RE:RE:RE:RE:What's our Oncology Option Worth?Very clear, thanks for digging a bit deeper on this. Agree it's no slam dunk and the endpoints are nice and clear (for a change).
qwerty22 wrote: "In the early study Trodelvy was well tolerated and produced an overall response rate of 30% in patients that had failed an average of 5 previous therapies. Additionally, 45% of patients had stable disease, with 16% of the responses lasting for greater than 6 months."
DOR 7.7months with a range of 2-30 months
I don't know exactly how to word this but here goes.
33% had PRs or CRs making up the ORR, further 45% had SD of which 16% was durable. That means about 22% had no response whatsoever and their disease progressed on first scan and a further 29% of the SD had none durable response, as close to non-response as you can get. All those outcomes go into the average numbers for the cohort which are the 7.7months PFS, in essence about 50% are failing rapidly and really dragging down that average number. So what you have is a group of individuals with no response, a group with a weak and short response and finally a group with a deep and long response. You are really approving for that final group who get real meaningful benefit not for the average, combining a deep response with a durable response and manageable side effect is the trick even if it is only in a minority of your patients. As we know most drugs tested can't achieve that and so don't get approved. So while you think the bar is set low, and the averages look attainable, it's still challenging in these very hard to treat patients to hit all three of those endpoints (tumour shrinkage, durability and tolerability) that end up contributing to meaningful clinical benefit. My guess is that what this drug has in enough patients in that final cohort of deep durable responders to make it worth trying. The averages are clearly a measure of the effectiveness of a drug but sometimes I think they don't always tell the whole story.
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.