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|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|
“Our goal with immuno-oncology is to change survival expectations and
the way patients live with cancer,” said
“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.
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
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.
Cancer cells may exploit “regulator” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor against immune attack. Nivolumab is an investigational, fully-human IgG4 PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. Nivolumab inhibits the binding of PD-1 with its tumor-expressed ligands, programmed death-ligand 1 (PD-L1/B7-H1) and PD-L2 (B7-DC). Blocking of the interaction of the PD-1 receptor with its ligands may allow T-cells to restore an anti-tumor immune response.
The development program for nivolumab consists of more than 25 studies – as monotherapy or in combination with other therapies – in multiple tumors types, including: NSCLC, small cell lung cancer, melanoma, renal cell carcinoma, hepatocellular carcinoma, hematological cancers, triple negative breast cancer, gastric cancer and pancreatic cancer. Among these are seven potentially registrational trials in NSCLC, melanoma and renal cell carcinoma.
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally, resulting in
more than 1.3 million deaths each year according the
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding product development. Such forward-looking statements are based
on current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and
could cause actual outcomes and results to differ materially from
current expectations. No forward-looking statement can be guaranteed.
Among other risks, there can be no guarantee that the clinical trials of
this compound will support regulatory filings, or that the compound will
receive regulatory approvals or, if approved, that it will become a
commercially successful product. Forward-looking statements in this
press release should be evaluated together with the many uncertainties