NOVARTIS, Outperform, PFIZER, Underperform - BOLERO-2 Positive: Afinitor Shaping Up As A Blockbuster

July 2011 | 1 pages | ID: N8D18F6A91AEN
MP Advisors

Abstracts

Independent data monitoring committee (IDMC) recommended early stoppage of the pivotal PhIII BOLERO-2 study ahead of time, as an interim analysis showed NVS mTOR inhibitor – Afinitor in combination with exemestane significantly extended progression free survival when compared to exemestane alone in women with ER+HER2-ve metastatic breast cancer whose disease had progressed after initial non steroidal endocrine therapy. The planned completion of BOLERO-2 was Dec 2013. With Afinitor having shown early benefit, NVS intends to file the NDA for approval by the end of this year. The current data improves expectation from other ongoing PhIII trials in HER2 positive breast cancer indication (BOLERO-1 and BOLERO-3). Exemestane (Aromasin, Pfizer) is current standard of care in ER+veHER2-ve breast cancer patients whose disease is progressed even after use of anastrozole or letrozole and this is currently constitutes 10% of Aromatase inhibitor class

Contents

COMPANIES MENTIONED

NOVARTIS, PFIZER