80P - RATIONALE-302: Tislelizumab vs chemotherapy as second-line treatment for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC): Impact on health-related quality of life (HRQoL) in Asian patients

Background

Analysis of the intent-to-treat (ITT) population of RATIONALE-302 (NCT03430843) found overall HRQoL, fatigue, and physical functioning were maintained in patients (pts) receiving tislelizumab, while worsening in pts receiving investigator-chosen chemotherapy (ICC). Post-hoc analysis examines HRQoL and ESCC symptoms in the Asian and non-Asian subgroups of pts in RATIONALE-302.

Methods

Patients with advanced or metastatic ESCC that progressed following systemic therapy were randomized 1:1 to receive either tislelizumab or ICC (paclitaxel, docetaxel, or irinotecan). HRQoL was measured using the EORTC QLQ-C30 and the QLQ-OES18. Least-squares mean score change from baseline to weeks 12 and 18 in HRQoL scores was assessed using a mixed model for repeated measurements. Reported nominal p-values are for descriptive purpose only.

Results

Of the total of 512 pts, this analysis was conducted in the subgroup of 392 Asian pts (tislelizumab N=192; ICC N=200). Tislelizumab pts had stable GHS/QoL, while fatigue scores worsened in both arms, though more so in ICC pts. Change from baseline was similar in both arms for physical functioning at weeks 12 and 18. The eating score remained stable in tislelizumab pts, while it worsened in ICC pts, particularly at week 18. Reflux improved at week 12 in the tislelizumab pts and worsened in ICC pts. Of note, a similar pattern of results was found in the smaller non-Asian subgroup (tislelizumab N=49; ICC N=47). Table: 80P

Least-squares (LS) mean change from baseline in Asian subgroup

Conclusions

The HRQoL and ESCC-related symptoms of the Asian subgroup of tislelizumab pts remained stable or improved while ICC pts experienced worsening. These HRQoL results in Asian pts corroborate the HRQoL findings in the total population, suggesting tislelizumab is a potential new second-line treatment option for pts with advanced or metastatic ESCC.

Clinical trial identification

Editorial acknowledgement

Writer: Jason C. Allaire, Generativity.

Legal entity responsible for the study

BeiGene.

Funding

BeiGene.

Disclosure

S. Kim: Financial Interests, Personal, Advisory Role: Novartis, AstraZeneca, Lilly, Dae Hwa Pharmaceutical Co. Ltd., ISU Abxis, Daiichi-Sankyo; Financial Interests, Personal, Leadership Role: ESMO Breast 2021; Financial Interests, Personal, Stocks/Shares: Genopeaks, NeogeneTC; Financial Interests, Personal, Research Grant: Novartis, Sanofi-Aventis, DongKook Pharm Co. E. Van Cutsem: Financial Interests, Personal, Advisory Role: Bayer, Lily, Roche, Servier, Bristol Myers Squibb, Celgene, Merck Sharp & Dohme, Merck KGaA, Novartis, AstraZeneca, Halozyme, Array BioPharma, Biocartis, GlaxoSmithKline, Daiichi Sankyo, Pierre Fabre, Sirtex Medical, Taiho Pharmaceutical, Incyte, Astellas Pharma; Financial Interests, Institutional, Research Grant: Amgen, Bayer, Boehringer Ingelheim, Lilly, Novartis, Roche, Celgene, Ipsen, Merck, Merck KGaA, Servier, Bristol Myers Squibb. J.A. Ajani, L. Shen: Financial Interests, Personal, Writing Engagements: BeiGene. G. Barnes: Financial Interests, Personal, Full or part-time Employment: Beigene Ltd.; Financial Interests, Personal, Stocks/Shares: Beigene Ltd. N. Ding: Financial Interests, Personal, Full or part-time Employment: BeiGene. T. Xia: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene. L. Zhan: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene. K. Kato: Financial Interests, Personal, Writing Engagements: BeiGene; Financial Interests, Personal, Sponsor/Funding: ONO, BMS, MSD, Shionogi, Beigene, Chugai, Astra Zeneca, BAYER, Oncolys Biopharma; Financial Interests, Personal, Advisory Role: BMS, MSD; Financial Interests, Personal, Invited Speaker: ONO, BMS, Eli Lilly, Taiho. All other authors have declared no conflicts of interest.