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ImmunoGen, Inc. (IMGN)
Q1 2018 Earnings Conference Call
May 04, 2018 08:00 AM ET
Sarah Kiely - Director, IR
Mark Enyedy - CEO
Anna Berkenblit - Chief Medical Officer
Dave Johnston - CFO
Jessica Fye - JPMorgan
Andy Hsieh - William Blair
Debjit Chattopadhyay - H.C. Wainwright
Biren Amin - Jefferies
Mara Goldstein - Cantor Fitzgerald
Good day everyone and welcome to ImmunoGen First Quarter 2018 Financial Results Conference Call. Today’s call is being recorded.
Previous Statements by IMGN
» ImmunoGen's (IMGN) CEO Mark Enyedy on Q4 2017 Results - Earnings Call Transcript
» Immunogen's (IMGN) CEO Mark Enyedy on Q3 2017 Results - Earnings Call Transcript
» ImmunoGen's (IMGN) CEO Mark Enyedy on Q2 2017 Results - Earnings Call Transcript
» ImmunoGen's (IMGN) CEO Mark Enyedy on Q1 2017 Results - Earnings Call Transcript
Good morning and thank you for joining today’s call. Earlier today, we issued a press release that includes a summary of our recent progress and third quarter 2018 operating results. This press release and a recording of the call can be found under the Investors section of our website at immunogen.com.
On the call today are our President and CEO, Mark Enyedy, our Chief Medical Officer, Anna Berkenblit; and our CFO, Dave Johnston. Rich Gregory, our Chief Scientific Officer will join the team for the Q&A session.
During today’s call, we will highlight key recent accomplishments, review first quarter financial results and outline milestones for the remainder of the year. During the call, we will use forward-looking statements and our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings.
With that, I will now turn the call over to Mark.
Thank you, Sarah. Good morning, everyone and thank you for joining us today.
Building on the momentum we generated in 2017, we started this year with a number of important milestones, highlighted by significant progress with our lead candidate, mirvetuximab, soravtansine for the treatment of women with ovarian cancer. As a reminder, our efforts at ImmunoGen focused on four strategic priorities.
First, completed the development and launched mirvetuximab by 2020. Second, accelerate our pipeline of novel IGN programs. Third, build on our leadership position in ADCs through continued innovation. And fourth, expand the reach of our innovation and maintain financial strength through high-value partnership.
Over the first four months of 2018, we’ve made significant progress towards each of these objectives. With mirvetuximab, we were pleased to report last week that we've completed patient enrolment in FORWARD I, our Phase 3 registration trial designed to support full approval of mirvetuximab and platinum-resistant ovarian cancer, well ahead of schedule. This accelerated and accrual reflects the increased interest in mirvetuximab from the ovarian cancer community and the need for new treatments for women with platinum-resistant disease. We also successfully completed the pre-specified interim futility analysis, following 80 progression-free survival events in FORWARD I. The study will continue as planned without modification based on the recommendation of the Independent Data Monitoring Committee and we’re on-track to report top-line results from this study in the first half of 2019.
In addition to advancing mirvetuximab as a single-agent therapy, we’re evaluating combination regimens to expand the eligible patient population and move into earlier lines of treatment for ovarian cancer in our FORWARD II trial. At SGO in March, we presented additional positive data from the cohort extracting mirvetuximab in combination with Keytruda, Anna will review these data with you in more detail shortly. We also look forward to sharing, maturing efficacy and safety data from the mirvetuximab plus Avastin expansion cohort in roughly 50 patients this June at ASCO.
Moving to our earlier-stage portfolio, accrual continues in a nice pace in dose escalation studies for IGN programs and we expect to report data from both programs at ASH later this year. In addition, earlier this this month, we presented three posters at AACR, highlighting our ongoing innovation in ADCs, including advancements and payloads for enhanced anti-tumor activity as well as insights into factors that determine the clinical efficacy of ADCs. So overall, sound execution across the business to start the year.
With that I will turn the call over to Anna to provide more detailed update on our clinical programs.
Thank you. As Mark mentioned, we are very pleased to have passed in interim analysis for futility and FORWARD I and that the independent data monitoring committee recommended to continue the study as planned.
The primary endpoint in FORWARD I is progression free survival or PFS in both the entire study population or the intensive treat population that includes both medium and high folate receptor alpha expressors and in the subset of patients with high folate receptor alpha expressions. Lastly, we also completed full enrollment in FORWARD I two months ahead of schedule.
We are on track to report topline data in the first half of 2019. The readout is event driven and will be based on 236 PSF events. Based on the encouraging and consistent safety and activity observed in clinical studies today, we believe that mirvetuximab has the potential to displace chemotherapy as a single agent treatment in the platinum resisting setting.
Beyond FORWARD I, we are conducting the FORWARD II trial evaluating mirvetuximab in multiple combination cohort to expand its benefits into platinum sensitive disease and position it as an earlier line therapy. Today, we have shown that full dose mirvetuximab can be combined safely with full doses of Avastin, Carboplatin and Keytruda with favorable tolerability consistent with immune safety profiles of each agent.
Over the course of this year, we will have multiple data readouts from FORWARD II culminating in data reported in more than 100 patients who have received mirvetuximab demand in combination with Avastin or Keytruda.