CG Oncology has commenced the Phase III PIVOT-006 clinical trial of cretostimogene for the treatment of intermediate-risk non-muscle invasive bladder cancer (NMIBC) with the dosing of the first subject.

The open-label, two-arm, monotherapy trial is enrolling 426 NMIBC patients following transurethral resection of the bladder tumour (TURBT).

The initial induction course of the PIVOT-006 trial involves six weekly doses of adjuvant cretostimogene, each containing 1×1012 VPs per ml.

Patients who show no signs of recurrence at the three-month mark will undergo a maintenance course. This includes three weekly doses of the same amount in months three and six, followed by single weekly doses in months nine and 12.

Overall recurrence-free survival (RFS) is the trial’s primary endpoint while secondary endpoints include RFS at 12 and 24 months and progression-free survival.

An investigational oncolytic immunotherapy, cretostimogene is also being assessed in the BOND-003 Phase III clinical trial for Bacillus Calmette-Guerin (BCG)-unresponsive NMIBC.

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In addition, cretostimogene is under evaluation in a Phase II trial (CORE-001) in combination with pembrolizumab for the same indication.

Another investigator-sponsored trial is assessing the combination of immunotherapy with nivolumab for the treatment of muscle-invasive bladder cancer.

CG Oncology chairman and CEO Arthur Kuan said: “The dosing of the first patient in our PIVOT-006 trial advances cretostimogene earlier in the treatment paradigm for NMIBC patients who face limited treatment options, frequent disease recurrence, and repetitive surgery.

“Intermediate-risk NMIBC patients face a difficult combination of disease characterised by tumour recurrence and a shortage of BCG therapy, which is often reserved for use only in high-risk patients, limiting treatment options for intermediate-risk patients. Our goal with the PIVOT-006 trial is to advance cretostimogene as a potential backbone oncolytic immunotherapy.”

In November 2021, the company reported initial data from the Phase II CORE1 clinical trial of its CG0070, along with Merck’s (MSD) Keytruda (pembrolizumab), to treat individuals with NMIBC who are unresponsive to BCG.