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http://dx.doi.org/10.21037/cco-22-103 | DOI Listing |
Nat Cancer
January 2024
Clinical Development, CStone Pharmaceuticals, Suzhou, China.
CPT Pharmacometrics Syst Pharmacol
March 2024
Cstone Pharmaceuticals (Suzhou) Co., Ltd., Shanghai, China.
Overall survival is vital for approving new anticancer drugs but is often impractical for early-phase studies. The tumor growth inhibition-overall survival (TGI-OS) model could bridge the gap between early- and late-stage development. This study aimed to identify an appropriate TGI-OS model for patients with non-small cell lung cancer from the GEMSTONE-302 study of sugemalimab.
View Article and Find Full Text PDFAdv Ther
October 2023
Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, 410000, Hunan, China.
Introduction: Sugemalimab is the first China-developed programmed death-ligand 1 inhibitor that has proved to be effective as a first-line treatment for both metastatic squamous and non-squamous non-small cell lung cancer (NSCLC) when used in combination with chemotherapy. This study compared the cost-effectiveness of sugemalimab plus chemotherapy (sugema + chemo) with placebo plus chemotherapy (placebo + chemo) among metastatic squamous and nonsquamous NSCLC, respectively.
Methods: Separate Markov models were constructed to generate the cumulative healthcare costs and quality-adjusted life-years (QALYs) associated with two treatment strategies over a 20-year time horizon.
Nat Cancer
June 2023
Clinical Development, CStone Pharmaceuticals, Suzhou, China.
The randomized, double-blinded, multi-center, phase III GEMSTONE-302 ( NCT03789604 ) study evaluated the efficacy and safety of sugemalimab versus placebo in combination with chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (NSCLC). In this study, 479 treatment-naive patients with stage IV squamous or non-squamous NSCLC without known EGFR sensitizing mutations, ALK, ROS1 or RET fusions were randomized (2:1) to receive 1,200 mg of sugemalimab (n = 320) or placebo (n = 159) every 3 weeks in combination with platinum-based chemotherapy for up to four cycles, followed by maintenance therapy with sugemalimab or placebo for squamous NSCLC and sugemalimab or placebo plus pemetrexed for non-squamous NSCLC. Placebo-treated patients could cross over to receive sugemalimab monotherapy on disease progression.
View Article and Find Full Text PDFFront Pharmacol
March 2023
Department of Pharmacoeconomics, School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, China.
Non-small cell lung cancer (NSCLC) is one of the most malignant cancer types that causes substantial economic burden in China. This study aimed to evaluate the cost-effectiveness of five first-line anti-PD-(L)1 treatments, including sintilimab, camrelizumab, atezolizumab, pembrolizumab and sugemalimab with each combined with chemotherapy, for treating advanced non-squamous NSCLC (nsq-NSCLC) from Chinese healthcare system perspective. Clinical data were obtained from the following clinical trials, namely, ORIENT-11, CameL, IMpower132, KEYNOTE-189 and GEMSTONE-302.
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