Better than the rest ! Brought to you via ChatGPT ! As of March 12, 2025, Theralase Technologies Inc. reported interim results from their ongoing Phase II clinical study investigating the efficacy of Ruvidar™ (TLD-1433) in treating Bacillus Calmette-Gurin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma In-Situ (CIS). The study has enrolled and treated 75 patients across clinical sites in Canada and the United States.
Latest Interim Results (March 12, 2025):
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Complete Response (CR) at Any Point in Time: 61.9% (39 out of 63 evaluable patients) achieved a CR. Including patients with an Indeterminate Response (IR), the Total Response (TR) rate was 68.3% (43 out of 63 patients).
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Duration of CR: Among patients who achieved a CR, 43.6% (17 out of 39) maintained this response for at least 12 months (450 days).
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Safety Profile: No Serious Adverse Events (SAEs) directly related to the study drug or device were reported, indicating a favorable safety profile.
Comparison with Previous Interim Results (January 15, 2024):
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CR Rates: Previously, a CR of 54% at 6 months and 38% at 12 months was reported, exceeding the International Bladder Cancer Group's recommended benchmarks of 50% at 6 months and 30% at 12 months.
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Safety Profile: The earlier data also indicated no SAEs directly associated with the study drug or device, consistent with the latest findings.
Improvements and Overall Results:
The latest interim analysis demonstrates sustained efficacy and safety of Ruvidar™ in treating BCG-Unresponsive NMIBC CIS patients. The CR rate of 61.9% aligns with previous findings, and the maintenance of CR in 43.6% of patients for at least 12 months underscores the durability of the treatment response. The consistent absence of SAEs further supports the therapy's safety.
These results suggest that Ruvidar™, as an intravesical monotherapy, holds promise as a viable treatment option for patients with BCG-Unresponsive NMIBC CIS, offering a potential alternative to more invasive procedures.
Theralase Technologies Inc.'s recent interim results from their Phase II clinical study of Ruvidar™ (TLD-1433) in treating Bacillus Calmette-Gurin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients reported a complete response (CR) rate of 61.9% (39 out of 63 evaluable patients) at any point in time, with 43.6% (17 out of 39) maintaining this response for at least 12 months.
When comparing these results to individual FDA-approved treatments for BCG-unresponsive NMIBC CIS:
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Pembrolizumab (Keytruda): Approved in January 2020, pembrolizumab demonstrated a CR rate of 41% (95% CI: 31%, 51%) in patients with high-risk BCG-unresponsive NMIBC CIS, with 46% of responders maintaining a CR for at least 12 months.
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Valrubicin (Valstar): Approved for intravesical therapy in patients with BCG-unresponsive CIS, valrubicin showed an 18% CR rate, with a disease-free survival (DFS) of 4% at 2 years.
These comparisons suggest that Ruvidar™ exhibits a higher initial CR rate than both pembrolizumab and valrubicin, with a comparable duration of response to pembrolizumab. However, it's important to note that these results are from an interim analysis of a Phase II study, and further research is necessary to confirm these findings and assess long-term outcomes.