@fattchoi reply to #74137950The RESIST and iRESIST guidelines...

@fattchoi reply to #74137950

The RESIST and iRESIST guidelines are rather specific about what constitutes a response or not. The MAST trial is open-label, meaning response to treatment for active patients is evaluated and accessible at each time point. There are regular time points in investigational trials.



IMU provided an update on the cholangiocarcinoma patient in the bell porter presentation, but nothing on other patients.

Phase 1 CF33-hNIS Study Update - Positive Early Signals (Data as of the 12th Jan 2024): Cholangiocarcinoma patient CR for 430 days



Bell Porter Presentation (30th May 2024): Cholangiocarcinoma patient CR for 532 days



Time difference between Cholangiocarcinoma patient update: 102 days
12th Jan + 102 days = 23rd April 2024

To be considered evaluable, the 9 additional patients have had at least their first scan, which means their response to treatment has been evaluated and is known. The cholangiocarcinoma patient remains actively involved in the study and is required to have their response to treatment measured just like other new inclusions to the trial. The 9 additional patients included since the 12th of January, including the 3 patients who had iUPD from the 4th dose level, are not responding to treatment. Pseudoprogression rates are low for immunotherapies and CF33 follows suit, so I don't put much weight in that explaining the lack of reporting.

In short, who cares what LC says. She said the HER-Vaxx data was beautiful (despite 80% CI used) and look where that got you. Clinical efficacy forms the foundation of a biotechnology company, which really is what you and others should be focused on.