ASH 2019 | CStone's anti-PD-L1 antibody demonstrates a complete response rate of 31.8% in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma

SUZHOU, China, Nov. 7, 2019 /PRNewswire/ -- CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) today announced that an abstract on the CS1001-201 trial (Abstract #2833) was accepted by the 2019 American Society of Hematology (ASH) Annual Meeting and has been published online yesterday on the meeting's official website. Additionally, the Company will release further updated data from the CS1001-201 trial in a poster presentation at the conference.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). The primary endpoint of the trial is objective response rate (ORR)A assessed by an independent radiological review committee (IRRC); the secondary endpoints include investigator-assessed ORR, IRRC-assessed complete and partial response (CR, PR) rates, time to response, duration of response, progression-free survival, overall survival, and safety.ENKTL is a subtype of mature T cell and NK cell lymphoma, with a higher incidence in Asia than in Europe or North America. ENKTL is an aggressive malignancy characterized by its rapid progression and poor prognosis. Patients with rr-ENKTL lack effective standard treatment after failing an L-asparaginase-based combination chemotherapy regimen. Studies to date have shown that Epstein-Barr virus (EBV) infection is linked to the pathogenic mechanisms of ENKTL, as EBV infection induces immune tolerance by upgrading PD-L1 expression in tumor cells, thus promoting tumor growth."In China, ENKTL accounts for approximately 6% of all lymphoma incidences, and those relapsed or refractory patients in particular have urgent unmet clinical needs. CS1001-201 is the first clinical trial worldwide investigating an anti-PD-L1 antibody in ENKTL patients, and promising initial antitumor activity has already been observed in the trial," said Dr. Frank Jiang, Chairman and CEO of CStone. "I am glad that the preliminary results from this trial will be announced for the first time at the 2019 ASH Annual Meeting. CStone remains committed to addressing treatment gaps in China and around the world. We hope this trial will continue its rapid progress and soon produce more breakthroughs in the treatment of ENKTL."CStone's Chief Medical Officer, Dr. Jason Yang, noted: "The close association between ENKTL and the increased PD-L1 expression resulted by EBV infection suggests that blocking the PD-1/PD-L1 pathway could be an effective treatment for ENKTL patients. In the abstract published by ASH, CS1001 demonstrated an ORR of 40.9%, a complete and durable response rate of 31.8% and a benign safety profile. These results represent a major breakthrough in the treatment of rr-ENKTL and support the further development of CS1001 as a treatment for rr-ENKTL. We look forward to sharing encouraging additional data updates in the poster presentation at the 2019 ASH Annual Meeting."
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