A recent study has shown that HLB’s combination therapy for liver cancer, using Rivoceranib + Camrelizumab, demonstrates consistent efficacy across all age groups. Notably, the treatment improved progression-free survival (PFS) even among younger liver cancer patients under 40, further supporting its potential for a wide range of patients.
Elevar Therapeutics, HLB’s U.S. subsidiary, announced on Tuesday that it will present a poster at the International Liver Cancer Association’s annual conference (ILCA 2026) in Belgium from September 3-5. The poster will detail age-based post-analysis results from the global Phase 3 CARES-310 trial, which focused on patients with unresectable hepatocellular carcinoma (uHCC).
The analysis revealed that patients under 50 had a median overall survival (mOS) of 21.5 months, significantly longer than the 15.2 months observed in the sorafenib group. Median PFS also improved to 5.5 months, compared to 2.7 months in the sorafenib group. For patients over 50, the combination therapy showed similar benefits, with mOS at 23.9 months versus 15.2 months, and mPFS at 6.2 months versus 3.7 months.
In clinical trials, overall survival (OS) and progression-free survival (PFS) are key metrics for assessing cancer drug efficacy. OS measures how long patients live after starting treatment, while PFS indicates the time before cancer worsens or death occurs.
Remarkably, patients under 40 showed similar positive trends. The combination therapy group had an mOS of 24.2 months, outperforming the sorafenib group’s 15.2 months. The mPFS for this younger cohort improved to 5.5 months, compared to 2.2 months in the sorafenib group.
Safety profiles remained consistent across age groups. Treatment-related adverse events (TRAEs) were similar, with hypertension being the most common Grade 3-4 TRAE in the combination group, while hand-foot syndrome was most prevalent in the sorafenib group.
Dr. Arndt Vogel, lead author and professor of medical oncology at the University of Toronto’s UHN-Princess Margaret Cancer Centre, commented that this combination therapy has shown consistent antitumor activity and manageable safety across various stages of hepatocellular carcinoma, both as a standalone treatment and in combination with local therapies. These results underscore its potential as a crucial option in multidisciplinary liver cancer treatment.
In July, Elevar received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the Rivoceranib and Camrelizumab combination as a first-line liver cancer treatment. The CRL cited issues related to the production facility with General Motors. The company is currently working with partners to address these concerns for resubmission.
Kim Dong-geun, Chief Executive Officer (CEO) of Elevar, stated that the clinical data from CARES-310 consistently supports the potential for improved survival with the combination therapy. This additional analysis reaffirms its broad applicability across patient populations. It’s committed to securing FDA approval to offer liver cancer patients this promising new treatment option.