Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany
Arndt Vogel , Ann-Lii Cheng , Wei Shi , Seong Jang , Laura Alexander , Xianzhang Meng , Natalia Raphael , Stephen Lam Chan
Background: CARES-310 study (NCT03764293) evaluated the combination of camrelizumab, an anti-PD-1 inhibitor, and rivoceranib, a highly selective VEGFR-2 tyrosine kinase inhibitor, (cam + rivo) vs sorafenib (sora) for the treatment of uHCC. Cam + rivo significantly improved median overall survival ([mOS] 22.1 months [mo] vs 15.1 mo) and median progression-free survival ([mPFS] 5.6 mo vs 3.7 mo) compared to sora. This post-hoc analysis evaluated the impact of baseline albumin-bilirubin (ALBI) grade and Child-Pugh (CP) class on survival outcomes. Methods: In this randomized, open-label, international, multicenter, phase 3 study, patients were randomized 1:1 to receive cam 200 mg IV Q2W + rivo 250 mg PO QD (n=272) or sora 400 mg PO BID (n=271). Median overall survival (mOS), median progression free survival (mPFS), objective response rate (ORR), disease control rate (DCR), and safety were assessed by baseline ALBI grade and CP class. Results: mOS, mPFS, DCR, and ORR improved with cam + rivo vs sora regardless of baseline liver function (Table). Although treatment-related grade 3/4 AEs occurred at a greater rate in the cam + rivo arm vs the sora arm, the rate of these events was similar for patients with baseline ALBI grade 1 and grade 2 (cam + rivo, 82.1% and 81.7% vs sora, 53.9% and 54.0%, respectively). Median time-to-deterioration (mTTD) to CP class B was similar between treatment arms for ALBI grade 1 (not evaluable [NE], NE) and grade 2 (cam + rivo, 10.1 mo; sora, 10.6 mo; HR, 0.99). Conclusions: In this post-hoc analysis of Study CARES-310, the efficacy of cam + rivo was superior to sora regardless of baseline liver function as measured by both ALBI grade and CP class. Despite a higher rate of grade 3/4 AEs, there was no detrimental effect of cam +rivo on liver function in patients with both well- and moderately- preserved liver function compared to sora. These results support cam + rivo as a potential new first-line treatment option for patients with uHCC regardless of baseline liver function. Clinical trial information: NCT03764293.
Impact of baseline ALBI grade and CP class on survival and other outcomes in Study CARES-310. | ||||||||||
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Overall ITT Population | ALBI Grade 1 | ALBI Grade 2 | CP Class A5 | CP Class A6 | ||||||
Rivo + Cam n=272 | Sora n=271 | Rivo + Cam n=200 | Sora n=206 | Rivo + Cam n=72 | Sora n=63 | Rivo + Cam n=236 | Sora n=230 | Rivo + Cam n=36 | Sora n=41 | |
mOS, mo | 22.1 | 15.2 | 23.9 | 15.4 | 19.1 | 12.3 | 23.9 | 15.6 | 22.0 | 9.2 |
0.62 (0.49,0.80)a | 0.62 (0.47, 0.83)a | 0.62 (0.4, 1.0)a | 0.65 (0.5, 0.85)a | 0.62 (0.35, 1.13)a | ||||||
mPFS, mo | 5.6 | 3.7 | 6.1 | 3.7 | 5.6 | 3.1 | 6.1 | 3.7 | 4.4 | 3.1 |
0.52 (0.41, 0.65)a | 0.57 (0.46, 0.73)a | 0.57 (0.38, 0.86)a | 0.58 (0.47, 0.72)a | 0.53 (0.32, 0.91)a | ||||||
DCR, % | 78.3 | 53.9 | 78.0 | 56.7 | 79.2 | 54.0 | 80.1 | 56.5 | 66.7 | 53.7 |
ORRb, % | 25 | 6 | 35.5 | 9.1 | 26.4 | 12.7 | 33.1 | 10.4 | 33.3 | 7.3 |
ITT, intent to treat; Rivo + Cam, rivoceranib + camrelizumab; Sora, sorafenib. aHR (95% CI); bAssessed by blinded independent review committee.
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