GEMSTONE-302 study of sugalimab injection in first-line treatment of metastatic non-small cell lung cancer reaches the study endpoint of overall survival

Zejimet® is the world's first PD-L1 mAb to significantly improve overall survival in both squamous and non-squamous stage IV-naïve NSCLC patients in combination with chemotherapy.
Overall survival benefits were observed in all subgroups, including different The pathological type and PD-L1 expression level of Zejimei® have been approved by the China National Medical Products Administration for marketing in combination with chemotherapy in the first-line treatment of patients with metastatic squamous and non-squamous non-small cell lung cancer.
The GEMSTONE-302 study The updated data, as well as clinical data for other indications, will be used to support the NDA application of sugelimab for this indication in multiple countries and regions outside of Greater China GEMSTONE-302, a registrational clinical study of first-line treatment of metastatic (stage IV) non-small cell lung cancer (NSCLC) with limumab injection, reached the study endpoint of overall survival (OS)
.
The study showed that Zejimet® combined with chemotherapy can significantly prolong the OS of patients and has clinical significance
.
Based on the excellent progression-free survival (PFS) data previously reported in the GEMSTONE-302 study, the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) of Zejimet® for combination chemotherapy in December 2021 First-line treatment of patients with metastatic squamous and non-squamous NSCLC
.
The detailed research data such as OS will be announced in the international academic conference held in the near future
.
Professor Zhou Caicun, the principal investigator of the GEMSTONE-302 study, a registrational clinical study of Zejimei®, and director of the Department of Oncology, Shanghai Pulmonary Hospital Affiliated to Tongji University, said: "Globally, the mortality rate of lung cancer ranks first among all malignant tumors
.
Advanced stage The goal of first-line treatment of lung cancer is to maximize the long-term survival benefit of patients and delay disease progression
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The prespecified OS analysis data of the study further confirms that the combination of ZEJME® and chemotherapy can bring durable survival benefits to patients
.
ZEJME® It is expected to change the first-line treatment pattern of advanced NSCLC and become the first-choice tumor immunotherapy drug for advanced NSCLC
.
Dr.
Yang Jianxin, Chief Medical Officer of CStone Pharmaceuticals, said: "Zejiemei® has been approved for marketing in China last month.
After the first batch of prescriptions has been issued recently, GEMSTONE-302 has proved in this OS analysis that Zejiemei ® has been approved for marketing in China last month.
® combined chemotherapy significantly improved overall survival, even though a higher proportion of patients in the chemotherapy arm received subsequent PD-1/PD-L1 inhibitor therapy after disease progression, including crossover based on protocol design
.
In cancer treatment, OS is the gold standard for evaluating efficacy
.
The achievement of the endpoint of this OS study further proves the important value of Zejimet® in the first-line NSCLC treatment
.
As a PD-(L)1 antibody that can benefit both stage III and IV NSCLC patients, the marketing application of Zejimet® for the treatment of stage III NSCLC is currently under review, targeting at the treatment of relapsed or refractory extranodal natural A pivotal Phase II study in killer cell/T-cell lymphoma also recently met its primary endpoint
.
In addition, we are making every effort to promote the registration study of Zejimei® in gastric cancer, esophageal squamous cell carcinoma and lymphoma, and hope that Zejimei® can benefit more tumor patients
.
About Zejimay® (sugelimab injection) Zejimay® (sugelimab injection) is an investigational anti-PD-L1 monoclonal antibody
developed by CStone.
The development of Zejimay® is based on OmniRat ® transgenic animal platform
.
This platform can produce fully human antibodies in one stop
.
As a fully human full-length anti-PD-L1 monoclonal antibody, Zejimet® is a natural G-type immunoglobulin 4 closest to the human body (IgG4) monoclonal antibody drugs.
Zerometrik®
has a lower risk of immunogenicity and related toxicity in patients, which gives Zejimax® a unique advantage compared to similar drugs
.
At present, the National Medical Products Administration (NMPA) of China has approved the New Drug Application of Zejimet® for the combination of pemetrexed and carboplatin for epidermal growth factor receptor (EGFR) gene mutation-negative and anaplastic lymphoma kinase ( First-line treatment of patients with ALK)-negative metastatic non-squamous non-small cell lung cancer, and combination paclitaxel and carboplatin for first-line treatment of patients with metastatic squamous non-small cell lung cancer
.
In addition, Zejimet® has undergone several registrational clinical trials, including a Phase II registrational clinical trial in lymphoma, and four Phase III registrations in Phase III, IV non-small cell lung cancer, gastric cancer, and esophageal cancer.
clinical trials
.
CStone and Pfizer (NYSE: PFE) have entered into a strategic partnership, which includes CStone and Pfizer investing in the development and commercialization of Zejimet® in mainland China, and CStone and Pfizer investing in bringing more oncology products to the market The cooperation framework in China has reached strategic cooperation,
etc.
About the GEMSTONE-302 Study GEMSTONE-302 is a multicenter, randomized, double-blind, Phase III clinical trial (clinicaltrials.
gov number: NCT03789604; Drug Clinical Trials number: CTR20181452) designed to evaluate ZETTEME® in combination with chemotherapy versus placebo Efficacy and safety of chemotherapy in combination with chemotherapy in first-line treatment-naïve, stage IV NSCLC patients
.
The primary endpoint of the trial was investigator-assessed PFS; secondary endpoints included overall survival, BICR-assessed PFS, and safety
.
In August 2020, the GEMSTONE-302 study met the prespecified primary endpoint of a significant improvement in Zejimet® plus chemotherapy compared with placebo plus chemotherapy as assessed by an independent data monitoring committee (iDMC) in a planned interim analysis.
The progression-free survival (PFS) of patients was prolonged, and the safety was good, and no new safety signals were found
.
The clinical trial data of PFS interim analysis was presented orally in the OfferedPaper session (Late-BreakingAbstract) of ESMOAsia 2020
.
In July 2021, the final PFS analysis of the GEMSTONE-302 study showed that Zejimet® in combination with chemotherapy further enhanced the primary efficacy endpoint of progression-free survival benefit, with a 52% reduction in the risk of disease progression or death in patients, and demonstrated overall survival A clear trend of benefit
.
Study data were presented as an oral presentation at the 2021 World Lung Cancer Congress and in The Lancet Oncology in January 2022
.