November 30, 2024

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Logo of HLB (HLB)

HLB’s precision cancer drug Rivoceranib has demonstrated the world’s longest median overall survival, or mOS, in phase 3 clinical trials of liver cancer, the South Korean biopharmaceutical company said Thursday.

According to HLB, Rivoceranib’s mOS recorded 22.1 months to mark the first drug in the world to break the 20-month barrier against liver cancer.

The company earlier released the abstract of phase 3 concomitant clinical trials of Rivoceranib and anticancer drug Camrelizumab, a day before the start of the European Society for Medical Oncology scheduled to take place in Paris from Friday through Tuesday.

HLB said Rivoceranib also displayed superior data in median progression free survival, overall response rate, disease control rate and duration of response when compared to the control group, indicating the clinical trials’ statistical significance.

According to HLB, Rivoceranib’s hazard ratio showed that the death risk of patients was reduced by 40 to 50 percent. It marked the safest test results so far in comparison to previously approved anticancer drugs’ clinical trial numbers, the company said.

The phase 3 concomitant clinical trials of Rivoceranib was approved by the US Food and Drug Administration. The testing was conducted on 543 patients in 13 countries including the US, Europe, China and South Korea.

In order to obtain FDA’s new drug approval for Rivoceranib, HLB applied for a pre-New Drug Application meeting with the FDA last month. The company expects the meeting to take place before mid-October.

“Liver cancer is an intractable disease that is very difficult to develop treatments for. The incidence rate is the sixth-highest among all cancers, while the five-year survival rate is only 38 percent, about half of the total cancer patients’ average. This makes (liver cancer research) a field where we need to urgently develop innovative treatments to treat patients under various conditions,” said Jang In-keun, vice president of the Bio Strategic Planning division at HLB.

“As the clinical results of Rivoceranib have confirmed that the patient’s survival period has improved dramatically along with the high response rate, we will do our best to obtain new drug approval early.”

By Kan Hyeong-woo (hwkan@heraldcorp.com)