Pfizer suffers late-stage cancer drug failures
pharmafile | March 12, 2010 | News story | Research and Development | Cancer, Pfizer, Sutent, figitumumab
Pfizer has suffered late-stage trial failures for Sutent and lung cancer candidate figitumumab.
Kidney cancer drug Sutent (sunitinib) failed to meet its primary endpoints in two phase III trials that were testing it as a treatment for advanced HER-2 negative breast cancer.
“While we are disappointed in the results, these trials have helped us define the limits and opportunities for the compound and better understand the complex biology of the disease,” said Dr Mace Rothenberg, a senior vice president in Pfizer’s oncology business unit.
He added: “Pfizer Oncology is committed to the rigorous evaluation of investigational therapies in breast cancer, which despite recent advancements, continues to claim far too many lives each year.”
The first, the SUN 1064 study, assessed Sutent in combination with docetaxel chemotherapy as the first-line treatment and did not show a statistically significant improvement in progression-free survival compared with docetaxel alone.
The second, the SUN 1099 study, looked at Sutent plus capecitabine for used in previously treated advanced breast cancer patients, and this too did not show a statistically significant improvement in progression-free survival compared with capecitabine alone.
Sutent is currently approved to treat advanced kidney cancer and gastrointestinal stromal tumour in patients who fail to respond to Novartis’ Glivec or are intolerant to it.
The drug is close to fulfilling the blockbuster predictions it received at launch, and last year brought in sales of $964 million.
But the two advanced breast cancer trials are not the first time Sutent has faltered in testing for further indications. Last year phase III trials for colon cancer and breast cancer had to be halted after disappointing results.
Discontinuation of figitumumab
Pfizer’s other new phase III failure was for investigational compound figitumumab, which was being tested in the ADVIGO 1018 trial for non-small cell lung cancer.
The trial was examining the effects of figitumumab in combination with chemotherapy erlotinib as a second/third-line treatment in patients with previously treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC).
It was halted after an independent Data Safety Monitoring Committee concluded the figitumumab combination was unlikely to improve overall survival compared to erlotinib alone.
Pfizer’s Rothenberg said the company remained committed to a thorough evaluation of figitumumab.
“We will carefully review our extensive clinical database and use this information to refine the figitumumab clinical programme with the goal of identifying the right patient population in which to evaluate this compound.”
He added: “This outcome is disappointing to us and to patients with NSCLC. Pfizer is working to thoroughly analyse all available data from the figitumumab programme to better understand the compound and the IGF-1R [insulin growth factor-1 receptor] pathway.”
News of the figitumumab and Sutent trial failures is a blow to Pfizer, which is focusing on oncology as one of six core therapeutic areas. Success there will be vital if the company is to stem the inevitable sales losses due next year when patents on its blockbusters Lipitor and Efexor expire.
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