SIU 2019 39th Annual Society of International Urology Congress

SIU 2019: Oncofid-P-B for the Treatment of BCG Unresponsive Carcinoma In Situ (CIS) of the Bladder – Results of the European Multicenter Phase 1 Study at the End of 12 Consecutive Weeks Intensive Course

Athens, Greece (Urotoday.com) Oncofid-P-B is a conjugate of paclitaxel and Hyaluronic acid (HA) for the treatment of non-muscle-invasive bladder cancer (NMIBC) by intravesical instillation.

This conjugate confers tumor-targeted activity, improves paclitaxel solubility, reduces paclitaxel toxicity, and confers mucoadhesive properties.

A phase 1 study with multiple escalating doses (150-750 mg for 6 weeks) in 16 BCG refractory carcinoma in situ (CIS) patients showed a complete response rate of 60%. Later, a phase two study (600 mg for 6 weeks + maintenance) in 60 Ta G1-G2 patients demonstrated a 45% complete response rate with disease-free survival of 15.7 months. The drug demonstrated excellent efficacy and safety in all preliminary trials.

The presented study was an open-label, multicenter, multinational, phase 1 study to evaluate the safety and efficacy of this drug in 20 patients with CIS +/- Ta/T1 who were unresponsive or intolerant to BCG and unwilling or unfit to undergo radical cystectomy.

A total of 12 consecutive weekly instillations (intensive phase) were given and followed by 12 monthly installations (maintenance phase). The primary endpoint was the overall safety profile. The secondary endpoints included efficacy, compliance, rate of discontinuation, and systemic absorption. Complete response was defined as a negative cystoscopy including biopsy of the urothelium and negative e cytology.

A total of 21 patients were approached, but 20 were ultimately analyzed. 16 were male, and the mean age was 72.8 years, with all patients being Caucasian. 17 patients had pure CIS and 4 had CIS + Ta.

During the intensive phase, 7 mid-moderate (G1-G2) drug-associated adverse effects including hematuria, proteinuria, nausea, and urticaria were reported. There were no withdrawals resulting from the drug during treatment.

A total of 15/20 patients (75%) reached a complete response rate at the end of the intensive phase. None of the non-responders developed disease progression.

Dr. Rodolfo Hurle concluded that Oncofid-P-B has an excellent safety profile even after a prolonged treatment schedule. The efficacy data is quite favorable. This study shows a potential new therapeutic option in BCG unresponsive CIS patients which deserves further clinical evaluation.

Presented by: Rodolfo Hurle, MD, Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy

Written by: Hanan Goldberg, MD, Urology Department, SUNY Upstate Medical University, Syracuse, New-York, USA @GoldbergHanan at the 39th Congress of the Société Internationale d'Urologie, SIU 2019, #SIUWorld #SIU2019, October 17-20, 2019, Athens, Greece  

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