RE: AVA6000 - remarkably consistent…13 Jun 2022 15:55
“It's a trial. It's designed to answer those exact questions. Patients might derive benefit from a higher dose - if you don't test it, you'll not learn as much from the trial.”
Quite. Well said.
The trial will continue until we see disease progression, death or toxicity reached. It’s very important that we haven’t seen these yet. Great signal.
Numbers, which I’m willing to be corrected on.
The dose is very small, relatively. DE was equivalent to 81mg/m2. Quite low. BUT the cumulative dose is circa 1,450mg/m2. Which is high. Doses >300mg/m2 requires cardioprotective drugs. Therefore, having received doses of nearly 5x this value, and over 3x the lifetime recommended dose of pure dox, we’re in a good place.
What I can’t decide is why we have not escalated the dose further, therefore reduced the number of cycles required to increase the cumulative dose? Yes, they may have, and not told us. But I doubt it.
I’d like to see a higher RP2B to take into P1b. However, having been dosing for this length of time (assuming C2 seeing 18 weeks of DE) without yet seeing a trial stopping outcome, results should be being confidently collated.