessments, and there is a trend toward prolonged PFS in responders with deeper tumor response.
