pharm edaily

[Kim Jin-soo, Edaily Reporter] HLB announced on Feb. 27 that its liver cancer drug, the Rivoceranib + Camrelizumab combination therapy, has been listed as a first-line treatment in the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the Diagnosis, Treatment, and Follow-up of Hepatocellular Carcinoma (HCC). The guideline strongly recommends prescribing this therapy.

The ESMO guideline, published by its hepatology division, provides comprehensive information on cancer diagnosis, treatment, and follow-up management. Alongside the National Comprehensive Cancer Network (NCCN) guidelines, it is widely used by physicians worldwide for patient treatment decisions.

It is highly unusual for a drug that has not yet received regulatory approval to be recommended for prescription in clinical settings.

The latest edition of this guideline, revised for the first time in three years since 2022, highlights Rivoceranib + Camrelizumab as the first-ever combination of a VEGFR-TKI angiogenesis inhibitor and an anti-PD-1 immunotherapy to demonstrate significant therapeutic efficacy. The guideline also includes key clinical data, noting the treatment’s median overall survival (mOS) of 23.8 months, the longest ever recorded in this field.

The guideline classifies the clinical evidence supporting Rivoceranib + Camrelizumab as “Level of Evidence I,” the highest rating. It strongly recommends this combination as a first-line treatment for liver cancer patients with relatively preserved liver function.

Additionally, the guideline also recommends other first-line therapies, including Bevacizumab + Atezolizumab and Durvalumab + Tremelimumab. However, it specifies that patients with a history or risk of gastrointestinal (GI) bleeding undergoing Bevacizumab-based therapy must undergo screening procedures beforehand. This reflects the necessity of conducting endoscopic examinations before prescribing Bevacizumab due to its high risk of causing GI bleeding.

Since Rivoceranib + Camrelizumab is a combination of an angiogenesis inhibitor and an immune checkpoint inhibitor, similar to Bevacizumab + Atezolizumab, but without the risk of GI bleeding, it is expected to quickly gain market share upon approval as a first-line treatment.

Han Yong-hae, chief technology officer of HLB Group, stated “With regulatory approval imminent, ESMO’s strong recommendation for Rivoceranib + Camrelizumab as a first-line liver cancer treatment signifies that HLB’s therapy has been internationally recognized as a standard treatment. This is a positive signal not only for obtaining EMA and FDA approvals but also for its inclusion in the NCCN guidelines.”