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Poster Display session 3

2382 - First Report of Efficacy and Safety From a Phase 2 Trial of Tislelizumab, an Anti-PD-1 Antibody, for the Treatment of PD-L1+ Locally Advanced or Metastatic Urothelial Carcinoma (UC) in Asian Patients

Date

30 Sep 2019

Session

Poster Display session 3

Topics

Tumour Site

Urothelial Cancer

Presenters

Dingwei Ye

Citation

Annals of Oncology (2019) 30 (suppl_5): v356-v402. 10.1093/annonc/mdz249

Authors

D. Ye1, J. Liu2, A. Zhou3, Q. Zou4, H. Li5, C. Fu6, H. Hu7, J. Huang8, S. Zhu9, J. Jin10, L. Ma11, J. Guo12, J. Xiao13, S.H. Park14, D. Zhang15, X. Qiu16, Y. Bao17, L. Zhang18, W. Shen18, B. Feng2

Author affiliations

  • 1 Genitourinary Cancer Committee, Fudan University - Shanghai Cancer Center, 200032 - Shanghai/CN
  • 2 Sichuan University, West China Hospital, Chengdu/CN
  • 3 Department Of Medical Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College - Cancer Institute & Hospital, Beijing/CN
  • 4 Medical Oncology, Jiangsu Cancer Hospital, Nanjing/CN
  • 5 Urology Department, Peking Union Medical College Hospital, Beijing/CN
  • 6 Department Of Urology Surgery, Liaoning Cancer Hospital & Institute, Shenyang/CN
  • 7 Department Of Urology, The Second Hospital of Tianjin Medical University, Tianjin/CN
  • 8 Department Of Urology, Sun Yat-sen University - Sun Yat-Sen Memorial Hospital, Guangzhou/CN
  • 9 Department Of Urology, Zhejiang Cancer Hospital, Hangzhou/CN
  • 10 Institute Of Urology, Peking University First Hospital, Beijing/CN
  • 11 Urologic Surgery Department, Peking University Third Hospital, Beijing/CN
  • 12 Department Of Urology, Fudan University - Zhongshan Hospital, Shanghai/CN
  • 13 Department Of Urology, Anhui Provincial Hospital, Hefei/CN
  • 14 Division Of Hematologyoncology, Department Of Medicine, Samsung Medical Center, Seoul/KR
  • 15 Department Of Urology, Zhejiang Provincial People's Hospital, Hangzhou/CN
  • 16 Clinical Development, BeiGene (Beijing) Co., Ltd., Beijing/CN
  • 17 Biostatistics, BeiGene (Beijing) Co., Ltd., Beijing/CN
  • 18 Medical Oncology, BeiGene (Beijing) Co., Ltd., Beijing/CN

Resources

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Abstract 2382

Background

Tislelizumab, an investigational anti-PD-1 antibody, was engineered to minimize binding to FcγR on macrophages in order to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. Previous reports showed tislelizumab was generally well tolerated and had antitumor activity in patients (pts) with advanced solid tumours, including UC.

Methods

This phase 2 clinical trial (CTR20170071) assessed the safety, tolerability, and efficacy of tislelizumab (200 mg Q3W) in Asian pts with PD-L1+ UC previously treated with ≥1 platinum-containing therapy. Prior treatment with a PD-(L)1 inhibitor was not allowed. During screening, archival tissue or fresh biopsy from all pts was sent to a central laboratory for PD-L1 testing via the VENTANA SP263 IHC assay. Patients were considered PD-L1+ if ≥ 25% of tumor or immune cells had PD-L1 expression. The primary efficacy endpoint was ORR (RECIST v1.1), assessed by an independent review committee (IRC). Secondary efficacy endpoints included DoR, PFS, and OS; AE incidence and severity were secondary safety endpoints.

Results

Between 04 Jul 2017 and 28 Feb 2019, 113 pts received tislelizumab for a median of 15 weeks and were followed up for a median of 8 mo. Urinary bladder (n = 51) and renal pelvis (n = 31) were common primary tumor sites. Of 104 evaluable pts, a confirmed objective response was observed in 24 pts (ORR=23%, 95% CI: 15.4, 32.4), including 8 CR and 16 PR per IRC assessment. Median DoR per IRC was not reached at the time of protocol-defined analysis; 19/24 (79%) responders had ongoing responses at data cutoff. Median PFS and OS were 2.1 and 9.8 mo, respectively. Anemia (27%), decreased appetite (19%), and pyrexia (17%) were the only TRAEs occurring in > 15% of pts; anemia (7%) was the only grade 3-4 TRAE occurring in ≥ 5% pts. Four pts experienced a grade 5 AE considered related to disease progression but also possibly related to treatment (hepatic failure, n = 2; respiratory arrest, n = 1; renal impairment, n = 1).

Conclusions

Tislelizumab was generally well tolerated and demonstrated clinical activity in pts with PD-L1+ UC.

Clinical trial identification

CTR20170071.

Editorial acknowledgement

Stephan Lindsey, PhD, at OPEN Health Medical Communications (Chicago, IL).

Legal entity responsible for the study

BeiGene, Ltd.

Funding

BeiGene, Ltd.

Disclosure

X. Qiu: Full / Part-time employment: BeiGene. L. Zhang: Full / Part-time employment: BeiGene. W. Shen: Full / Part-time employment: BeiGene. All other authors have declared no conflicts of interest.

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