Novartis has been boosted by late-stage data showing that Afinitor could be an effective treatment for advanced breast cancer.
The Swiss major noted that an interim analysis of a 700-patient Phase III study showed that Afinitor (everolimus) in combination with Pfizer's Aromasin (exemestane) significantly extended progression-free survival (PFS) when compared to placebo plus exemestane in women with advanced breast cancer. The trial, which included postmenopausal women with ER+HER2- metastatic breast cancer whose disease has progressed despite initial endocrine therapy, was halted as interim results showed the primary endpoint (PFS) was met.
Novartis will present full results from the study at an upcoming medical conference and make worldwide regulatory submissions by the end of 2011. Herve Hoppenot, president of the firm's oncology unit, said that based on these study results, "this combination has the potential to extend the time until chemotherapy is needed for these patients".
Afinitor is already approved for Afinitor is already approved in the USA for advanced kidney cancer in patients who do not benefit from Pfizer's Sutent (sunitinib) or Bayer's Nexavar (sorafenib) and for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis who are not candidates for curative surgical resection. It also received the thumbs-up in May from the US Food and Drug Administration for a rare type of pancreatic cancer.