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immun - gen ImmunoGen Reports Recent Progress and Third Quarter 2021 Financial Results October 29 , 2021 Top - Line Data from Pivotal SORAYA Trial Evaluating Mirvetuximab Soravtansine in Platinum - Resistant Ovarian Cancer on Track for Release this Quarter IMGN632 AML Combination Data to be Highlighted at ASH Annual Meeting PICCOLO , Single - Arm Study of Mirvetuximab in Platinum - Sensitive Ovarian Cancer , Open for Enrollment Earlier - Stage Pipeline Continues to Progress Conference Call to be Held at 8:00 a.m. ET Today WALTHAM , Mass .-- ( BUSINESS WIRE ) -- Oct . 29 , 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 September 30 , 2021 . " We look forward to announcing top - line data from our pivotal SORAYA trial this quarter , including data on the primary endpoint of overall response rate and key secondary endpoint of duration of response . With positive data , we will move quickly to complete the BLA , with the goal of submitting the filing in the first quarter of 2022 , " said Mark Enyedy , ImmunoGen's President and Chief Executive Officer . " In addition to SORAYA , we continue to advance a broad program to establish mirvetuximab as the standard of care for patients with FRa - positive ovarian cancer . Our confirmatory MIRASOL trial is enrolling at over 160 sites in 18 countries in North America , Europe , Asia , and Australia , and we have initiated the PICCOLO trial , which could support label expansion in recurrent platinum - sensitive ovarian cancer . Beyond mirvetuximab monotherapy , the first patients have been enrolled in the large investigator - sponsored studies evaluating mirvetuximab combined with carboplatin in both the neoadjuvant and recurrent platinum - sensitive settings to support our objective of making mirvetuximab the combination agent of choice in ovarian cancer , and we look forward to sharing our label enabling combination strategy early next year . " Enyedy continued , " In addition , our IMGN632 , IMGC936 , and IMGN151 programs are advancing as planned . We anticipate presenting data on IMGN632 in AML at ASH in December , have escalated dosing in multiple solid tumors with our ADAM - 9 targeting ADC , IMGC936 , and expect to file the IND for IMGN151 , our next - generation FRa - targeting ADC , by year - end . As we close out 2021 , we remain focused on execution and look forward to transforming ImmunoGen into a fully integrated oncology company with the potential for commercial launch next year . " RECENT PROGRESS • Further enrolled patients in the confirmatory MIRASOL study for mirvetuximab . • Initiated PICCOLO , a single - arm study of mirvetuximab monotherapy in high folate receptor alpha ( FRA ) recurrent platinum - sensitive ovarian cancer . • Enrolled the first patients in the investigator - sponsored trials of mirvetuximab plus carboplatin in a single - arm study in the neoadjuvant setting and a randomized study in patients with recurrent platinum - sensitive ovarian cancer . • Advanced accrual in the pivotal 801 Phase 2 study , now known as CADENZA , 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 . ● Appointed Helen M. Thackray , MD , to the Board of Directors . ANTICIPATED UPCOMING EVENTS • Release top - line data from the pivotal SORAYA study this quarter , with the goal of submitting the biologics license application ( BLA ) in the first quarter of 2022 to support potential accelerated approval in 2022 . • Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology ( ASH ) Annual Meeting in December . • Submit the IND application for IMGN151 by the end of 2021 . • Complete dose - escalation in the Phase 1 study evaluating IMGC936 , with initial data anticipated in 2022 . • Generate top - line data for the confirmatory MIRASOL study in the third quarter of 2022 . FINANCIAL RESULTS Revenues for the quarter ended September 30 , 2021 were $ 9.2 million , compared with $ 18.2 million for the quarter ended September 30 , 2020. This decrease was driven by a reduction in non - cash royalty revenue due to the completion of the first tranche of payments under the 2015 transaction covering the sale of Kadcyla® royalties . Revenues for the quarter ended September 30 , 2021 also included recognition of an anticipated $ 2.5 million