I don't think the abstract will have any updated numbers. However in the press release I think the bogie is 30% (especially for TNBC) for a positive reaction and if we get 40% in either its going above 7 (depending on the total patients)
The Company will not have data to report until 110 events are completed. Had thought the Company's interim analysis would include results of the survival analysis but that appears not to be the case?
At least 5 stable disease patients from July who received an additional 4 months of treatment. Will be very interesting to see what happened to them.
I keep coming back to that TNBC case in the Phase I - dosed twice a week at 144mg/m2
After 2 cycles, demonstrated stable disease per RECIST;
After 4 cycles demonstrated 31% reduction in target lesion size (partial response)
Our stable disease patients will have received at least 6 cycles by end of October and would have been scanned again at 18 weeks (after cycle 4) and 24 weeks (after cycle 6)
Just a fun thought. If all the stable disease patients became partial responders with treatment that would mean that 9 out of the 15 patients with ORs or a 60% response rate among the original 15 patients. If this happens will all hell break loose? Will we see the greatest short squeeze of all time? Will anyone sell a share below $15?
Haha, maybe half at $10. We may be on the cusp of something very special here and like with KERX before their big news last year we are flying under the radar. Good things happen when you fly under the radar into a major event.
Shortnstock, WaitingforKerx, Kerx4Sale... drinks are on me if I'm right.
Agreed. These conferences are always hyped and never ever ever actually have anything new or interesting in them. Good stuff will come when nobody is looking.
I think the one that matters is Enchant and that is on Thursday morning. The others are your usual preclinical analysis I would bet - though they might reference the Enchant results. I had though that Harvard would also present data, but it appears that was a false hope. The Ongoing Trial presentations only report details of the study design and current recruitment statistics. Never actual data it seems. Given the small number of sites currently recruiting there may actually not have been that much progress on the Fluvorscent combo trial at Harvard - they may be trying to get more sites active.
This will all come down to answering the question - does dosing twice a week turn Ganetespib into a monster monotherapy agent in breast cancer. My bet is that it does and this will be the first study to prove it.
Its all about the data now. If dosing really makes a difference it will show up in this study. They have no other results other than the Phase1 for this level of dosing and in the Phase 1 there was a PR in triple negative that showed increasing tumor elimination over time. It was actually a SD that turned into a PR between month 2 and month 4. Triple negative may be our ace in the hole.
Results that blow expectations out of the water are possible here. The drug has a long half life already (58 hours and maintains a relevant concentration inside tumors for 96 hours or more) and now it will be active for nearly the entire treatment period. Effectively giving almost no time for the proteins to rebound and growth to resume. You take away all growth momentum and you continually bash the tumor with volume losses. It is possible that some of those stable diseases at 12 weeks turn into PRs. I see lots of reasons for this to go very very right in a big way
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.