Found 1 Presentation For Request "148P"
148P - A Phase II Study of tislelizumab plus chemotherapy in EGFR mutated advanced non-squamous NSCLC patients failed to EGFR TKI therapies: first analysis
- Baohui Han (Shanghai, China)
- Baohui Han (Shanghai, China)
- Panwen Tian (Chengdu, China)
- Yanqiu Zhao (Zhengzhou, China)
- Xinmin Yu (Hangzhou, China)
- Qisen Guo (Jinan, China)
- Zhuang Yu (Qingdao, China)
- Xueyan Zhang (Shanghai, China)
- Yalun Li (Chengdu, China)
- Lijuan Chen (Zhengzhou, China)
- Xun Shi (Hangzhou, China)
- Yan Zhang (Jinan, China)
- Jing Wang (Qingdao, China)
Abstract
Background
Although EGFR tyrosine kinase inhibitors (TKI) have improved the survival of EGFR mutated NSCLC pts, drug resistance inevitably develops in almost all pts. Tislelizumab (tis), an anti-PD-1 mAb, has shown improved efficacy when combined with chemotherapy in pts with advanced EGFR-wt NSCLC with a tolerable safety profile. This study aims to evaluate the efficacy and safety of tis plus chemotherapy in EGFR-mut nsq-NSCLC pts failed to EGFR TKI therapies.
Methods
This multicenter, single-arm, phase II study enrolled pts with EGFR sensitizing mutations who have failed prior EGFR-TKI therapies. Pts were treated with tis plus carboplatin and nab-paclitaxel Q3W for up to 4 cycles, followed by tis plus pemetrexed maintenance therapy. Primary endpoint was 1-year PFS rate, and secondary endpoints included ORR, DCR and safety, etc. First analysis is planned at 7 weeks after 50% planned enrollment (33 pts) for early efficacy and safety.
Results
From Jul 15, 2020 to Jul 13, 2021, 40 pts were enrolled, and 32 pts were evaluable for response with 15 (46.9%) females. 17 pts (53.1%) harbored EGFR exon 19del, and 14 pts (43.8%) with exon 21 L858R. 17 pts (53.1 %) had progression on both 1st /2nd and 3rd EGFR-TKIs treatment. 10 pts (31.3%) had prior anti-angiogenesis treatment. The ORR and DCR were 59.4% (95%CI 40.6-76.3) and 90.6% (95%CI 75.0-98.0), respectively. Median TTR was 80 (41-93) days. Favorable ORR was observed in all subgroups (Table). Among 40 pts, TEAE occurred in 37 pts (92.5%), and ≥grade 3 TEAE occurred in 13 pts (32.5%). Most common TRAE (>25%) included leukopenia, neutropenia, anemia, thrombocytopenia, alopecic, rash, and hypaesthesia. SAEs were observed in 7 pts (17.5%). BOR, best overall response; PR, partial response; SD, stable disease; PD, progressive disease; ORR, objective response rate; DCR, disease control rate*Including 4 unconfirmed PR;#1 pts with exon 18 G719X was PR.
Response Total (N=32) EGFR mutation# Prior EGFR TKI treatment prior anti-angiogenesis treatment Exon 19del (N=17) Exon 21 L858R (N=14) 1/2nd and 3rd TKI (N=17) 1/2nd or 3rd TKI (N=15) Yes (N=10) No (N=22) BoR, n (%) PR 19 (59.4%)∗ 12 (70.6%) 6 (42.9%) 10 (58.8%) 9 (60.0%) 7 (70.0%) 12 (54.6%) SD 10 (31.3%) 3 (17.7%) 7 (33.3%) 5 (29.4%) 5 (33.3%) 1 (10.0%) 9 (40.9%) PD 3 (9.4%) 2 (11.8%) 1 (7.1%) 2 (11.8%) 1 (6.7%) 2 (20.0%) 1 (4.6%) ORR 19 (59.4%) 12 (70.6%) 6 (42.9%) 10 (58.8%) 9 (60.0%) 7 (70.0%) 12 (54.6%) DCR 29 (90.6%) 15 (88.2%) 13 (92.9%) 15 (88.2%) 14 (93.3%) 8 (80.0%) 21 (95.5%)
Conclusions
Tislelizumab plus chemotherapy has preliminarily shown a promising anti-tumor efficacy with manageable safety profile for EGFR TKI failure pts. Efficacy and safety of the combination will be continuously monitored.
Clinical trial identification
NCT04405674.
Legal entity responsible for the study
The authors.
Funding
BeiGene (Beijing), Co. Ltd.
Disclosure
All authors have declared no conflicts of interest.