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ImmunoGen Presses Forward

ImmunoGen (NASDAQ: IMGN) is in waiting mode with its lead drug, mirvetuximab, being tested in the phase 3 Forward I trial in patients with ovarian cancer, making for a relatively quiet first-quarter earnings release.

ImmunoGen results: The raw numbers

Metric

Q1 2018

Q1 2017

Year-Over-Year Change

Revenue

$19.8 million

$28.5 million

(30%)

Income from operations

($36.7 million

($12.9 million)

N/A

Earnings per share

($0.30)

($0.20)

N/A

Data source: ImmunoGen.

What happened with ImmunoGen this quarter?

  • Without any revenue-generating drugs, the GAAP results aren't particularly important. The only number that really matters is that ImmunoGen ended the quarter with $218 million in cash and cash equivalents, enough to get it into the fourth quarter of next year.

  • In April, ImmunoGen completed enrollment in the Forward I trial testing mirvetuximab as a monotherapy in platinum-resistant ovarian cancer.

  • During a prespecified peek at the data from Forward I in April, the independent data monitoring committee recommended continuing the trial, putting it on schedule to read out top-line results in the first half of next year.

  • At the Society of Gynecologic Oncology meeting in March, ImmunoGen presented data from the Forward II trial testing mirvetuximab in combination with Merck's (NYSE: MRK) Keytruda. In the eight patients with medium or high expression of folate receptor alpha -- the protein which mirvetuximab targets -- 63% of patients responded to the combination for a median of 36.1 weeks. While it's a small number of patients, the response is encouraging, leading ImmunoGen to enroll an additional 35 patients in the treatment cohort.

Cancer patient and friend holding hands
Cancer patient and friend holding hands

Image source: Getty Images.

What management had to say

On the potential to partner mirvetuximab, Mark Enyedy, ImmunoGen's president and CEO, stressed that it wouldn't likely occur before the Forward I data was released, adding: "We would need to be able to convince ourselves and our shareholders that anything that we did with a partner would enhance the value of the program, which means that the partner would need to subscribe to a broad vision of the program and enable us to do things that we may not have as the highest priority at the current time."

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The Forward II trial is testing multiple combinations with mirvetuximab, including a triple combination started earlier this year with carboplatin and Avastin in patients with recurrent platinum-sensitive disease, but Anna Berkenblit, ImmunoGen's chief medical officer, warned that the data wouldn't be ready this year: "Given the relatively high response rates observed in mirvetuximab plus carboplatin and the durability of responses, we think it will be into 2019 before we would have initial data on this triplet combination."

Data taking awhile to read out because patients respond well isn't necessarily a bad problem to have.

Looking forward

While investors wait for the Forward I data and the triple combination in Forward II next year, there will be some data from other cohorts in the Forward II trial, including the doublet of mirvetuximab plus Avastin, which will be presented at the American Society of Clinical Oncology meeting next month.

And further back in the pipeline, ImmunoGen has two phase I blood cancer drugs, IMGN779 and IMGN632, which should both have data available at the American Society of Hematology meeting in December.

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Brian Orelli has no position in any of the stocks mentioned. The Motley Fool recommends ImmunoGen. The Motley Fool has a disclosure policy.