CStone Pharmaceuticals Announces that the International Multicenter Registration Study of PD-1 Antibody Nofazinlimab Combined with Lenvatinib in First-Line Treatment of Advanced Hepatocellular Carcinoma Successfully Achieved the Predefined Patient Enrollment Target

CStone Pharmaceuticals (Hong Kong Stock Exchange: 2616) recently announced that its PD-1 antibody nofazinlimab (CS1003) combined with lenvatinib in the first-line treatment of patients with advanced hepatocellular carcinoma (HCC) is an international multicenter Phase III registrational study CS1003- 305 The pre-set patient enrollment target was successfully achieved
.
Dr.
Jianxin Yang, Chief Medical Officer of CStone, said: "We are pleased to see that the CS1003-305 study successfully achieved the pre-set patient enrollment target ahead of schedule.
, CStone recently completed the third large-scale registration study with pre-set enrollment targets in high-incidence tumors of the digestive tract
.
Early clinical data showed that [1], nofazinlimab combined with lenvatinib has achieved excellent efficacy and good efficacy in patients with advanced HCC.
The
U.
S.
FDA granted orphan drug designation for nofazinlimab for the treatment of HCC in 2020.

We look forward to the results of the CS1003-305 study to provide better treatment options for advanced HCC patients worldwide
.
” The CS1003-305 study is an international A multicenter, double-blind, randomized controlled Phase III registration study with 74 sites worldwide to evaluate the safety and efficacy of nofazinlimab plus lenvatinib versus placebo plus lenvatinib in first-line treatment of patients with advanced HCC.
effectiveness
.
The primary endpoints were overall survival (OS) and progression-free survival (PFS)
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Academician Fan Jia, academician of the Chinese Academy of Sciences and president of Zhongshan Hospital affiliated to Fudan University, served as the global principal investigator of the study
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The study design of the CS1003-305 study was based on the excellent data from the CS1003-102 study
.
The CS1003-102 study[1] (NCT03809767) is a multicenter, open-label, dose-escalation and indication-expansion Phase I study in China.
The Phase Ib part of the fifth arm of the study was designed to evaluate nofazinlimab in combination with lenvatinib Safety and efficacy of first-line therapy in Chinese patients with unresectable hepatocellular carcinoma (uHCC)
.
The primary endpoint of the study was the objective response rate (ORR) assessed by investigators based on RECIST V1.
1
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As of June 22, 2020, a total of 20 patients were enrolled and treated
.
The majority of enrolled patients were male (90%), had an ECOG status score of 1 (75%), BCLC stage C HCC (90%), and 65% had HBV infection
.
Nofazinlimab combined with lenvatinib achieved excellent efficacy and favorable safety results: 20 patients were included in the efficacy analysis set, and the ORR reached 40% (8/20)
.
The median follow-up time was 6.
2 months, and the median PFS was 8.
4 months
.
As of the data cutoff date, the median OS has not been reached, and the median time to response has not been reached
.
Twenty patients were included in the safety analysis set
.
The most common treatment-related adverse events were increased blood bilirubin, positive urine protein, and proteinuria
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One grade 3 treatment-related adverse event occurred in each of the five patients, including hypertension, increased conjugated bilirubin, diarrhea, diabetes, and hypophosphatemia
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No patients experienced grade 4 or higher treatment-related adverse events
.
About Hepatocellular Carcinoma (HCC) Liver cancer is a common malignant tumor of the digestive system worldwide.
According to the "Global Cancer Epidemiological Statistics (GLOBOCAN) 2020" published by the International Institute for Cancer Research (IARC) of the World Health Organization, in 2020, the number of The number of people newly diagnosed with liver cancer exceeds 900,000, and the number of deaths due to liver cancer exceeds 830,000, and the number of deaths is close to the number of new cases
.
The main pathological type of liver cancer is hepatocellular carcinoma, accounting for about 75% to 85%
.
Due to the insidious onset of liver cancer, less than 30% of liver cancer patients are suitable for radical treatment at the first diagnosis.
Systemic anti-tumor therapy plays an important role in the treatment of advanced liver cancer [2]
.
In general, advanced HCC patients have rapid disease progression and poor prognosis, with a 5-year survival rate of only 12.
1% [3]
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About nofazinlimab (CS1003) Nofazinlimab is a humanized recombinant IgG4 monoclonal antibody targeting human programmed cell death protein 1 (PD-1), which is being developed for the immunotherapy of tumors
.
Nofazinlimab has high affinity for human, cynomolgus and mouse PD-1, and blocks the interaction of PD-1 with PD-L1 and PD-L2 ligands
.
Nofazinlimab was granted Orphan Drug Designation (ODD) by the U.
S.
Food and Drug Administration (FDA) in July 2020 for the treatment of hepatocellular carcinoma
.
CStone has reached a strategic cooperation with EQRx, an American company, to exclusively authorize EQRx to develop and commercialize two tumor immunotherapy drugs, sugelimab and nofazinlimab, outside of Greater China
.
CStone will retain the development and commercialization rights for nofazinlimab in Greater China, and will continue to explore its development prospects as a single-agent and combination therapy backbone product
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About CStone CStone (SEHK: 2616) is a biopharmaceutical company focused on the research, development and commercialization of innovative immuno-oncology and precision medicines to meet the high medical needs of cancer patients in China and around the world
.
Founded at the end of 2015, CStone has assembled a world-class management team with extensive experience in new drug R&D, clinical research and commercial operations
.
With tumor immunotherapy combination therapy as the core, the company has established a rich product pipeline consisting of 15 tumor candidates
.
At present, CStone has obtained approvals for seven new drug marketing applications for four innovative drugs
.
Several late-stage drug candidates are in pivotal clinical trials or registration stages
.
CStone's vision is to become a world-renowned biopharmaceutical company leading the way in the fight against cancer
.