On June 1, 2024 CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of sugemalimab in combination with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC), which is one of the largest cancer indications and a leading cause of cancer death in the world (Press release, CStone Pharmaceauticals, JUN 1, 2024, View Source [SID1234643950]). Sugemalimab is expected to become the first anti-PD-L1 monoclonal antibody (mAb) approved in Europe for both first-line squamous and non-squamous NSCLC, regardless of PD-L1 expression, also making CStone the very first biopharmaceutical company in China to potentially launch a domestic anti-PD-L1 mAb in ex-China markets.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, said, "The positive opinion from EMA CHMP normally indicates an upcoming approval for market authorization by the European Commission, marking a significant milestone not only for sugemalimab but also for CStone and the entire pharmaceutical industry in China. The CHMP recommendation brings us closer to delivering this innovative treatment to European patients with lung cancer, and it also highlights a major milestone in CStone’s global strategy. Stage IV NSCLC is the first of several other indications where sugemalimab has been shown to bring significant benefits and we are planning to file for registration in these other important indications including stage III NSCLC, gastric cancer, esophageal cancer, etc. In addition, we have been actively engaging in substantive discussions with numerous other potential partners in various countries or regions to follow our recently announced strategic commercial collaboration with Ewopharma in Central Eastern Europe and Switzerland. We are confident and eagerly anticipate collaborating to swiftly propel sugemalimab into broader global markets and benefiting more patients across multiple indications. I would also like to thank the CStone team for their hard work and persistence over the years to achieve this important milestone."
CHMP recommendation is primarily based on the results of GEMSTONE-302, a multi-center, randomized, double-blind, Phase 3 clinical trial. Sugemalimab in combination with chemotherapy significantly improved PFS and OS compared to placebo in combination with chemotherapy in previously untreated stage IV NSCLC patients. The study results have been published in The Lancet Oncology and Nature Cancer and reported in oral sessions at various international academic conferences.
Sugemalimab is an anti-PD-L1 monoclonal antibody developed by CStone, which has been approved in China for five indications, including stage III and IV NSCLC, extranodal NK/T-cell lymphoma, esophageal squamous cell carcinoma, and gastric cancer. Additionally, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is currently reviewing the marketing authorization application for sugemalimab combined with chemotherapy as a first-line treatment for metastatic NSCLC. The company is also in communications with regulatory authorities such as the EMA, MHRA, and U.S. Food and Drug Administration (FDA) regarding additional indications for sugemalimab and is actively seeking development and commercialization partnerships in other countries and regions worldwide.
About Lung Cancer
In 2020, lung cancer was the third most diagnosed cancer in Europe and the leading cause of cancer-related mortality, accounting for one fifth of cancer deaths.i Approximately fifty to seventy percent of lung cancer cases in Europe are diagnosed in Stage IVii Globally, it is estimated that NSCLC accounts for approximately 85% of all lung cancers.iii
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:
In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC;
For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy;
For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression (Combined Positive Score [CPS] ≥5).
In addition to the EMA, the UK MHRA has also accepted the MAA for sugemalimab in combination with chemotherapy as first-line treatment for metastatic NSCLC. The application is currently under review.