Pfizer (PFE) Announces Strong Data from SUTENT Phase 3 in RCC; DFS Extension Noted

October 10, 2016 8:05 AM EDT

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Pfizer Inc. (NYSE: PFE) announced results from the Phase 3 S-TRAC clinical trial (Sunitinib Trial as Adjuvant Treatment of Renal Cancer) investigating SUTENT (sunitinib) as adjuvant therapy. The trial showed SUTENT extended disease-free survival (DFS) by more than one year versus placebo in patients who were at high risk for recurrence after surgical resection of renal cell carcinoma (RCC) (HR 0.761; P=0.030 [95% CI: 0.594-0.975]). These results will be presented today during a Presidential Symposium (Abstract #LBA11_PR) at the ESMO 2016 Congress, the annual meeting of the European Society for Medical Oncology being held in Copenhagen, Denmark. The results have also been published online by The New England Journal of Medicine.

Adjuvant therapies are treatments that can be given to reduce the likelihood of the cancer returning after initial treatment such as surgery.

“We are encouraged by the S-TRAC results because this is the first clinical trial to show increased disease-free survival in the adjuvant setting for RCC,” said lead investigator Alain Ravaud, M.D., Ph.D., CHU de Bordeaux Hôpital Saint André. “These data are promising for RCC patients as there are no effective treatments currently available in this setting.”

The results from the S-TRAC trial showed that after one year of treatment, the median time until disease recurrence in participants treated with SUTENT after surgery was 6.8 years compared with 5.6 years for patients treated with placebo as assessed by independent central review, resulting in an overall risk reduction of 24 percent. At the time of the analysis, overall survival (OS) data was immature.

Based on the results of S-TRAC, Pfizer is in discussions with global regulatory authorities to determine potential next steps.

“For the past 10 years, Pfizer has been a leader in developing new treatments for patients with kidney cancer, and SUTENT has been the most widely prescribed first line treatment for thousands of patients with advanced RCC around the world,” said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development. “The results of S-TRAC suggest that SUTENT has the potential to extend this benefit by reducing the risk of recurrence in patients who have undergone complete surgical removal of their kidney cancer and are at high risk of cancer recurrence.”

The adverse events seen in the trial were consistent with SUTENT’s known safety profile. The most common adverse reactions (>20%) are fatigue, asthenia, and fever. Grade ≥3 adverse events were more frequent with SUTENT (62.1%) vs. placebo (21.1%). No deaths occurred due to treatment toxicity.

SUTENT is an oral cancer medication that was first approved in the United States in 2006 for the treatment of advanced RCC. It is currently approved in 119 countries.i Worldwide more than 250,000 patients across diagnoses have been treated with SUTENT in its approved indications of advanced RCC, imatinib-resistant or -intolerant gastrointestinal stromal tumors (GIST) and advanced pancreatic neuroendocrine tumors (pNET).ii SUTENT is not approved in the adjuvant setting.

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