The phase 1/2 LUMINOS-103 trial will evaluate the intravesical instillation of lerapolturev in a cohort of patients with non-muscle-invasive bladder cancer.
Trial Name: LUMINOS-103: A Basket Trial Evaluating the Safety and Efficacy of Lerapolturev (PVSRIPO) and Lerapolturev in Combination With Anti-PD-1/L1 Checkpoint Inhibitors in Patients With Advanced Solid Tumors
ClinicalTrials.gov Identifier: NCT04690699
Sponsor: Istari Oncology, Inc.
Recruitment Contact: Istari Clinical, 919-245-7662, LUMINOS-103@IstariOncology.com, and Lisa Franklin, lfranklin@istarioncology.com
Completion Date: May 2025
The first patient has been dosed with lerapolturev (PVSRIPO) via intravesical instillation in the non-muscle-invasive bladder cancer (NMIBC) cohort of the phase 1/2 LUMINOS-103 basket trial (NCT04690699), according to Istari Oncology, Inc.1
The open-label, multi-center, single arm, phase 1/2 LUMINOS-103 trial aims to administer lerapolturev with or without PD-1/L1 inhibitors to adult patients with solid cancers. NMIBC has been selected as the tumor specific cancer of interest for enrollment in the study.
Lerapolturev is an investigational immunotherapy which is made from the live attenuated Sabin type 1 polio vaccine and was genetically modified for safety. The target of lerapolturev is the poliovirus receptor CD155, which is widely expressed in the neoplastic cells of most solid tumors. The agent recalls the polio vaccine specific T-cells, allowing lerapolturev to amplify the body’s immune response. Further, the treatment activates and engages antigen presenting cells (APCs), provides sustained immunity, and directs the killing of tumor cells and antigen release.
“We’re pleased to be the exclusive site for the NMIBC sub-study,” said Neal Shore, MD, principal investigator, and director at the Carolina Urologic Research Center, in the press release. “This is a largely unaddressed population of [patients with] NMIBC that, if we can identify and intervene early and effectively with a therapy like lerapolturev, can avoid progression and repeated surgeries or treatment with BCG [Bacillus Calmette-Guérin], which has experienced severe shortages.”
Within the substudy, investigators will examine the intravesical instillation of lerapolturev and determine its effect when infecting tumor cells and infiltrating antigen presenting cells within tumor tissue lining the bladder mucosa.
Approximately 12-15 patients aged 18 years and older with measurable disease, an ECOG performance status of 0 or 1, adequate bone marrow and liver function, and resolution of all non-hematologic toxicities resulting from a previous therapy or surgical procedure to ≤ grade 1 or baseline, excluding alopecia, will be enrolled in the study.2
Further, patients must have received the prior CDC-recommended vaccination series against PV and have received a boost immunization with trivalent Poliovirus Vaccine Inactivated at least 1 week, but less than 6 weeks, prior to day 1 of cycle 1, and a formalin-fixed paraffin-embedded tumor specimen along with a pathology report stating the histology of the tumor type must be confirmed and sent to the sponsor.
The primary end point of the study is to assess the proportion of patients who undergo trans urethral resection of bladder tumor (TURBT) or cystectomy as scheduled.
Patients are being recruited who have a prior history of stage Ta, T1, or Tis urothelial carcinoma of the bladder, recurrent disease requiring TURBT, or cystectomy.
If findings from the trial are successful, phase 2 of the study will enroll the planned patient population of individuals with low- to intermediate-risk BCG-naïve disease.
Recruitment for the NMIBC cohort of this substudy remains ongoing and is expected to reach full enrollment by the middle of 2023.
“We know that NMIBC tissue expresses the poliovirus receptor, CD155 and is responsive to immunotherapy, providing the rationale for intravesical lerapolturev for patients with low to intermediate risk BCG-naïve NMIBC,” said W. Garrett Nichols, MD, MS, chief medical officer at Istari Oncology. “Approximately 60,000 patients with low to intermediate risk NMIBC are identified each year in the US alone; these patients could benefit from a well-tolerated immunotherapy such as lerapolturev as a replacement for repeat resections and intravesical chemotherapy.”
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