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Buoyed By T-DM1 EMILIA Data, Roche Leaps To Early Breast Cancer Trial

 
• By Emily Hayes

In Phase III EMILIA study, Herceptin-containing antibody drug conjugate demonstrates three-month progression-free survival benefit, trend toward overall survival and, importantly, better safety profile. Results pave way for new trials in earlier disease using new FDA approval pathway.

CHICAGO–Roche/Genentech Inc. is riding the momentum created with the release of the EMILIA trial of its Herceptin-based antibody conjugate T-DM1 in late-stage breast cancer and preparing to conduct a study in early-stage breast cancer using a new accelerated approval pathway created by FDA, as part of the company’s “three-pronged” development strategy in breast cancer, Roche execs said during an analyst briefing at the annual American Society of Clinical Oncology meeting June 3.

A follow-on to the blockbuster Herceptin (trastuzumab), T-DM1 (trastuzumab emtansine) combines trastuzumab with a highly potent, cytotoxic agent called DM1, which is similar to taxane chemotherapy, connected by a stable...

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