The US Food and Drug Administration (FDA) has agreed once again to review a kidney cancer drug for approval, and noteworthy results from a phase 3 trial of a different drug for kidney cancer may yield further exploration.
Aveo Pharmaceuticals (Cambridge, MA) filed a New Drug Application (NDA) with the FDA. Aveo is seeking approval for tivozanib (brand name Fotivda), a vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) to treat relapsed or refractory renal cell carcinoma (RCC). The drug was approved for the European market in 2017.
Aveo failed to obtain US approval in 2013 and again in the fall of 2019, when the FDA ruled that it remained concerned about the results of the TIVO-3 trial. In November 2019, Aveo noted that the FDA denied approval in part because “median OS (overall survival) for tivozanib is worse than that of sorafenib,” a drug co-developed and co-marketed by Bayer and Onyx Pharmaceuticals as Nexavar, a treatment for primary kidney cancer (advanced RCC).
Aveo said in a presentation of results at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program that tivozanib showed an increased median progression-free survival when compared with sorafenib. It is now in the FDA’s court.
At the same meeting, researchers announced positive results for the drug savolitinib, a small-molecule MET tyrosine inhibitor aimed at treating patients with advanced papillary RCC (PRCC). Savolitinib is being developed by AstraZeneca and Chi-Med (based in Hong Kong).
Precision Oncology News reported that after promising phase 1 and 2 trials, a research team headed by Director Toni Choueiri of the Dana Farber kidney cancer center explored whether the drug might improve progression-free survival for locally advanced or metastatic PRCC cases involving MET drivers.
The phase 3 SAVOIR trial ended early, however, with just 60 patients enrolled (rather than the target number of 180) when researchers discovered that the comparator drug sunitinib (Sutent by Pfizer), approved for treating RCC, had released promising data. The data from Pfizer (based in New York, NY) showed that sunitinib had similar effects on the parameter of time-to-disease-recurrence in patient cases that did or did not involve MET drivers.
Because savolitinib showed promise, such as a nonstatistically significant difference in median progression-free survival time of 7 months for savolitinib compared to 5.6 months in the sunitinib group, Choueiri said that further investigation of savolitinib is warranted.
