Wino115 wrote: And here's the topline from the Phase 3 that was halted because of "
compelling evidence". By the way, they talk about their ADC having the "bystander effect" that you all have mentioned before.
It tested Trodelvy vs. "standard" chemo (listed as TPC) for TNBC. 468 patients in Can, US, Euro.
Primary Endpoint was Median Progression Free Survival (PFS): Trodelvy was 5.6 months vs. 1.7 for standard.
Secondary Endpoints were Overall survival (OS) which improved to 12.1 mo vs. 6.7 mo.
An Objective Response Rate (ORR) of 35% vs. 5%.
As for safety, Trodelvy had 51% neutropenia vs. 33%, so was worse. Diarhea, leukopenia and febrile neutropenia were also all worse off by a decent amount (5x-3x worse) in Trodelvy. So every major SAE area was worse, not better, than standard.
CONCLUSION:
"Compelling" is considered 4 more months of PFS, 5.4 mo of added OS, and an objective response rate 30% greater than standard chemo. And this is considered breakthrough even those you have grade 3 adverse events that are 1.5x higher for neutropenia and 3-5x higher for other SAEs.
This is all just interesting to note as we progress though trials. What it really tells you is that breakthroughs in cancer are really, really hard and what appear to be modest improvements are really ground breaking and leading edge. Adding 4 months, have 30% more responses and adding 5 months to survival are amazing feats, even with a some heighted adverse effects.
But this is what you'd have to show to basically cancel your Phase 3 and hit the road selling your drug.
Wino115 wrote: Looks like they were granted Accellerated Approval in April 2020 and started recognizing revenue from April onwards.
"...Trodelvy, which was granted Breakthrough Therapy Designation and Priority Review, was approved under the FDA’s Accelerated Approval Program based on the objective response rate of 33.3 percent and duration of response of 7.7 months observed in 108 adult mTNBC patients who had previously received a median of three prior systemic therapies in the metastatic setting in a single-arm, multicenter Phase 2 study. Continued approval may be contingent upon verification of clinical benefit in the Phase 3 confirmatory ASCENT study. On April 6, 2020, we announced that the ASCENT study was halted due to compelling evidence of efficacy across multiple endpoints. This decision was based on the unanimous recommendation by the independent Data Safety Monitoring Committee during its recent routine review. Top-line data for the ASCENT study is expected to be available mid-2020." Conclusions: 1) The annualized first year run rate of revenue was more like $225mil.
2) If you show RR of 30% or greater and a Dur of Resp 7 months or greater, you should get Accelerated Approval after your Phase 2.
I believe one of you all mentioned this already, but what it means is that if you can hit those hurdles above safely, you may be able to start revenues after a Phase 2 and during your Phase 3. It's just a contingent verification in the Phase 3 that is needed and if the review committee likes what it sees, you're off to the races.
qwerty22 wrote: You can't charge money for an unauthorized drug, u go to jail I think (at the very least you're a cad), so that revenue must be from something else. Maybe milestone payments, idk.