Dive Brief:
- Roche's Kadcyla reduced the risk of disease recurrence in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment, according to results of a Phase 3 study.
- Patients were given the company's Herceptin and chemotherapy to shrink tumors before surgery, followed by either Herceptin or Kadcyla. Those receiving Kadcyla had significantly improved invasive disease-free survival compared with Herceptin, Roche said in a Monday statement.
- Roche will submit data to health authorities, including the Food and Drug Administration and the European Medicines Agency, and plans to present the results at the the 2018 San Antonio Breast Cancer Symposium in December.
Dive Insight:
While Kadcyla (ado-trastuzumab emtansine) is a relatively small contributor to Roche's bottom line, the trial success is a step in the Swiss pharma's broader HER2 strategy to complement Herceptin as biosimilars come in.
Herceptin (trastuzumab) gained FDA marketing approval in 1998, and rapidly became a standard treatment for HER2-positive breast cancer. Sales totaled 3.6 billion Swiss francs, or about $3.7 billion, in the first half of 2018, a slight increase over the same period last year.
But competition is looming.
Biocon and Mylan have received U.S. approval for the first Herceptin biosimilar Ogivri, and have reached a settlement deal with Roche. There's been no date announced for Ogivri's launch, but competition is drawing closer.
Roche also faces a biosimilar threat to its blockbusters Rituxan (rituximab) and Avastin (bevacizumab).
Kadcyla, developed by Roche's Genentech, was approved in the U.S. in February 2013 as the first antibody-drug conjugate (ADC) for treating HER2-positive metastatic breast cancer.
It's approved as a single agent in the U.S. and EU for the treatment of people with HER2-positive metastatic breast cancer who have previously received Herceptin and taxane chemotherapy, separately or in combination.
Also in its HER2 franchise, Roche has Perjeta (pertuzumab), which was approved as an adjuvant in the U.S., the EU, and 18 other countries, for use in higher-risk patients who represent between 70% and 75% of the early breast cancer population.