HLB's liver cancer drug combination of Riboceranib and Camrelizumab has demonstrated consistent treatment efficacy across all age groups. The therapy showed improved progression-free survival (PFS) even in younger liver cancer patients under 40, reaffirming its potential for a broad patient population.
HLB's U.S. subsidiary Elevate Therapeutics announced on September 1 that it will present the results of a post-hoc analysis by age from the global Phase 3 trial 'CARES-310' for patients with unresectable hepatocellular carcinoma (uHCC) at the International Liver Cancer Association's annual conference (ILCA 2026) in Brussels, Belgium, from September 3 to 5.
The age-based analysis revealed that the median overall survival (mOS) for patients under 50 was 21.5 months, compared to 15.2 months for the sorafenib group. The median PFS (mPFS) was also improved at 5.5 months versus 2.7 months in the sorafenib group. For patients aged 50 and older, the mOS was 23.9 months compared to 15.2 months, and the mPFS was 6.2 months versus 3.7 months, confirming the treatment's efficacy.
Similar results were observed in the cohort of patients under 40, where the mOS was 24.2 months, significantly longer than the 15.2 months in the sorafenib group, and the mPFS was 5.5 months compared to 2.2 months in the sorafenib group.
Safety profiles showed no significant differences across age groups. Treatment-related adverse events (TRAEs) were similar across age ranges, with the most common grade 3-4 TRAEs being hypertension in the combination group and hand-foot syndrome in the sorafenib group.
Arndt Vogel, a professor of medical oncology at the University Health Network-Princess Margaret Cancer Centre in Toronto and the study's lead author, stated, "This age-based subgroup analysis provides additional evidence that the combination of Camrelizumab and Riboceranib may improve treatment outcomes for liver cancer patients across various age groups, supporting its potential as an important treatment option in multidisciplinary liver cancer care."
In July, Elevate received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Riboceranib and Camrelizumab as a first-line treatment for liver cancer, due to issues related to current Good Manufacturing Practice (cGMP) at its production facility. The company is currently working with its partners on the resubmission process to the FDA.
Dong-geun Kim, CEO of Elevate, remarked, "With this additional analysis confirming treatment potential across a broad patient population, we will do our utmost to provide new treatment options for hepatocellular carcinoma patients through FDA approval."
Meanwhile, HLB Group announced last month the launch of a new group identity (GI) and declared the 'HLB WAY,' which embodies the values and principles the group pursues. The HLB WAY emphasizes a spirit of challenge that is unafraid of failure, turning new possibilities into reality, connecting people, technology, affiliates, and industries to create greater value, and expanding this to a wider world to realize 'Human Life Better.'
* This article has been translated by AI.
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