Torisel fails in head-to-head study with Nexavar
pharmafile | May 16, 2012 | News story | Research and Development, Sales and Marketing | Bayer, Nexavar, Pfizer, Torisel, inlyta, rcc
Pfizer’s kidney cancer drug Torisel has failed to best Bayer’s Nexavar in a head-to-head trial.
The Phase III study was comparing Torisel to Nexavar in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after Pfizer’s Sutent, which is licensed as a first line therapy for the disease.
Torisel did not meet its primary endpoint of prolonging progression-free survival (PFS) when compared to Bayer’s drug, dealing a blow to Pfizer.
Although PFS was numerically higher in patients treated with Pfizer’s drug, the difference was not statistically significant, the firm said.
Torisel also failed to meet its secondary endpoint of increasing overall survival. Nexavar, however, did create a statistically significant increase in OS, chalking up a significant victory for Bayer and partner Onyx over its rival.
Dr Mace Rothenberg, senior VP of clinical development and medical affairs for Pfizer’s oncology business unit, said: “This trial advances our knowledge about Torisel in RCC.
“Torisel remains an important drug for treatment of advanced kidney cancer based on its pivotal study in first line patients with poor prognostic risk [and] continues to be an important part of Pfizer’s portfolio of therapies for advanced kidney cancer,” he added.
But Pfizer may not be too downcast, as its third RCC drug Inlyta (axitinib) was approved by the FDA in January for RCC patients after the failure of one prior systemic therapy.
Inlyta has had more luck against Nexavar, and last year a Phase III head-to-head study showed it could outperform Bayer’s drug and produced a median PFS of 6.7 months compared to 4.7 months in Nexavar patients.
Torisel is approved in the US and other countries for the treatment of advanced RCC and in Europe for the first line treatment of patients with advanced RCC, who have at least three of six specific risk factors.
Torisel is the only intravenous mammalian target of rapamycin (mTOR) inhibitor approved for the treatment of advanced RCC.
Nexavar works as a multiple kinase inhibitor and also has a licence to treat unresectable hepatocellular carcinoma (HCC), a type of liver cancer.
The RCC market has a number of drugs vying for market share, and includes GlaxoSmithKline’s Votrient, Roche’s Avastin and Novartis’ Afinitor.
Ben Adams
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