2019 CSCO| CStone announces promising ORR, anti-tumor activity and safety data with its anti-PD-L1 antibody CS1001 in MSI-H/dMMR solid tumors
2019 CSCO| CStone announces promising ORR, anti-tumor activity and safety data with its anti-PD-L1 antibody CS1001 in MSI-H/dMMR solid tumors |
[22-September-2019] |
SUZHOU, China, Sept. 22, 2019 /PRNewswire/ -- CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) today announced results from the microsatellite instability high/deficient mismatch repair (MSI-H/dMMR) solid tumor cohort in the GEMSTONE-101 Phase Ib study of the Company's investigational anti-PD-L1 antibody CS1001 for the first time in an oral presentation at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (CSCO, 2019 CSCO Annual Meeting). The objectives of the MSI-H/dMMR cohort study were to assess CS1001's preliminary anti-tumor efficacy as a second-line or later monotherapy, and to further evaluate the safety and tolerability of CS1001. Microsatellites (MS) are repetitive genetic sequences consisting of repeated DNA motifs. Defective DNA mismatch repair pathway causes instability in the length of DNA motifs, resulting in a phenomenon that is called microsatellite instability (MSI). MSIâ€H indicates a high level of MSI, which is predictive of the loss of mismatch repair function and the possible presence of a large amount of mutation-derived tumor antigens that produce good responses to immunotherapies. Published data suggests MSI-H/dMMR is most common in patients with endometrial cancer, gastric adenocarcinoma, malignant small intestine tumor, and colorectal adenocarcinoma. Professor Lin Shen, Vice President of Beijing Cancer Hospital, and the presenter of the results, commented: "Preliminary efficacy data from this study cohort indicates CS1001's promising anti-tumor activity in patients with MSI-H/dMMR solid tumors. Also shown in the results are CS1001's good safety and tolerability." Dr. Frank Jiang, Chairman and CEO of CStone, commented: "I am pleased that CS1001, our core PD-L1 drug candidate, has achieved favorable preliminary results in this MSI-H/dMMR study cohort. At present, no PD-L1 inhibitor has been approved worldwide for the treatment of this type of solid tumors. We hope in future studies CS1001 will demonstrate its therapeutic potential in more tumor types and become the most rapidly developed immuno-oncology drug for MSI-H/dMMR solid tumors." CStone's Chief Medical Officer, Dr. Jason Yang, noted: "In view of the good responses to immunotherapies in MSI-H/dMMR solid tumors, effective immuno-oncology treatments will hopefully bring survival benefits to such patient population. The results from this study has shown CS1001's therapeutic potential, and its 38% overall response rate (ORR), with 28.6% confirmed, in these heavily pretreated patients is remarkable compared to some of the approved PD-1 drugs. CS1001 is the monoclonal antibody that most closely mirrors natural G-type immune globulin 4 (IgG4) human antibody, which hopefully can lead to the demonstration of its unique safety advantage in subsequent clinical studies." Overview of the MSIâ€H/dMMR cohort of the GEMSTONE-101 Phase Ib ≥2L study Demographics and baseline characteristics
Preliminary efficacy data
Safety data CS1001 has shown a good safety profile
About CS1001 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 stage of the 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 For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com Forward-looking Statement SOURCE CStone Pharmaceuticals | ||
Company Codes: HongKong:2616 |
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