Phase III registration trial

WILEX conducted a Phase III registration trial with REDECTANE®. In total 226 patients suspected of having kidney cancer were enrolled in more than 14 centres in the USA. Patients included were scheduled for complete or partial surgical removal of the affected kidney. They were imaged with computer tomography (CT) and REDECTANE® (PET/CT) prior to surgery to examine whether they have clear cell renal cell carcinoma. The trial will evaluate whether imaging with REDECTANE® can improve the diagnosis in comparison to the current standard (CT alone).

FIG 1: Contrast CT in a patient with a renal mass in the right kidney.
FIG 2: REDECTANE® PET/CT clearly identifies ccRCC in the right kidney.
Image courtesy of Memorial Sloane-Kettering Cancer Center, New York, NY

Status

In May 2010 WILEX published final data of the Phase III trial with REDECTANE®. REDECTANE® fulfilled expectations in distinguishing clear cell from non-clear cell renal cell carcinoma. The results of the study demonstrate that PET/CT with REDECTANE® lead to a significantly improved diagnosis in comparison to CT alone.

In contrast to the preliminary data published in November 2009, the endpoint sensitivity, the correct diagnosis that clear cell renal cell cancer is present, was reached with statistical significance (p value, p) (p=0.016) compared to CT. The study endpoint specificity, the correct diagnosis that clear cell renal cell cancer is not present, was confirmed with a highly statistical significance (p<0.001). To rule out that the superiority of REDECTANE® resulted from the poor performance of CT, the endpoints of REDECTANE® were also compared to an arbitrary value of 75% for specificity and sensitivity as defined in the study protocol. REDECTANE® achieved sensitivity of 86% (p=0.002) and specificity of 87% (p=0.057).

WILEX plans to prepare application for approval by the US Food and Drug Administration (FDA) in the next months.

Specific protocol assessment

WILEX has received a special protocol assessment (SPA) from the US Food and Drug Administration (FDA) for this Phase III registration trial. With this SPA the FDA confirms that the design and planned analysis of the clinical trial adequately address the requirements for a regulatory submission for REDECTANE®. The FDA is considered to be bound by this protocol assessment as part of the approval process.