Not much new from the Telik audio presentation that I could gather.
Wick went over the general trial designs for ASSIST 1 (3rd line ovarian monotherapy against doxil or hycamtin, SPA), ASSIST 2 (3rd line NSCLC monotherapy against Iressa, SPA) and ASSIST 3 (2nd line ovarian in carbo resistant refractory; carbo + telcyta vs doxil, no SPA).
1 and 2 have overall survival as primary endpoints, whereas 3 uses response rate. To date, the company has not revealed the % improvement that they are aiming for in these trials, but it is fair to say that ASSIST-1 and 2 will likely require a 30-40% increase in overall survival to hit their endpoints.
One new/odd thing I did hear is the median duration of response for their phase II trial in platinum resistant / refractory ovarian cancer treated with carboplatin + telcyta. This trial had a 54% response rate, and Wick cited a median duration of response greater than 52 weeks. That would suggest a median PFS of at least 52 weeks. According to the mature data from Gordon et al (Gynecologic Oncology, 2004), median survival for platinum refractory patients receiving Doxil in the second line is about 42 weeks. However, in a previous PR (october 04), they noted the median PFS was ~26 weeks and median survival was about 52. Either 1) the company updated their median duration of response numbers for this trial and that is what Wick presented, or 2) Wick slipped up and confused their median survival estimate with their duration of response estimate. I'm assuming the latter because it is more conservative and he is a fast talker; however, if the former, then the ASSIST-3 trial will hit its secondary endpoints of PFS and overall survival without blinking.
Really nothing new in the OSIP webcase. Goddard cited Tarceva net sales of 13.3 million since launch (28 selling days). They expect to file the pancreatic cancer sNDA by 1H05, and are looking for profitability 3 years from tarceva launch (this was originally estimated at 18 months, but got pushed back to 3 years at the Tarceva approval conference call.... go figure).
Goddard does expect to be able to increase the number of patients who show up for treatment in 2nd / 3rd line NSCLC by offering them an alternative to chemo. He may be right, but time will tell. |
