Abstract 963P
Background
Study CARES-310 (NCT03764293) evaluated cam, an anti-PD-1 inhibitor, in combination with rivo, a VEGFR tyrosine kinase inhibitor, vs sora in pts with uHCC. As compared with sora, cam+rivo significantly improved median overall survival (22.1 vs 15.2 months, HR 0.62) and median progression-free survival by BIRC assessment (5.6 vs 3.7 months, HR 0.52). Rates of grade 3/4 adverse events (G 3/4 AEs) were higher with cam+rivo arm vs sora (82% vs 53%). We performed a Q-TWiST analysis to assess the impact of treatment with cam+rivo on quality of life as compared with sora.
Methods
All pts were evaluated for: duration of time before disease progression with G3/4 AEs (TOX), duration of time before disease progression without G3/4 AEs (TWiST), and duration of time between disease progression and death or censoring (REL). Utility coefficients (u) of 1 for TWIST, 0.5 for TOX and REL were used to calculate Q-TWiST (Q-TWiST = [uTOX * TOX] + [uTWiST * TWiST] + [uREL * REL]; mean duration in each state was calculated using the method of Restricted Mean Survival Time (RMST).
Results
Duration of TOX and TWiST was longer for pts in the cam+rivo arm vs sora arm; duration of REL was not significantly different between arms (Table). Clinically important relative Q-TWiST gains favored cam+rivo vs sora by 10.6% (= difference 1.61/mOS of sora 15.2). Table: 963P
Mean duration of TOX, TWiST, REL, and Q-TWiST
| Mean duration, months (SE) | Cam+rivo (n=272) | Sora (n=271) | Difference Cam+rivo vs Sora | P value |
| TOX | 2.18 (0.2) | 1.21 (0.14) | 0.97 (0.25) | ConclusionsPts with uHCC treated with cam+rivo had clinically meaningful quality-adjusted survival benefits compared with pts treated with sora, a benefit driven primarily by time before disease progression without toxicity, supporting that the higher incidence of AEs in pts treated with cam+rivo vs sora is likely due to longer treatment duration with cam+rivo. Clinical trial identificationNCT03764293. Editorial acknowledgementOlivia Adams The Phillips Group Oncology Communications, Inc. Legal entity responsible for the studyElevar Therapeutics; Jiangsu Hengrui Pharmaceuticals Co., Ltd. FundingElevar Therapeutics; Jiangsu Hengrui Pharmaceuticals Co., Ltd. DisclosureA. Moon: Financial Interests, Personal, Speaker, Consultant, Advisor: Target RWE; Financial Interests, Personal, Advisory Board: Intercept Pharmaceuticals. N. Raphael: Financial Interests, Personal, Full or part-time Employment: Elevar Therapeutics; Financial Interests, Personal, Stocks/Shares: Elevar Therapeutics. 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. A.O. Kaseb: Financial Interests, Personal, Research Grant: BMS, Roche, Genentech, Merck, Eisai, Exelixis, Hengrui, Adaptimmune, Tyardi; Financial Interests, Personal, Speaker, Consultant, Advisor: BMS, Roche, Genentech, Merck, Eisai, Exelixis, Elevar; Financial Interests, Personal, Speaker’s Bureau: BMS, Roche, Genentech, Merck, Eisai, Exelixis, Elevar. S.H. Jang, X. Meng: Financial Interests, Personal, Full or part-time Employment: Elevar Therapeutics; Financial Interests, Personal, Stocks/Shares: Elevar Therapeutics. A. Cheng: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, BMS, Genentech/Roche, Eisai, Sanofi, MSD, Bayer, BeiGene, Ipsen Innovation, Ono Pharmaceutical, Omega Therapeutics; Financial Interests, Personal, Speaker’s Bureau: Amgen Taiwan, Ipsen Innovation, Bayer, Eisai, Sanofi, MSD, Genentech/Roche, AstraZeneca, BMS, Ono Pharmaceutical, Omega Therapeutics; Financial Interests, Personal, Advisory Board: Abbisko Therapeutics. A. Vogel: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Amgen, BeiGene, Boehringer Mannheim, BMS, BTG, Daiichi Sankyo, Eisai, Incyte, Ipsen, MSD, Pierre Fabre, Roche, Servier, Sirtex, Tahio, Terumo; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Amgen, BeiGene, Boehringer Mannheim, BMS, BTG, Daiichi Sankyo, Eisai, GSK, Imaging Equipment Ltd. (AAA), Incyte, Ipsen, Jiangsu Hengrui, Medicines MSD, Pierre Fabre, Roche, Servier, Sirtex, Tahio, Terumo; Financial Interests, Personal, Funding, support for attending meetings and/or travel: Roche, MSD, Astellas; Financial Interests, Personal, Advisory Board: AstraZeneca, Amgen, BeiGene, Boehringer Mannheim, BMS, BTG, Daiichi Sankyo, Eisai, Incyte, Ipsen, MSD, Pierre Fabre, Roche, Servier, Sirtex, Tahio, Terumo. All other authors have declared no conflicts of interest. 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