Anktiva plus BCG Durable CR numbersNow that Anktiva plus BCG has received FDA approval for the treatment of
BCG-unresponsive NMIBC with CIS with or without papillary tumors it is important for Theralase shareholders to go beyond the Internet headlines and be aware of the exact durable complete response numbers that the FDA based their approval on. How does the durable complete response of
Ruvidar PDT compare?
It's not easy to find the
Anktiva plus BCG results expressed in an easily comparable way but the following link provides the numbers we need to make the comparison:
FDA Approves Bladder Cancer Immunotherapy Here is the relevant paragraph:
"The approval is based on the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR). The 77 evaluable patients in a single-arm QUILT 3.032 study received Anktiva with BCG maintenance therapy for up to 37 months. The complete response rate was 62% and the duration of complete response as of the November 2023 cut-off was more than 47 months and is ongoing. Fifty-eight percent (58%) of patients with complete response had a duration of response ≥ 12 months and 40% had a duration of response at ≥ 24 months." Approval was based on the
77 patients who have been
evaluated at 3 years.
CR at any time was
62% which represents
48 out of 77 patients
. 58% of these 48 CR patients had a CR at 12 months.
58% of 48 patients = 28 patients
28 out of 77 patients = 36%
12 month CRR 36% 40% of these 48 patients had a CR at 24 months
40% of 48 patients = 19 patients
19 out of 77 patients = 25%
24 month CRR 25%
Anktiva plus BCG and Ruvidar PDT Durable CRR Comparison | | CRR any time | 12 month CRR | 24 month CRR |
| Anktiva plus BCG | 62% | 36% | 25% |
| Optimized Ruvidar PDT | 64% | 41% | - |
The durable CRR of the standalone optimized Ruvidar PDT treatment is clearly better than that of the Anktiva plus BCG durable CRR. There is good reason to think that Ruvidar PDT patients will have a much higher CR rate at 12 months than 25%. A quick glance at the latest swimmer's plot shows that all of the Ruvidar patients who were CR at 12 months maintained their CR at 15 months.
Ruvidar PDT is a
standalone treatment and achieved it's results after
only 2 treatments. Anktiva is a
combo treatment with BCG (which is in short supply) and going by the prescription label just released by the FDA, patients might require
up to 36 treatments! Label • For induction: 400 mcg administered intravesically with BCG once a
week for 6 weeks. A second induction course may be administered if
complete response is not achieved at month 3. (2.1)
• For maintenance: 400 mcg administered intravesically with BCG once a
week for 3 weeks at months 4, 7, 10, 13 and 19. For patients with an
ongoing complete response at month 25 and later, additional
maintenance instillations with BCG may be administered once a week
for 3 weeks at months 25, 31, and 37. (2.1)