HLB Presents Liver Cancer Clinical Results at ESMO: "Longest Survival and Efficacy Confirmed Across All Ethnicities"

On the 10th (local time), a Q&A session was held following the presentation of the clinical trial results of the combination therapy with Rivoceranib at the European Society for Medical Oncology (ESMO) held in Paris, France. / Photo by HLB

[Asia Economy Reporter Myunghwan Lee] HLB announced on the 13th that its liver cancer treatment drug, 'Rivoceranib,' demonstrated the longest survival period and efficacy across all races in the Phase 3 clinical trial results.

HLB stated that on the 10th (local time), at the European Society for Medical Oncology (ESMO) held in Paris, France, it presented the results of the Phase 3 clinical trial of the combination therapy of Rivoceranib and Camrelizumab. The presentation was delivered by Professor Shu Kui Qin, president of the Chinese Society of Clinical Oncology (CSCO) and a specialist at Nanjing Military Hospital.

Professor Qin gave an oral presentation on the Phase 3 liver cancer trial results conducted since 2019 involving 543 patients worldwide. The clinical results showed that compared to the control group treated with Sorafenib (Nexavar), there were 3 complete responses (CR) versus 1, median overall survival (mOS) was 22.1 months versus 15.2 months, median progression-free survival (mPFS) was 5.6 months versus 3.7 months, and objective response rate (ORR) was 25.4% versus 5.9%. HLB explained that these results confirmed high therapeutic efficacy and safety regardless of race or cause of onset.

HLB stated that these results represent the first clinical data combining a low-molecular-weight anti-angiogenic tyrosine kinase inhibitor (TKI) drug with an immune checkpoint inhibitor (PD-1), showing the longest patient survival period ever recorded for liver cancer treatments, with statistical significance confirmed across all indicators.

The most common Grade 3 or higher adverse events observed were hypertension, elevated liver enzymes, and hand-foot syndrome. However, since the treatment duration was significantly longer than the control group and these side effects were manageable through additional medication or dose adjustments, clinicians including Professor Qin announced that the safety profile was also confirmed.

Professor Ahmed Kaseb, a specialist at the Anderson Cancer Center of the University of Texas who participated in the trial, stated, "Hepatocellular carcinoma is the most difficult-to-treat and has the lowest survival rate among liver cancers," adding, "Rivoceranib and Camrelizumab have shown high potential as new treatments for liver cancer patients worldwide with high unmet needs."

Following the final success of the Rivoceranib combination therapy in liver cancer clinical trials, HLB plans to expedite the FDA and NDA (New Drug Application) procedures. Jin Yang-gon, chairman of HLB, said via YouTube immediately after the ESMO presentation, "The Pre-NDA meeting application was completed last August, and the meeting will be held in October," adding, "We are establishing regional sales strategies for the U.S., Europe, and other markets."

Regarding the composition of clinical trial patients, Chairman Jin explained, "In consultation with the FDA, we increased the proportion of Caucasian patients. Although the number of patients is higher in Asia, the market size in the U.S. accounts for about 40% of the global market, making it the largest."