Locations of urinary bladder in males (left) and females (right). Credit: GregZak.

Inovio Pharmaceuticals has dosed its first patient in a Phase l/lla trial to analyse the safety, immunogenicity and clinical efficacy of INO-5401 plus INO-9012 in combination with atezolizumab for the treatment of advanced or metastatic bladder cancer.

The non-randomised, open-label, multi-centre trial is expected to enrol 85 patients who have been divided into two cohorts.

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Cohort A comprises patients with confirmed disease progression during or following prior checkpoint inhibitor therapy, while Cohort B includes patients who are treatment naïve and unfit for cisplatin-based therapy.

As part of the trial, Inovio seeks to conduct a safety run-in for the first six patients of Cohort A to observe emergence of any dose-limiting toxicities.

INO-5401 and INO-9012 will be given by intramuscular injection followed by electroporation every three weeks for the first four doses, every six weeks for six doses and every 12 weeks until the disease progression reached.

“We remain on track and look forward to producing interim clinical results in 2019.”

In addition, a 1,200mg intravenous dose of atezolizumab will be given every three weeks until disease progression.

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Among other tests, tumour imaging and disease assessment will be carried out as per RECIST and iRECIST.

The trial’s primary endpoints are incidence of adverse events (AEs), antigen-specific immunologic activation and objective response rate (ORR) in Cohort A.

Its secondary endpoints include Cohort B’s ORR, duration of response, progression-free survival and overall survival.

Inovio Pharmaceuticals president and CEO Dr J Joseph Kim said: “Bladder cancer is considered an immunogenic tumour and our approach is to combine INO-5401/INO-9012 with atezolizumab as we believe this may provide a synergistic therapeutic effect by generating functional and activated T-cells while simultaneously inhibiting PD-L1.

“We remain on track and look forward to producing interim clinical results in 2019.”