CrystalGenomics' partner seeks FDA nod for camrelizumab drug combo to treat liver cancer
CrystalGenomics said on Thursday that its partner Jiangsu Hengrui Pharmaceuticals submitted a biological license application (BLA) to the FDA on Wednesday for approval of camrelizumab in combination with apatinib as a first-line treatment for liver cancer.
The BLA was submitted through Jiangsu Hengrui Pharmaceuticals U.S. subsidiary Luzsana.
The global phase 3 clinical results of camrelizumab in combination with apatinib showed that the primary endpoints were met. When compared to Nexavar (ingredient: sorafenib), the combination drug displayed a median overall survival (mOS) of 22.1 months versus 15.2 months, a median progression-free survival (mPFS) of 5.6 months versus 3.7 months, and an objective response rate (ORR) of 25.4 percent versus 5.9 percent.
When stratified by primary hepatocellular carcinoma (HCC) etiology, survival benefit was exhibited in patients with both hepatitis B virus (HBV)-associated HCC, which is more prevalent in Asians, and hepatitis C virus (HCV)-associated HCC, which is more prevalent in Westerners.
This demonstrates the broad therapeutic benefit of the drug regardless of geography or etiology, said a company official from Crystal Genomics.
Immune checkpoint inhibitor-antiangiogenesis combination therapy is based on the idea that antiangiogenic drugs can alter the tumor endothelium to improve drug delivery, which can lead to increased infiltration of effector immune cells.
Earlier in February, China became the first country to approve the camrelizumab combination drug as a first-line treatment for liver cancer.
Presently, only PD-L1 inhibitor atezolizumab and VEGFR inhibitor bevacizumab combination and tyrosine kinase inhibitor, sorafenib monotherapy are recommended for the first-line treatment of liver cancer.
"Camrelizumab is now conducting a bridging study in the final step of marketing authorization from the Ministry of Food and Drug Safety for non-small cell lung cancer,” said an official from CrystalGenomics. “We are also considering submitting a BLA in Korea for liver cancer with HLB Life Sciences alongside Jiangsu Hengrui Pharmaceuticals’ BLA submission in the U.S. and plan to strengthen cooperation with them to actively expand Korean clinical trials."