Abstract 936P
Background
In a multi-national phase II study (NCT03419897), single-agent TIS, an anti-PD-1 antibody, was well tolerated and demonstrated durable antitumor activity in patients with previously systemically treated unresectable HCC. This study also assessed the effects of TIS on health-related quality of life (HRQoL) using the EORTC QLQ-C30 and QLQ-HCC18 instruments. Here we present the results from the QLQ-C30 global health status (GHS)/QoL scale and the QLQ-HCC18 index and the scales for the key symptom of fatigue.
Methods
Tislelizumab (200 mg) was administered IV every 3 weeks until no further clinical benefit was observed. HRQoL was assessed at baseline and every 6 weeks thereafter up to cycle 12. Least-squares mean score change from baseline to cycles 6 and 12 was assessed using a mixed model for repeated measurement; change from baseline ≥10 points was considered clinically meaningful. Analysis was conducted for the overall population and by subgroups with 1 prior or ≥2 prior lines of therapy.
Results
Of the 249 enrolled patients (1 prior line, n=138; ≥2 prior lines, n=111), most were male (87%), median age was 62 years (28-90 years), and the majority (94%) had previously received sorafenib. Across the population, median treatment duration was 4.1 months and the median number of cycles completed was 6. At cycles 6 and 12 GHS/QoL, index and fatigue scores remained stable (Table). Table: 936P
| All (N=249) LS mean change (95% CI) | 1 Prior Line (n=138) LS mean change (95% CI) | ≥2 Prior Lines (n=111) LS mean change (95% CI) | |||||
| Cycle 6 | Cycle 12 | Cycle 6 | Cycle 12 | Cycle 6 | Cycle 12 | ||
| QLQ-30 | n = 127 | n = 59 | n = 75 | n = 34 | N = 52 | n = 25 | |
| GHS/QoL | -2.0 (-4.7, 0.6) | 0.4 (-3.3, 4.1) | -2.4 (-5.8, 1.0) | -0.9 (-5.8, 4.0) | -1.7 (-5.6, 2.3) | 1.7 (-3.9, 7.4) | |
| QLQ-HCC-18 | n = 128 | n = 60 | n = 75 | n = 35 | n = 53 | n = 25 | |
| Index | 2.6 (0.8, 4.4) | 2.2 (0.4, 4.1) | 0.9 (-1.5, 3.3) | 4.1 (1.7, 6.5) | 4.3 (1.6, 7.0) | 0.3 (-2.5, 3.1) | |
| Fatigue | 3.7 (0.4, 6.9) | 1.3 (-1.9, 4.5) | 0.6 (-3.6, 4.9) | 3.5 (-0.7, 7.7) | 6.7 (1.7, 11.6) | -0.9 (-5.8, 4.0) |
Abbreviations CI, confidence interval; GHS/QoL, global health status/quality of life scale; LS mean, least-squares mean.
Conclusions
These results showed no deterioration of HRQoL in patients treated with TIS with unresectable HCC, a patient population where HRQoL often deteriorates overtime. These results, along with promising efficacy and manageable tolerability findings from this trial, are promising results highlighting a good benefit risk profile of TIS in HCC patients particularly in pretreated patients.
Clinical trial identification
Editorial acknowledgement
Medical writing support was provided by Jason Allaire, PhD (Generativity).
Legal entity responsible for the study
BeiGene, Ltd.
Funding
BeiGene, Ltd.
Disclosure
Z. Ren: Financial Interests, Personal, Other, Consulting: AstraZeneca; Financial Interests, Personal, Other, Consulting: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Other, Consulting: Merck; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. E. Assenat: Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. L. Rimassa: Financial Interests, Institutional, Research Grant: Agios, ARMO BioSciences, AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, Roche, Zymeworks; Financial Interests, Personal, Other, Consulting fees: Amgen, ArQule, AstraZeneca, Basilea, Bayer, BMS, Celgene, Eisai, Exelixis, Genenta, Hengrui, Incyte, Ipsen, IQVIA, Lilly, MSD, Nerviano Medical Sciences, Roche, Sanofi, Zymeworks; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene; Financial Interests, Personal, Speaker’s Bureau: AbbVie, Amgen, Bayer, Eisai, Gilead, Incyte, Ipsen, Lilly, Merck Serono, Roche, Sanofi; Financial Interests, Personal, Advisory Board, Travel expenses: Ipsen. W. Fang: Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. B. Tang: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. S. Chica Duque: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. V. Li: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. J. Wu: Financial Interests, Personal, Full or part-time Employment: BeiGene; Non-Financial Interests, Personal, Other, Medical writing: BeiGene. Y. Wang: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. G. Barnes: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene; Non-Financial Interests, Personal, Other, Medical writing support; conference registration and travel: BeiGene.