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news.Dendreon has reported positive results from a Phase I study of Neuvenge, an investigational active cellular immunotherapy, in advanced breast cancer patients who have failed standard therapy.
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“In addition to demonstrating that Neuvenge was safe and well tolerated, the T-cell responses seen in these patients and the prolonged disease stabilization in the absence of other anticancer therapies in many patients is promising,” said John Park, associate clinical professor of medicine and neurosurgery at the University of California, San Francisco.
“The findings warrant additional studies of Neuvenge for the many women with advanced breast cancer who have exhausted many of their treatment options,” he added.
The Phase I study was conducted to evaluate the safety and immunologic activity of Neuvenge in patients with HER2-overexpressing metastatic breast cancer who had failed standard therapy, including prior treatment with chemotherapy and trastuzumab. All patients had experienced disease progression while on standard therapy.
There were 19 patients enrolled in the study with 18 patients receiving treatment with Neuvenge. Patients underwent three infusions of Neuvenge at weeks 0, 2, and 4 following randomization. Patients who achieved a partial response, or had stable disease lasting through week 52, were eligible for re-treatment, a booster, using the same protocol and dose as the initial treatment. Endpoints included safety, immunologic activity and antitumor activity.
Dendreon says treatment with Neuvenge was generally well tolerated. The majority of side effects were mild, and no patient discontinued the trial because of toxicity. The product stimulated significant immune responses, which were shown to be enhanced following booster infusions. In total, 22% of patients had evidence of anticancer activity.
This included one patient who experienced a partial response lasting approximately six months and three patients who had stable disease for over a year (74.9-94.0 weeks) without the addition of any other cancer therapy other than the continuation of bisphonates.
Two additional patients had stable disease for up to 20 weeks. The study concluded that Neuvenge was feasible, well-tolerated and showed evidence of anticancer activity.
“These data, together with the data we have published on the use of Provenge in prostate cancer, further substantiate the promise of active cellular immunotherapies as new treatments for different types of cancer,” commented Mark Frohlich, vice president of clinical affairs at Dendreon.