RE:Comparisons of single agents Enriquesuave ... Great post. Comparison table like you just showed is the proper thing that all investors should focus on.
You list Vicinium in your table. The FDA didn't approve it in 2021 because of clinical data and manufacturing issues.
Additional clinical and statistical data and analyses are being requested by the FDA to potentially approve the agent for this indication in the future. In addition, the CRL noted Chemistry, Manufacturing and Controls issues that need to be addressed.
But let's just compare the treatment aspect:
During the single-arm study, patients received 30mg of Vicinium in 50ml of saline, twice weekly for 6 weeks followed by once weekly for 6 weeks. After the 12-week induction period, patients received maintenance Vicinium in 50 ml of saline administered once weekly every other week up to 104 weeks.
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enriquesuave - (4/5/2022 11:38:32 AM)
Comparisons of single agents
90 days 12 months # of treatments in 12 months period
Keytruda. 41%. 19%. 18. IV
Vicinium. 42%. 17%. 36
Adstiladrin. 50%. 24%. 4
TLD-1433. 50%. 25%. 2. Non optimized evaluable patients
TLD-1433. 60%. 11.1%. 2. Too early to assess not enough data
Data is beating all single agents and potential for PR patients to convert to CR status increases the potential to beat present data.