HLB "Lenvatinib Liver Cancer Phase 3 Results Published in Medical Journal 'The Lancet'"

Clinical Results of Lenvatinib and Camrelizumab Combination Therapy

HLB announced on the 25th that the results of the global Phase 3 clinical trial for first-line liver cancer treatment combining rivoceranib, for which it holds global rights, and camrelizumab from Jiangsu Hengrui Medicine, have been published in 'The Lancet,' a medical science journal, marking the first time a domestic company's anticancer drug has been featured.

Phase 3 clinical results of Lenvatinib and Camrelizumab for liver cancer published in The Lancet. [Image provided by HLB]

According to HLB, as of the 24th (local time), detailed results of the Phase 3 liver cancer clinical trial (CARES 310) of the rivoceranib combination therapy were disclosed for the first time on The Lancet's website. Given that rivoceranib's liver cancer clinical results, which recently received FDA's new drug application (NDA) acceptance for full review, have been published in a prestigious medical journal, HLB explained that this would create favorable conditions for the upcoming approval review process.

The Phase 3 liver cancer clinical trial, which began in April 2019, was conducted on 543 patients across 13 countries worldwide, including the United States and China. This trial combined the targeted anticancer drug rivoceranib, which inhibits tumor angiogenesis (VEGFR-2 inhibitor), with the immuno-oncology drug camrelizumab (PD-1 inhibitor), and was conducted in comparison with sorafenib (brand name Nexavar), the then standard first-line treatment for liver cancer.

Clinical results showed that the median overall survival (mOS), the primary efficacy endpoint, was 22.1 months for the rivoceranib group versus 15.2 months for the control group receiving Nexavar (sorafenib). The median progression-free survival (mPFS) was 5.6 months versus 3.7 months. Additionally, the objective response rate (ORR) was 25.4% versus 5.9%, disease control rate (DCR) was 78.3% versus 53.9%, and duration of response (DoR) was 14.8 months versus 9.2 months. All these figures met statistical significance (P<0.0001). Notably, the hazard ratio was 0.62 for overall survival and 0.52 for progression-free survival, indicating a 40-50% reduction in the risk of death for patients.

Based on these results, HLB's U.S. subsidiary Elevar and Jiangsu Hengrui Medicine sequentially submitted the new drug application (NDA) and biologics license application (BLA) in May. The FDA notified Elevar on the 14th of this month of the formal acceptance of the NDA and the commencement of the full review. With the standard review officially underway under the Prescription Drug User Fee Act (PDUFA), HLB expects the approval decision to be made by May 16, 2024, at the latest, within 10 months.

Han Yonghae, Chief Technology Officer (CTO) of HLB Group, stated, "At a time when the FDA approval process is progressing smoothly, having the rivoceranib combination therapy published in The Lancet, the world's leading medical journal, is a remarkable and honorable recognition that reaffirms our drug as a beneficial treatment for liver cancer patients." He added, "Following the praise from global cancer experts at various academic conferences, the attention from the prestigious Lancet suggests that our new drug will become not only the first-line treatment approval for liver cancer but also the best drug."

Meanwhile, according to the Journal Citation Reports (JCR) published annually by Clarivate, an international academic information analysis company, The Lancet has an impact factor of 202.73, making it the most influential professional journal worldwide based on total citation counts and other metrics.

This content was produced with the assistance of AI translation services.