RE: From Inan19 Mar 2021 12:53
Knowlesi,
Basically yes. We see so many drugs which do well in P1/2 and then fall at the last hurdle when they go into a bigger patient population. I guess my biggest worry is that keytruda removes the brakes from the immune system, SCIB1 produces potent T-cell response.... if there were any very underlying off target effects in the single arm trial that were not at a measurable level, these could be magnified in the combo trial. Hence I will sit with baited breath until we start getting efficacy and safety data from the trial once it gets going.
If we did see these problems, then I would hope that falling back to a single therapy trial would help, but it would be a bumpy ride for everyone involved. Having said all that, I have absolute confidence in LD and the rest of the team. They have demonstrated that they will only move forward when they are sure of the data that they have generated so far. Hence, I don't think LD would have moved to a combo trial if she didn't believe the data that had been generated in the pre-clinical studies and mouse data etc. That fills me with confidence that we will see benefits to patients, but until they are dosed we will never know whether this translates.