FDA Fast Tracks Novel Immunotherapy-Keytruda Combo for HPV-related Head and Neck Cancer

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According to PDS Biotech, the pharmaceutical company that makes PDS0101, the Food and Drug Administration (FDA) has PDS0101 plus Keytruda (pembrolizumab) fast-track designation for the treatment of patients with recurrent or metastatic HPV16-positive head and neck cancer granted.

According to the FDA, the goal of fast-track approvals is to fill unmet medical needs by accelerating the review and development of promising drugs. Such is the case with head and neck cancer, a disease whose incidence in the United States continues to increase. Research has also shown that the majority of HPV-related head and neck cancers are caused by the HPV16 strain.

“The prevalence of HPV-associated head and neck cancer continues to rise, leaving only limited treatment options available to this affected group. Receiving this designation underscores… the need for a new therapy that can improve outcomes for patients with this devastating disease,” said Frank Bedu-Addo, CEO of PDS Biotech, in a press release.

PDS0101 is an HPV-specific immunotherapy that may be able to stimulate high levels of HPV16-specific CD8+ and CD4+ T cells to attack the disease. The drug is given by injection under the skin, and previous research has shown that it can potentially target anal, cervical, head and neck, penile, vaginal, and vulvar cancers associated with HPV-16 infection keep in touch.

The drug duo is currently being evaluated in the open-label phase 2 clinical trial VERSATILE-002, in which all patients will receive both PDS0101 and Keytruda; there is no placebo or control group.

Preliminary data from the first 19 patients enrolled in the study showed that PDS0101 plus Keytruda resulted in a 41% response rate in patients with recurrent or metastatic head and neck cancer. Eighty-nine percent of patients survived for a median of nine months, and 76.5% of patients experienced either disease stabilization or tumor shrinkage. The majority (94%) of patients in the study received four out of five doses with no serious (Grade 3 or greater) adverse events.

Data from the VERSATILE-002 clinical study will be presented at the upcoming ASCO Annual Meeting.

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