Today, AVEO Oncology announced it had inked a clinical trial collaboration and supply deal with Bristol Myers Squibb to study Fotivda in combination with BMS’s checkpoint inhibitor Opdivo in advanced r/r RCC after previous immunotherapy exposure.
Fotivda is put on test for kidney cancer.
Today, AVEO Oncology announced it had inked a clinical trial collaboration and supply deal with Bristol Myers Squibb to study Fotivda in combination with BMS’s checkpoint inhibitor Opdivo (nivolumab) in advanced r/r RCC after previous immunotherapy exposure.
The two companies plan to enroll about 326 patients in the open-label, controlled TiNivo-2 Phase III trial in the U.S., Europe and Latin America. Participants will be randomized 1:1 to receive either Fotivda in combination with Opdivo or Fotivda alone. The primary endpoint will be to assess progression free survival (PFS), with key secondary endpoints including overall survival (OS), overall response rate (ORR), duration of response (DR), and safety.
AVEO is the primary sponsor of the trial and will be responsible for costs. Bristol Myers Squibb is providing Opdivo.
“With the U.S. FDA approval of Fotivda in the relapsed/refractory RCC setting, I look forward to further exploring Fotivda’s immunomodulatory effects and differentiated tolerability profile in combination with Opdivo,” said Toni Choueiri, director, Lank Center for Genitourinary Oncology; director, Kidney Cancer Center; Jerome and Nancy Kohlberg Chair and Professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute. “This combination was first explored in the Phase I/II TiNivo study, where it demonstrated favorable tolerability and prolonged PFS using the combination of Fotivda and Opdivo in both treatment naïve and previously treated patients with advanced RCC. The TiNivo-2 Phase III study is expected to further our understanding of the activity and tolerability of this combination following prior immunotherapy.”
Earlier this week, the U.S. Food and Drug Administration (FDA) approved AVEO Oncology’s Fotivda (tivozanib) for adults with relapsed or refractory advanced renal cell carcinoma (RCC) in people who have had two or more previous systemic therapies. The drug is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).
The approval was built on data from the Phase III TIVO-3 trial that compared Fotivda to sorafenib (Bayer’s Nexavar) in the reported indication. There were three other trials in RCC that included safety data from more than 1,000 trial volunteers.
Patients in TIVO-3 were randomized 1:1 to receive either Fotivda or sorafenib. The main efficacy endpoint was progression-free survival (PFS). Other efficacy endpoints included overall survival (OS) and objective response rate (ORR).
The median PFS was 5.6 months in the Fotivda arm compared to 3.9 months in the sorafenib cohort. Median OS was 16.4 and 19.2 months, respectively, and ORR was 18% and 8%, respectively.
The most common side effects were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia (difficulty speaking), hypothyroidism, cough, and stomatitis (inflammation of the mouth and lips). The most common grade 3 or 4 clinical laboratory anomalies were decreased sodium, increased lipase, and decreased phosphate.
The recommended regimen is a 28-day cycle for the drug at 1.34 mg once a day with or without food for 21 days followed by 7 days off treatment until disease progression or unacceptable toxicity.
RCC is a cancer in the tubules of the kidney. These tubules filter and clean blood, remove waste products and make urine.
