|It occurred to me this morning that this may actually be a very significant event. To my mind, it suggests that they have accrued enough patients in both hormone positive breast cancer, as well as urothelial cancer to satisfy the FDA requirements(which presumably have been communicated to the company during FDA meetings) for accelerated approval in these two indications. I suppose other alternatives are that they are planning separate P2 studies in both urothelial and breast to complete accrual of necessary patients, OR, they aren't planning on AA in one or both indications. The first of those options seems unnecessarily onerous and expensive when they could have easily accrued the patients under the auspices of the already existing basket trial. The second option seems unlikely especially in urothelial. In terms of breast, we'll know quite a bit more after June 3rd. |
In terms of timing, if we assume the last urothelial patient was just dosed, and PFS for urothelial is a median of 7 months, by early next year(significantly sooner than I had initially thought) they could be ready to apply for AA. If I play devil's advocate, the Cowan presentation on the company website suggests that at least in March, the company thought they would need more patients admitted; maybe they received input from the FDA that they had enough? I don't know, but we should have more clarity from management in 37 days.
In terms of hormone receptor positive breast we have no idea of the efficacy of SG yet, but presumably PFS would be longer than for TNBC, which is about 5 1/2 months. We also know that the combo of palbociclib-plus-fulvestrant given in metastatic hormone receptor positive breast cancer patients has a PFS of 9.2 months in patients who had received one prior chemo(PALOMA3 trial). Presumably SG will be positioned as a 3rd line agent, so I would expect the requirement for PFS would be less than that, but would also expect it to be longer than the 5 1/2 months in TNBC.
Needless to say, if we were to get AA in TNBC, urothelial, AND hormone rec pos breast, even 3rd line for all indications, valuation of the company will be vastly increased, and I would expect to see huge acquisition offers from big pharma.