Updated Trial Results Demonstrating Benefit of Opdivo® Were Released Today at the 16th World Conference on Lung Cancer

Posted on September 10th, 2015 by

Results from the CheckMate -017 and -063 clinical trials evaluating Opdivo® (nivolumab) in previously treated squamous cell non-small cell lung cancer (NSCLC) were released today at the 16th World Conference on Lung Cancer (Abstract #736), and the studies showed sustained survival benefit. Both trials showed an estimated 18-month overall survival (OS) rate of 27% (CheckMate -063) to 28% (CheckMate -017).

Lung cancer remains the leading cause of cancer-related deaths worldwide. In the United States, NSCLC accounts for 75–80% of all lung cancers. Although progress has been made in recent years, the majority of patients with advanced-stage lung cancer still die from their disease. New treatments are sorely needed.

Opdivo is a precision cancer medicine that belongs to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to help the immune system recognize and attack cancer. PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1 may enhance the ability of the immune system to fight cancer. Opdivo works by blocking PD-1. PD-1 inhibitors are being investigated in more than 30 different cancers, and early studies in melanoma are promising.

CheckMate -063 is a single-arm, open-label trial that included patients with metastatic squamous cell NSCLC who had progressed after receiving a platinum-based therapy and at least one additional systemic treatment regimen. In this trial, Opdivo showed an estimated 18-month OS rate of 27%. At 18 months, confirmed objective response rate—the study’s primary endpoint—was 15%.  Median OS was 8.1 months and the therapy was well tolerated.

Previously reported one-year results from CheckMate -017 showed a significantly superior OS rate of 42% versus 24% for docetaxel. In CheckMate -063, the estimated one-year survival rate was 39%.

Precision cancer medicine is an evolving concept in the treatment of lung cancer that aims to leverage new genomic information about a specific cancer to more precisely target treatment. Precision medicine seeks to define the genomic alterations that are driving a specific cancer, rather than relying on a simple broad classification of cancer solely based on its site of origin.

Genomic tests are used to identify the specific genes in a cancer that are abnormal or are not working properly. In essence, this is like identifying the genetic signature or fingerprint of a particular cancer. Genomic testing is different from genetic testing. Genetic tests are typically used to determine whether a healthy individual has an inherited trait (gene) that predisposes them to developing cancer. Genomic tests evaluate the genes in a sample of diseased tissue from a patient who has already been diagnosed with cancer. In this way, genes that have mutated, or have developed abnormal functions, are identified in addition to those that may have been inherited.

Most or all lung cancers result from abnormal genes or gene regulation. The cause of these changes can be environmental, spontaneous, or inherited. By identifying the genomic changes and knowing which genes are altered in a patient, cancer drugs that specifically attack that gene (or the later consequences of that gene) can be used to target the cancer and avoid the more general side effects of chemotherapy.

Recently, precision, targeted, and more individualized treatment for NSCLC has become a reality. Results from studies evaluating ALK-inhibitors continue to show efficacy and initial studies exploring immunomodulatory approaches using anti-PD-1 antibodies have demonstrated high response rates and slowed cancer progression in previously untreated stage IV NSCLC. Several advances have recently been reported and it is anticipated that results from these trials will be presented along with new information on the management of lung cancer.

Source: Bristol-Meyers Squibb Press Release

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Tags: CheckMate, Lung Cancer, Lung Cancer - Non-Small Cell, News, nivolumab, non-small cell lung cancer, nsclc, opdivo, PD-1 inhibitors, Recurrent Lung Cancer - Non-Small Cell, stage III, stage IV

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