New Drug For Late Stage Breast Cancer Shows Success

This is great news for those women who wait to have mammograms or the mammograms did not show the existing cancer.  When breast cancer is found in Stage 4 the prognosis has not been good.  So there is hope because of a successful drug trial. Roche Holding AG ROG.VX +0.06% Friday reported positive results from a late-stage study that compared its experimental breast cancer drug trastuzumab emtansine to a rival product from GlaxoSmithKline GSK -0.11% PLC, paving the way to file the potential blockbuster drug for regulatory approval in Europe and the U.S. later this year.
The Basel-based drug maker said women whose breast cancer had spread despite earlier treatment lived longer without their disease getting worse when treated with Roche's trastuzumab emtansine, or T-DM1, compared with those who received Glaxo's Tykerb plus chemotherapy.
The study involved 991 women previously treated with another Roche drug Herceptin plus chemotherapy, whose cancer spread after this initial treatment. "We believe this suggests that the observed benefit is likely to be a meaningful one and that at least a trend toward a survival improvement is likely," Deutsche Bank analysts said in a note to investors. Roche said data to show if the drug helps prolonging patients life wasn't available yet.

T-DM1 is an antibody drug which delivers the chemotherapy agent directly inside cancer cells, with the aim of causing fewer side effects. Roche said final results for overall survival aren't yet complete. Analysts said the trial results, which were expected after a similarly good outcome of intermediate tests, are a sign that the company's strategy to improve standard care through innovative drug discovery is paying off. But they noted that, until the drug proves to work also as first-line treatment, market potential is limited.
"These results enable Roche to register the drug, but as a second-line treatment, the market opportunity is limited," said Andrew Weiss, an analyst in Zurich with Vontobel. "If the second set of data shows it also works as a first-line treatment, then that will open up the market," Weiss said, adding the drug carries a sales potential of 1.7 billion Swiss francs ($1.8 billion) if marketed globally. Another ongoing late-stage study, dubbed MARIANNE, is testing if T-DM1 also works on patients who weren't previously treated with established drugs. This trial's results are expected in 2014.
"We have significantly increased confidence that the front-line trial…will report positively," analysts at Deutsche Bank said, adding that annual sales could reach more than $1.5 billion if the drug was approved for this use. Mr. Weiss, who has a buy rating on Roche, also said that T-DM1 results, coupled with "stellar" data on experimental compound pertuzumab can help Roche alleviate competitive pressure on its blockbuster breast cancer drug Herceptin. He said Roche is likely to present detailed results at the American Society of Clinical Oncology Annual ASCO meeting in June.

ImmunoGen's Chief Executive Daniel M. Junius said in an interview that the top-line results from Roche were symbolically significant because it validated the company's antibody technology. He also said first-line study data on TDM-1 isn't expected until late 2013 into 2014, but a second-line application is important, representing the most immediate opportunity to make the drug available to patients. He said the current second-line treatment has a limited patient population and hasn't been very successful.

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