Bristol Myers Squibb Announces CheckMate-870 Trial Meets Primary Endpoint with No New Safety Signals for Opdivo in Asian Patients with Advanced NSCLC
May 15, 2020 12:32
CST Updated
12:32
Bristol-Myers Squibb
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On May 15, 2020, Bristol-Myers Squibb (NYSE: BMY) announced that the CheckMate 870 study had met its primary clinical endpoint. CheckMate 870 is an open-label, Phase IIIB clinical study designed to evaluate the safety and efficacy of Opdivo monotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have received one or two prior systemic therapies. The study enrolled a total of 400 Asian patients, including 394 Chinese patients. The primary endpoint was to assess the incidence of high-grade (Grade 3–5) adverse reactions to Opdivo in previously treated patients with advanced NSCLC who were not infected with hepatitis B virus (HBV). Opdivo was administered at a fixed dose of 240 mg via 30-minute intravenous infusion every two weeks, until disease progression, unacceptable toxicity, or for a maximum treatment duration of 24 months. The study results demonstrated that the safety profile of Opdivo in the treated population was consistent with that observed in previous pivotal studies using weight-based dosing, with no new safety signals identified.
The intention-to-treat population in the CheckMate-870 study included not only patients with PD-L1 expression ≥1% and <1%, but also a subset of patients with EGFR/ALK mutations and HBV infection. Safety and efficacy were similarly demonstrated among patients with EGFR mutations and HBV infection treated with Opdivo. Detailed results from the CheckMate-870 study will be presented at an upcoming international medical conference.
Professor Lu Shun, Director of the Department of Medical Oncology at Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, and principal investigator of the CheckMate-870 study, stated: “This study is the first to prospectively evaluate a fixed-dose, short-infusion regimen in a large cohort of predominantly Chinese Asian patients, confirming that this approach delivers comparable therapeutic benefits. Furthermore, the study assessed treatment outcomes in patients with EGFR/ALK mutations and hepatitis B virus (HBV) infection—populations prevalent in China—providing robust evidence to guide therapy for these special patient groups. By filling critical gaps in immuno-oncology research, these findings enable more patients with advanced lung cancer to access innovative treatments, marking a significant advancement in the field.”
Dr. Hong Xusheng, Head of Medical Affairs for Bristol-Myers Squibb China and the Asia-Pacific region, stated, “With the widespread global application of tumor immunotherapy, the safety, efficacy, and convenience of treatment remain focal points of continuous attention from all stakeholders. The results of the CheckMate-870 study have once again validated the safety and efficacy of Opdivo in Asian patients, particularly those with advanced non-small cell lung cancer (NSCLC) in China, offering new therapeutic insights for the treatment of advanced lung cancer by enhancing convenience in clinical practice. As the first company to introduce tumor immunotherapy to China, Bristol-Myers Squibb will continue to explore and optimize treatment regimens to help patients overcome serious diseases.”
Regarding the CheckMate 870 Study
CheckMate 870 is an open-label, Phase IIIb clinical study that enrolled 400 Asian patients with non-small cell lung cancer (NSCLC), predominantly from China (394 Chinese patients), to evaluate the efficacy and safety of Opdivo monotherapy administered as a 240 mg intravenous infusion over 30 minutes every two weeks in patients with advanced NSCLC (including both squamous and non-squamous histologies) who had progressed after one or two prior lines of systemic therapy.
This study enrolled a total of 400 patients with advanced or metastatic squamous and non-squamous non-small cell lung cancer (NSCLC), including 44 patients with EGFR/ALK mutations who had previously received two prior systemic therapies, including TKI-targeted agents and chemotherapy; and 17 patients with hepatitis B virus (HBV) infection with HBV DNA <500 IU/ml. All patients received intravenous infusions of Opdivo 240 mg over 30 minutes every two weeks until disease progression or occurrence of intolerable toxicity, for a maximum treatment duration of 24 months.
The primary endpoint of the study is to evaluate high-grade (Grade 3–5) adverse events in patients without HBV infection. Secondary endpoints include safety in patients with HBV infection, safety in all patients, and efficacy across different histopathological types, PD-L1 expression statuses, and HBV infection statuses, including overall survival (OS), objective response rate (ORR), and progression-free survival (PFS). Exploratory analyses will also be conducted on pharmacoeconomics, changes in HBV DNA levels in patients with hepatitis B virus infection, patient-reported outcomes, and biomarkers.
The intention-to-treat population in the CheckMate-870 study included not only patients with PD-L1 expression ≥1% and <1%, but also a subset of patients with EGFR/ALK mutations and HBV infection. Safety and efficacy were similarly demonstrated among patients with EGFR mutations and HBV infection treated with Opdivo. Detailed results from the CheckMate-870 study will be presented at an upcoming international medical conference.
Professor Lu Shun, Director of the Department of Medical Oncology at Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, and principal investigator of the CheckMate-870 study, stated: “This study is the first to prospectively evaluate a fixed-dose, short-infusion regimen in a large cohort of predominantly Chinese Asian patients, confirming that this approach delivers comparable therapeutic benefits. Furthermore, the study assessed treatment outcomes in patients with EGFR/ALK mutations and hepatitis B virus (HBV) infection—populations prevalent in China—providing robust evidence to guide therapy for these special patient groups. By filling critical gaps in immuno-oncology research, these findings enable more patients with advanced lung cancer to access innovative treatments, marking a significant advancement in the field.”
Dr. Hong Xusheng, Head of Medical Affairs for Bristol-Myers Squibb China and the Asia-Pacific region, stated, “With the widespread global application of tumor immunotherapy, the safety, efficacy, and convenience of treatment remain focal points of continuous attention from all stakeholders. The results of the CheckMate-870 study have once again validated the safety and efficacy of Opdivo in Asian patients, particularly those with advanced non-small cell lung cancer (NSCLC) in China, offering new therapeutic insights for the treatment of advanced lung cancer by enhancing convenience in clinical practice. As the first company to introduce tumor immunotherapy to China, Bristol-Myers Squibb will continue to explore and optimize treatment regimens to help patients overcome serious diseases.”
Regarding the CheckMate 870 Study
CheckMate 870 is an open-label, Phase IIIb clinical study that enrolled 400 Asian patients with non-small cell lung cancer (NSCLC), predominantly from China (394 Chinese patients), to evaluate the efficacy and safety of Opdivo monotherapy administered as a 240 mg intravenous infusion over 30 minutes every two weeks in patients with advanced NSCLC (including both squamous and non-squamous histologies) who had progressed after one or two prior lines of systemic therapy.
This study enrolled a total of 400 patients with advanced or metastatic squamous and non-squamous non-small cell lung cancer (NSCLC), including 44 patients with EGFR/ALK mutations who had previously received two prior systemic therapies, including TKI-targeted agents and chemotherapy; and 17 patients with hepatitis B virus (HBV) infection with HBV DNA <500 IU/ml. All patients received intravenous infusions of Opdivo 240 mg over 30 minutes every two weeks until disease progression or occurrence of intolerable toxicity, for a maximum treatment duration of 24 months.
The primary endpoint of the study is to evaluate high-grade (Grade 3–5) adverse events in patients without HBV infection. Secondary endpoints include safety in patients with HBV infection, safety in all patients, and efficacy across different histopathological types, PD-L1 expression statuses, and HBV infection statuses, including overall survival (OS), objective response rate (ORR), and progression-free survival (PFS). Exploratory analyses will also be conducted on pharmacoeconomics, changes in HBV DNA levels in patients with hepatitis B virus infection, patient-reported outcomes, and biomarkers.