Novartis drug Afinitor is first treatment for advanced pancreatic NET to provide overall survival of more than 3.5 years in Phase III trial - Seite 3

In the double-blind phase, serious adverse events (SAEs) were reported more often in the everolimus arm than in the placebo arm (41.2% vs. 25.6%)[4]. The most commonly reported SAEs (>=2% incidence) in the everolimus arm were pyrexia (3.9%), pneumonitis (3.4%), anemia (3.4%), abdominal pain (2.9%), dyspnea (2.9%), diarrhea (2.5%), pulmonary embolism (2.5%), asthenia (2.5%) and dehydration (2.5%)[4]. The frequency of AEs leading to study drug discontinuation during the double-blind period was higher for the everolimus treatment group (21.1%) compared to the placebo group (5.9%)[4]. In the open-label period, 23.6% of patients discontinued treatment due to AEs[4].

At the time of the final OS analysis there were 126 (60.9%) deaths in the everolimus arm and 130 (64.0%) deaths in the placebo arm[1]. While no statistically significant difference was evident in terms of OS, the median OS favored the everolimus arm, with a clinically meaningful improvement of 6.34 months over placebo, and supports the concept of starting treatment with everolimus early, once progression is detected[1]. The OS benefit is consistent with the statistically significant gain of 6.44 months in PFS (HR 0.35; 95% CI: 0.27-0.45; p<0.001) observed in the primary analysis[1],[6].

About Afinitor^® (everolimus) tablets
Afinitor^® (everolimus) is approved in more than 85 countries including the United States and European Union for locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin. It is also approved in more than 100 countries, including the United States and throughout the European Union, for advanced renal cell carcinoma following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy.

Afinitor (everolimus) is approved in the European Union for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor (NSAI). In the United States, Afinitor is approved for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2 negative (advanced HR+/HER2-) breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.