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immun - gen ImmunoGen Reports Recent Progress and First Quarter 2021 Financial Results May 10 , 2021 Top - Line Data from Pivotal SORAYA Trial of Mirvetuximab Soravtansine in Ovarian Cancer Expected in the Fourth Quarter of 2021 FORWARD II Mirvetuximab Plus Avastin® Doublet Cohort in Recurrent Ovarian Cancer , Regardless of Platinum Status , Selected for Oral Presentation at ASCO Preclinical Data Demonstrating Anti - Tumor Activity of First - in - Class ADAM9 - Targeting ADC , IMGC936 , Presented at AACR Conference Call to be Held at 8:00 a.m. ET Today WALTHAM , Mass .-- ( BUSINESS WIRE ) -- May 10 , 2021-- ImmunoGen Inc. ( Nasdaq : IMGN ) , a leader in the expanding field of antibody - drug conjugates ( ADCs ) for the treatment of cancer , today reviewed recent progress in the business and reported financial results for the quarter ended March 31 , 2021 . " During the first quarter , we advanced our portfolio of innovative ADCs and accelerated preparations for two potential product launches next year , " said Mark Enyedy , ImmunoGen's President and Chief Executive Officer . " We saw a limited delay in patient enrollment in the pivotal SORAYA trial for our lead program , mirvetuximab soravtansine , which has shifted the anticipated timing of top - line data from the third into the fourth quarter of this year and the projected submission of the BLA into the first quarter of 2022. We have also experienced some COVID - related impact on accrual to our confirmatory MIRASOL trial and now expect the read - out on the primary endpoint to move from the second into the third quarter of 2022. Beyond SORAYA and MIRASOL , we are commencing several studies to move mirvetuximab into earlier lines of ovarian cancer therapy , including an investigator - sponsored trial of mirvetuximab in combination with carboplatin in the neoadjuvant setting that initiated this quarter . We are also supporting a randomized study comparing mirvetuximab combined with carboplatin to standard of care in patients with recurrent platinum - sensitive disease and have submitted a protocol to FDA for a single - arm study of mirvetuximab monotherapy in later - line platinum - sensitive patients , with both studies anticipated to begin enrollment in the second half of this year . Finally , we were pleased to receive notice that mature data from our mirvetuximab plus Avastin® doublet cohort in recurrent ovarian cancer , regardless of platinum status , have been selected for an oral presentation at ASCO in June . " Enyedy added , " We continued enrollment for our second pivotal program , IMGN632 , in patients with frontline and relapsed / refractory BPDCN , with top - line data expected in the first half of 2022. IMGN632 is also in ongoing development in AML , both as a monotherapy and in combinations . Moving to our earlier - stage portfolio , we presented preclinical data at AACR last month on IMGC936 , our first - in - class ADAM9 - targeting ADC , demonstrating anti - tumor activity in multiple solid tumor models , and we advanced dose escalation in the Phase 1 study for this program . IND - enabling activities for our next - generation anti - FRa ADC , IMGN151 , are on track to submit an application to the FDA by the end of 2021. With pre - commercial activities underway , we look forward to a meaningful year ahead with a number of important milestones across the business as we work towards bringing our first two therapies to market next year . " RECENT PROGRESS • Further enrolled patients in the pivotal SORAYA and confirmatory MIRASOL trials . ● Supported initiation of an investigator - sponsored trial of mirvetuximab plus carboplatin in the neoadjuvant setting . • Submitted to the US Food and Drug Administration ( FDA ) a single - arm study protocol for mirvetuximab monotherapy in later - line platinum - sensitive ovarian cancer patients . • Advanced accrual of the pivotal 801 Phase 1/2 study of IMGN632 in frontline and relapsed / refractory ( R / R ) blastic plasmacytoid dendritic cell neoplasm ( BPDCN ) patients . • Continued patient enrollment in the 802 Phase 1b / 2 study of IMGN632 in combination with Vidaza® ( azacitidine ) and Venclexta® ( venetoclax ) in R / R and frontline acute myeloid leukemia ( AML ) patients and as a monotherapy in minimal residual disease positive ( MRD + ) AML . • Presented preclinical data on IMGC936 , our novel ADAM9 - targeting ADC in co - development with MacroGenics , in a poster at the virtual American Association for Cancer Research ( AACR ) Annual Meeting . • Moved through dose - escalation cohorts in the Phase 1 study of IMGC936 in multiple solid tumor types . ● Progressed activities to support an investigational new drug ( IND ) application for IMGN151 . ANTICIPATED UPCOMING EVENTS • Generate top - line pivotal SORAYA data in the fourth quarter of 2021 and submit the biologics license application ( BLA ) in the first quarter of 2022 to support potential accelerated approval in 2022 . • Complete patient enrollment in MIRASOL and generate top - line data in the third quarter of 2022 . • Present mature data from the Phase 1b FORWARD II cohort evaluating mirvetuximab in combination with AvastinⓇ ( bevacizumab ) in recurrent ovarian cancer in an oral presentation at the 2021 American Society of Clinical Oncology ( ASCO ) Annual Meeting in June . • Initiate a single - arm study of mirvetuximab monotherapy in recurrent platinum - sensitive ovarian cancer in the second half of 2021 to support potential label expansion .