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ImmunoGen, Inc. (IMGN)
F2Q10 (Qtr End 12/31/09) Earnings Call Transcript
January 28, 2010 4:30 pm ET
Carol Hausner – Executive Director, IR & Corporate Communications
Dan Junius – President & CEO
Greg Perry – SVP & CFO
Joel Sendek – Lazard Capital Markets
Bret Holley – Oppenheimer
Ling Wang – Brean Murray
Jason Kantor – RBC Capital Markets
Shiv Kapoor – Morgan Joseph
Pamela Bassett – Cantor Fitzgerald
David Miller – Biotech Stock Research
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. F1Q09, (Qtr End 9/30/08) Earnings Call Transcript
Thank you. Good afternoon. At 4 o'clock this afternoon we issued a press release that summarizes our financial results for the quarter ending December 31st, 2009, which is the second quarter of our 2010 fiscal year. I hope you have all had a chance to review it. If not it is available on our website. 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 also can be accessed through our website, immunogen.com.
In our call today, our Chief Executive Officer, Dan Junius, will provide an update on ImmunoGen, and our Chief Financial Officer, Greg Perry, will discuss our financial results and guidance. We will then open the call to questions. Dan.
Thank you, Carol, and good afternoon everyone. Thank you for joining us today. The opening quote in our press release this quarter indicated that this is possibly
ImmunoGen’s most significant quarter to date, and it is a statement that was not made lightly. I think in the quarter our technology achieved a new level of validation. We saw significant clinical progress across our product portfolio, both our own products as well as our partners with more visibility coming next year, and we have reached a level of unprecedented interest in our TAP technology.
In my comments, I would like to focus on three dimensions to support our excitement about our progress. First, the clinical data reported with multiple TAP compounds demonstrating activity and safety in solid and liquid tumors. I also want to comment on the tracking towards our first marketed TAP compound, and also how we and our partners are driving deeper and broader clinical progress.
Let me start in going back and talking about the activity and safety that we are seeing in solid and liquid tumors with our TAP compound, and I will start with T-DM1 given that is the most visible compound and the data that they have generated in third-line metastatic breast cancer.
This came out of the San Antonio Breast Cancer Symposium in December. It was a poster presentation that was then changed to an oral discussion session. So, something of an upgrade there, and what it showed was continued compelling activity for this compound. An objective response rate of 32.7% was reported. This coming out of independent radiologic review and this is for patients previously treated with herceptin, taxane, anthracycline, Tykerb and Xeloda, and actually the median of prior drugs treated for metastatic breast cancer was seven. So a heavily pretreated population.
In talking about the objective response rate, it is worth noting that Tykerb plus Xeloda achieved an objective response rate of 23.7, and this was in second-line metastatic breast cancer. The clinical benefit rate, which pulls in patients, who had stable disease of at least six months, was 44.5%, and again this coming from independent review. While progression-free survival and duration of response data is not yet mature, it is expected to be reported in an upcoming medical meeting.
We heard at SABCS that it would probably be reported in March, and what they did disclose is an interim PFS of 7.3 months. Complementing the compelling activity is the tolerability of the compound. Thrombocytopenia was the most common grade 3 and 4 adverse event at 5.5% of patients. They continue to note a lack of clinically significant cardiac changes, and no association with neutropenia or other side-effects that would limit the ability to study T-DM1 in combination or in earlier stage patients.
Moving on to IMGN901, wholly owned by ImmunoGen, we reported findings in solid tumors at AACR-NCI-EORTC in November, specifically in metastatic Merkel cell carcinoma. Of the six patients reported, we had one complete response. This patient has been in remission for over four years. We have a partial response in a patient who continues to improve, with the potential to become a CR and that was after one treatment cycle, and stable disease, in a patient that was receiving IMGN901 fourth line. This patient came into the study with bone metastasis or the patient was very advanced, very advanced cancer.
This is a very difficult disease, metastatic Merkel cell. There are no approved treatments in the median survival for these patients when diagnosed in 6.8 months. So we view this activity to be pretty exciting. I should note that we earlier reported data on 901 in small cell lung cancer, a cancer that shares characteristics with metastatic Merkel cell, and here we reported a 25% clinical benefit rate but that includes patients with objective responses and extended stable disease.