China-based biopharmaceutical company CStone Pharmaceuticals (HKEX: 2616) announced on Sunday that its key product, Cejemly (sugemalimab) has been included in the European Society for Medical Oncology (ESMO) Non-Oncogene-Addicted Metastatic Non-Small-Cell Lung Cancer (NSCLC) Living Guideline.

Sugemalimab is recommended as a first-line combination therapy for both squamous and non-squamous NSCLC, with substantial clinical benefits.

As per the ESMO Guideline, sugemalimab-platinum-doublet chemotherapy is recommended as a Level [I, A] first-line combination therapy, with an ESMO-MCBS v1.1 score of four for patients with squamous NSCLC, performance status (PS) 0-1, regardless of tumour PD-L1 status and without contraindications for immune checkpoint inhibitors (ICI). The product is recommended as a Level [I, A] first-line combination therapy, with an ESMO-MCBS v1.1 score of four for patients with non-squamous NSCLC, PS 0-1, regardless of tumour PD-L1 status and without contraindications for ICI.

CStone says that these recommendations are supported by robust clinical data from the Phase III GEMSTONE-302 trial, which demonstrated significant benefits in progression-free survival (PFS) and overall survival (OS) with sugemalimab plus platinum-based chemotherapy, compared to placebo plus platinum-based chemotherapy. Notably, sustained and consistent benefits were observed across various histological subtypes and PD-L1 expression levels.

Long-term survival data from the GEMSTONE-302 study were presented at the 2024 ESMO Annual Meeting.