China-based CStone Pharmaceuticals has commenced two pivotal Phase II trials designed to evaluate the efficacy and safety of CS1001 to treat patients with natural killer cell/T-cell lymphoma and classical Hodgkin’s lymphoma.

The trial is associated with natural killer cell/T-cell lymphoma and named CS1001-201, while the classical Hodgkin’s lymphoma trial is known as CS1001-202.

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CStone has already enrolled and dosed the first patient in both open-label, single-arm trials.

Primary goal of the trials is the objective response rate (ORR) of CS1001. The trials will also investigate the drug’s safety, pharmacokinetics, and immunogenicity.

Both the trials are currently being conducted at various clinical centres across China, including Sun Yat-sen University Cancer Center and Beijing Cancer Hospital.

Results from the studies will be used to support the registration application of CS1001.

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“The clinical development of CS1001 and its future registration will provide an effective therapy and an additional option to patients.”

CStone Pharmaceuticals chief medical officer Dr Jason Yang said: “Natural killer cell/T-cell lymphoma and classical Hodgkin’s lymphoma are relatively rare malignant cancers that affect the blood system, and most patients are young and middle-aged.

“Patients who fail the current standard treatment normally have a very short survival period. As such, there are significant unmet medical needs in these diseases.

“According to recent preclinical and clinical studies, targeting the PD-1/PD-L1 pathways is the most effective way to treat these hematological malignancies. The clinical development of CS1001 and its future registration will provide an effective therapy and an additional option to patients.”

CS1001 is an investigational monoclonal antibody that targets PD-L1.

The fully human, full-length anti-PD-L1 monoclonal antibody has been authorised by US-based Ligand.

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