2026-10-10T18:41:32Z https://api.figshare.com/v2/oai

oai:figshare.com:article/33981772 2026-09-25T09:35:40Z category_7 portal_147 item_type_3 month_year_09_2026

Supplemental Material for: Quavonlimab Coformulated With Pembrolizumab Plus Lenvatinib for Advanced Hepatocellular Carcinoma: Nonrandomized Phase 2 KEYSTEP-004 Trial figshare admin karger (2628495) Daneng Li (4399006) Lorenza Rimassa (11243) Masafumi Ikeda (5329037) Mark Yarchoan (349367) Baek-Yeol Ryoo (3409577) Thibaud Koessler (22571) Ho-Yeong Lim (15112075) Mariusz Kwiatkowski (25108675) Ting-Tsung Chang (170605) Jee Hyun Kim (77143) Andrea Casadei-Gardini (6938207) Masatoshi Kudo (453006) Zhenggang Ren (728520) Maria Varela (1525843) Josep M. Llovet (25108678) Razi Ghori (18315836) Ken Hatogai (3422465) Abby B. Siegel (25109153) Ann-Lii Cheng (285432) Medicine Medicine <p dir="ltr">Introduction: Despite the availability of several approved therapies, continued investigation of novel treatment options is needed to further improve outcomes in advanced hepatocellular carcinoma (HCC). The phase 2 KEYSTEP-004 study evaluated safety and efficacy of quavonlimab coformulated with pembrolizumab (quavonlimab/pembrolizumab) plus lenvatinib as first-line therapy for advanced HCC. Methods: Adults with confirmed advanced HCC and no prior systemic therapy were enrolled. In the safety lead-in phase, participants received intravenous quavonlimab 25 mg coformulated with pembrolizumab 400 mg every 6 weeks plus oral lenvatinib 12 mg (body weight ≥60 kg) or 8 mg (body weight <60 kg) once daily (dose level 0 [DL0]). Allocation to the efficacy expansion phase was permitted if lenvatinib DL0 plus quavonlimab 25 mg coformulated with pembrolizumab 400 mg every 6 weeks was determined to be tolerable. Primary end points were objective response rate (ORR) per RECIST v1.1 by blinded independent central review (BICR) and safety. Secondary end points included duration of response (DOR) and progression-free survival (PFS) per RECIST v1.1 by BICR, and overall survival (OS). Results: As of June 22, 2023, 116 participants were enrolled and 115 were treated. No dose-limiting toxicities were observed in the safety lead-in phase. Lenvatinib DL0 in combination with quavonlimab 25 mg coformulated with pembrolizumab 400 mg every 6 weeks was determined to be tolerable. Median study follow-up was 18.0 months (range, 12.0-26.6). Confirmed ORR was 37.4% (95% CI, 28.5-46.9). Median DOR was 10.6 months (range, 1.2+ to 23.1+), median PFS was 8.2 months (95% CI, 6.2-10.2), and median OS was 22.1 months (95% CI, 15.5-not reached). Grade 3-5 treatment-related adverse events (AEs) occurred in 66 participants (57.4%); 14 (12.8%) required high-dose steroids for management of a treatment-related AE. Conclusion: Quavonlimab coformulated with pembrolizumab plus lenvatinib is an active combination and has a manageable safety profile in advanced HCC.</p> 2026-09-25T09:35:40Z Dataset Dataset 10.6084/m9.figshare.33981772.v1 https://figshare.com/articles/dataset/Supplemental_Material_for_Quavonlimab_Coformulated_With_Pembrolizumab_Plus_Lenvatinib_for_Advanced_Hepatocellular_Carcinoma_Nonrandomized_Phase_2_KEYSTEP-004_Trial/33981772 CC BY 4.0