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PD18-04 A PHASE 1 SAFETY STUDY OF ONCOFID-P-B ADMINISTERED FOR 12 CONSECUTIVE WEEKS IN BCG UNRESPONSIVE/INTOLERANT PATIENTS WITH BLADDER CARCINOMA IN SITU (CIS): PRELIMINARY RESULTS

INTRODUCTION AND OBJECTIVES: Oncofid-P-B (Fidia Farmaceutici) is a novel water-soluble muco-adhesive conjugate of paclitaxel-hyaluronic acid (P-HA. Very favorable safety and efficacy after 6 weeks in BCG unresponsive CIS patients and after 6 weeks followed by 6+6 months in Ta G1-G2 patients was previously reported. The excellent safety profile prompted the design of this trial to assess safety, tolerability and efficacy of P-HA administered for 12 consecutive weeks, followed by 12 monthly instillations, in BCG unresponsive/intolerant CIS patients. METHODS: This is an open-label, single arm, multicenter study to assess safety, tolerability and efficacy of P-HA administered in 20 patients with CIS, who are unresponsive or intolerant to BCG and unwilling or unfit for cystectomy. P-HA was administered weekly by intravesical instillation for 12 consecutive weeks (intensive phase), followed, in responsive patients, by 12 monthly instillations (maintenance). The primary end-point is the overall safety profile. Secondary endpoints include i) efficacy after the intensive phase and after the entire treatment period, ii) compliance, iii) systemic absorption. The complete response (CR) is defined as a negative cystoscopy including biopsy of the urothelium and negative cytology. Patients who achieve a CR after intensive phase are followed up every 3 months for up to 1 year during maintenance, by flexible cystoscopy and urine cytology. For PK assessment, blood samples are collected after the 1stand 12th instillation. RESULTS: Of the 17 patients enrolled (15 M, 2 F), 11 have completed the 12 weeks intensive course. The instillations were very well tolerated; no patients withdrew from the study. Only one drug related AE (orticaryoid reaction) was reported in one patient after the 1st maintenance. All plasma samples collected at any time were below the limit of quantification (1 ng/mL). Of the 11 patients who completed the intensive course, 8 (73%) showed a CR. Of these, 1 was still disease free after 12 months, 1 relapsed after 3 months, 6 are continuing the monthly instillations without disease relapse. CONCLUSIONS: Our preliminary data show that P-HA is very well tolerated when administered for up to 12 consecutive weeks, with no drug related AEs and no study withdrawal. 73% (8/11) of patients who completed the 12-week phase were disease free. No systemic absorption was observed at any time. The excellent tolerability for a prolonged treatment schedule coupled with the good clinical results support its further clinical development. Source of Funding: None