Bristol-Myers Squibb has announced positive findings from their phase 2 clinical study called CheckMate-063, which investigated the efficacy and safety of nivolumab in patients with squamous non-small cell lung cancer (NSCLC). For the study, researchers enrolled 117 patients with NSCLC whose disease had progressed after two or more prior treatments.
All patients were treated with nivolumab. Statistical analyses shows a 1-year survival rate of 41%, much higher than the estimated 5.5-18% typically seen in patients with NSCLC who have progressed after two or more prior therapies.
In addition, they found a median overall survival of 8.2 months, while they had not yet determined the median duration of response. An independent review committee found the objective response rate to be 15%.
In regard to safety, the most common adverse effects observed were diarrhea, fatigue, and lung tissue inflammation. Of the 117 participants, 12% discontinued treatment with nivolumab due to drug-related adverse effects. The company also acknowledged two drug-related deaths.
The findings were presented at the 2014 Multidisciplinary Symposium in Thoracic Oncology in Chicago, Illinois. The findings suggest that nivolumab may also be effective in an ongoing phase 3 study that is investigating nivolumab in patients with NSCLC who have progressed after one prior treatment.
Treatment of a common form of advanced lung cancer with Bristol-Myers Squibb Co’s experimental immunotherapy nivolumab led to a one-year survival rate of 41 percent in a midstage clinical trial, according to data to be presented at a medical meeting, sending the drugmaker’s shares up 8.8 percent.
While the study, called CheckMate-063, did not compare nivolumab with another drug or placebo, the historical one-year survival rate for patients like those in the trial, whose squamous non-small cell lung cancer (NSCLC) had progressed after treatment with two or more prior therapies, is between 5.5 percent and 18 percent, the company said on Thursday. Squamous cell cancer tends to be found in the middle of the lung.