GlaxoSmithKline's efforts to expand the indications for its breast cancer drug Tykerb stumbled slightly last week when the company shut down one arm of a phase III trial when it was determined to be less effective than Herceptin.
The trial, known as ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization) had four arms:
1. Tykerb
2. Herceptin (trastuzumab)
3. Herceptin (trastuzumab) followed by Tykerb
4. Herceptin and Tykerb together.
The first arm has been shut down because it is already obvious to investigators that Tykerb alone is inferior to Herceptin.
The study was designed to determine if a combination of the drugs was more effective than Herceptin alone. GSK is hoping to have Tykerb approved for certain breast cancers as an adjuvant treatment as well as its current indication, which is as a primary treatment for patients with HER-2 positive breast cancer.
The remaining arms of the ALTTO trial will continue.
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