HLB's Riboceranib NDA Submission Followed by Hansoh Pharmaceutical's Camrelizumab BLA Submission
Combination Therapy First to Exceed 20 Months mOS in Liver Cancer
CrystalGenomics announced on the 1st that its partner, China’s Hansoh Pharmaceutical, submitted a Biologics License Application (BLA) for 'Camrelizumab' to the U.S. Food and Drug Administration (FDA) on the 31st of last month (local time). Camrelizumab is an immuno-oncology drug for which CrystalGenomics holds domestic distribution rights.
Camrelizumab demonstrated efficacy by surpassing 20 months for the first time ever, with a median overall survival (mOS) of 22.1 months in a Phase 3 combination clinical trial with 'Lenvatinib (Apatinib)' presented at the European Society for Medical Oncology (ESMO) last year. In contrast, the mOS for the control group receiving 'Sorafenib' monotherapy was only 15.2 months. Other key indicators such as median progression-free survival (mPFS) and objective response rate (ORR) also showed superiority: mPFS was 5.6 months compared to 3.7 months in the control group, and ORR was 25.4% versus 5.9% in the control group.
When analyzed by major causes of hepatocellular carcinoma, significant survival benefits were observed in patients with hepatitis B virus (HBV)-related liver cancer, which is more prevalent among East Asians, as well as hepatitis C virus (HCV)-related liver cancer, which is more common in Western populations, confirming the treatment’s effectiveness regardless of region or cause of onset.
Meanwhile, Lenvatinib, the targeted anticancer drug partnered with Camrelizumab for first-line liver cancer combination therapy, also submitted a New Drug Application (NDA) to the FDA on the 17th of last month. Unlike Camrelizumab, which is an antibody drug undergoing BLA, Lenvatinib is a synthetic drug proceeding through the NDA process.
The combination therapy of Camrelizumab, a programmed cell death protein 1 (PD-1) immune checkpoint inhibitor, and Lenvatinib, an oral tyrosine kinase inhibitor (TKI) targeting vascular endothelial growth factor receptor (VEGFR)-2, works by modifying tumor endothelium through anti-angiogenic agents to improve drug delivery, thereby increasing infiltration of effector immune cells.
In China, this combination therapy for liver cancer was already approved as a first-line treatment in February. This marks the first combination of a TKI inhibitor and an immune checkpoint inhibitor. Currently, the first-line liver cancer treatment market recommends only the combination therapy of the PD-L1 inhibitor 'Atezolizumab' and the VEGFR inhibitor 'Bevacizumab' or Sorafenib monotherapy.
The combination therapy of Lenvatinib and Camrelizumab has also been proven applicable not only for first-line liver cancer treatment but also for various solid tumors such as germ cell tumors, small cell lung cancer, non-small cell lung cancer, and gastric cancer, with multiple papers published consecutively.
A CrystalGenomics official stated, "Camrelizumab has currently obtained approval for the final stage of clinical trial plans for sales purposes from the Ministry of Food and Drug Safety targeting non-small cell lung cancer, and bridging clinical trials are underway." The official added, "With Hansoh Pharmaceutical submitting the liver cancer product approval application in the U.S., we are discussing submitting the product approval application in Korea together with HLB Life Science." The official further explained, "We plan to actively expand clinical trials in Korea by strengthening cooperation with Hansoh Pharmaceutical."
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