Oncofid-P-B for High Risk NMIBC: Do We Really Need a Phase III? Yes, We Do - Beyond the Abstract

Dr. Rodolfo Hurle and co-workers showed, in their phase I multicentric international study, that Oncofid-P-B development by Fidia Farmaceutici S.p.A. (Italy), may be considered an innovative compound for the treatment of high-risk and very high-risk nonmuscle-invasive bladder cancer (NMIBC).1 Oncofid-P-B results from the chemical conjugation of paclitaxel with hyaluronic acid (HA). HA has been studied for a long time from urologists and it was used for the treatment of urinary tract infection, interstitial cystitis, and late radiation induced cystitis.2 Hurle’s report opens a new scenario. One of the main functions of urologists, who are involved in the management of bladder cancer, is to discover and deliver safe, effective, and affordable treatments to patients, based on their personalized needs. The treatment of high-risk and very high-risk NMIBC remains challenging. Preliminary results showed that Oncofid offers a new paradigm for how to manage those patients.


The complete response rate at the end of the intensive phase was 75.0% [95% CI: 50.90 to 91.34], while at month 3 of the maintenance therapy (6 months after treatment start) was 65.0% [95% CI: 40.78 to 84.61] and at the end of the maintenance phase (15 months after treatment start) was 40.0% [95% CI: 19.12 to 63.95]. The combination of paclitaxel and HA revealed an excellent safety and tolerability profile, with a good compliance rate and without systemic absorption, when administered at a dose of 600 mg weekly for 12 consecutive weeks followed by 12 monthly administrations. Unfortunately, those results are limited to phase I and limit their clinical use.

The BCG shortage, the FDA not approval of Vicinium for BCG-unresponsive NMIBC, and the poor safety/efficacy profile of Keytruda prompt a confirmatory larger phase III study for Oncofid-P-B to allow patients receiving innovative “bladder sparing” treatment for high-risk NMIBC.

Very high-risk group, risk factors: age>70, multiple papillary tumors, tumor diameter > 3 cm.

  • Ta HG/G3 and CIS with all 3 risk factors
  • T1 G2 and CIS with at least 2 risk factors
  • T1 HG/G3 and CIS with at least 1 risk factor
  • T1 HG/G3 no CIS with all 3 risk factors
High-risk group, risk factors: age>70, multiple papillary tumors, tumor diameter > 3 cm.

  • All T1 HG/G3 without CIS, EXCEPT those included in the very high-risk group
  • All CIS patients, EXCEPT those included in the very high-risk group
  • Ta LG/G2 or T1 G1, no CIS with all 3 risk factors
  • Ta HG/G3 or T1 LG, no CIS with at least 2 risk factors
T1 G2 no CIS with at least 1 risk factor.

Written by: Rodolfo Hurle, Roberto Contieri, Massimo Lazzeri, Department of Urology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

References:

  1. Hurle R, Guazzoni G, Colombo P, et al. Oncofid-P-B: a novel treatment for BCG unresponsive carcinoma in situ (CIS) of the bladder: Results of a prospective European Multicentre study at 15 months from treatment start. Urol Oncol. 2021 Oct 11:S1078-1439(21)00308-2. doi: 10.1016/j.urolonc.2021.07.007.
  2. Redorta JP, Sanguedolce F, Pardo GS, et al. Multicentre International Study for the Prevention with iAluRil of Radio-induced Cystitis (MISTIC): A Randomised Controlled Study. Eur Urol Open Sci. 2021 Feb 23;26:45-54. doi: 10.1016/j.euros.2021.01.016.

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