SUZHOU, China, Dec. 10, 2019 /PRNewswire/ -- CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) updated results from the CS1001-201 trial in a poster presentation at the 2019 American Society of Hematology (ASH) Annual Meeting.
CS1001-201 trial is a single-arm, multicenter Phase II clinical study designed to evaluate CS1001 monotherapy in relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (rr-ENKTL).
ENKTL is a subtype of mature T cell and NK cell lymphoma. It has a higher incidence in Asia than in Europe or North America. ENKTL is characterized by its rapid progression and poor prognosis. Currently, patients with rr-ENKTL lack effective treatment after failing an L-asparaginase-based combination chemotherapy regimen and targeted monotherapy only produces a complete response (CR) rate of below 10%.
"ENKTL accounts for approximately 6% of all lymphoma incidences, and there are vast unmet medical needs in this patient population that has failed the first-line treatment," said Dr. Frank Jiang, Chief Executive Officer and Chairman of CStone. "The CS1001-201 trial is the first clinical study of an anti-PD-L1 antibody in ENKTL worldwide. Our latest data have shown CS1001 to be well-tolerated with preliminary antitumor efficacy and survival benefit in rr-ENKTL patients. We will continue to advance this development program and hope that CS1001 will soon become a new treatment option for rr-ENKTL patients."
"CR is a critical outcome measure for the treatment of ENKTL. Studies have shown that ENKTL patients who achieved CR prior to autologous transplantations have a significantly better prognosis and longer survival than those who achieved partial response," said Dr. Jason Yang, Chief Medical Officer of CStone. "These latest results of CS1001 demonstrated a CR rate of 33.3% with durable response, an objective response rate of 43.3%, and a 1-year overall survival rate of 72.4%. These results represent a major breakthrough compared to current treatment options and support CS1001 as a potential conditioning regimen for hematopoietic stem cell transplantations."
Overview of the CS1001-201 trial
CS1001-201 is a single-arm, multicenter Phase II clinical study designed to evaluate CS1001 monotherapy in relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (rr-ENKTL).
Results reported in the poster at the 2019 ASH Annual Meeting
As of October 8, 2019, 32 patients were enrolled in the study. Among them, 24 patients (75.0%) had Stage IV ENKTL at screening, 9 patients (28.1%) received 2 lines of prior treatments, and 7 patients (21.9%) received 3 or more lines of prior treatments. All patients received 1200 mg CS1001 intravenously every 3 weeks for up to 2 years, until disease progression, intolerance, etc. The median duration of follow-up was 6.54 months (range, 0.72-15.64).
Preliminary efficacy data
CS1001 demonstrated promising antitumor activity and a favorable CR rate with durable response and survival benefit in rr-ENKTL patients.
Safety data
CS1001 was well tolerated in patients with rr-ENKTL
About CS1001
CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S. based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 is similar to natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities, potentially representing a unique advantage over similar drugs.
CS1001 has completed a Phase I dose-escalation study in China, in which CS1001 showed good tolerability and produced sustained clinical benefits during the Phase Ia study.
CS1001 is being investigated in a number of ongoing clinical trials, including one Phase I bridging study in the U.S. In China, its clinical program includes one multi-arm Phase Ib study, two pivotal Phase II studies, and three Phase III studies for several tumor types.
About CStone
CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and molecularly-targeted drugs to address unmet medical needs for cancer patients in China and worldwide. Since the Company's inception in 2015, CStone has assembled a world-class management team that has a full spectrum of complementary skillsets from preclinical research to clinical development and commercialization. With combination therapies as a core strategy, the Company has built a rich oncology pipeline of 15 oncology drug candidates. Currently, five late-stage drug candidates are at or near pivotal trials. With an experienced team, a rich pipeline, a robust clinical development-driven business model, and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative and differentiated oncology therapies to cancer patients worldwide.
For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com
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