Clinically Meaningful Improvements in Progression Free Survival and Overall Survival Observed with ELAHERE Regardless of Prior Bevacizumab Status MIRASOL Results to be Highlighted in Late-Breaking Oral Presentation Today at ASCO Annual Meeting and Selected for the 2023 Best of ASCO Program®
WALTHAM, MA, USA I June 04, 2023 I ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced detailed results from the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of ELAHERE® (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC)folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC). The results are being presented by Dr. Kathleen Moore in a late-breaking oral abstract session today at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. These data have also been selected for the 2023 Best of ASCO program, which will be held this summer following the ASCO Annual Meeting. "I am thrilled to share these impressive results from the confirmatory MIRASOL trial at ASCO, which further demonstrate the potential of ELAHERE to become the new standard of care for patients with FRα-positive PROC," said Kathleen Moore, Associate Director of Clinical Research and Director of the Oklahoma TSET/Sarah Cannon Phase I Program, Professor of the Section of Gynecologic Oncology at The University of Oklahoma and MIRASOL Principal Investigator. "As we saw in the top-line data announced last month, ELAHERE demonstrated an improvement versus chemotherapy across all efficacy endpoints and, importantly, is the first treatment to show an overall survival benefit in this patient population. The 33% reduction in the risk of death, along with the differentiated and well-characterized safety profile seen in MIRASOL, reinforce the potential of ELAHERE to serve as a transformative option for ovarian cancer patients and change how this disease is treated." MIRASOL is a randomized Phase 3 trial of ELAHERE versus investigator's choice (IC) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with PROC whose tumors express high levels of FRα, using the Ventana FOLR1 Assay, and who have been treated with up to three prior regimens. The primary endpoint of this trial is progression-free survival (PFS) by investigator assessment. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). MIRASOL enrolled 453 patients. Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 40% had two prior lines of therapy, and 46% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%). 62% of patients received prior bevacizumab; 55% received a prior PARP inhibitorPARP inhibitor. As of the data cutoff on March 6, 2023, the median follow-up time for OS was 13.1 months; 14% of patients on the ELAHERE arm remained on study drug compared to 3% on the IC chemotherapy arm. In addition to data on the primary and key secondary endpoints, further safety and efficacy analyses from MIRASOL will be presented:
"We are incredibly pleased the MIRASOL results were selected as a late-breaking presentation at ASCO," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "As the first novel therapy to extend overall survival in platinum-resistant disease, and with consistent efficacy regardless of prior bevacizumab use, ELAHERE is a much-needed advance in the ovarian cancer treatment paradigm. We look forward to submitting the MAA and sBLA for ELAHERE in the EU and US, respectively, during the second half of the year, and to progressing the broader ELAHERE development program as we work to deliver this biomarker-directed ADC to eligible patients." LATE-BREAKING ORAL PRESENTATION
Presenter: Dr. Kathleen Moore, Associate Director of Clinical Research and Director of the Oklahoma TSET/Sarah Cannon Phase I Program, Professor of the Section of Gynecologic Oncology at The University of Oklahoma and MIRASOL Principal Investigator Session: Late-Breaking Abstract Session: Presentation and Discussion of LBA5507
Date: Sunday, June 4, 2023
Time: 7:30 am to 8:05 am CT / 8:30 am to 9:05 am ET
ImmunoGen is also presenting two trial-in-progress posters at ASCO. Additional information can be found at www.asco.org.
Ovarian cancer is the leading cause of death from gynecological cancers in the US. Each year, roughly 20,000 patients are diagnosed, and 13,000 patients will die. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. In this setting, standard of care single-agent chemotherapies are associated with low response rates, short durations of response, and significant toxicities. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full Prescribing Information, including Boxed Warning for ELAHERE. ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™. Learn more about who we are, what we do, and how we do it at www.immunogen.com.