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Proffered Paper session 2

121O - RATIONALE 309: A randomized, global, double-blind, Phase 3 trial of tislelizumab (TIS) vs placebo, plus gemcitabine + cisplatin (GP), as 1L treatment for recurrent/metastatic nasopharyngeal cancer (RM-NPC)


10 Dec 2021


Proffered Paper session 2


Yunpeng Yang


Annals of Oncology (2021) 32 (suppl_7): S1428-S1457. 10.1016/annonc/annonc787


Y. Yang1, J. Pan2, H. Wang3, S. Qu4, N. Chen5, X. Chen6, Y. Sun7, X. He8, C. Hu9, L. Lin10, Q. Yu11, S. Wang12, G. Wang13, F. Lei14, J. Wen15, K. Yang16, Z. Lin17, Y. Wu18, W. Fang19, L. Zhang1

Author affiliations

  • 1 Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
  • 2 Fuijan Cancer Hospital, Fuijan/CN
  • 3 Hunan Cancer Hospital, Changsha/CN
  • 4 The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning/CN
  • 5 West China Hospital of Sichuan University, Chengdu/CN
  • 6 Zhejiang Cancer Hospital, Hangzhou/CN
  • 7 Beijing Cancer Hospital, Beijing/CN
  • 8 Cancer Hospital Chinese Academy of Medical Sciences, Beijing/CN
  • 9 Fudan University Shanghai Cancer Centre, Shanghai/CN
  • 10 The First Affiliated Hospital of Guangzhou Traditional Chinese Medicine University, Guangzhou/CN
  • 11 The Affiliated Cancer Hospital of Guangxi Medical University, Nanning/CN
  • 12 The Fifth Affiliated Hospital Sun Yat-sen University, Zhuhai/CN
  • 13 Changsha Central Hospital, Changsha/CN
  • 14 The People's Hospital of Zhongshan City, Zhongshan/CN
  • 15 Affiliated Hospital of Guangdong Medical University, Zhanjiang/CN
  • 16 Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan/CN
  • 17 Cancer Hospital of Shantou University Medical College, Shantou/CN
  • 18 BeiGene (Shanghai) Co., Ltd., Shanghai/CN
  • 19 Sun Yat-sen University Cancer Center, Guangzhou/CN


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Abstract 121O


TIS is an anti-PD-1 antibody engineered to minimize FcγR binding, a mechanism of T-cell clearance and potential anti-PD-1 resistance. TIS demonstrated antitumor activity in NPC as a single agent in a Phase I/II study (CTR20160872). This randomized, double-blind, Phase III study evaluated TIS + GP vs placebo + GP as 1L treatment for RM-NPC (NCT03924986).


Eligible pts with RM-NPC were randomized 1:1 to receive TIS (Arm A) or placebo (Arm B) (200 mg IV D1) plus G (1 g/m2 IV D1, D8) and P (80 mg/m2 D1) every three weeks (Q3W) for 4–6 cycles followed by TIS or placebo Q3W until disease progression, unacceptable toxicity, or withdrawal. After disease progression, patients in Arm B could crossover to receive TIS monotherapy. The primary endpoint was independent review committee-assessed progression-free survival (PFSIRC). Secondary endpoints included objective response rate (ORRIRC), duration of response (DoRIRC), investigator-assessed PFS (PFSINV), and safety.


A total of 263 pts were randomized to Arm A (n=131) and Arm B (n=132). At the interim analysis (data cut-off: Mar 26, 2021), median follow-up was 10.0 months (m). Median PFSIRC was significantly longer for Arm A vs B (HR 0.52 [95% CI: 0.38, 0.73]; median PFS: 9.2 vs 7.4 m; p<0.0001). PFS benefit in Arm A was consistent across most subgroups. PFSINV was consistent with PFSIRC (HR 0.54 [0.38, 0.76]; median 9.8 vs 7.6 m). ORRIRC and median DoRIRC were 69.5% and 8.5 m (Arm A) and 55.3% and 6.1 m (Arm B), with 21 (16.0%) and 9 (6.8%) patients achieving complete response, respectively. The 12-month PFSIRC event-free rate was 35.7% (Arm A) and 12.2% (Arm B). Safety is described in the table. Table: 121O

Summary of TEAEs

% Arm A (n=131) Arm B (n=132)
≥ 1 TEAE 100.0 99.2
≥ Grade 3 TEAE 80.9 81.8
Serious TEAE 27.5 33.3
TEAE leading to discontinuation of TIS/placebo 5.3 3.8
≥ Grade 3 immune-mediated TEAE 2.3 -

TEAE, treatment emergent adverse event; TIS, tislelizumab.


TIS + GP significantly prolonged PFS vs GP alone as 1L therapy for RM-NPC. ORR and DoR were increased for TIS + GP vs GP alone. The safety profile of TIS + GP was manageable and consistent with previous reports, with no new safety signals identified.

Clinical trial identification


Editorial acknowledgement

Editorial writing support for the development of this abstract, under direction of the authors, was provided by Jenny Feehan, BSc, of Ashfield MedComms, an Ashfield Health company, and was funded by BeiGene Ltd.

Legal entity responsible for the study

BeiGene Ltd.


BeiGene Ltd.


Y. Wu: Financial Interests, Personal, Full or part-time Employment: BeiGene. L. Zhang: Financial Interests, Personal, Invited Speaker: Hengrui Pharm; Financial Interests, Institutional, Research Grant: Hengrui Pharm; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Personal and Institutional, Proprietary Information: Hengrui Pharm. All other authors have declared no conflicts of interest.

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