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immun - gen ImmunoGen Reports Recent Progress and Second Quarter 2021 Financial Results July 30 , 2021 Compelling Final Data from FORWARD II Study Combining Mirvetuximab Soravtansine with AvastinⓇ in Recurrent Ovarian Cancer , Regardless of Platinum Status , Presented at ASCO Top - line Data from Pivotal SORAYA Trial on Track for Q4 Release Continued Progress in Ongoing MIRASOL , IMGN632 , and IMGC936 Studies Conference Call to be Held at 8:00 a.m. ET Today WALTHAM , Mass .-- ( BUSINESS WIRE ) -- Jul . 30 , 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 June 30 , 2021 . " With top - line data from our pivotal SORAYA trial on track for release in Q4 , we have accelerated preparations for the BLA submission and commercial launch of mirvetuximab . In parallel , we continue to generate data that support mirvetuximab as the combination agent of choice for ovarian cancer patients , " said Mark Enyedy , ImmunoGen's President and Chief Executive Officer . " At ASCO , we presented final data from our mirvetuximab plus Avastin® doublet , showing compelling and durable anti - tumor activity , with a 64 % ORR , 11.8 month mDOR , and 10.6 month mPFS in patients with high FRa recurrent ovarian cancer , regardless of platinum status . We believe these data are highly encouraging , particularly given outcomes with available therapies in this setting . As we continue to accrue our confirmatory MIRASOL trial , we are working to establish mirvetuximab as the new standard of care in patients with high FRa ovarian cancer , who comprise roughly 40 % of the market . To this end , this quarter we are initiating PICCOLO , a single - arm study of mirvetuximab monotherapy in recurrent platinum - sensitive ovarian cancer to support label expansion . " Enyedy added , " Beyond mirvetuximab , our IMGN632 , IMGC936 , and IMGN151 programs are progressing as anticipated . Patient accrual continues in our IMGN632 trials in BPDCN and AML , with data from our AML cohort expected at ASH next quarter . Our dose - escalation study of IMGC936 is enrolling in multiple solid tumor types and we are on track to file the IND for IMGN151 by year - end . With a focus on execution towards key inflection points , we look forward to transforming ImmunoGen into a fully integrated oncology company with the potential for two innovative ADCs on the market in 2022. " RECENT PROGRESS • Presented final data from the FORWARD II study evaluating mirvetuximab in combination with Avastin® ( bevacizumab ) in patients with medium and high folate receptor alpha ( FRa ) -expressing recurrent ovarian cancer for whom a non - platinum based combination regimen is appropriate at the 2021 American Society of Clinical Oncology ( ASCO ) Virtual Annual Meeting . • Completed accrual in the pivotal SORAYA study and further enrolled patients in the confirmatory MIRASOL study for mirvetuximab . Supported enrollment of investigator - sponsored trials of mirvetuximab plus carboplatin in a single - arm study in the neoadjuvant setting and in a randomized study in patients with recurrent platinum - sensitive ovarian cancer . • Advanced accrual in the pivotal 801 Phase 2 study of IMGN632 in frontline and relapsed / refractory ( R / R ) blastic plasmacytoid dendritic cell neoplasm ( BPDCN ) . • Continued patient enrollment in the 802 Phase 1b / 2 study of IMGN632 in combination with Vidaza® ( azacitidine ) and Venclexta® ( venetoclax ) in R / R acute myeloid leukemia ( AML ) patients and as a monotherapy in minimal residual disease positive ( MRD + ) AML . • Escalated dosing 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 • Release top - line data from the pivotal SORAYA study 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 . • Generate top - line data for the confirmatory MIRASOL study in the third quarter of 2022 . • Enroll the first patient in PICCOLO , a single - arm study of mirvetuximab monotherapy in high FRa recurrent platinum sensitive ovarian cancer , in the third quarter of 2021 , designed to support potential label expansion . • Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology ( ASH ) Annual Meeting in December 2021 . • Complete dose - escalation in the Phase 1 study evaluating IMGC936 , with initial data anticipated in early 2022 . • Submit the IND application for IMGN151 by the end of 2021 . FINANCIAL RESULTS