Ongoing Trial Investigates Cancer Vaccine Plus Keytruda for TNBC

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An ongoing phase 1 trial is analyzing the use of a novel cancer vaccine plus the immunotherapy agent, Keytruda, for patients with triple-negative breast cancer.

Researchers are investigating the combination of a novel cancer vaccine with Keytruda for triple-negative breast cancer.

Patients with triple-negative breast cancer (TNBC) are now being enrolled in an expansion phase of an ongoing phase 1 clinical trial that is evaluating a novel cancer vaccine in addition to the immunotherapy agent, Keytruda (pembrolizumab), according to a press release from Anixa Biosciences, the manufacturer of the vaccine.

The first phase of the trial determined the proper dosing of the drugs, while this next step — which is kicking off at the Cleveland Clinic in Ohio —will determine if the vaccine/Keytruda combination boosts the immune response against cancer for patients with TNCBC who have previously undergone curative standard of care and, at the time of treatment with the vaccine, have no tumors remaining, but are at a high risk of recurrence.

The TNBC vaccine works by creating T cells (a type of immune “fighter” cell) that will target TNBC cells, while Keytruda works by inhibiting PD-1 receptors, which are found on cancer cell surfaces and help tumors hide from the immune system. By inhibiting PD-1, T cells can better find and fight the cancer.

The “triple negative” in TNBC refers to the fact that the cancer is estrogen or progesterone-receptor (ER and PR)-negative, as well as HER2 negative, according to the American Cancer Society. While approximately 10-15% of all breast cancer cases are TNBC, the aggressive disease subtype tends to account for a disproportionately higher percentage of breast cancer-related deaths and recurrences. Additionally, TNBC is more likely to occur in African American women and in individuals with a BRCA1 mutation.

"Cleveland Clinic has demonstrated in both preclinical and clinical studies that our breast cancer vaccine induces an immune response — including, we believe, production of T cells that can target TNBC — so we believe that the addition of Keytruda could have a synergistic effect,” Dr. Amit Kumar, chairman and CEO of Anixa said in the press release.

This is not the only current clinical trial that is investigating the use of vaccines to treat cancer. Read more about ongoing cancer vaccine trials:

“If a vaccine induces the creation of T cells targeting TNBC, and Keytruda generally maintains T cell activity, the combination could be very potent. We are grateful to the U.S. Department of Defense for providing the funding for this new arm of the trial and look forward to Cleveland Clinic's presentation of the updated data from this trial at the San Antonio Breast Cancer Symposium (SABCS) in December,” Kumar said.

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