Pfizer's Sutent presents significant hesitation as adjuvant RCC therapy due to toxicities despite Phase III DFS success - experts

31 Aug 2016

Pfizer's (NYSE:PFE) Sutent (sunitinib) may face uptake barriers in the adjuvant setting for renal cell carcinoma (RCC) due to its side-effect profile despite the Phase III S-TRAC study reaching its primary endpoint, said experts.

In the absence of any approved adjuvant therapies, the S-TRAC trial' (NCT00375674) improving disease-free survival (DFS) is significant, said experts. It is nonetheless surprising, they noted, since the previous NCI-led Phase III ASSURE trial (NCT00326898) of Sutent as an adjuvant therapy did not reach its DFS primary endpoint.

S-TRAC safety and efficacy results will be presented at the European Society for Medical Oncology (ESMO) meeting, which will take place 8-12 September.

According to an analyst report, 65% of localized RCC patients may be eligible for a year of adjuvant Sutent therapy, depending on the clinical benefit seen at ESMO. Sutent use in first-line RCC therapy may be eroded as checkpoint inhibitors get approved, but the S-TRAC data might alter that outlook, said the report.

Interviewed experts, however, approached the data announcement with caution since ASSURE patients experienced known Sutent side effects. ASSURE’s Sutent starting dose had to eventually be lowered, they said, noting a decreased tolerance for side effects in the absence of disease.

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