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. Resources from the same session973P - Atezolizumab plus bevacizumab or lenvatinib versus sorafenib as first-line therapy for advanced hepatocellular carcinoma: Overall survival using real-world data from TrinetX platformPresenter: Lisardo Ugidos De La Varga Session: Poster session 17 977P - Transarterial chemoembolization combined with lenvatinib plus tislelizumab for unresectable hepatocellular carcinoma: A multicenter cohort studyPresenter: Yi Chen Session: Poster session 17 978P - Efficacy and safety analysis of transarterial chemoembolization combined donafenib with or without immune checkpoint inhibitors in for unresectable hepatocellular carcinoma (HCC): A prospective, single-arm, single center, phase Ⅱ clinical studyPresenter: Jinpeng Li Session: Poster session 17 979P - Initial results from the phase II randomized trial comparing TACE with irinotecan and mitomycin C to doxorubicin in intermediate stage HCC (IRITACE trial)Presenter: Oliver Waidmann Session: Poster session 17 This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
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