Pfizer Oncology Head Charles Baum: An Interview With "The Pink Sheet" DAILY
"The Pink Sheet" DAILY: Let's move to the CTLA4 inhibitor, now called tremelimumab. Can you expand on that opportunity in melanoma?
Baum: The key is that we have initial results that are quite encouraging from a Phase II study [showing] that the patients who respond and have a confirmed response, that they have a long duration of response, which is very encouraging for patients with melanoma. It's not a randomized study so it's not a definitive study, but it's very encouraging.
The Phase III trial which was looking at tremelimumab versus the standard of care treatment in this area, temozolomide or chemotherapy, that study has completed enrollment, and we should have the results from the study next year. We don't have it yet, but we are very enthusiastic, and we believe that we'll know relatively soon what those results show. Things are looking good. We're also looking at tremelimumab in other indications as well. We're looking at it in kidney cancer in combination with Sutent. We're looking at colorectal cancer and others as well. We have great hopes there, and we will build on that initial result with melanoma.
"The Pink Sheet" DAILY: How do you expect tremelimumab to compare to Bristol's candidate ipilimumab?
Baum: There is a competitor as you know, ipilimumab, from BMS. We're neck and neck there in the race to get those results out and get the approval. Based on what we've seen so far, and this is not a direct comparison (we've never done a direct head-to-head trial of the two together in the same study) ...it's hard to compare. We're encouraged of course by the data in looking at the comparison as we saw at ASCO this last year that the side effect profile looks very favorable for tremelimumab versus ipilimumab, and we think that that could be a positive certainly for tremelimumab.
The efficacy side is just hard to tell yet because we don't have the Phase III data out to compare, and they've done their studies a little bit differently, so that's a tougher comparison. They are different in terms of their isotype, and that may make a difference, and we think that the longer half life of tremelimumab would be a further advantage. So again, no direct comparison but those are some of the things that we think distinguish the two programs. We have completed enrollment in the Phase III so we will know relatively soon, in the next several months, what that result shows.
[Bristol-Myers Squibb is studying ipilimumab in combination with chemotherapy as a first-line treatment for metastatic melanoma in Phase III under partnership with Medarex ("The Pink Sheet" DAILY, June 19, 2006).]
"The Pink Sheet" DAILY: Would it be possible to file tremelimumab based on that Phase III?
Baum: Yes, we expect it will be depending on the results.
oncologystat.com |
