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HER2-Targeted Cancer Therapy Vaccine Provides Clinical Benefits for Multiple Patients With HER2-positive Metastatic Cancer Who Have Not Previously been Treated with Her2-targeting Therapy, National Institutes of Health Researcher (NIH).
Targeted cancer treatments are drugs that block the growth and spread of cancer by interfering with specific molecules involved in the growth and spread of cancer, the NIH said.
Of the 11 evaluable patients who received more than the lowest dose of the vaccine, six (54%) had clinical benefit, reported this small phase 1 clinical trial.
This study showed that a patient with ovarian cancer had a complete response for 89 weeks, a patient with gastroesophageal cancer had a partial response for 16 weeks and 4 patients had a stable disease.
Patient vaccines are individually customized by these NIH researchers using their own immune cells isolated from their blood. Immune cells derived from blood are modified in several ways in the laboratory.
The final product, which is administered between the layers of the skin, comprises dendritic cells derived from the patient genetically modified with an adenovirus to produce portions of the HER2 protein.
"Immunotherapy emphasizes the exquisite specificity of the immune system to destroy cancer, and some types could potentially have fewer side effects than traditional chemotherapy," said Jay A. Berzofsky, MD, PhD, responsible for the vaccine branch of the Cancer Research Center, National Cancer Institute, National Institutes of Health, in a press release.
"We use a vaccine approach to generate an immune response to HER2, which is at elevated levels and promotes the growth of several types of cancer, including breast, ovarian, lung, colorectal and breast cancers. gastroesophageal. "
"Our results suggest that we have a very promising vaccine for cancers overexpressing HER2," Berzofsky continued. "We hope that one day the vaccine will provide a new treatment option for patients with these cancers," said Dr. Berzofsky.
During the phase escalation phase of the Phase I clinical trial, the vaccine was injected to patients at weeks 0, 4, 8, 16 and 24 after enrollment for the study. Of the six patients who received the lowest dose of the vaccine, 5 million dendritic cells per injection, no clinical benefit was observed.
Of the 11 patients who received either 10 million or 20 million dendritic cells per injection, six had clinical benefit.
The adverse reactions were primarily injection site reactions that did not require treatment. No cardiotoxicity was observed.
"On the basis of current safety and clinical benefit data, the vaccine dose was increased to 40 million dendritic cells by injection and the trial was opened to patients previously treated with HER2 targeting treatment, including breast cancer patients, "says Dr. Berzofsky.
"We hope in the future to study whether we can increase the proportion of people benefiting from treatment with the vaccine by combining it with treatment with a checkpoint inhibitor," he added.
According to Dr. Berzofsky, the main scientific limitation of the study is that it is a relatively small Phase I clinical trial with no placebo control. However, the approach is promising enough to warrant additional testing.
Preclinical Studies, previously published in AACR Research against cancer, have shown that this type of vaccine can eliminate large established tumors as well as lung metastases in mice.
This Phase I clinical trial will be presented at the Fourth International Conference on Cancer Immunotherapy organized by CRI-CIMT-EATI-AACR: Translating Science into Survival, September 30, 2018.
This study was funded by intramural funds from the National Cancer Institute. Berzofsky does not declare any conflict of interest.
Media Contact: Julia Gunther [email protected]
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