IN MY VIEW MODERATORS, Leslie didn't explain things clearly. When you decrease the size of the trial, the HR can be significantly affected by just one or two patients - which is why she was nervous. However, this could go either way.
If you've flipped a coin 4 times and got two heads and two tails, you claim that there's a 50% chance of a head. If you flip it two more times you could end up with the chance of heads being 33%, 50% or 67%. It all depends on the next two flips.
Of course, if you had flipped the coin 1,000 times previously, then flipping it twice more will have almost no impact on the probability.
Since the HER-Vaxx trial was so small (remember, only 18 patients were administered the drug), Leslie was nervous that the additional results between the interim and final o/s results might have resulted in the survival HR being significantly decreased. As it turned out, there wasn't a significant difference. Using the example above, effectively one more head and one more tail were recorded.
It could easily have gone the other way and the survival HR could have come back at (say) 48% instead of 58%. Imagine what would have happened to the SP in that situation.
Unfortunately, by ending up with such a small sample set, IMU can no more claim that the people on the HER-Vaxx arm did better because of HER-Vaxx than because of drinking orange juice. That's just statistics and the rules of the FDA game.
Why do I believe that the HER-Vaxx data is weak? Because:
- IMU didn't even want to complete its Phase 2 trial (no, I don't believe the "ethics" malarkey, see the third point below);
- no one else wants to progress the drug;
- why would anyone deny terminally ill patients a drug that could extend their lives with no harmful side effects. Yet this is where we are at with HER-Vaxx
The initial intention of IMU was to have HER-Vaxx replace Herceptin. It became clear after seven years and the interim trial results that this wasn't feasible, so they then started talking about using it in combination. How weak is HER-Vaxx? Weak enough that no one even wants to sponsor a combination trial, let alone licence or purchase HER-Vaxx. Instead, IMU is going to progress with nextHERIZON (a trial announced in September and still not commenced) where HER-Vaxx will be administered in combination with Chemo or Pembrolizumab
AFTER the patient has been treated with Herceptin.
No one should draw the conclusion that HER-Vaxx has demonstrated any superiority to Herceptin. It hasn't. The trial was too small and therefore the results inconclusive. On the other thread
@Mokom123 is an example of someone who has. But ask yourself this, if HER-Vaxx had proven itself better than Herceptin, why would IMU conceive of a trial that calls for the administration of HER-Vaxx AFTER the administration of Herceptin?
I have
@fattchoi on ignore (too many posts, too little value), so I don't know what he's suggested. A "partnership" is fine if that's what it is. But IMU keeps designing and paying for its own trials. I don't call that a partnership. Had any of the mooted dance partners been interested in HER-Vaxx, we would have heard so by now.
(20min delay)
