Some points from today's presentation:
Taxol / Carboplatin / Telcyta
Advanced, metastatic NSCLC. No exclusion for patients with metastases to the brain (many trials NSCLC will, from what I've encountered).
Finished phase I portion, 13 patients evaluable by RECIST. 1 CR and 7 PR for 62% response rate. They noted that there was a 100% concurrence between investigator assessed responses and the independent reviewers. Attributed that concordance more to the fact that the partial responses in the trial were of the obvious variety. Along this line, Wick outlined the following notables:
- 1 male smoker, stage IV with 80% reduction by the second cycle
- 1 female nonsmoker, stage IV with 70% reduction by second cycle and a scar remaining by 4th cycle. Wasn't called a complete response because they did not follow up with PET scan.
- 1 patient with 80% reduction by the 4th cycle
- 1 patient with 90% reduction by the 4th cycle
In comparison to the standard doublet, Wick noted that the control arm of the recent Avastin NSCLC trial had a 10% response rate.
Telcyta / Cisplatin
36% response rate, and a 77% 1 year survival estimated from the kaplan-meier analysis. Gave a comparison of 9 months median survival for this population otherwise. (I'll also add that taxol / carbo have median survival of 10 months; avastin raised that to 12.5).
He noted that the doctors did drop the cisplatin from the regimen for patients that were receiving more cycles than usual. Presumably this was because some docs were uneasy about using cisplatin at cumulative doses beyond their routine experience. Those patients for whom cisplatin was dropped remained on single agent Telcyta.
- 1 patients with 80% reduction in tumour size
- 1 patient, smoker, with scar remaining... no PET scan follow up to determine if this was actually a CR.
- 1 patient, prior asbestos exposure... also large reduction (missed the percentage for this one)
Wick noted that they're thinking about possible phase 3 designs in front line NSCLC. In the meantime, they will expand the size of the front line NSCLC phase 2s that are running.
Expected to complete Telintra phase 2 and present at ASH. Also looking to enter oral telintra analog into the clinic this summer.
Noted that they're looking for rest-of-the-world partner. This was a reiteration of their strategy to keep the US market to themselves. |
