HLB, a Korean anticancer drug developer, has announced the publication of positive results from its global phase 3 trial of rivoceranib in combination with camrelizumab for patients with unresectable hepatocellular carcinoma (HCC) in The Lancet on Monday.

The Lancet is the world’s highest-impact general medical journal.

The global phase-3 study, conducted from June 28, 2019, to March 24, 2021, spanned across 95 sites in 13 countries, including the U.S. and China. It involved 543 patients diagnosed with unresectable or metastatic HCC. 

During the study, the combination of rivoceranib, which targets cancer angiogenesis by inhibiting VEGFR-2, and camrelizumab, an immunotherapy that inhibits PD-1, was compared to sorafenib (brand name: Nexavar), the standard first-line treatment for HCC at the study's onset.

The results demonstrated significant advantages for the combo therapy group. The median overall survival (mOS), which was the primary endpoint, was found to be 22.1 months in the combo therapy group, compared to 15.2 months in the sorafenib group. The median progression-free survival (mPFS) was 5.6 months for the combo therapy group, in contrast to 3.7 months for the control group. Moreover, the objective response rates (ORR) were 25.4 percent for the combo therapy, and only 5.9 percent for the sorafenib group. The disease control rate (DCR) was 78.3 percent for the combo therapy, compared to 53.9 percent in the sorafenib group. Additionally, the duration of response (DoR) was significantly longer in the combo therapy group, with 14.8 months, compared to 9.2 months in the sorafenib group.

Of particular note, the combination of rivoceranib and camrelizumab showed a harzard ratio of 0.62 in OS and 0.52 in PFS, indicating a 40-50 percent reduction in the risk of death for patients, HLB said.

Based on these results, HLB's U.S. subsidiary, Elevar Therapeutics, and Chinese company Jiangsu Hengrui Pharmaceuticals submitted New Drug Application (NDA) and Biologics License Application (BLA), respectively, in May. 

The U.S. FDA has recently informed Elevar Therapeutics about the formal acceptance of the NDA and initiation of a full review process. 

HLB expects the FDA's decision on the approval of rivoceranib within the next 10 months, with an estimated timeline set by May 16, 2024, at the latest.

In preparation for potential approval, Elevar Therapeutics and Jiangsu Hengrui Pharmaceuticals are preparing to receive the Chemistry Manufacturing and Controls (CMC) inspection.