Biotechnology company ImmunoGen Inc. (IMGN:NASDAQ), which is engaged in creating targeted antibody-drug conjugates (ADCs) therapies to treat of cancer, today announced "positive top-line data from the pivotal SORAYA trial evaluating the safety and efficacy of mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin® (bevacizumab)."
Robert Coleman, M.D., SORAYA trial Co-Principal Investigator and Chief Scientific Officer of U.S. Oncology Research, stated, "Despite advances in the platinum-sensitive setting, most patients with ovarian cancer eventually develop platinum-resistant disease, for which there are limited treatment options, especially for those patients who have previously received bevacizumab…Data from SORAYA have the potential to redefine the standard of care for patients with FRα-high platinum-resistant ovarian cancer, as this trial has demonstrated that mirvetuximab delivers clinically meaningful benefit in this setting, with significant and durable responses and a favorable tolerability profile."
The company advised that the single-arm Phase 3 SORAYA trial's objective is to evaluate the use of mirvetuximab in patients with platinum-resistant ovarian cancer. To be included in the study, participants included only those patients "whose tumors express high levels of FRα and who have been treated with up to three prior regimens– at least one of which included bevacizumab."
The firm noted that the pre-established primary endpoint in the study was defined as confirmed objective response rate (ORR) which included both complete and partial responses. In addition, the firm measured the duration of response (DOR) as an important key secondary endpoint.
ImmunoGen pointed out that in the SORAYA study, ORR was also assessed by blinded independent central review (BICR) and that the study was fashioned to exclude a 12% ORR base case, predicated upon expected prior outcomes associated with available single agent chemotherapy as demonstrated in patients in the AURELIA study.
The firm indicated that the Phase 3 SORAYA study enrolled a total of 106 patient subjects who had all previously received a median of three lines of therapy. Of the 106 participants, 51% had been through three prior lines of therapy and 48% had underwent either one or two prior lines of therapy. The company reported that "all patients received prior bevacizumab; 48% of patients received a prior PARP inhibitor and that as of the data cutoff on November 16, 2021, the median follow-up time was 8.1 months."
ImmunoGen advised that the ORR as measured by the investigator in the study was 32.4% and included five complete responses (CRs). ORR determined via BICR methods was quite similar at 31.6% and also included five CRs. The firm added that median DOR achieved to date is 5.9 months, but is possible that with longer follow-up, median DOR might range from 5.7 to slightly above 7.0 months.
The SORAYA study's Co-Principal Investigator Ursula Matulonis, M.D., Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, commented, "These data have the potential to be transformative for ovarian cancer patients and their physicians…In the platinum-resistant setting and particularly in later-line treated patients, response rates with available therapy are in the single digits with significant toxicities. With an ORR above 30%, a duration of response of around six months, and a treatment-related discontinuation rate below 10%, mirvetuximab shows impressive activity and tolerability for patients with platinum-resistant ovarian cancer. If approved, mirvetuximab will become a critical therapeutic option for patients with FRα-high ovarian cancer."
ImmunoGen's SVP and Chief Medical Officer Anna Berkenblit, M.D. remarked, "We are extremely pleased with the top-line data from SORAYA, which support our strategy to position mirvetuximab as the standard of care for patients with FRα-high ovarian cancer…Mirvetuximab's efficacy far exceeds that which is expected with available therapies."
The company's President and CEO Mark Enyedy stated, "This is an exciting moment, both for the field of ovarian cancer and for ImmunoGen, and the outcomes from SORAYA further validate our longstanding history of innovation in ADCs…We are moving forward expeditiously to complete the BLA for mirvetuximab, with the goal of submitting the application to FDA for accelerated approval in the first quarter of 2022. In parallel, commercial preparations are well underway to support the potential launch of mirvetuximab next year."
"Beyond SORAYA, we expect to generate top-line data from our confirmatory MIRASOL trial in the third quarter of 2022 to support the potential full approval of mirvetuximab and are also working to expand mirvetuximab monotherapy into later-line platinum-sensitive disease," CEO Enyedy added.
The company described mirvetuximab soravtansine (IMGN853) as "a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells."
ImmunoGen is a clinical-stage biotechnology firm based in Waltham, Mass. that concentrates its efforts on developing next generation antibody-drug conjugates (ADCs) to improve outcomes in cancer patients. The company is focused on generating targeted therapies with enhanced anti-tumor activity and excellent tolerability profiles in order to disrupt cancer progression giving patients the opportunity for many more good days ahead.
ImmunoGen began the day with a market cap of around $962.4 million with approximately 202.6 million shares outstanding and a short interest of about 5.1%. IMGN shares opened 44% higher today on the news at $6.84 (+$2.09, +44.00%) over yesterday's $4.75 closing price. The stock has traded today between $5.75 and $6.91 per share and is currently trading at $6.22 (+$1.47, +30.95%).
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