MacroGenics touts a PhIII win in a head-to-head with best-seller Herceptin — shares rocket higher
MacroGenics $MGNX has claimed success in their Phase III trial of their drug margetuximab for metastatic breast cancer, putting them on the path to a BLA filing. But they’re not offering a lot of detail.
The top-line number cleared the bar for statistical significance, but not by a wide margin.
In a head-to-head with Herceptin (trastuzumab), the biotech reports that their drug won out in prolonging progression-free survival among heavily treated third- and fourth-line HER2+ patients. The p-value on the primary endpoint was 0.033 with a 24% risk reduction for disease progression. A much better score of 0.005, though, was recorded for the majority of patients in the trial who were carriers of the CD16A (FcγRIIIa) 158F allele, which is linked to resistance to Herceptin.
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