MHRA Approves CStone's Sugemalimab for Adult Lung Cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for CStone Pharmaceuticals’ drug sugemalimab, branded as Eqjubi, to be used as part of a first-line treatment for lung cancer. This anti-PD-L1 monoclonal antibody is authorized to be used in conjunction with platinum-based chemotherapy for adults dealing with metastatic non-small cell lung cancer (NSCLC) lacking EGFR-sensitive mutations or genetic alterations in ALK, ROS1, or RET.

The authorization was based on positive data from the phase III GEMSTONE-302 trial. In this study, sugemalimab combined with chemotherapy significantly improved both progression-free survival and overall survival among treatment-naïve patients with metastatic NSCLC compared to a placebo plus chemotherapy. Julian Beach, MHRA’s interim executive director of healthcare quality and access, emphasized that the regulatory standards for safety, quality, and efficacy were thoroughly met for this new formulation. He also mentioned that continuous monitoring of the drug’s safety will be maintained.

In the UK, approximately 49,200 individuals are diagnosed with lung cancer annually, with NSCLC comprising up to 85% of these cases. Sugemalimab functions by inhibiting the PD-1 protein, thereby preventing cancer cells from deactivating immune cells and enhancing the immune system’s capability to eliminate cancer cells. The drug is delivered intravenously in a hospital or clinic setting every three weeks, with each infusion taking around 60 minutes.

The MHRA’s approval follows the European Commission's recent endorsement of sugemalimab under the brand name Cejemly for the same use. Jason Yang, CEO, president of research and development, and executive director of the board at CStone, hailed the approval as a significant milestone in the company’s global expansion efforts. Yang also mentioned that CStone is actively engaging with the European Medicines Agency and other regulatory bodies to pursue additional approvals for sugemalimab for various other indications, including stage 3 NSCLC, first-line gastric cancer, and first-line oesophageal squamous cell carcinoma.

Moreover, CStone has recently announced that the population pharmacokinetics modeling results of sugemalimab have been published in the British Journal of Clinical Pharmacology, marking another achievement for the company.