CStone Pharmaceuticals will announce the registration clinical trial data of sugarizumab in the treatment of stage III non-small cell lung cancer in the form of an oral report at the 2021 European Society of Medical Oncology (ESMO) annual meeting

Shuxarizumab is the world's first PD-1 or PD-L1 monoclonal antibody trial to significantly improve the progression-free survival of patients with stage III non-small cell lung cancer without disease progression after concurrent or sequential radiotherapy and chemotherapy.

Suzhou, September 17, 2021/PRNewswire/ - CStone Pharmaceuticals (Hong Kong Stock Exchange code: 2616), a leading biopharmaceutical company focusing on research, development and commercialization of innovative tumor immunotherapies and precision therapeutic drugs, today Announced that at the 2021 European Society of Medical Oncology (ESMO) annual meeting, the registered clinical study GEMSTONE-301 for the treatment of stage III non-small cell lung cancer (NSCLC) with sugarizumab was selected as a late-breaking abstract at the ESMO annual meeting.

Research field: Non-metastatic non-small cell lung cancer and thoracic tumors Date: September 18, 2021 23:50-23:55 (Beijing time) Report format: Oral report Title: GEMSTONE-301: A Shuglizumab A randomized, double-blind, placebo-controlled phase III study in unresectable stage III non-small cell lung cancer patients without disease progression after concurrent/sequential radiotherapy and chemotherapy as a consolidation treatment.

The GEMSTONE-301 study aims to evaluate the effectiveness and safety of sugarizumab as a consolidation therapy in unresectable stage III NSCLC patients who have not progressed after concurrent or sequential radiotherapy and chemotherapy

The median PFS assessed by BICR was 9.

Professor Wu Yilong, Guangdong Provincial People’s Hospital, the main investigator of the GEMSTONE-301 study, said: “At present, clinically, there is no effective treatment for patients with stage III NSCLC who have not progressed after sequential radiotherapy and chemotherapy.

Dr.

At present, NMPA has accepted a new drug application for sugarizumab for the treatment of unresectable stage III NSCLC

In Mainland China, CStone Pharmaceuticals is working closely with Pfizer, a partner that has obtained the commercial authorization of the drug, to accelerate the commercialization of suglimumab

About non-small cell lung cancer (NSCLC)

The incidence of lung cancer has continued to increase in China in recent years

About sugarizumab (anti-PD-L1 monoclonal antibody)

Suglizumab is an anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals

At present, sugarizumab has undergone a number of registered clinical trials, including one phase II registered clinical trial (CS1001-201) for lymphoma, and four phase III and IV non-small cell lung cancer and gastric cancer.

The CS1001-201 study is a single-arm, multi-center phase II key study, which aims to evaluate sugarizumab as a single agent for the treatment of adult relapsed or refractory extranodal natural killer cell/T cell lymphoma (R/ R ENKTL) effectiveness and safety

CStone Pharmaceuticals and Pfizer have reached a strategic cooperation, including CStone and Pfizer Investment on the development and commercialization of suggliumab in mainland China, and CStone and Pfizer Investment to introduce more oncology products into the Greater China region.

CStone Pharmaceuticals has reached a strategic cooperation with EQRx of the United States to exclusively authorize EQRx to develop and commercialize two tumor immunotherapeutic drugs in the late stage of research and development outside of Greater China.

About the GEMSTONE-301 study

GEMSTONE-301 is a multicenter, randomized, double-blind phase III clinical trial (clinicaltrials.

In May 2021, in the planned interim analysis of the GEMSTONE-301 study, the independent data monitoring committee (iDMC) assessed that it reached the preset primary study endpoint
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The results of the trial showed that suglimumab significantly improved the progression-free survival (PFS) assessed by the blinded independent central review (BICR), and the difference was statistically significant and clinically significant
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The PFS results assessed by the investigator were consistent with the primary study endpoint
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The safety of Shuglizumab is good, and no new safety signals have been found
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Subgroup analysis showed that patients after concurrent or sequential radiotherapy and chemotherapy showed clinical benefit
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In September 2021, the National Medical Products Administration of China has accepted a new drug listing application for sugarizumab for the treatment of stage III NSCLC indications for the treatment of unresectable stage III non-resectable non-resectable patients with no disease progression after concurrent or sequential radiotherapy and chemotherapy.
Patients with small cell lung cancer
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About the GEMSTONE-302 study

GEMSTONE-302 is a multicenter, randomized, double-blind phase III clinical trial (clinicaltrials.
gov registration number: NCT03789604; drug clinical trial registration number: CTR20181452) designed to evaluate sugarizumab combined with chemotherapy versus placebo combined with chemotherapy , Effectiveness and safety in stage IV NSCLC patients without first-line treatment
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The primary endpoint of the trial is PFS assessed by the investigator; secondary endpoints include overall survival, PFS assessed by BICR, and safety
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In August 2020, in the planned interim analysis of the GEMSTONE-302 study, the independent data monitoring committee (iDMC) assessed that it reached the preset primary study endpoint, that is, compared with placebo combined with chemotherapy, sugarizumab combined Chemotherapy significantly prolonged the patient's progression-free survival (PFS), and the safety was good, and no new safety signals were found
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The mid-term analysis of clinical trial data was presented orally in the Proffered Paper session (Late-Breaking Abstract) of the ESMO Asia conference in 2020
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In November 2020, NMPA accepted a new drug listing application for suglimumab for the first-line treatment of patients with metastatic squamous and non-squamous non-small cell lung cancer in combination with chemotherapy
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In July 2021, the final analysis of the PFS of the GEMSTONE-302 study showed that sugarizumab combined with chemotherapy further enhanced the primary efficacy endpoint progression-free survival benefit, the patient's risk of disease progression or death was reduced by 52%, and the total The survival period has a trend of obvious benefit, and the 2-year survival rate is 47.
1%
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The data will be published as an oral report at the 2021 World Lung Cancer Conference
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About CStone Pharmaceuticals

CStone Pharmaceuticals (Hong Kong Stock Exchange code: 2616) is a biopharmaceutical company that focuses on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs to meet the ardent medical needs of cancer patients in China and around the world
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Established at the end of 2015, CStone Pharmaceuticals has assembled a world-class management team with extensive experience in new drug development, clinical research and commercial operations
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With tumor immunotherapy combination therapy as the core, the company has established a rich product pipeline consisting of 15 tumor drug candidates
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At present, CStone Pharmaceuticals has obtained three new drug marketing approvals worldwide, two new drug marketing approvals in Mainland China, and one new drug marketing approval in Taiwan
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Many late-stage drug candidates are in critical clinical trials or registration stages
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CStone's vision is to become a world-renowned biopharmaceutical company, leading the way to overcome cancer
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For more information about CStone Pharmaceuticals, please visit:
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Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether new information, future events or other circumstances appear
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Please read this article carefully and understand that our actual future results or performance may differ materially from expectations
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Source: CStone Pharmaceuticals