With the Forward I clinical trial testing mirvetuximab as a monotherapy in platinum-resistant ovarian cancer fully enrolled, it's a waiting game for ImmunoGen's (NASDAQ: IMGN) investors until the results are released in the first half of next year.
Fortunately, there are some earlier-stage clinical trials to keep investors occupied while they wait.
ImmunoGen results: The only number that really matters
Cash and cash equivalents
Data source: ImmunoGen.
What happened with ImmunoGen this quarter?
- Without any drugs generating revenue for the company, the only important number is the biotech's cash runway, which increased year to date, thanks to an approximately $163 million secondary offering in June.
- At the American Society of Clinical Oncology meeting in June, ImmunoGen presented data from the Forward II trial, testing mirvetuximab plus Roche's Avastin. The data showed the combination produced an overall response rate of 43%, while patients were able to live without their tumors progressing -- called progression-free survival -- for 7.8 months. Given the strong response rate, the company added a cohort to the trial testing the two drugs plus a chemotherapy called carboplatin.
- In May, ImmunoGen's partner, Takeda, started a phase 1 trial testing TAK-164 in patients with gastrointestinal cancers.
Image source: Getty Images.
What management had to say
The Forward II trial is testing multiple combinations. But Anna Berkenblit, ImmunoGen's chief medical officer, noted that the combination with Merck's (NYSE: MRK) Keytruda would likely get priority, saying, "So our intent for the next registrational study is -- if the Keytruda combination data hold up -- to engage [the Food and Drug Administration] on a conversation and then pursue an accelerated approval with that combination as our next approval and label expansion."
The aforementioned triple combination has potential, but Berkenblit pointed out that it'll take a while to get the data, "The progression-free survival for this cohort should be pretty long, on the order of -- I don't know -- it's 15 months with just the carboplatin doublet, so I wouldn't be surprised if it would be longer than that."
Management now expects to end the year with $265 million to $270 million in the bank, which gets the company into 2020, a full year beyond when the results of the Forward I study are expected. That would give ImmunoGen plenty of time to get the data reviewed by the FDA.
In October, investors can expect additional data from the patients in the Forward II study treated with mirvetuximab and Keytruda at the European Society for Medical Oncology meeting. And in December, at the American Society of Hematology meeting, investors should get an update on a pair of phase 1 assets, IMGN779 and IMGN632. The results shouldn't necessarily drive the stock substantially higher, but they do give investors something to look forward to while waiting for the Forward I results.
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