I'm nervous about how many patients will be OR's. Nobody can know that - but then this would be boring. However, I do know the change in dosing makes a big difference. For dogs that were switched to twice weekly dosing vs once weekly (with the same overall amount of medication) there appears to be a 17-25% greater decrease in tumor size among susceptible tumor types during a 4 week treatment period. That is without the 50% increase in the amount of medication per week that our patients are getting. That can turn those who would be stable disease in 2011 into responders.
Add to that a lack of patients already treated with multiple lines of therapy and I am liking our chances to hit that magic 40% OR number.
Its not a lock, but I like our chances of posting those ultra-impressive numbers. We might really have a new monotherapy here that blows people away.
Nervous and excited :)
I think they would be violating the conference rules if they did that. It seems similar to ASCO level protocols.
No, think it will be Thursday morning. They are embargoed until the time of the presentation - and the boards are set up at 7am on the day they are presenting. Its Thursday for sure. I would expect the abstract to be embargoed as well until Thursday morning, but hopefully our resident attendee can confirm that.
The other interesting thing is that they changed the patient population slightly by having patients that only had one line of prior therapy - where the 2011 study allowed up to three lines of prior therapy. Less compelling than the dose increase, but certainly another possible reason why results would improve.
Cohorts A and B: No prior therapy in metastatic setting
– Patients with ER+ and/or PR+ and HER2+ who received one prior hormone therapy in the metastatic
setting are eligible; however, two weeks must have elapsed since the last dose of hormonal treatment.
» Cohort C: up to one prior chemotherapy is allowed in metastatic setting
Thanks. I think the secret sauce for enchant may really be the improved dosing regimen. 300 per week is not only 50 percent more medication than the 2011 study but also the two doses effectively doubles the time the drug is active in the cells each week. I overlooked this previously. Not something I ha noticed in my previous analysis and gives a basis for the significantly improved July numbers beyond just luck of the draw.
So here is my personal breakdown of Enchant results and expectations on price. Let me know what you think if you wouldn't mind.
If we pull off a 40% OR for HER+ (meaning 4 more OR's in each 10 additional patients) then I think we are looking at 7+ (higher if we have for more patients)
If we pull off a 30% OR for HER+ (meaning 3 more ORs in 10 additional patients) then I think we are looking at 6+
If we pull off a 25% OR for HER+ (meaning 2 more ORs in 10 additional patients) then I think we are looking at low 6s
If we pull of a 20% OR for HER+ (meaning 1 OR in 10 additional patients) then we are looking at 5+
For TNBC -
30% OR (3 in additional 10 patients) = 7+
20% OR (2 in additional 10 patients) = 6+
You have to look at the group for the Phase 3 which was the chemo refractory. Then you have to think about if they had a good reason to remove the Easter European outliers. HR is going to be in the range of .75-.5 with statistical signficance when the Phase III interim results come out.
P value is only achievable with a larger population, but the p values we got for the chemo refractory were solid.
For Enchant we will definitely have data for 30 initial patients and whoever they enrolled else they enrolled in August at the 25 study centers. Should have biomarker analysis as well.
Also possibly data from cohort 3 - which was the combo therapy arm which would show benefit of combining with chemo
Will have to see if Harvard is ready to present data. I would think so since trial will be so far along.
Holy #$%$ seriously?!?! Would you be able to post the abstract from the fulvestrant combo study when you have it? Or at least report if they will be presenting results or not.
Is it normal to get results presented in the Ongoing Trial presentation sessions? Have been noodling that quite a bit overnight - and it seems a few do and its probably indicated in the abstract if they have results to present.
I like to look at existing study results to try to glean a clearer glimpse into the future - objectively. This is what I have for Enchant-1 results based on the prior studies.
2011 - monotherapy study with once weekly administration at 200mg of G in HER positive produced 2 objective response and 6 stable disease out of 13 HER positive patients.
The same study also produces substantial tumor shrinkage in 1 out of 3 TNBC patients - evaluated to be stable disease because shrinkage is less than 20%.
July 2013 - monotherapy study with twice weekly administration of 150mg of G in HER positive produced 2 OR and and 2 stable disease out of 5 patients meaning that out of 18 total treated between the studies we have 22% with OR and 44% with stable disease.
I believe the modification in dosing regimen to twice weekly will improve the performance of the drug in the Enchant study compared to the 2011 study - as it did in dogs. All of this in a herceptin pre-treated population that has already progressed after such treatment.
Finally we have TNBC where we have 2 Objective Response (including one CR) and 4 stable disease out of 13 total patients in the two studies = 15% OR and 30% stable disease.
But the real fireworks will be when they show what this baby can do as a combo therapy in HER positive. This really is a drug that plays well with others and this combo study may be the first to prove that.
Also note that for an interesting wrinkle, the ongoing phase 2 as a combo therapy will have results Friday morning.
I've heard 4th quarter predictions before. Then results come end of January :) Hope I am right.
Catalyst next week for SNTA. Data from two Phase 2 breast cancer studies - one with an active control. Last time preliminary data was releases for breast cancer the stock traded up 40 percent to 7.50 and those were extremely preliminary results.
Why do you think the results will come out this December? It is a blinded study so interim analysis will be unveiled at an unknown point once a certain number of events have occurred. They estimated September 2013 originally so obviously overdue but no way to predict when from my perspective other than guessing February as an outside date, unless I missed some update on progress?
Haha, an oversimplification of why the study was expanded if there ever was one. Remember, they will need a day or two to write their slam pieces anyway. These will not be weekend results, but my favorite type of a.m. pre-market announcement. Momentum will kick in. Have fun wasting your money on puts :)
And a 6 month extension of the study and a need for financing. Thats all it took, lol. You forgot that part.
These are brand spanking new results. Not final versions of results already released. We will have confirmation of a breast cancer treatment. It will be good.