Eli Lilly and Company Earnings Call Insights: Progression-Free Survival Advantage and Phase II Efficacy Data
Progression-Free Survival Advantage
Catherine Arnold – Credit Suisse: I had a question for Sue. I was wondering if she could comment on if there is a scenario in the cancer area where a drug hit PFS and OS and wasn’t approved or didn’t get priority review and whether she could just comment on now that the data is out what was most surprising to her as far as the total dataset released? Thanks.
Sue Mahony, Ph.D. – SVP and President, Lilly Oncology: With regards to your first question about whether there’s been an agent in the cancer market that has overall survival and PFS data without approval, I am not aware of any molecule in the cancer market that has had overall survival and PFS data that hasn’t been approved or indeed had priority review. With regards to your question about the data with regard to ramucirumab obviously we were very pleased to see the data and we were pleased by the reaction that we had from investigators and leaders in prescribing physicians at ASCO-GI last week. I think specifically this is the first study to show both an overall survival and progression-free survival advantage in a difficult to treat patient population in a high unmet need as a single agent and this was a single agent study for ramucirumab. And in addition to that we saw a safety and side effect profile with – again, we were pleased to see with just 10%, 10.5% of patients coming off therapy because of side effects in the ram ARM versus 6% in the placebo ARM. So I think it’s the balance between the efficacy that we saw and the safety that we saw in that trial that we were presently pleased to see.
Phase II Efficacy Data
Tim Anderson – Sanford Bernstein: Couple of pipeline questions. Your pipeline charge sort of you have a CDK 4/6 inhibitor in Phase II that’s similar to the Pfizer compound, I’m wondering when we might see efficacy data from that Phase II trial? Then on solanezumab, just a regulatory update, in ex-U.S. markets, if I understand it correctly that you could potentially file the drug for approval in certain ex-U.S. markets without the need for the additional trial that you described on December 12 and if that is a possibility, when might we hear more from you on this matter?
Derica W. Rice – EVP, Global Services, and CFO: Sue, do you want to answer the question on the CDK 4/6 timing? You have to give the update on the – okay, very good.
Sue Mahony, Ph.D. – SVP and President, Lilly Oncology: Yes, you are correct, we do have a CDK 4/6 inhibitor in Phase II study, it’s currently being developed for relapsed and refractory mantle cell lymphoma and we expect this trial to conclude in 2014 we’re also planning on future trials with this molecule.
Jan M. Lundberg, Ph.D. – EVP, Science and Technology, and President, Lilly Research Laboratories: In relation to our plans with solanezumab outside U.S., we are in preliminary discussions with a number of regulators, but it’s too early to comment, if there could be different actions being taken in different geographies, but the systems are somewhat different compared to the FDA.
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