98P - Efficacy and safety of durvalumab plus gemcitabine and cisplatin in Chinese participants with advanced biliary tract cancer: Extension cohort of the phase III, randomised, double-blind, placebo-controlled, global TOPAZ-1 study

Background

At the TOPAZ-1 (NCT03875235) primary analysis, first-line treatment with durvalumab (D) + gemcitabine and cisplatin (GC) significantly improved overall survival (OS) and progression-free survival (PFS) v placebo (P) + GC; the regimen has been approved by multiple health authorities globally for advanced biliary tract cancer (BTC).¹ Here, we present prespecified exploratory analyses in an extended cohort of TOPAZ-1 enrolled in China.

Methods

Participants (pts) with BTC were randomised 1:1 to D (1500 mg) or P every 3 weeks (Q3W) + GC (G 1000 mg/m² and C 25 mg/m² on Days 1 and 8 Q3W) for ≤8 cycles, followed by D (1500 mg) or P Q4W until disease progression, unacceptable toxicity or other discontinuation criteria. The primary endpoint was OS. Secondary endpoints included PFS, objective response rate (ORR) and safety. Results from the China cohort (data cut-off [DCO] 14 Oct 2022, 72.3% OS maturity) are compared with the global cohort (primary analysis; DCO 11 Aug 2021, 61.9% OS maturity)¹ and a pooled global + China cohort (China and pooled cohort analyses are exploratory).

Results

In the China cohort, 130 pts were randomised (65 to D + GC, 65 to P + GC; 5/130 were recruited to the global cohort and 125/130 to the extension). OS and PFS benefit with D + GC v P + GC in the China cohort (hazard ratio [HR], 0.78 and 0.79) were consistent with the global¹ and pooled cohorts (Table). OS rates at 12 and 18 months and ORR in the China cohort were numerically higher for D + GC v P + GC. D + GC was tolerable across cohorts. Table: 98P

*In safety analysis set. ^†Total n=343. ^‡Total n=404. AE, adverse event; TRAE, treatment-related AE

Conclusions

Consistent with the global cohort, D + GC demonstrated a clinically meaningful OS and PFS benefit compared with PBO + GC in pts enrolled in China. D + GC was tolerable and represents a potential new first-line standard of care regimen in China. References 1. Oh et al. NEJM Evid 2022.

Clinical trial identification

NCT03875235.

Editorial acknowledgement

Medical writing support, under the direction of the authors, was provided by Elaine Groat, PhD, of CMC Connect, a division of IPG Health Medical Communications, funded by AstraZeneca, in accordance with Good Publication Practice (GPP 2022) guidelines.

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

E. Li: Non-Financial Interests, Personal and Institutional, Principal Investigator: Department of Oncology, The First Affiliated Hospital of Xi’an Jiaotong University. B. Xing: Non-Financial Interests, Personal and Institutional, Principal Investigator: Beijing Cancer Hospital. C. Dai: Non-Financial Interests, Personal and Institutional, Principal Investigator: Shenjing Hospital of China Medical University. Z. Chen: Non-Financial Interests, Personal and Institutional, Principal Investigator: Department of Medical Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, China. L. Liu: Non-Financial Interests, Personal and Institutional, Principal Investigator: Department of Hepatobiliary Surgery, Anhui Province Key Laboratory of Hepatopancreatobiliary Surgery, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China. Z. Lu: Non-Financial Interests, Personal and Institutional, Principal Investigator: Department of Hepatobiliary Surgery, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China. H. Liang: Non-Financial Interests, Personal and Institutional, Principal Investigator: Department of oncology, the first affiliated hospital of AMU. X. Liu: Non-Financial Interests, Personal and Institutional, Principal Investigator: Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China Non-Financial Personal and Institutional Principal Investigator. J. Wang: Non-Financial Interests, Personal and Institutional, Principal Investigator: Department of Internal Medicine, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, 127 Dongming Road, Jinshui District, Zhengzhou City, Henan Province, China. R. Miao: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. X. Qu: Other, Personal, Full or part-time Employment: China R&D, AstraZeneca, Shanghai, China. All other authors have declared no conflicts of interest.