Sugemalimab Nears Approval in China for First-Line Treatment of Advanced NSCLC

On December 13, according to the NMPA official website, the marketing application (acceptance number: CXSS2000056) for CStone Pharmaceuticals' PD-L1 monoclonal antibody, Sugemalimab, has entered the "under review" stage and is expected to be approved soon. The indication for this acceptance number is for first-line treatment of advanced NSCLC in combination with chemotherapy.

Source: NMPA Official Website

In September 2021, CStone Pharmaceuticals also submitted a new indication marketing application for sugemalimab for the consolidation treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) who did not experience disease progression after concurrent or sequential chemoradiotherapy. According to a previous press release from CStone Pharmaceuticals, these two marketing applications position sugemalimab to potentially become the world’s first approved PD-1 or PD-L1 antibody covering locally advanced/unresectable (stage III) and metastatic (stage IV) non-small cell lung cancer.

The marketing application of Sugrelizumab is based on the positive results of a multicenter, randomized, double-blind Phase III study named CS1001-302. This study aims to evaluate the efficacy and safety of CS1001 in combination with platinum-based chemotherapy compared to placebo in combination with platinum-based chemotherapy in previously untreated patients with Stage IV NSCLC.

CS1001-302 is the first randomized, double-blind, Phase III clinical trial of an anti-PD-L1 monoclonal antibody combined with chemotherapy as a first-line treatment in patients with Stage IV squamous and non-squamous non-small cell lung cancer (NSCLC) across both histological subtypes. The interim analysis showed that, compared with placebo plus chemotherapy, CS1001 combined with chemotherapy significantly prolonged progression-free survival (PFS) and reduced the risk of disease progression or death by 50%. The safety profile of CS1001 combined with chemotherapy was favorable, with no new safety signals identified.

In all patients including squamous and non-squamous NSCLC, the investigator-assessed PFS hazard ratio HR (95% CI) was 0.5 (0.39, 0.64), p<0.0001. The median PFS for CS1001 combined with chemotherapy was 7.8 months, while the median PFS for placebo combined with chemotherapy was 4.9 months. Subgroup analysis showed that clinical benefits were observed in patients with squamous and non-squamous NSCLC, as well as in patients with PD-L1 expression >=1% and PD-L1 expression <1%.

Currently, CS1001 is undergoing multiple clinical trials. Apart from a Phase I bridging study in the United States, in China, according to the Insight database, CStone Pharmaceuticals has initiated eight clinical trials for CS1001 targeting various cancer types such as esophageal squamous cell carcinoma, gastric cancer, NSCLC (non-small cell lung cancer), classical Hodgkin lymphoma, and T/NK-cell lymphoma. Among these are several registrational clinical trials, including a Phase II registrational trial for lymphoma (CS1001-201) and four Phase III registrational trials for Stage III NSCLC, Stage IV NSCLC, gastric cancer, and esophageal cancer respectively. Click here to view details of the clinical trials.

Clinical Trials of Sugemalimab Registered and Initiated in China

From Insight database (http://db.dxy.cn/v5/home/)

Currently, three PD-L1 monoclonal antibodies have been approved for marketing in China, including two imported products: durvalumab (AstraZeneca) and atezolizumab (Roche). The first domestically produced PD-L1, envafolimab, from Alphamab Oncology/3D Medicines, was just approved for marketing on November 25.