950P - Outcomes by baseline tumour burden in EMERALD-1: A phase III, randomised, placebo (PBO)-controlled study of durvalumab (D) ± bevacizumab (B) with transarterial chemoembolisation (TACE) in participants (pts) with embolisation-eligible unresectable hepatocellular carcinoma (uHCC)

Background

In EMERALD-1 (NCT03778957), D + B + TACE significantly improved progression-free survival (PFS) vs TACE in pts with embolisation-eligible uHCC. The up-to-7 criterion measures tumour burden based on tumour number and diameter, which are prognostic for HCC. Here, outcomes were assessed by baseline tumour burden based on the up-to-7 criterion.

Methods

Pts were randomised 1:1:1 to D + B + TACE, D + TACE or TACE arms. Pts received D (1500 mg) + TACE or PBO for D (Q4W) + TACE. After completing last TACE, pts received D (1120 mg) + B (15 mg/kg), D (1120 mg) + PBO for B or PBOs for D and B (Q3W). PFS and time to progression (TTP) (BICR RECIST 1.1) in the intent-to-treat (ITT) population and safety in the safety analysis set (SAS; pts received ≥1 dose of study treatment [tx], regardless of randomisation) are reported by baseline tumour burden (within [≤7] or beyond up-to-7 criterion [>7]).

Results

At screening, the >7 group included more pts with ECOG PS1, BCLC Stage C, HAP C or D scores or PVI vs the ≤7 group. Disease characteristics were generally consistent across arms in the ≤7 and >7 groups. PFS improved with D + B + TACE vs TACE in the ≤7 and >7 groups, while PFS improved with D + TACE in the ≤7 group only. Trends were similar for TTP with marked improvement with D + B + TACE vs TACE in the ≤7 and >7 groups, and TTP improvement with D + TACE vs TACE, which was greater in the ≤7 group. Max Grade 3–4 tx-related adverse event (TRAE) frequencies were numerically higher with D + B + TACE vs TACE in the ≤7 and >7 groups; differences were reduced when adjusted for exposure. No tx-related deaths with D + B + TACE were observed. Table: 950P

HR, hazard ratio; m, median

Conclusions

In a broad population, PFS and TTP benefits were observed with D + B + TACE vs TACE with manageable safety, regardless of tumour burden. Data further support a favourable risk-benefit profile with D + B + TACE in embolisation-eligible uHCC.

Clinical trial identification

NCT03778957.

Editorial acknowledgement

Medical writing support, under the direction of the authors, was provided by Justine Juana, BHSc, CMC Connect, a division of IPG Health Medical Communications.

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

M. Kudo: Financial Interests, Personal, Invited Speaker: Eisai, Chugai, Eli Lilly, Takeda, AstraZeneca; Financial Interests, Personal, Advisory Board: Roche, Chugai, Eisai, AstraZeneca; Financial Interests, Institutional, Research Grant: Otsuka, Taiho, Eisai, AbbVie, GE Healthcare, Chugai. R. Lencioni: Financial Interests, Personal, Other, Consulting or Advisory Role: AstraZeneca; Financial Interests, Personal, Research Funding: AstraZeneca. J.P. Erinjeri: Financial Interests, Personal, Other, Consulting or Advisory Role: AstraZeneca. S.L. Chan: Financial Interests, Personal, Advisory Board: Eisai, AstraZeneca, MSD, Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Eisai, Roche, Ipsen; Financial Interests, Personal, Research Grant: Eisai, MSD. Z. Ren: Financial Interests, Personal, Advisory Board, Consulting or Advisory Role: AstraZeneca, MSD, Roche. J. Heo: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Other, Consultant: GSK. V. Breder: Financial Interests, Personal, Advisory Board, payment for lectures: Roche, AstraZeneca, Eisai, Bayer, Novartis. M. Bouattour: Financial Interests, Personal, Advisory Board: MSD, BMS, Sirtex Medical, Ipsen, AbbVie, AstraZeneca, Servier, Taiho; Financial Interests, Personal, Invited Speaker: Roche; Non-Financial Interests, Principal Investigator: MSD, BMS, Sirtex Medical, AstraZeneca. F. Dayyani: Financial Interests, Personal, Advisory Board: Eisai, AstraZeneca; Financial Interests, Personal, Invited Speaker: Ipsen, Sirtex, Takeda; Financial Interests, Institutional, Local PI: AstraZeneca, BMS, Bayer, Roche, Ipsen, Merck; Financial Interests, Institutional, Coordinating PI: Exelixis, Signatera, Taiho. T. Suttichaimongkol: Financial Interests, Personal, Other, Honoraria: Takeda (Thailand). T. Decaens: Financial Interests, Personal, Advisory Board: BMS, Bayer, Becton Dickinson, AstraZeneca, Ipsen, Roche, Sirtex, Terumo, Guerbet; Financial Interests, Personal, Invited Speaker: AbbVie, Gilead, MSD; Financial Interests, Institutional, Research Grant: ArQule, Guerbet, Genoscience Pharma. R. Griffin: Financial Interests, Personal, Other, Contracted employee: AstraZeneca. C. Morgan, S.K. Ali, K. Balaji: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. B. Sangro: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, Boston Scientific, Roche, Sirtex; Financial Interests, Personal, Invited Speaker: Roche, Sirtex, Eisai, AstraZeneca; Financial Interests, Institutional, Research Grant: Roche. All other authors have declared no conflicts of interest.