Tykerb: Phase III data

Researchers at Massachusetts General Hospital Cancer Center and colleagues reported data from the open-label, international Phase III NeoALTTO trial in 455 HER2-positive primary breast cancer patients with tumors >2 cm in diameter showing that a significantly greater proportion of patients receiving Herceptin trastuzumab plus Tykerb lapatinib achieved a pCR at the time of surgery, the primary endpoint, vs. Herceptin alone (51.3% vs. 29.5%, p=0.0001). pCR was defined as no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. There was no significant difference in the proportion of patients who achieved a pCR between the Herceptin alone and Tykerb alone (23.4%) treatment groups (p=0.34).

Additionally, Herceptin plus Tykerb led to a significantly higher objective clinical response rate at week 6 vs. both Herceptin alone and Tykerb alone (67.1% vs. 30.2% and 52.6%, respectively, p<0.0001 for both). At the time of surgery, there were no significant differences between the Herceptin plus Tykerb, Herceptin alone or Tykerb alone treatment groups in objective clinical response rate (80.2%, 70.5% and 74%, respectively). Patients received anti-HER2 therapy alone for 6 weeks followed by the addition of paclitaxel for a further 12 weeks before undergoing definitive surgery. GlaxoSmithKline sponsored the trial. Data were published in The Lancet. ...