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Welcome to our new series where we take a look at what’s happening in kidney cancer each month! From treatments and clinical trials to genetic testing and government regulations, the KCA’s Medical Director, Sallie McAdoo, MS, CGC, will show you what’s new and why it matters.

Facebook Live

I had a great discussion about the basics of clinical trials in a Facebook Live event yesterday with two members of the KCA’s Patient and Caregiver Advisory Council – John Ferrell and Peggy Zuckerman. John and Peggy are both stage IV kidney cancer patients and veteran clinical trial participants. They talked about how to learn more about clinical trials and why participating – in John’s case, more than once – was the right choice for them.

I encourage you to check out the discussion. It’s relevant because today’s column is a timely example of what’s possible through clinical trials – in this case, a new treatment option for people with advanced kidney cancer.

FDA approves tivozanib for third-line treatment

Earlier this month, a new drug called tivozanib (the brand name is Fotivda) received FDA approval as a third-line therapy for people with advanced renal cell carcinoma (RCC).  

That means people with advanced kidney cancer who have tried multiple treatment options and still find their cancer has returned (a relapse or recurrence) or has stopped responding to treatment (it is refractory) now have another treatment option to turn to.

Since up to 20% of people with cancer advance beyond two lines of therapy, tivozanib’s approval as a third- or fourth-line treatment is a positive step in helping more people with RCC.

“It’s important for patients to have as many effective lines of therapy as possible,” said Dr. Brian Rini, chief of clinical trials at Vanderbilt Ingram Cancer Center in Nashville, Tennessee, Vice Chair of the KCA’s Medical Steering Committee, and principal investigator of the TIVO-3 study on which the FDA approval was based. “Tivozanib also has an excellent tolerability profile, which is more important in later lines of therapy.”

As a TKI inhibitor – a type of targeted therapy that keeps cancer cells from growing – tivozanib appeared to be one of the better-tolerated drugs in its category. Fewer participants in the TIVO-3 study needed to reduce their dose or stop treatment because of adverse side effects if they were on tivozanib. The main findings were greater tumor shrinkage and longer time without progression for people on tivozanib compared to people on sorafenib (Nexavar) with or without previous treatment with axitinib (Inlyta), although overall survival was not significantly different.  [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30735-1/fulltext]

An additional commentary paper by Dr. Mary Westerman and Dr. Christopher Wood, both of the Department of Urology at the University of Texas MD Anderson Cancer Center in Houston, Texas, highlighted the need to examine where tivozanib fits into the treatment paradigm, particularly for patients who are treated with combination therapies like ipilimumab plus nivolumab, which has become more common as a first-line RCC therapy.

According to Dr. Rini, the next step will be to investigate tivozanib in combination with nivolumab in cases where people are not responding to immunotherapy, which, if the results are positive, could provide yet another treatment option.

Read more about tivozanib:

FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma

AVEO Oncology Announces U.S. FDA Approval of FOTIVDA® (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma

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