Weak SOPHIA OS Signal Dampens Enthusiasm For MacroGenics’ Margetuximab
Whether MacroGenics’ margetuximab can produce an overall survival benefit from the SOPHIA study could be key to its commercial fortunes, say analysts. The company remains optimistic.
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While the general lack of an overall survival benefit for MacroGenics’ drug in later-line breast cancer was not surprising, OS data were seen as important for commercial uptake of the drug.
The company expects to file an NDA for tucatinib in the first quarter after a pivotal trial showed a significant improvement in PFS and OS for patients with advanced or metastatic HER2-positive breast cancer, including those with brain metastases.
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