Suzhou, China, September 14th, 2024---CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced the presentation of long-term treatment and survival data for sugemalimab in combination with platinum-based chemotherapy from the GEMSTONE-302 study at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting.
GEMSTONE-302 study is a multicenter, randomized, double-blind phase 3 trial evaluating the efficacy and safety of sugemalimab in combination with platinum-based chemotherapy as a first-line treatment for patients with Stage IV non-small cell lung cancer (NSCLC) versus placebo in combination with platinum-based chemotherapy. The primary endpoint was investigator-assessed progression-free survival (PFS). Key secondary endpoints included overall survival (OS), PFS assessed by blinded independent central review (BICR), PFS in patients with PD-L1 expression ≥1% as assessed by investigators, objective response rate (ORR), duration of response (DoR), and safety.
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, said, “Following the recent European Commission's approval based on the predefined PFS and OS analyses in the GEMSTONE-302 study, the four-year follow-up data presented at ESMO further confirmed the significant long-term benefit of sugemalimab combined with platinum-based chemotherapy as a first-line treatment of Stage IV NSCLC. These data demonstrate sugemalimab's potential to significantly improve patient outcomes on a global scale. We plan to continue expanding patient access to this important treatment globally and dedicateing to addressing unmet medical needs.”
Professor Caicun Zhou from East Hospital, Tongji University, the Principal Investigator of the GEMSTONE-302 study, commented, “The primary goal of the first-line treatment for advanced lung cancer is to maximally improve a patient's long-term survival benefit. The results of the GEMSTONE-302 study have confirmed the long-term clinical benefits of sugemalimab combined with platinum-based chemotherapy in first-line Stage IV NSCLC, with the extension of patient survival and the quality-of-life improvement. Sugemalimab combination treatment also significantly extended the PFS and OS of patients with brain metastases, highlighting the benefit of sugemalimab regimen to patients with high-risk NSCLC. We expect this regimen will become one of preferred immunotherapy options for NSCLC.”
The detailed data from the GEMSTONE-302 study presented at this ESMO are as follows:
ITT N=479 |
TPS≥1% n=291 |
TPS<1% n=188 |
TPS 1-49% n=140 |
TPS≥50% n=151 |
sq-NSCLC n=192 |
nsq-NSCLC n=287 |
|
OS HR (95% CI) |
0.68 (0.54, 0.85) |
0.63 (0.47, 0.85) |
0.75 (0.53, 1.08) |
0.68 (0.45, 1.04) |
0.58 (0.38, 0.89) |
0.61 (0.43, 0.87) |
0.72 (0.53, 0.98) |
4-y OS rate, % a |
32.1 vs 17.3 |
37.7 vs 17.4 |
23.2 vs 16.6 |
29.3 vs NE |
45.3 vs 20.1 |
27.6 vs 11.7 |
35.5 vs 20.2 |
PFS HR (95% CI) b |
0.49 (0.39, 0.60) |
0.46 (0.35, 0.60) |
0.58 (0.42, 0.80) |
0.52 (0.36, 0.75) |
0.41 (0.28, 0.60) |
0.37 (0.26, 0.51) |
0.57 (0.44, 0.75) |
4-y PFS rate, % a |
12.4 vs NE |
16.6 vs NE |
NE vs NE |
12.7 vs NE |
18.8 vs NE |
15.3 vs NE |
11.9 vs NE |
HR, Hazard Ratio; ITT, intention-to-treat; NE, not estimable; NSCLC, non-small cell lung cancer; nsq, non-squamous; OS, overall survival; PFS, progression-free survival; sq, squamous; TPS, tumour proportion score. Data are for suge + chemo vs placebo + chemo. aKaplan-Meier estimate. bPer RECIST v1.1 by investigator. |
About Sugemalimab
The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs. Sugemalimab's unique molecular design enables a dual mechanism of action that not only blocks PD-1/PD-L1 interaction, but also induces antibody dependent cellular phagocytosis (ADCP) by cross-linking PD-L1 expressing tumor cells with tumor associated macrophages (TAMs) without harming Effector T-cells. This differentiation has resulted in potentially best-in-class efficacy/safety across a variety of tumor types.
The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:
The European Commission (EC) has approved sugemalimab (brand name: Cejemly®) in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.
The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has accepted the marketing authorization application for sugemalimab in combination with platinum-based chemotherapy for first-line treatment of metastatic NSCLC with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. The application is currently under review.
About CStone
CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 14 new drug applications (NDAs) covering 9 indications. The company's pipeline is balanced by 16 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization.
For more information about CStone, please visit bjjmwy.com.cn.
IR contact: ir@cstonepharma.com
PR contact: pr@cstonepharma.com
Forward-looking statements
The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments.
Disclaimer: only for communication and scientific use by medical and health professionals.
Your privacy is important for us. We use cookies to enhance your experience when visiting our websites: performance cookies show us how you use this website, functional cookies remember your preferences and targeting cookies help us to share content relevant to you. Select “Accept all” for giving your consent to all cookies or select “Reject all” for using only strictly necessary cookies.