Three developments over the past week spanned oncolytic immunotherapy, cardiovascular outcomes and rare-disease gene therapy.
Each one carries read-through past the individual program, so we dig into what happened and what the people closest to the data had to say for Trial Tuesday.
Replimune's RP-1 Review Offers A Design Brief For The Next Intratumoral Trials
The advisory committee that reviewed Replimune's RP-1 in melanoma spent less time on the product than on a question the field has left open for years: how to design and measure trials of intratumoral therapies in the first place.
In examining vusolimogene oderparepvec (RP-1) plus nivolumab in patients whose melanoma had progressed on a PD-1 inhibitor, members treated the IGNYTE study's flaws as a case study in what future sponsors should do differently. The clearest lesson concerned endpoints.