IMGN ImmunoGen Inc

ITEM 8.01. – OTHER EVENTS.

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On December 17, 2019, ImmunoGen, Inc. (also referred to as “we”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine. Based on this guidance, we will initiate SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with bevacizumab. SORAYA is a single-arm trial that will enroll approximately 100 patients. Eligibility criteria include patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα using the PS2+ scoring method, and who have been treated with up to three prior regimens – at least one of which included bevacizumab. The primary endpoint of this study is overall response rate by investigator assessment and the key secondary endpoint is duration of response. A copy of such press release is being filed with this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

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Forward-Looking Statements

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This report includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, our expectations with respect to the future development of mirvetuximab soravtansine. For these statements, we claim the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Various factors could cause our actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this report. It should be noted that there are risks and uncertainties related to the development of novel anticancer products, including risks related to the timing, expense, and results of clinical studies and regulatory processes; ImmunoGen’s, and the potential that earlier clinical studies may not be predictive of future results. A review of these risks can be found in our Annual Report on Form 10-K for the year ended December 31, 2018 and other reports filed with the Securities and Exchange Commission.

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