Phase 3 renal cell carcinoma trial misses primary endpoint
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Key takeaways:
- Nivolumab-tivozanib did not increase PFS compared with tivozanib alone.
- Tivozanib monotherapy exhibited clinically meaningful efficacy and safety for patients who received front-line immune checkpoint inhibitor combinations.
The addition of nivolumab to low-dose tivozanib did not improve PFS for patients with advanced renal cell carcinoma, according to data from the agent’s manufacturer.
Tivozanib (Fotivda, AVEO Oncology), a VEGF receptor tyrosine kinase inhibitor, is approved in the United States for treatment of patients with advanced relapsed or refractory renal cell carcinoma who received at least two prior systemic therapies.
The randomized phase 3 TiNivo-2 trial assessed the efficacy of low-dose tivozanib and nivolumab (Opdivo, Bristol Myers Squibb) vs. standard-dose tivozanib monotherapy for patients with advanced metastatic renal cell carcinoma whose tumors progressed after receiving immune checkpoint inhibitor therapy.
PFS served as the primary endpoint. Secondary endpoints included OS, overall response rate, duration of response and safety.
Results showed no PFS benefit with the combination.
However, researchers reported what they considered clinically meaningful PFS in the control arm, supporting tivozanib’s use for patients in this setting.
“The PFS and safety results from the control arm support tivozanib as an effective and well-tolerated treatment option in the second line following an [immune checkpoint inhibitor] combination as prior systemic therapy,” Toni Choueiri, MD, director of Lank Center for Genitourinary Oncology and director of the kidney cancer center at Dana-Farber Cancer Institute, said in an AVEO Oncology-issued press release.
Adverse reactions that occurred among at least 20% of patients included fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough and stomatitis.
The most common serious adverse reactions included bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%) and hepatobiliary disorders (2.3%).
Full data the trial will be presented at a medical meeting.
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