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The first patient has been dosed in the bladder cancer sub-study of the LUMINOS-103 basket trial exploring the novel intratumoral viral immunotherapy PVSRIPO across a variety of solid tumors.1
The sub-study is initially assessing adult patients with resectable bladder cancer who are not eligible for chemotherapy. The treatment is being administered in the neoadjuvant setting both as a monotherapy and in combination with a PD-1 inhibitor. If safety and efficacy outcomes are positive, the investigators hope to launch a future trial to assess whether this treatment can help patients avoid radical cystectomy.
"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," Neal Shore, MD FACS, US chief medical officer of surgery and urology at GenisisCare US and principal investigator responsible for dosing the first patient in the LUMINOS-103 bladder cancer sub-study, stated in a press release.
"We are excited to be initiating the LUMINOS-103 sub-study at the Carolina Urologic Research Center, and we are hopeful that the promising data achieved in previous clinical studies investigating PVSRIPO in patients with glioblastoma and melanoma will translate to positive outcomes for those in the bladder cancer community," added Shore.
According to its developer Istari Oncology, the investigational immunotherapy PVSRIPO is “based on the live-attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety.” Utilizing the poliovirus receptor CD155, the treatment is able to enter both “solid tumor cells and antigen-presenting cells in the tumor microenvironment.” Early research has shown the capacity of PVSRIPO to activate an individual’s immune system to help trigger a systemic antitumor response, according to the company.
Overall, the multi-center phase 1/2 LUMINOS-103 study is an open-label, single-arm basket trial examining PVSRIPO alone or combined with PD-1/L1 inhibitors across multiple tumor types. The bladder cancer sub-study is being conducted at approximately 10 research facilities in the United States. After initial assessment in the neoadjuvant setting, the study will also assess the treatment in the first- and second-line setting for patients with unresectable/metastatic disease. End points of the study include objective response rate (RECIST criteria), durability of response, progression-free survival, recurrence-free survival, and overall survival.
"PVSRIPO has shown impressive responses with monotherapy in patients participating in two phase 1 clinical trials focused on glioblastoma and melanoma," Matt Stober, president and CEO at Istari Oncology, stated in the press release. "We look forward to further evaluating its therapeutic value as we aim to expand the potential treatment options for patients living with bladder cancer."
First Patient Dosed With PVSRIPO in Istari Oncology’s LUMINOS-103 Phase 1/2 Bladder Cancer Sub-Study. Published online October 12, 2021. Accessed October 13, 2021. https://yhoo.it/3aGai2V.