Threshold Pharmaceuticals Announces Completion of Patient Recruitment for Phase 2 TH-302 Pancreatic Cancer Study
-this appears to be several weeks ahead of schedule as management had guided toward early July---overenrolled and increased the power of the study
since this is an open-label study, the overenrollment seems to be very bullish as investigators clearly knew how well the drug was tolerated and if patients were responding.
Seems you are struggling with a number of things. Statistically significant results were seen in both 240 and 340 dose levels, so they are testing both in the Phase II trial to see there is an advantage at 340 worthy of any additional tolerability issues.
If you are referring to the Phase I/2a trial. it was a dose escalation trial and only a portion of the treated population are in the final dose cohorts. Besides, like any cancer trial, once the patient progresses, treatment is discontinued. Just curious why you are clueless enough not to know that...
Oh, and to close with the fact that a borderline successful drug in the most recent trial triggered issues with 25% (15 of 60 patients) for grade 3/4 neutropenia and 33% for grade 3/4 thrombocytopenia (20 of 60) is a VERY serious concern at the elevated dosages necessary to drive the responses. We are not talking about rashes and nausea, but systematic issues that are particulary disruptive considering the relative state of the patients. This is not something that should be easily dismissed. . .
these incidence rates are quite normal for cancer trials; most chemotherapeutics have hematologic toxicity. This regimen is much less toxic than Folfirinox and less toxic than Gemzar/Abraxane
No offense, but you are clearly unfamiliar with oncology trials.
Your "facts" seem to be more like idiotic assertions. TH-302 more than doubled response rates in most cases and extended PFS and OS rates significantly and you describe that as "borderline". If TH-302 is as weak as you portray it, why did the FDA fast track a pivotal trial in sarcoma based on the results from a non-controlled, Phase I/2a trial and did enrollment in the Phase 2b trial for pancreatic cancer exceed the target so substantially - seem the clinicians that are watching their patient's respond to the treatment and managing their tolerance would disagree with your idiotic assertions. Where did you come from, anyway - time to go back!
Additionally, the toxicity against the recent and histoical results demonstrates that a dosage necessary to drive responses might exceed the maximum allowable dosage. Review the prior results (going back to '09 for 302) and dosages against 300+ mg's necessary to drive statistically relevant results - it's not the data, but patient tolerance that I am struggling with. . .
I really don't think it's an issue
a) if it was, enrollment woudl have been slow, not ahead of schedule
b) most of the rash has been Grade 1
c) this is pancreatic cancer we're talking about---I highly doubt a patient would drop out of a trial that might be benefiting him/her because of a rash
I really don't think so---if the skin rash was a problem, the trial would have had a hard time enrolling, not enroll ahead of schedule
In addition, most of the skin rash is Grade 1, which rarely if ever, would lead to dropouts.
Dermatologic issues could be a factor in the future for a larger number of pacients dropping out of treatment. We may have to check carefully as this could be a reason for the latest PPS decline last several weeks. I saw this happen to ANDS last year.
Not much can be done - I think the execs have done a decent job telling the company's story at various conferences, etc. The thing that boggles my mind is how a company like DNDN, with their ultra-expensive Provenge vaccine becomes a $5Billion+ company by generating a 20% survival benefit (27 months vs 22). They showed no evidence that their vaccine generated objective responses (i.e. shrank tumors) or cured anyone (by the end of the 5-year trial, the same percentage of patients in the placebo vs treated group were dead), yet the market has turned DNDN into a large-cap stock. The 40,000 pancreatic cancer patient population is as large as the late-stage prostate population that Provenge addresses, so is it naive to expect if TH-302 shrinks tumors and doubles survival of pancreatic patients, that THLD can become a $5B company?