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Reviewed by: Dr. Daniel Heng and Dr. Lori Wood Abstract: 5021 Date posted: June 9, 2009

ASCO 2009 A randomized, double-blind phase III study of pazopanib in treatment-naive and cytokine-pretreated patients with advanced renal cell carcinoma (RCC) C. Sternberg et al. Reviewed by: Dr. Daniel Heng and Dr. Lori Wood Abstract: 5021 Date posted: June 9, 2009. BACKGROUND.

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Reviewed by: Dr. Daniel Heng and Dr. Lori Wood Abstract: 5021 Date posted: June 9, 2009

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  1. ASCO 2009A randomized, double-blind phase III study of pazopanib in treatment-naive and cytokine-pretreated patients with advanced renal cell carcinoma (RCC)C. Sternberg et al. Reviewed by: Dr. Daniel Heng and Dr. Lori Wood Abstract: 5021 Date posted: June 9, 2009

  2. BACKGROUND • Pazopanib is a potent VEGFR and PDGFR tyrosine kinase inhibitor • This phase III trial accrued patients with metastatic renal cell carcinoma in non-North American countries since April 2006 • Because of the placebo arm, patients that had access to sunitinib or other VEGF targeted therapy were likely not included

  3. STUDY DESIGN Pazopanib 800mg qd N=290 Primary Endpoint: PFS Secondary Endpoints: OS, ORR R 2:1 Randomization Placebo N=145 Treatment naïve or cytokine refractory Metastatic clear- cell renal cell carcinoma ECOG<2 Nephrectomy optional Stratified by: ECOG 0 or 1 Nephrectomy Prior Treatment

  4. PATIENT CHARACTERISTICS

  5. RESULTS ALL PATIENTS TREATMENT NAIVE PRIOR CYTOKINE

  6. STUDY COMMENTARY • It is likely that no OS benefit will be seen on final analysis because 48% of placebo patients crossed over to receive pazopanib on progression • This trial was designed to meet its primary endpoint because of the use of a placebo arm. Activating in 2006 just before the presentation of the landmark sunitinib results, this trial would be unethical to activate now in North America due to the availability of standard treatment • The patient population is likely composed of those with limited drug access to sunitinib. Additionally, it is unclear if these results are generalizable to those with poor MSKCC prognostic profiles as only 3% of patients were in this category • Side effects include diarrhea, hypertension, proteinuria, hypothyroidism, hand-foot syndrome

  7. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Pazopanib is another VEGFR tyrosine kinase inhibitor with activity and PFS benefit in patients with mRCC • It is unknown if the pazopanib benefit is similar to sunitinib benefit • A phase III trial randomizing treatment-naïve patients to pazopanib or sunitinib is currently underway • The results of this latter trial are required before pazopanib can enter the mainstream treatment algorithm

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