Additional Survival Data on Nivolumab, an Investigational PD-1 Immune Checkpoint Inhibitor, from Lung Cancer Cohort of a Phase 1 Study Presented at 15th World Conference on Lung Cancer
•Across dose cohorts, 42% and 24% of heavily pre-treated patients with non-small cell lung cancer were alive at one and two years, respectively, based on Kaplan-Meier estimates
•Spectrum, frequency and severity of treatment-related adverse events were consistent with those initially reported
•Development program consists of more than 25 studies in broad range of tumors, including seven potentially registrational trials in lung cancer, melanoma and renal cell carcinoma
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced long-term follow-up results (median follow up of 20.3 months) from the lung cancer cohort (n=129) of the expanded Phase 1 dose-ranging study (003) of nivolumab, an investigational PD-1 immune checkpoint inhibitor. Results showed sustained activity in heavily pre-treated patients with non-small-cell lung cancer (NSCLC) as defined by one- and two-year survival rates of 42% and 24%, respectively, across dose cohorts. These data, which are based on Kaplan-Meier estimates, will be presented on October 29 at the World Conference on Lung Cancer (Abstract # MO18.03).
“Our goal with immuno-oncology is to change survival expectations and the way patients live with cancer,” said Michael Giordano, senior vice president, Head of Development, Oncology & Immunology, Bristol-Myers Squibb. “These are encouraging Phase 1 results from the expanded cohort of patients with lung cancer, the leading cause of cancer deaths globally, and we are seeking to confirm these early data in ongoing Phase 3 trials.”
“Lung cancer is very difficult to treat and there continues to be a high unmet medical need for these patients, especially those who have received multiple treatments,” added Dr. David Spigel, program director of Lung Cancer at Sarah Cannon Research Institute and Study 003 investigator. “With nivolumab, we are investigating an approach to treating lung cancer that is designed to work with the body’s own immune system, and these are encouraging Phase 1 results that support further investigation in larger scale trials.”
Study 003 Results
This analysis is reflective of 129 NSCLC patients, including both squamous and non-squamous histologies. All patients had at least one therapy prior to nivolumab and 54% received three or more therapies prior to nivolumab. Across dose cohorts, the one- and two-year survival rates were 42% and 24%, respectively, based on Kaplan-Meier estimates, and median overall survival (mOS) was 9.9 months. In all treated patients, the objective response rate (ORR) was 17%, as measured by RECIST criteria. An analysis of the 129 NSCLC patients in this study by select patient characteristics demonstrated that nivolumab had activity across a broad range of patients, including those with mutations in key signaling pathways in lung cancer such as EGFR and KRAS.
Data presented at the 2013 American Society of Clinical Oncology (ASCO) annual meeting, with all patients having greater than or equal to one year of follow up, demonstrated a spectrum, frequency and severity of treatment-related adverse events (AEs) that were consistent with those initially reported in the study in 2012. As reported at ASCO 2013, common drug-related AEs included fatigue, decreased appetite, diarrhea, nausea, constipation, cough and dyspnea. Drug-related select AEs with potential immunologic etiologies, defined as adverse events that may require more frequent monitoring and/or unique intervention, included rash, diarrhea and pruritus.
About Study 003
Study 003 is a Phase 1 study (n=306) evaluating the safety, antitumor activity and pharmacokinetics of nivolumab in patients with NSCLC (n=129), advanced melanoma (n=107), renal cell carcinoma (n=34), castration-resistant prostate cancer (n=17) and colorectal cancer (n=19). Based on an amendment to the protocol, patients were followed-up for survival.
Eligible patients were administered nivolumab as an intravenous infusion every 2 weeks of each 8-week treatment cycle. Cohorts of three to six patients per dose level (0.1, 0.3, 1.0, 3.0 or 10 mg/kg) were enrolled sequentially. Patients continued treatment ≤2 years (maximum of 12 cycles; 4 doses per 8-week cycle), unless they experienced complete response, unacceptable toxicity, progressive disease or withdrew consent. In clinically stable patients, treatment could be continued beyond apparent initial disease progression until confirmed progression, as defined by proposed immune response criteria. Patients with stable disease or an ongoing objective response (OR) at the completion of treatment were followed for ≤1 year and offered retreatment for one additional year if their disease progressed. OR was defined as complete or partial response.
|
提升卡
置顶卡
沉默卡
喧嚣卡
变色卡
千斤顶
显身卡
