MorphoSys AG (NASDAQ:MOR) Q3 2018 Earnings Conference Call - Final Transcript
Nov 06, 2018 • 08:00 am ET
(Started Abruptly) A warm welcome to our Q3 call. The third quarter of 2018 was a productive one for us, highlighted by very encouraging progress in therapeutic programs within both our proprietary development and partnered development segments. I will go through the highlights in both areas starting with our proprietary programs. The most advanced program is MOR208, the Fc-enhanced antibody in clinical development for B cell malignancies. You'll recall that we're running the L-MIND and B-MIND trials in relapsed/refractory DLBCL and the COSMOS trial in BTK inhibitor refractory or intolerant CLL and SLL.
I'll start with L-MIND, our chemotherapy free regimen for DLBCL, comprising MOR208 plus lenalidomide. Last Thursday, we were pleased to announce that the abstract we have submitted on L-MIND was selected for an oral presentation at this year's ASH Conference in December in San Diego. In accordance with ASH rules relating to prior disclosure of conference presentations, we are unable to go into detail here on the new L-MIND data beyond what is in the abstract. Therefore, I'll just mention the key points and ask for your understanding that we will not be able to say much more during the discussion.
The abstract outlines preliminary safety and efficacy data on all 81 patients enrolled in the L-MIND trial. By the time of the data cutoff on June 5 of this year, the overall response rate was 58%, comprising 33% complete responses and 25% partial responses. Very significantly, Median PFS was 16.2 months. Median duration of response and Median overall survival were not yet reached, but we highlighted the 12-month overall survival rate of 73%, and the 12 months there had been no disease progression in 70% of patients. We are pleased to see both ORR and mPFS, Median Progression Free Survival, improving compared to the last data cutoff. We will, of course, speak to these data in detail at ASH. As a reminder, we've announced an Investor event in New York City on December 5, at which we will be joined by one of our investigators, and there too, we will be available to speak about the data in as much detail as possible. We hope to see many of you there.
We see you're very encouraged by the latest data for our plans to seek US regulatory approval on the basis of the L-MIND study. As of now, our plans are unchanged. We expect to have final data from the study available for an appropriate medical conference in the middle of next year and we remain on track to completing a rolling submission by the end of next year, which would allow for a potential approval in mid-2020. This program has the highest priority within the company.
Meanwhile, the B-MIND trial of MOR208 and relapsed/refractory DLBCL also continues. B-MIND is a Phase III study evaluating MOR208 plus bendamustine. This is rituximab plus bendamustine, and approximately 230 patients with relapsed/refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplantation and who have failed prior rituximab