Bristol Myers Squibb Announces Phase 3 CheckMate-870 Results of Opdivo in Chinese Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

Recently, Bristol-Myers Squibb (BMS) announced the results of the CheckMate-870 study at the American Association for Cancer Research (AACR) 2020 Annual Meeting. The study confirmed that a fixed dose of 240 mg Opdivo (nivolumab), administered via a 30-minute infusion, is safe and reliable in previously treated patients with advanced or metastatic non-small cell lung cancer (NSCLC), predominantly from China.

CheckMate-870 is an open-label, Phase 3B clinical study designed to evaluate the safety and efficacy of Opdivo monotherapy in patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC). The study employed a fixed dose of 240 mg administered via 30-minute intravenous infusion every two weeks, until disease progression or unacceptable toxicity occurred, with a maximum treatment duration of 24 months. Results showed that among non-HBV-infected patients, the most common grade 3–4 selective treatment-related adverse events (TRAEs) were hepatic (2.3%), cutaneous (1.6%), pulmonary (1.0%), and endocrine (0.8%) disorders; the incidence of grade 5 selective TRAEs was 0%. Among HBV-infected patients, the incidence of grade 3–5 selective TRAEs was 0%. Across all patients, the overall incidence of grade 3–4 TRAEs was 12.8%, and the discontinuation rate due to grade 3–4 TRAEs was 2.0%. The study demonstrated that the safety profile of Opdivo in the treated population was consistent with previous pivotal studies using a weight-based dose (3 mg/kg) administered via 60-minute infusion, with no new safety signals identified.

In the intent-to-treat population of CheckMate-870, investigators conducted subgroup analyses based on EGFR mutation status, HBV infection status, histological type, and PD-L1 expression. The results showed that at a median follow-up of 9.6 months, the 6-month overall survival rate for all treated patients was 75% (95% CI: 70–79%), and the objective response rate (ORR) was 15.5%. The ORRs were 17.6% and 15.4% in patients with and without HBV infection, respectively, and 14.7% and 14.2% in patients with and without EGFR gene mutations, respectively. These findings confirm the antitumor activity of Opdivo in patients with HBV infection and those with EGFR mutations.

Professor Lu Shun, Chief Investigator of the CheckMate-870 trial and Director of the Department of Oncology at Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, stated: “As the first tumor immunotherapy drug approved for marketing in China, the safety profile of Opdivo has been extensively validated in clinical practice both domestically and internationally. This study further confirms that the fixed-dose 30-minute infusion regimen is equally safe in previously treated patients with advanced or metastatic non-small cell lung cancer (NSCLC), predominantly Chinese patients, including those with EGFR mutations and HBV infection. These findings provide new evidence supporting improved convenience in clinical use and application in special populations, enabling more patients with advanced NSCLC to benefit from Opdivo treatment.”

Yan Qiao, Head of Medical Affairs for Bristol-Myers Squibb in Mainland China and Hong Kong, stated, “Lung cancer is one of the most prevalent diseases in China and globally, and there is a significant unmet treatment need among patients with advanced non-small cell lung cancer (NSCLC). The CheckMate-870 study provides new scientific insights into the dosing of Opdivo in the Chinese population and its application in special populations. In the future, we will continue to explore the potential benefits of tumor immunotherapy for different patient groups, providing comprehensive treatment solutions to bring more innovative and convenient therapeutic options to a broader range of patients, helping them overcome serious diseases.”

About the CheckMate-870 Study

CheckMate-870 is an open-label, Phase 3b clinical study designed to evaluate the safety and efficacy of Opdivo monotherapy in predominantly Chinese patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), including both squamous and non-squamous histologies. A total of 400 Asian patients were enrolled, of whom 394 were Chinese. All patients received intravenous infusions of Opdivo at a dose of 240 mg over 30 minutes every two weeks, until disease progression or unacceptable toxicity occurred, with a maximum treatment duration of 24 months.

The study enrolled 17 patients with hepatitis B virus (HBV) infection (HBV DNA < 500 IU/mL), as well as patients with EGFR gene mutations (n=34) and ALK gene fusions (n=10). All patients had previously received two prior lines of systemic therapy, including targeted therapy and chemotherapy.

The primary endpoint was the incidence of high-grade (Grade 3–5) treatment-emergent selected adverse events in patients without HBV infection. Secondary endpoints included the incidence of high-grade (Grade 3–5) treatment-emergent selected adverse events in patients with HBV infection, safety in all patients, and efficacy outcomes—including overall survival (OS), objective response rate (ORR), and progression-free survival (PFS)—stratified by histological subtype, PD-L1 expression status, HBV infection status, and EGFR mutation status. Exploratory analyses were also conducted on pharmacoeconomics, changes in HBV DNA levels in patients with HBV infection, patient-reported outcomes, and biomarkers.

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