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Homepage – Forum Forums Raising Awareness Disadvantages of Non Onco-Tice BCG

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    Joe
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    Patients who are being treated with Non Onco-Tice BCG, e.g. Verity-BCG may not be able to receive some of new treatments developed in the US.

    Onco-Tice BCG is the only BCG approved in the US.   Consequently, any new treatment developed in the US for non muscle invasive bladder cancers (NMIBC) patients must use Onco-Tice if the treatment involves BCG.   For example, currently Merck is sponsoring a clinical trial for BCG Unresponsive (those who have recurrence after at least receiving  6 weeks induction + one 3 weeks maintenance) in the US and Canada.  Only patients being treated with Onco-Tice has been participate in this clinical trial.    The main focus of drug companies is the US market which  is 10 times bigger than in Canada.  Also, drug companies want  to complete a clinical trial as short as possible to reduce the cost for clinical trials and to shortened  the time to market the new drug so they can  start earning money on the new drug.   Average cost for conducting clinical trial for  cancer drugs is US$20M and clinical trials take 6-7 years on average to complete.  So, designing a clinical trial working with the FDA which can minimize the cost and the length of the clinical trial is critical for pharmaceutical companies. To achieve this, pharmaceutical companies do not want to bring many variables into the clinical trial.  For example, for any new drug/treatment  involving BCG, only the ONCO-TICE BCG is used in the USA.   Drug companies do not want other BCGs including Verity-BCG in the clinical trial.   FDA’s role is to make sure that the new drug or treatment is safe and effective for patients in American population.   Canada takes advantage of FDA’s result so spend less to qualify the new drug for Canadian.  Note that the annual budget of Health Canada and FDA is $100 million and $8.4 billion respectively.   Canadian can take advantage of proximity of two countries by being able to participate clinical trials which are hosted by drug companies in the US.

    A certain percentage of high risk NMIBC patients will experience recurrence in spite of BCG treatment.  Up to recently, radical cystectomy remained the mainstay after BCG failure. To provide bladder preservation opportunities, a few new treatments have been approved by FDA and several new treatments are in clinical trial phase for BCG Unresponsive patients.  Some of those new promising treatments require patients having been treated with ONCT-TICE BCG.only   This leaves BCG Unresponsive with Verity-BCG not accessible to those clinical trials.   Also, it is questionable for BCG Unresponsive patients with Non Onco-Tice BCG to qualify for the treatment approved in the US if the treatment involves ONCO-TICE BCG.  Below are such examples.

    KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC    (BCG + Immunotherapy Keytruda)
    KEYNOTE-676 started in December 2018, and the estimated study completion date is 25 November 2024.The planned sample size is approximately 550 participants, including no more than 182 patients with non-CIS disease.  180 study locations including 8 locations in Canada.     Only patients with Onco-Tice BCG have been included.

    The reason this issue is pointed out is because sponsors (drug company) refused to include patients who have been treated with reduced dosage, i.e. ⅓  of BCG even if 1/3 dosage was on the consensus  by AUA and other urology communities to alleviate BCG shortage problem in the USA.  In recent years, FDA and drug companies are working together to include patients with reduced doses. But they find it challenging as they need another cohort. Because of this reason, only ONCO-TICE BCG will be used as the BCG if BCG is involved in clinical trial and patients who have been treated with ONCO-TICE BCG will be included in the clinical trial which involve BCG.

    QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer    (BCG + Interleukin 15)

    Quit-3.032 clinical trial is sponsored by Immunity Bio. Inc.  The phase ⅔ study started in 2017 with 200 patients enrolled at 32 study sites in the US.   Estimated study completion date is January 2023.   The result of the trial was published in New England Journal of Medicine on November 10, 2022.  The result was very impressive and it is expected to be early 2023 and can be used  the first line treatment of BCG Unresponsive.

    The complete response rate 71% of 58 patients with median duration of 26.6 months. At 24 months in patients with complete response, 89.2% avoided cystectomy and disease specific survival rate was 100%.  All BCG Unresponsive patients had been treated Onco-Tice BCG and all patients on his trail have been treated with Onco-Tice BCG.  The price of this treatment is expected to be $100K+ a year in the US as other bladder cancer drugs for NMIBC were priced over $100K+ year.   If Immunitybio, the company who developed the drug, wants to sell it to Canada, the company must give a heavy discount as other bladder cancer drugs were sold to Canada with heavy discount. Canadian patients who have been treated with Onco-Tice would qualify for this treatment.  Question is we do not know if ImmunityBio and Health Canada approves this treatment for patients who have been treated with non ONCO-TICE BCG, i.e.Verity-BCG.  There exist uncertainty for patients being treated with Verity-BCG.

    To mitigate such risk, one solution is that ONCO-TICE BCG should be used as much as possible by ordering ONCO-TICE BCG as much as MERCK can allocate to Canada, and the rest can be supplemented with Verity-BCG.  In this way, majority patients will be able to benefit from the new drug development which involves BCG.  However, I sense that is not happening in Canada.  As Marysue mentioned, if Alberta is prescribing Verity-BCG to every high risk NMIBC patient, none of those patients  can benefit from those two treatments if BCG is involved in the treatment, whereas patients in other provinces such as British Columbia where Onco-Tice are being prescribed can.

     

     

     

    • This topic was modified 1 year, 3 months ago by Joe.
    • This topic was modified 1 year, 3 months ago by Joe.
    • This topic was modified 1 year, 3 months ago by Joe.
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