RE: Monotherapy Indications10 Dec 2022 11:21
These new monotherapy arms have got me wondering.
In the original trial design, the monotherapy cohorts were those that didn't have approved checkpoint inhibitors. In those cases, giving Modi 1 as a monotherapy was better than giving the patient nothing. In cancers that do have approved Checkpoint Inhibitors, then the patient is foregoing the Checkpoint Inhibitor combination.
I wonder what the driver for this design is? Are they patients that have failed to respond to CIs? In which case, wouldn't adding Modi in, in combination be a better option? Are they patients that have had a bad reaction to CIs, or are contra-indicated? In which case would they be allowed or willing to take a different immunotherapy? Are they patients that have refused the CIs? How likely would they be to refuse one immunotherapy but accept another? The only conclusion I can come to is that they are fairly confident they can deliver equivalent or better results with a lower side effect profile, and they are asking patients to try the monotherapy. What's the ethics of this? I'd be interested to hear the thoughts of others on this.