CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that the registrational clinical data from sugemalimab (the GEMSTONE-301 study) in stage III non-small cell lung cancer (NSCLC) were published in the world-leading clinical oncology journal, The Lancet Oncology. Sugemalimab as a consolidation therapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in patients with unresectable stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. After being selected as a late-breaking abstract (LBA) at the European Society of Medical Oncology (ESMO) Congress 2021, this study has been honored on the international academic stage, fully demonstrating its great academic value and clinical potential. The leading principal investigator of GEMSTONE-301 is Professor Yi-Long Wu from Guangdong Provincial People's Hospital. This randomized, double-blind phase 3 trial was done in 50 hospitals and research centers in China. With an innovative study design, this study enrolled patients with either concurrent or sequential chemoradiotherapy to better reflect real-world clinical practice and covered a broad NSCLC patient population.
The GEMSTONE-301 study is designed to evaluate the efficacy and safety of sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy.
GEMSTONE-301 study met its primary endpoint at a pre-planned interim analysis. The findings showed that sugemalimab demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) as assessed by blinded independent central review (BICR). The BICR-assessed median PFS was 9.0 months vs 5.8 months, stratified HR=0.64 (95% CI:0.48, 0.85), p-value=0.0026. Consistent PFS benefit favoring sugemalimab was observed in patients who received either concurrent or sequential chemoradiotherapy prior to randomization. The median PFS was 10.5 months vs. 6.4 months in the concurrent radiotherapy group, HR=0.66 (95% CI: 0.44, 0.99), and 8.1 months vs. 4.1 months in the sequential radiotherapy group, HR=0.59 (95% CI: 0.39, 0.91). Sugemalimab had a well-tolerated safety profile with no new safety signals observed.
Professor Yi-Long Wu, Guangdong Provincial People's Hospital, the corresponding author and leading principal investigator on the GEMSTONE-301 study, said, "The publication of the results from the GEMSTONE-301 study in The Lancet Oncology demonstrates the international medical community has fully affirmed the study's forward-looking design, research quality and clinical value. It also showcases Chinese researchers have taken a broad scientific perspective to explore and conduct high-quality innovative research that fits in with the real clinical needs in China."
Dr. Jason Yang, Chief Medical Officer of CStone, said, "The Lancet Oncology is an international trusted source that is devoted to publishing high-quality research papers to help advance practice in clinical oncology and potentially reshape the landscape of cancer control and prevention. The publication of data from the GEMSTONE-301 study in The Lancet Oncology is powerful proof of CStone's clinical development capabilities and research quality. It also highlights the outstanding clinical value of sugemalimab. The new drug application (NDA) of sugemalimab in patients with stage III NSCLC is under review by the National Medical Products Administration (NMPA) of China, and we expect it to benefit more Chinese patients."
The NMPA of China has approved the NDA of sugemalimab (Cejemly®) in combination with chemotherapy for treatment-naïve metastati...
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