PRNewsWire
01 Jun 2026, 00:00 UTC · 2h ago
Source · https://www.prnewswire.com/news-releases/immvira-reports-100-complete-response-rate-at-9-months-in-bladder-carcinoma-in-situ-with-mvr-t3011-at-asco-302785507.html
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ImmVira's lead candidate MVR-T3011 achieved a 100% complete response rate (CRR) in BCG-unresponsive carcinoma in situ (CIS) during Phase IIa preliminary trials. — A 100% response rate in a high-need, treatment-resistant population is a highly positive clinical signal that significantly increases the probability of future regulatory success.
+0.80MVR-T3011 showed a 90% recurrence-free survival (RFS) rate in papillary (Ta/T1) tumors over a 9-month period. — High durability of response suggests a strong therapeutic effect and expands the potential target market for the drug.
+0.60The trial reported no Grade 4 or 5 treatment-emergent adverse events (TEAEs) and no treatment-attributable deaths across two dose levels. — A favorable safety profile reduces the risk of clinical hold or regulatory rejection, supporting the viability of the candidate.
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The results are based on a small sample size of 46 patients and are subject to statistical uncertainty as the trial is in an early, interim phase. — Small sample sizes increase the risk that early success may not be replicated in larger, pivotal Phase III trials.
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The company reported a 100% complete response rate in Phase IIa clinical data for its lead candidate MVR-T3011.
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