RE:Competitor results ! Oden6570 wrote: Findings
Between Sept 19, 2016, and May 24, 2019, 198 patients were assessed for eligibility. 41 patients were excluded, and 157 were enrolled and received at least one dose of the study drug. Six patients did not meet the definition of BCG-unresponsive non-muscle-invasive bladder cancer and were therefore excluded from efficacy analyses; the remaining 151 patients were included in the per-protocol efficacy analyses. 55 (53·4%) of 103 patients with carcinoma in situ (with or without a high-grade Ta or T1 tumour) had a complete response within 3 months of the first dose and this response was maintained in 25 (45·5%) of 55 patients at 12 months. Micturition urgency was the most common grade 3–4 study drug-related adverse event (two [1%] of 157 patients, both grade 3), and there were no treatment-related deaths.
Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial - ScienceDirect
So the above findings basically mean that only 24% of patients (25 of 103) maintained their CR at 12 months...a relatively small hurdle to jump over imo. Furthermore, it is my opinion that the FDA, investigators/urologists & patients are all urgently demanding for more "options"....additional treatments that go beyond the boundaries of systemic therapies & many immunotherapies. And when considering all clinical trial parameters (I.e. efficacy, safety, ease of delivery, cost, etc.), intravesical options compare favorably to systemic therapies. And not to be outdone, TLT's ACT is truly in a technological class of its own, unlike much of the competition. TLT stands alone & has no in-class competition. In the end, I believe some efficacy leeway will be allowed by the FDA (just look at the Keytruda results), & it seems unlikely to me that an FDA final decision would hinge on a few efficacy points difference...though I believe TLT has the potential to redefine efficacy for this & other indications. JMHO.