An additional analysis has shown that HLB's liver cancer combination therapy (rivoceranib + camrelizumab) demonstrates improved survival outcomes regardless of patient age. Notably, progression-free survival (PFS) improvement was confirmed even in hepatocellular carcinoma patients under 40, highlighting the potential to broaden the eligible patient population.

■ Age-Based Post Hoc Analysis of CARES-310 Presented at ILCA 2026

Elevar Therapeutics, HLB's U.S. subsidiary, presented the results of an age-based post hoc analysis of the global Phase 3 CARES-310 study in unresectable hepatocellular carcinoma patients in a poster session at the International Liver Cancer Association's annual conference, 'ILCA 2026.' The conference was held in Brussels, Belgium, from the 3rd to the 5th local time.

■ Survival and Progression-Free Survival Compared by Age Group

The analysis compared the survival benefits of the rivoceranib and camrelizumab combination therapy across different age groups.

△ Under 50: The median overall survival for the combination therapy group was 21.5 months, longer than the comparator sorafenib group (15.2 months). The median progression-free survival also favored the combination group at 5.5 months versus 2.7 months for the sorafenib group.

△ 50 and over: A similar trend continued. The combination group's median overall survival was 23.9 months, exceeding the sorafenib group's 15.2 months, while median progression-free survival was recorded at 6.2 months and 3.7 months, respectively.

△ Under 40: The therapeutic effect of the combination therapy was confirmed even in an analysis isolating younger patients. The combination group's median overall survival was 24.2 months versus 15.2 months for the sorafenib group. Median progression-free survival also differed, at 5.5 months for the combination group and 2.2 months for the sorafenib group.

■ No Major Safety Differences Across Age Groups

The analysis also found no significant safety differences by age. Treatment-related adverse events generally showed similar patterns across age groups; among grade 3-4 severe adverse events, hypertension was relatively more frequently reported with the combination therapy, while hand-foot syndrome was more common in the sorafenib group.

Arndt Vogel, the study's lead researcher and professor of medical oncology at the University of Toronto's UHN-Princess Margaret Cancer Centre, assessed this subgroup analysis as additional evidence suggesting that the therapeutic effect of the rivoceranib and camrelizumab combination is not limited to a specific age group. He also emphasized that the combination therapy has been studied alone or alongside locoregional therapy across multiple stages of hepatocellular carcinoma, consistently demonstrating antitumor activity and a manageable safety profile.

■ U.S. Approval Process Still Ongoing

However, the U.S. approval process is still underway. In July, Elevar received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application for rivoceranib and camrelizumab combination therapy as a first-line liver cancer treatment, citing cGMP issues at a manufacturing facility. Elevar is currently working with its partner on the subsequent procedures needed to resubmit to the FDA.

Accordingly, investor attention is expected to focus not only on additional clinical data but also on the remediation work related to the manufacturing facility, the resubmission timeline, and whether the FDA review will resume.

Dong-Keon Kim, CEO of Elevar, explained that the clinical data obtained from CARES-310 continues to demonstrate the survival improvement potential of the rivoceranib and camrelizumab combination, and that this age-based analysis reconfirmed its therapeutic potential across a broad patient population.

■ Future Key Variable: Progress at the Approval Stage

This presentation is significant in that it re-examined the existing Phase 3 clinical results through the lens of age. In particular, with PFS improvement confirmed even in younger patients, the key variable going forward will be how much progress HLB's liver cancer combination therapy makes at the actual approval stage.

[※ This article is based on information related to clinical trials and drug development by bio and pharmaceutical companies and does not recommend buying or selling specific stocks or guarantee investment returns. Clinical outcomes and approval procedures may change subject to further review and regulatory decisions. Investment decisions and any resulting responsibility rest with the investor. This article was written with AI assistance.]