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What: Shares of ImmunoGen (IMGN +0.00%), a biopharmaceutical company focused on developing antibody-drug conjugates to heighten the effectiveness of the therapeutic delivery process, lost as much as 51% on Friday after it and partner Roche (RHHBY 0.42%) provided an update on the MARIANNE study for HER2-positive metastatic breast cancer drug Kadcyla.
So what: According to the early morning press release regarding the phase 3 study, which evaluated using Kadcyla by itself, Kadcyla with Roche's Perjeta, and a control group of Herceptin plus a taxane chemotherapy, all three studies led to a similar period of progression-free survival. This means Kadcyla meets the definition of noninferiority, according to an independent review committee, but it wasn't established as a statistically significant improvement in progression-free survival compared to the control group.
The purpose of MARIANNE was to expand Kadcyla's label to previously untreated metastatic HER2-positive breast cancer patients. Its current indication is to treat HER2-positive breast cancer patients only after existing treatments have failed.
Said ImmunoGen CEO Daniel Junius in the press release, "While we are disappointed by this unexpected outcome, we are pleased that so many patients can benefit from Kadcyla with its already approved use and also with the breadth of Roche's Kadcyla clinical development program. Roche has a number of other trials under way with Kadcyla, and in 2015 expects data and -- if positive -- regulatory submission from its GATSBY study in gastric cancer."
Source: ImmunoGen.
Now what: The past year has not been a particularly good for ImmunoGen investors. The company shelved its most developed in-house therapy late last year and now has seen its only approved drug return mediocre results in a study that would have expanded its usage to first-line status.
I don't believe this puts Kadcyla on the back burner just yet, but it's also unlikely to make Wall Street or investors feel confident about the drug's immediate future. ImmunoGen is unlikely to turn the corner to profitability anytime soon with its lone indication for Kadcyla, meaning cash conservation and potentially a share offering could be in its future.
On the flip side, ImmunoGen has 23 compounds in preclinical and clinical development with seven mostly high-profile collaborative partners. ImmunoGen has ways to raise cash if necessary by licensing its in-house products or granting access to its technology. In other words, it is pretty well diversified, which makes today's failure a potentially attractive entry point. That doesn't mean ImmunoGen isn't without risk, as most of its 23 compounds beyond Kadcyla are still in the preclinical, phase 1, and phase 2 stages of development, but there's enough potential for a home run here that it could make sense to dip your toes into the water.
