Novartis shares have risen on data which shows that the firm’s new oncology agent everolimus can slow the progression of advanced kidney cancer in patients who have failed standard therapies.
Interim findings from the 400-patient Phase III study, called RECORD-1, demonstrated that RAD-001 (everolimus) significantly extended the time without tumour growth from 1.9 to 4 months and reduced the risk of cancer progression by 70%. Full details of the study, which was stopped early on the strength of interim results, will be presented on May 31 at the meeting of the American Society of Clinical Oncology.
RECORD-1 is the first study to show clinical benefit in patients with advanced kidney cancer “who have experienced treatment failure with the most commonly used first-line therapies”, such as Bayer’s Nexavar (sorafenib) and Pfizer’s Sutent (sunitinib), said Robert Motzer of the Memorial Sloan-Kettering Cancer Center in New York. The study, of which he is the principal investigator, “has given us a new and clearly useful tool for treating renal cell tumours” and he added that everolimus “is an important step forward in terms of disease management and quality of life”.
Everolimus is a once-daily, oral therapy that represents a novel approach to treating cancer in that it inhibits the mTOR protein, which plays a key role in regulating tumour cell division and the growth of blood vessels in cancer cells. According to David Epstein, president and chief executive of Novartis Oncology,
RAD001 also has the potential to benefit patients “living with a variety of cancers including neuroendocrine, breast, gastric, and lung”.
Novartis added that during the second half of 2008, the interim results from RECORD-1 will be used to submit a New Drug Application for RAD001 as a treatment for metastatic renal cell carcinoma.
