Chidamide plus envafolimab as subsequent treatment in advanced non‐small cell lung cancer patients resistant to anti‐PD‐1 therapy: A multicohort, open‐label, phase II trial with biomarker analysis

Autor: Yaxiong Zhang, Zihong Chen, Yu Liu, Liang Han, Wei Jiang, Qiming Wang, Jianhua Shi, Liqin Lu, Jianying Li, Mingjun Zhang, Yan Huang, Yunpeng Yang, Xue Hou, Li Zhang, Jing Li, Wenfeng Fang, Gang Chen
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Cancer Medicine, Vol 13, Iss 7, Pp n/a-n/a (2024)
Druh dokumentu: article
ISSN: 2045-7634
DOI: 10.1002/cam4.7175
Popis: Abstract Background Combination of chidamide and anti‐PD‐L1 inhibitor produce synergistic anti‐tumor effect in advanced NSCLC patients resistant to anti‐PD‐1 treatment. However, the effect of chidamide plus envafolimab has not been reported. Aims This study aimed to evaluate the efficacy of chidamide plus envafolimab in advanced NSCLC patients resistant toanti‐PD‐1 treatment. Materials and Methods Eligible advanced NSCLC patients after resistant to anti‐PD‐1 therapy received chidamide and envafolimab. The primary endpoint was objective response rate (ORR). The secondary end points included disease control rate (DCR), progression‐free survival (PFS), and safety. The expression of histone deacetylase 2 (HDAC2), PD‐L1, and blood TMB (bTMB) was also analyzed. Results After a median follow‐up of 8.1 (range: 7.6–9.2) months, only two patients achieved partial response. The ORR was 6.7% (2/30), DCR was 50% (15/30), and median PFS (mPFS) was 3.5 (95% confidence interval: 1.9–5.5) months. Biomarker analysis revealed that patients with high‐level HDAC2 expression had numerically superior ORR (4.3% vs. 0), DCR (52.2% vs. 0) and mPFS (3.7 vs. 1.4m). Patients with negative PD‐L1 had numerically superior DCR (52.2% vs. 33.3%) and mPFS (3.7m vs. 1.8m), so were those with low‐level bTMB (DCR: 59.1% vs. 16.7%, mPFS: 3.8 vs.1.9m). Overall safety was controllable. Discussion High HDAC2patients showed better ORR, DCR, and PFS. In addition, patient with negative PD‐L1 and low‐level bTMB had better DCR and PFS. This may be related to the epigenetic function of chidamide. However, the sample size was not big enough, so it is necessary to increase sample size to confirm the conclusion. Conclusion Combination of chidamide and envafolimab showed efficacy signals in certain NSCLC patients. But further identification of beneficial population is necessary for precision treatment.
Databáze: Directory of Open Access Journals
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