HLB's 'Rivoceranib' Demonstrates Longest Survival Period in Liver Cancer Treatment Success

Phase 3 Trial of Camrelizumab Combination, ESMO Abstract Released
mOS 22.1 Months... Surpassing Tecentriq and Avastin at 19.2 Months
Likely to Establish as 'Best in Class' First-Line Therapy

[Asia Economy Reporter Lee Chun-hee] HLB's anticancer new drug 'Rivoceranib' has successfully proven effects surpassing existing treatments. In the camrelizumab combination therapy, the key efficacy measure, overall survival (OS), confirmed the longest OS among all first-line treatment results published so far.

On the 8th (local time), the abstract of the Phase 3 clinical trial results of Rivoceranib combined with Hansoh Pharmaceutical's 'Camrelizumab' for unresectable hepatocellular carcinoma (uHCC) was released at the European Society for Medical Oncology (ESMO). These results are scheduled to be presented at the ESMO upper gastrointestinal session on the 10th at 8:40 a.m. (local time).

This clinical trial was conducted by setting the Rivoceranib and Camrelizumab combination group alongside the existing treatment group receiving 'Lenvax (generic name Sorafenib)' as the control group. It was a global trial involving 543 patients across 13 countries including the United States, Europe, and Asia, starting from June 2019.

The most critical measure, median overall survival (mOS), was 22.1 months, demonstrating improved efficacy compared to existing treatments. Following the Phase 2 first-line treatment cohort result of 20.3 months, this trial succeeded in proving an even higher mOS. The conventional standard treatments for first-line liver cancer have been Bayer's Nexavar and Eisai's 'Lenvima (generic name Lenvatinib)', with OS around 12 to 13 months. Recently, Roche's combination therapy of 'Tecentriq (generic name Atezolizumab)' and 'Avastin (generic name Bevacizumab)' has emerged as a standard treatment with a result of 19.2 months. However, since Rivoceranib has succeeded in surpassing these results, expectations are rising that it will establish itself as the 'best-in-class' drug in the liver cancer treatment market.

Besides OS, other key endpoints in anticancer drug trials such as progression-free survival (PFS) and objective response rate (ORR) also showed higher efficacy than the control group. PFS refers to the time from the start of drug treatment until the first confirmation of disease progression. The median PFS (mPFS) was 5.6 months, exceeding the control group's 3.7 months, and the ORR was 25.4%, higher than the control group's 5.9%. However, mPFS and ORR were slightly lower compared to Phase 2 results of 5.7 months and 34%, and also lower than the Tecentriq and Avastin combination therapy's 6.8 months and 29.8%, respectively.

The hazard ratio was 0.62 for overall survival and 0.52 for progression-free survival, reducing the risk of death by approximately 40-50%. These are the best figures compared to clinical results of existing drugs. Side effects such as hypertension and hand-foot syndrome, commonly observed signs, appeared but seem manageable with drug treatment.

On the other hand, liver cancer treatments whose abstracts were also released that day did not reveal any significant achievements. The combination therapy of 'Keytruda (generic name Pembrolizumab)' and Lenvima by MSD and Eisai, as well as Novartis's 'Tislelizumab', either failed to meet efficacy endpoints or only demonstrated non-inferiority compared to existing treatments.

MSD and Eisai conducted a Phase 3 trial comparing Keytruda and Lenvima combination therapy to Lenvima monotherapy for advanced hepatocellular carcinoma (aHCC), but failed to achieve statistical significance for both OS and PFS endpoints. However, they reported effects such as mOS of 21.2 months, mPFS of 8.2 months, and ORR of 26.1%, describing it as "the longest median OS reported in a Phase 3 study."

Tislelizumab succeeded in proving non-inferiority against Nexavar as the control group for uHCC. However, with an mOS of 15.9 months in the treatment group compared to 14.1 months in the control group, it is difficult to consider this an innovative achievement.

HLB is also proceeding with regulatory approval procedures for the new drug alongside the ESMO announcement. Last month, they submitted a Pre-NDA (Pre-New Drug Application) to the U.S. Food and Drug Administration (FDA). Since both Rivoceranib and Camrelizumab have been designated as orphan drugs in the U.S., the NDA process is expected to proceed relatively quickly.

Jang In-geun, Vice President of the Bio Strategy Planning Division, stated, "Liver cancer is a very difficult-to-treat refractory disease, ranking sixth in incidence among all cancer types, but with a 5-year survival rate of about 38%, which is half the average for all cancers. Therefore, the development of innovative treatments for patients under various conditions is an urgent area." He added, "Since the clinical trial confirmed a high response rate along with a breakthrough improvement in patient survival, we will do our best to obtain early new drug approval."

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