Pfizer says that it has begun a late-stage trial of Sutent, already approved for advanced kidney cancer, to see how effective the drug is, when combined with Roche’s Tarceva, as a treatment for lung cancer.
The New York-based behemoth made the announcement after presenting data from a Phase II trial at the International Association for the Study of Lung Cancer congress in Seoul, South Korea, on the safety and tolerability of Sutent (sunitinib) in combination with Roche’s Tarceva (erlotinib), which is already approved to treat non-small cell lung cancer.
Preliminary results from the study revealed that the combination produced mild to moderate adverse events in 12 patients with advanced non-small cell lung cancer, with the most frequent being diarrhoea and fatigue, Pfizer noted, adding that as of August 2007, two patients had experienced a partial response. On the basis of these results, the firm is cracking on with a large (956-patient), global Phase III trial to evaluate Sutent, a multi-kinase inhibitor, with Tarceva, an EGFR inhibitor.
The firm quoted Keunchil Park, of the Samsung Medical Center at Sungkyunkwan University in Seoul, as saying that “survival rates in lung cancer continue to be low in comparison with other cancers despite currently available treatments. It is our hope that this approach will provide an option for patients”. Charles Baum, Pfizer’s head of oncology, added that “we are encouraged by the early data we are seeing for sunitinib in NSCLC”.
Phase III trials are underway to evaluate the role of Sutent in the treatment of various solid tumors including advanced breast and advanced colorectal cancer. The drug, which had sales of $146 million in the second quarter of 2007, is approved in the USA for the treatment of advanced renal cell carcinoma and gastrointestinal stromal tumours after failure of therapy with Novartis’ Glivec (imatinib).