First Patient Receives Novel Immunotherapy in Bladder Cancer Sub-Study


The first patient with bladder cancer was dosed in a phase 1/2 trial examining responses to an investigational immunotherapy.

In early October, the first patient with bladder cancer was dosed in a stage 1/2 trial of an investigational intratumoral viral immunotherapy called PVSRIPO. The treatment is being given as a neoadjuvant therapy with or without PD-1 inhibitors in patients with adult bladder cancer who aren’t eligible for chemotherapy.

The study, LUMINOS-103, is being conducted at 10 different research sites in the U.S. and will examine results for patients with resectable disease as well as those with metastatic disease. Researchers will also evaluate PVSRIPO in patients with other tumor types, such as head and neck cancer.

“Bladder cancer patients, particularly those who cannot receive cisplatin-based chemotherapy or who have advanced disease, are urgently in need of viable treatment options that limit systemic toxicity and improve patient outcomes,” said Dr. Neal Shore, U.S. chief medical officer of surgery and urology at GenisisCare US and principal investigator responsible for dosing the first patient, in a release.

The sub-study analysis will occur once 25 to 30 patients have been enrolled and treated for at least two months in each treatment group.

PVSRIPO activates patients’ immune systems to create an antitumor response and uses the poliovirus receptor – CD155 – to enter tumor cells and antigen-presenting cells in the tumor microenvironment. This gives it the potential to treat a variety of cancers.

The treatment showed positive results with monotherapy for patients with glioblastoma and melanoma who participated in phase 1 clinical trials.

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