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ImmunoGen, Inc. (IMGN)
F1Q09 Earnings Call
October 27, 2008, 16.30 pm ET
Carol Hausner - Executive Director, Investor Relations and Corporate Communications
Mitch Sayare - Chairman and Chief Executive Officer
Dan Junius - President, Chief Operating Officer, Acting Chief Financial Officer
Joel Sendek - Lazard Capital Markets
Shiv Kapoor - Morgan Joseph
Brian Rye - Janney Montgomery
Shin Shan - RBC Capital Markets
Pamela Bassett - Cantor Fitzgerald
Good day and welcome everyone, to this ImmunoGen's First Quarter Fiscal Year 2009 Conference Call. Today's call is being recorded.
Previous Statements by IMGN
» ImmunoGen, Inc. F3Q09 (Quarter End 03/31/09) Earnings Call Transcript
» ImmunoGen, Inc. F2Q09 (Qtr End 12/31/08) Earnings Call Transcript
» ImmunoGen, Inc. F4Q08 (Qtr End 06/30/08) Earnings Call Transcript
Carol Hausner – Executive Director, Investor Relations and Corporate Communications
Thank you. At 4 p.m. this afternoon, we issued a press release that summarizes our financial results for our first quarter ending September 30, 2008, which is the first quarter of our 2009 fiscal year.
I hope you've all had a chance to review it. If not, it's available on our website at ImmunoGen.com.
During today's call, we will make forward-looking statements. Our actual results may differ materially from the projections made. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings, which are also can be accessed through our website.
With me today are Mitch Sayare, our Chairman and Chief Executive Officer, and Dan Junius, our President, and Chief Operating Officer and also currently our acting Chief Financial Officer. Mitch and Dan will provide an update on ImmunoGen, and Dan will also discuss our financial results. We'll then open the call to questions.
I'll now turn the call over to Mitch.
Mitch Sayare - Chairman and Chief Executive Officer
Thanks, Carol. So we begin by saying that I am delighted that earlier this month our collaborator Genentech announced that they've made a Phase III go decision for trastuzumab-DM1 where T-DM1 as its called. This is a real turning point for ImmunoGen, our first partnered product in Phase-III testing. It's taken a long time for ImmunoGen to get to this stage, but we are very happy to be here.
The Phase III trial that the Genentech has outlined is impressive, its scheduled to start in the first half of 2009 and we'll evaluate trastuzumab-DM1 head-to-head against Tykerb+Xeloda improved to second line treatment for HER2-positive breast cancer in the US and in some international markets.
The primary endpoint to this study is progression-free survival. This will be the first large trial to assess progression-free survival with T-DM1 used in second line therapy and that's we don’t know what the study outcome will be. What we do know is that in Phase I testing at second line treatment with the same dosing schedule. T-DM1 achieved to medium progression-free survival of 9.8 months.
According to the FDA approved labeling for Tykerb the combination of Tykerb+Xeloda achieved medium time to progression of 24 or 27 weeks depending on whether you use the investigator assessment or the assessment by an independent third party. So it's roughly six months. As you can tell we are excited to see T-DM1 being compared head-to-head with these agents.
Additionally the start of Phase-III testing at T-DM1 triggers a milestone payment to ImmunoGen and we are looking forward to that too. It is also a second potential route to market for T-DM1 and that's as a third line treatment for HER2-positive metastatic breast cancer. That is as a treatment for patients whose cancer progressed on treatment with herceptin plus chemotherapy and then on Tykerb+Xeloda. Currently there is no approved third line therapy for metastatic breast cancer.
Genentech has initiated a Phase II study evaluating T-DM1 in just such a patient population and they have noted that to discuss with FDA an accelerated approval pathway if the study results merit it. This potentially pivotal trial is a 100 patient's single arm study with objective response as the primary end point. We know that at least 40 medical centers are participating in the study and the dosing began in August of this year.
Patient enrollment is expected to take a year, which will be about the same amount of time as for the first Phase II trial conducted with T-DM1 the 100 patient second line plus study. In the past three months, the first findings from that second line plus trial we'll report it. The data presented at the ASCO Breast Cancer Symposium in September were from a planned interim analysis of the findings in the first 30 evaluated patients enrolled in the trial. Like we are doing with our IMGN242 Phase II study, this T-DM1 Phase II study has efficacy threshold that had to be met to trigger expansion of the trial to the full group of patients planned. That efficacy threshold was met and Genentech reported in July that they had completed enrollment of the full 100 patients planned by June 2008.
The findings in the interim analysis were impressive. In this Phase II study all patients had to have HER2-positive metastatic breast cancer that had progressed on treatment with herceptin plus chemo as in the Phase I trial. However, patients also could have gone on to treatment with Tykerb+Xeloda and in fact close to half of the 29 patients included in the interim analysis had been treated with those agents in addition to herceptin plus chemo prior to entering the study.
Among the 29 patients 23 benefited from treatment with T-DM1 having either an objective response over stable disease. 13 of these patients had an objective response including one patient who had had a complete response that had been ongoing for 30 weeks at the time of data cutoff for the presentation. These results are consistent with the excellent activity and tolerability reported in Phase I and the tolerability of T-DM1 was also comparable to the Phase I findings. These interim data suggested prior treatment with Tykerb+Xeloda had little, if any impact on the tolerability or activity of T-DM1. Early data to be sure and we learn more as the full study results become available.