Abstract 80P
Background
Although IMpower150 demonstrated atezolizumab combined with bevacizumab plus chemotherapy was a standard of care for advanced NSCLC, the efficacy and safety remained to be improved. This study was aimed to evaluate the efficacy and safety of tislelizumab (tis)plus anlotinib (anlo) combined with 2-cycles chemotherapy as first-line treatment for advanced NSCLC.
Methods
This study was a single-arm, one set and phase II study. Eligible patients were histologically confirmed locally advanced or metastatic (Stage IIIB-IV) NSCLC and untreated, excluding driver mutations. Twenty patients received 2 cycles of tis (200mg, iv, Q3W) plus anlo (12mg, QD for 2W, Q3W) and platinum-based dual agent chemotherapy, followed by tis plus anlo maintenance therapy. The primary endpoint was progression free survival. The second endpoints included over survival, object response rate, during of response, disease control rate and safety. The number of planned enrollment patients was 30.
Results
As of the data cutoff of August 31, 2023, the median follow-up time was 8 months (95%CI 4-12).There were 20 pts eligible for inclusion,18/20 pts were stage IV and 14/20 pts were non-squamous NSCLC. The median PFS was 8.5months(95%CI:4.5-NA), the 6m-PFS% and 12m-PFS% were 75.9% (95%CI 0.477-0.902) and 36.1% (95%CI 0.103-0.634) respectively. The median OS has not arrived, the 12m-OS% was 77.9% (95%CI 0.440-0.927). The ORR was 75% and DCR was 100%, the median DOR was 5.2months (95%CI 1.68-NA). The safety was manageable and none ≥3TRAE and ≥3irAE occurred. Table: 80P
| AEs, n (%) | N=20 | |
| Any TEAEs | 20(100) | |
| TEAEs ≥15% | Grade1-2 | Grade 3 |
| WBC decreased | 6 (30) | 2 (10) |
| Neutrophil count decreased | 6 (30) | 2 (10) |
| Canker sores | 5 (25) | 1 (5) |
| Rash | 5 (25) | 1 (5) |
| Anemia | 5 (25) | |
| Hand-foot-syndrome | 5 (25) | 2 (10) |
| Decreased platelet count | 5 (25) | 2 (10) |
| Pulmonary infection | 4 (20) | |
| Hypertension | 4 (20) | 1 (5) |
| GGT increased | 4 (20) | |
| Hypertriglyceridemia | 3 (15) | |
| Hyperuricemia | 3 (15) | |
| Vomiting | 3 (15) |
Conclusions
The preliminary result of this study indicated that tislelizumab, anlotinib combined with 2-cycles chemotherapy as first-line treatment for advanced NSCLC showed promising efficacy and good safety.
Clinical trial identification
TISAL-FE-01.
Legal entity responsible for the study
The authors.
Funding
BeiGene and Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
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