Roche’s Perjeta (pertuzumab)-based regimen has demonstrated sustained survival benefits in patients with early-stage breast cancer, according to new results from a long-term study of the drug.
The phase 3 APHINITY trial has been evaluating the safety and efficacy of Perjeta plus Herceptin (trastuzumab), two HER2-targeted therapies, and chemotherapy against Herceptin, chemotherapy and placebo as a post-surgery treatment in over 4,800 patients with operable HER2-positive early-stage breast cancer.
Data announced by Roche, the Breast International Group, Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation showed that patients treated with the Perjeta-based regimen for a year post-surgery experienced a 17% reduction in their risk of death after ten years compared to those receiving Herceptin plus chemotherapy. This reduction rose to 21% in a pre-specified subgroup of patients with lymph node-positive disease.
Among patients receiving the Perjeta-based regimen, 91.6% were alive at ten years versus 89.8% of those treated with Herceptin plus chemotherapy. The previously reported invasive disease-free survival benefit was also maintained, however, no benefit was seen in the node-negative subgroup.
“Adding Perjeta to a standard adjuvant treatment is most beneficial for people with HER2-positive breast cancer with lymph-node positive disease who are at high risk of recurrence,” said APHINITY study chair, Sibylle Loibl.
Approximately 56,800 new breast cancer cases are diagnosed in the UK every year, and up to 20% of breast tumours have higher levels of the HER2 protein. Although HER2-positive breast cancers typically grow and spread faster than those that are HER2-negative, they are much more likely to respond to HER2-targeted therapies.
Roche’s Perjeta-based regimen is already approved in over 120 countries/regions to treat early-stage and metastatic HER2-positive breast cancer.
The company’s chief medical officer and head of global product development, Levi Garraway, said the new results from APHINITY “validate the sustained benefits of the Perjeta-based regimen” and “reinforce the regimen’s value as a well-established standard-of-care treatment in the curative setting”.
Full results from the trial will be presented at this year’s European Society for Medical Oncology Breast Cancer Congress.