The antibody-drug conjugate field has had its ups and downs, but lately developers of such therapies--which use targeted antibodies attached to anti-cancer toxins to home in on tumor cells--have been kicking butt on the clinical and regulatory fronts. Roche has registered the latest win with data from a mid-stage trial that showed that T-DM1, an antibody linked to a toxin, outperformed the standard treatment of two separate drugs for an advanced form of breast cancer.
T-DM1, which failed to gain FDA approval last year, showed in a 137-patient trial that people on the experimental drug lived for 14.2 months without their cancer getting worse compared with 9.2 months of progression-free survival for patients taking the standard treatment, Roche's targeted antibody Herceptin and a chemotherapy drug. There were also about half as many instances of side effects among patients on T-DM1, which uses Herceptin as the targeted antibody, compared with the standard treatment. This bolsters the case for technology from ImmunoGen ($IMGN) that chemically links the cytotoxin DM1 to the antibody trastuzumab, the generic name for Herceptin.
Roche is conducting three late-stage trials for T-DM1, including one that tests the therapy as a second-line treatment and is expected to yield data next year. The Swiss drug giant aims to include data from that Phase III trial called "EMILIA" in submissions for approval in major markets such as the U.S. in 2012, according to partner ImmunoGen. An approval of T-DM1 would provide ImmunoGen with its first commercial asset as it concentrates on advancing other antibody-drug conjugates through trials.
Seattle Genetics ($SGEN) could have the first commercially successful antibody-drug conjugate with Adcetris, which the FDA approved in August for treating two types of lymphoma. Clearly, the field of arming antibodies with cytotoxins is enjoying an upswing, and it is one that is worth following for those interested in drug-delivery technologies. Yet the long-term success of this field could ride in part on whether payers are willing to swallow the high prices of such therapies.
ImmunoGen's shares were up 9.6% this week as of early Tuesday morning, presumably getting a boost from the new data on T-DM1 presented on Saturday at the 2011 European Multidisciplinary Cancer Congress in Stockholm.
- here's ImmunoGen's release
- check out the Reuters article