CStone Gains EU Nod for Sugemalimab as First-Line NSCLC Treatment

CStone Pharmaceuticals, a China-based biopharmaceutical company, has achieved a significant milestone with the European Commission's (EC) approval of sugemalimab (Cejemly®) in combination with chemotherapy for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC). This marks the first time an anti-PD-L1 monoclonal antibody (mAb) developed in China has received international approval, specifically in Europe, for treating both squamous and non-squamous NSCLC.

The approval is founded on the GEMSTONE-302 Phase 3 clinical trial, a comprehensive multicenter, randomized, double-blind study. The trial's results indicate that sugemalimab, when combined with chemotherapy, significantly extends both progression-free survival and overall survival in patients newly diagnosed with metastatic NSCLC compared to a placebo combined with chemotherapy. These findings have been well-documented in reputable medical journals such as The Lancet Oncology and Nature Cancer and were shared at various international scientific conferences. Future presentations of long-term treatment and survival data from the GEMSTONE-302 study are planned, including a session at the 2024 ESMO Annual Meeting.

Dr. Jason Yang, CStone’s CEO, expressed his excitement about the approval, highlighting it as a pivotal achievement in the company's quest to combat cancer globally. Dr. Yang noted that this approval is not only a first for CStone’s independently developed products but also showcases the high standards of research and development, as well as manufacturing, upheld by the company. This international recognition is expected to propel CStone’s globalization strategy forward, as the company looks to form commercial partnerships in regions such as Western Europe, Latin America, the Middle East, and Southeast Asia.

CStone is also preparing to submit additional Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) for several new indications, which include Stage III NSCLC, first-line gastric cancer, first-line esophageal cancer, and relapsed/refractory extranodal natural killer/T-cell lymphoma (r/r ENKTL).

In May 2023, CStone regained the development and commercialization rights for sugemalimab outside Greater China. The company quickly mobilized to review regulatory documents, perform gap analyses, and update submission dossiers. This effort resulted in a comprehensive response to the EMA’s Day 120 List, which contained 194 questions. Nearly 90% of these issues were resolved by Day 180, leading to a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), recommending the approval of sugemalimab.

Dr. Yang underscored that the approval and commercialization of sugemalimab represent a significant milestone in the company’s Pipeline 1.0 strategy. This strategy focuses on developing best-in-class immuno-oncology drugs. Looking forward, CStone’s Pipeline 2.0 includes multiple promising candidates in international multicenter clinical trials or approaching the clinical stage, which could be first-in-class or best-in-class. The company is also exploring the combination of sugemalimab with other treatments, such as antibody-drug conjugates (ADCs) and bi-/tri-specific antibodies, to enhance its therapeutic efficacy.

The journey of sugemalimab's development underscores the expertise of Chinese oncology specialists and the dedication of patients and researchers involved in its clinical trials. The GEMSTONE-302 study's outcomes provide robust scientific support for using sugemalimab with chemotherapy as a first-line therapy for Stage IV NSCLC, offering patients longer survival and improved quality of life.

CStone continues to work on submitting MAAs for additional indications, aiming to expand the therapeutic uses of sugemalimab. This includes targeting various stages and types of cancer, such as Stage III NSCLC, gastric cancer, esophageal cancer, and r/r ENKTL.