CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines.
Today announced that the results from multiple clinical trials of anti-PD-L1 antibody sugemalimab (CS1001) and anti-PD-1 antibody nofazinlimab (CS1003) will be presented at the 2022
American Society of Clinical Oncology (ASCO) Annual Meeting, including an oral presentation of the primary analysis of GEMSTONE-201 study of sugemalimab treating patients with relapsed or refractory extranodal natural killer cell/T-cell lymphoma (R/R ENKTL), and a poster presentation of the pre-specified overall survival results from the registrational GEMSTONE-302 study of sugemalimab for the first-line stage IV non-small cell lung cancer (NSCLC).
In addition, CStone the updated results from the phase 1b study of anti-PD-1 antibody nofazinlimab combined with lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma (uHCC) will be presented via online publication. The ASCO Annual Meeting will be held on June 3-7, 2022.
Results from CStone GEMSTONE-201 study of sugemalimab, the first successful registrational clinical study to date evaluating an anti-PD-(L)1 antibody targeting patients with relapsed or refractory extranodal natural killer/T-cell lymphoma, will be presented in an oral abstract session.
The protocol pre-specified interim overall survival analysis results from GEMSTONE-302 study of sugemalimab will be presented in a poster session.
In addition, Sugemalimab is the world’s first anti-PD-L1 monoclonal antibody. To improve overall survival when administered with chemotherapy for patients. With first-line stage IV squamous and non-squamous non-small cell lung cancer.
The updated results from the phase 1b study of nofazinlimab combined with lenvatinib as first-line treatment in Chinese patients with unresectable hepatocellular carcinoma was selected for online publication
CStone’s presentations at 2022 ASCO annual meeting:
Session title: Unresectable HCC Session Date and Time: June 3-7, 2022. CDT Session Type: online publication only Abstract Title: Updated efficacy and safety results from a phase 1b study of the PD-1 antagonist CS1003 combined with lenvatinib (LEN) as first-line (1L) treatment in Chinese patients (pts) with unresectable hepatocellular carcinoma (uHCC).
Abstract Number for Publication: e16191Presenter: Dr. Lin Shen, Peking University Cancer Hospital
About the GEMSTONE-201 study
The GEMSTONE-201 study is a single-arm, multicenter, Phase 2 pivotal study. Designed to evaluate the efficacy and safety of sugemalimab as monotherapy for the treatment of adult patients with R/R ENKTL.
Based on the encouraging preliminary efficacy results. sugemalimab has been granted the Orphan Drug Designation and Breakthrough Therapy Designation by the U.S. FDA for the treatment of T-cell lymphoma and adults with R/R ENKTL respectively.
It has also been granted BTD by the National Medical Products Administration of China. The study includes investigational sites in both China and the U.S. In January 2022, the GEMSTONE-201 study, as assessed by the Independent Radiology Review Committee, met its pre-specified primary endpoint.
About the GEMSTONE-302 study
The GEMSTONE-302 study is a randomized, double-blind Phase 3 study, designed to evaluate the efficacy and safety of sugemalimab in combination with chemotherapy as a first-line treatment for patients with stage IV NSCLC as compared to placebo in combination with chemotherapy.
The primary endpoint of the study was investigator-assessed progression-free survival (PFS). Secondary endpoints included OS, BICR-assessed PFS and safety.
In August 2020, the GEMSTONE-302 study met its primary endpoint of significantly prolonged progression-free survival, with a favorable safety profile and no new safety signals, as compared to placebo combined with chemotherapy, as assessed by the independent data monitoring committee at the planned interim analysis.
PFS data were presented in a Proffered Paper Oral Presentation (Late-Breaking Abstract) at ESMO Asia 2020. In July 2021, the final analysis of PFS from the GEMSTONE-302 study showed that sugemalimab in combination with chemotherapy demonstrated continuous improvement in PFS, with the risk of disease progression or death reduced by 52%, together with a trend toward improved OS.
Data were presented in a Mini Oral Presentation (Late-Breaking Abstract) at the IASLC 2021 World Conference on Lung Cancer. The results of the GEMSTONE-302 study were published in The Lancet Oncology in January 2022.
In January 2022, the GEMSTONE-302 study met the overall survival endpoint.
Based on the results from the GEMSTONE-302 study, the NMPA of China has approved sugemalimab (Cejemly®) in combination with pemetrexed and carboplatin as first-line treatment of patients with metastatic non-squamous NSCLC, lacking EGFR and ALK genomic tumor aberrations; and in combination with paclitaxel and carboplatin as first-line treatment of patients with metastatic squamous NSCLC.
About CS1003-102 study
Nofazinlimab is a humanized recombinant IgG4 monoclonal antibody targeting human programmed cell death protein 1 (PD-1) being developed in solid tumors.
Nofazinlimab shows comparable high binding affinities to the PD-1 of humans, cynomolgus monkey, and mouse, and can block the interaction of PD-1 with its ligands PD-L1 and PD-L2.
The U.S. FDA has granted nofazinlimab Orphan Drug Designation in July 2020 for the treatment of patients with HCC.
CS1003-102 is a phase Ia/Ib, open-label, multi-center, dose-escalation and expansion study conducted in China.
The primary objectives of Arm 5 of phase Ib was to evaluate the preliminary anti-tumor activity of nofazinlimab in combination with lenvatinib in first-line treatment of uHCC in China, the primary endpoint was objective response rate (ORR) per RECIST V1.1 by investigators.
CS1003-305 is an international, multi-center, double-blind, randomized, phase 3 registrational clinical trial to evaluate the efficacy and safety of nofazilimab in combination with lenvatinib compared with placebo in combination with lenvatinib in subjects with no prior systemic treatment and with unresectable advanced HCC.
The primary endpoints are overall survival and progression-free survival. Dr. Jia Fan, academician of Chinese Academy of Sciences and president of Zhongshan Hospital affiliated to Fudan University, is the global principal investigator for this trial. In March 2022, the CS1003-305 study had successfully reached its prespecified enrollment target.