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

The Food and Drug Administration granted a fast track designation to PDS0101 plus Keytruda for the treatment of patients with recurrent or metastatic HPV16-related head and neck cancer.

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

The goal of fast track designations, according to the FDA, is to fill unmet medical needs by expediting the review and development of promising drugs. This is the case for head and neck cancer, a disease whose incidence continues to increase in the United States. Research has also shown that the majority of HPV-driven head and neck cancers are driven by the HPV16 strain.

“The HPV-associated head and neck cancer prevalence continues to rise, leaving this affected group with limited treatment options to date. Receiving this designation underscores … the need for a new therapy that may improve outcomes for those with this devastating disease,” Frank Bedu-Addo, CEO of PDS Biotech, said 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 delivered via injection under the skin, and prior research has shown that it can potentially target anal, cervical, head and neck, penile, vaginal and vulvar cancers that are related to the HPV 16 infection.

The drug duo is currently being investigated in the open-label phase 2 VERSATILE-002 clinical trial, where 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 trial showed that PDS0101 plus Keytruda led to a 41% response rate in patients with recurrent or metastatic head and neck cancer. Eighty-nine percent of patients were alive at an average of nine months, and 76.5% of patients experienced either disease stabilization or tumor shrinkage. The majority (94%) of patients on the trial received four out of five of the doses, with no severe (grade 3 or higher) side effects.

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

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