Biotech Mailbag: Study Boosts ImmunoGen

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Vic R. asks for an ImmunoGen (IMGN Quote) update after Tuesday's third-quarter earnings report from Genentech (DNA Quote).

Genentech's pipeline update Tuesday brought good news for ImmunoGen when the company announced that it was advancing T-DM1 into a phase III study as a second-line treatment for Her-2 positive metastatic breast cancer.

Recall that Genentech is using technology from ImmunoGen to develop a second-generation version of Herceptin that combines the monoclonal antibody with a tumor-killing chemotherapy payload. That drug is T-DM1.

The newly announced phase III study will enroll 580 Her-2 positive metastatic breast cancer patients who have failed first-line treatment with Herceptin. Patients will be randomized to treatment with either T-DM1 or a combination of GlaxoSmithKline's (GSK Quote) Tykerb and the chemo drug capecitabine. The primary endpoint of the study is progression-free survival.

Explained simply, this new phase III study is designed to pit T-DM1 head to head against Tykerb, which is currently the only drug approved to treat breast cancer patients whose tumors continue to grow after treatment with Herceptin.

One more T-DM1 update to note. Genentech will be presenting updated phase II data on T-DM1 at the San Antonio Breast Cancer Symposium in December.

ImmunoGen is a long pick in the Biotech Select model portfolio. My investment thesis hinges largely on Genentech pushing ahead with development of T-DM1, so Tuesday's announcement was very important -- and very welcome.

ImmunoGen shares fell 10% Wednesday, which isn't exactly the reaction I wanted to see, but then, this market isn't too friendly to small-cap biotech stocks, as we know all too well.

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From Alex S.: "Why, and under what circumstances, would a company release important Phase III trial data only after they submit a new drug application for their product?"