A fully approved breast cancer drug from MacroGenics (MGNX) failed to pass muster in a final analysis, and MGNX stock dipped Wednesday.
The final analysis pitted MacroGenics’ Margenza and chemotherapy against Roche‘s (RHHBY) Herceptin plus chemo. But the MacroGenics combination failed to extend overall survival beyond the regimen from Roche. Overall survival is how long a patient lives prior to any cause of death.
However, a subset of patients with a specific genetic variation lived a median of 2.5 months longer on the Margenza-chemotherapy combination.
In morning trading on the stock market today, MGNX stock fell 4.8% near 20.70. That improved from an 8.6% dive in earlier action.
MGNX Stock Dives On Cancer Test
The Margenza-chemotherapy regimen was approved based on the results from a test called Sophia. In that test, the regimen improved the length of time patients lived before their cancer returned.
But the final analysis didn’t confirm an overall survival benefit for all patients. At the median, the patients who received Margenza plus chemotherapy lived for 21.6 months. The Herceptin-chemo recipients lived a median of 21.9 months.
A subset of patients with a specific genetic variation responded better to the MacroGenics combo. They lived 23.3 months at the median vs. 20.8 months for the Herceptin-chemo group. That group represents about 82% of all patients in the study.
European Approval At Risk
Wedbush analyst David Nierengarten reiterated his outperform rating and 32 price target on MGNX stock.
“While the data reported are top-line negative, it does not come as much of a surprise given the previously reported data,” he said in a note to clients. “While there was an outside chance that overall survival would meet statistical significance, it was not in our model.”
European regulators would likely only approve the combination if it improved overall survival, he said.
MacroGenics said it will need to further test the combination in patients with the specific genetic variation.
“We continue to believe Margenza may be the right choice for certain patients,” Chief Executive Scott Koenig said in a written statement.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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