Remember back in the summer when Juno Therapeutics disclosed three patient deaths in one of their CAR-T oncology trials and the trial was put on hold? And then the hold was lifted about ten minutes later? OK, three days, but by clinical death standards, that’s pretty fast. Perhaps too fast, because now there have been more deaths in the same trial. They’ve only treated twelve more patients, and two of them have died of cerebral edema.
Adam Feuerstein has been wondering on Twitter whether the FDA would now shut down Juno’s entire clinical program until someone has a better idea of what’s going on, and I can’t say that he doesn’t have a case there. One could easily ask, if that doesn’t happen, just what it does take to halt clinical research these days. This particular trial (ROCKET) is halted, of course, and you’d have to be pretty damned optimistic to imagine it ever starting up again at this point. But what makes Juno’s other trials different from this one, and how do they know that they’ve identified what the problems are and which patients might be at risk? Assuming that such identification is even possible, that is. You’re going to have to have a pretty convincing argument to answer such questions, and it’s going to take time and data to put one together. Not good.
Between this and Lilly’s announcement this morning, it has not been a particularly good day for the biopharma industry, or the patients that we’re trying to help. Things have to look up from here; some good news would be very welcome.