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Poster session 04

1297P - An open-label, prospective phase II study of tislelizumab in combination with chidamide as consolidation therapy in locally advanced, unresectable, stage III NSCLC

Date

21 Oct 2023

Session

Poster session 04

Topics

Immunotherapy

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Yi Hu

Citation

Annals of Oncology (2023) 34 (suppl_2): S746-S754. 10.1016/S0923-7534(23)01266-8

Authors

Y. Hu, F. Zhang, T. li, Z. hu, X. han, Z. ma, L. Wang, H. tao

Author affiliations

  • Department Of Medical Oncology, Chinese PLA General Hospital (301 Military Hospital), 100853 - Beijing/CN

Resources

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Abstract 1297P

Background

The PACIFIC trial established consolidation therapy with PD-L1 inhibitor as standard of care for patients with unresectable, stage III NSCLC and no disease progression after definitive chemoradiotherapy (CRT). PD-1 antibodies may synergize with HDAC inhibitors by inducing and activating NK cell and cytotoxic T cell (CTL) -mediated cellular immunity in previous studies. It is worth exploring new regimens to further improve survival for this population.

Methods

This was an open-label, prospective study. Patients with histologically or cytologically documented stageⅢ,locally advanced, unresectable NSCLC without progression following definitive platinum-based concurrent chemoradiation therapy (2∼4 cycles) were enrolled. After cCRT, patients received Tislelizumab 200 mg Q3W intravenously and Chidamide 30 mg twice weekly orally. The primary endpoint was safety. Secondary endpoints include 6-month and 12-month PFS rates、OS and ORR. Tumor response was assessed using RECIST V1.1.

Results

At the data cut-off April 22, 2023(median follow-up time, 23.6m), 19 patients were enrolled, mean-aged was 66.3 years (range: 53-78). Patients received combination consolidation therapy for a median of 6.37 months. Adverse events of any cause and grade occurred in 68.4% (13). 3 patients (16.7%) had Grade≥3 TRAEs. The most common Grade≥ 3 TRAEs were pneumonitis (10.5%). The confirmed ORR was 84.2% (95%CI:60.4%-96.60%). The DCR was 100%. Median PFS was 20.5 months (95%CI: 4.37m-NA), and 6-month and 12-month PFS rate were 65.7% (95%CI:38.8%-83.0%) and 58.4% (95%CI:31.5%-77.8%), respectively.

Conclusions

Tislelizumab combined with Chidamide showed encouraging antitumor activity and a favorable safety profile as consolidation therapy for locally advanced, unresectable stage III NSCLC. Further sample and longer follow-up are required to obtain more accurate results.

Table: 1297P

Incidence of TRAEs

TRAEs (N=19) Any Grade, n (%) ≥Grade 3, n(%)
Pneumonitis 7 (36.8%) 2 (10.5%)
Liver injury 5 (26.3%) 0
Nausea/emesis 5 (26.3%) 0
Alopecia 4 (21.1%) 0
Hypothyroidism 2 (10.5%) 0
Myelosuppression 2 (10.5%) 0
Hepatitis 1 (5.3%) 1 (5.4%)
Myocarditis 1 (5.3%) 1 (5.4%)
Neurotoxicity 1 (5.3%) 1 (5.4%)

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Beijing Cancer Prevention & Treatment Society.

Disclosure

All authors have declared no conflicts of interest.

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