Fotivda Boosts Survival and Has ‘Interesting’ – and Tolerable – Safety Profile for Kidney Cancer Treatment

Fotivda – a TKI drug that was approved last year – not only improved survival outcomes, but was also very tolerable in terms of side effects for patients with metastatic renal cell carcinoma.

Frontline Fotivda (tivozanib), a tyrosine kinase inhibitor (TKI), had similar efficacy as Nexavar (sorafenib) in patients with metastatic kidney cancer. And considering the drugs tolerable side effect profile, it may be an attractive treatment option for patients with the disease, according to findings from a real-world study, where the drug’s use was analyzed in the hospital (not clinical trial) setting.

“We set out to evaluate the real-world use of (Fotivda) because we had some signals that this might be the preferred drug because of the toxicity profile. So, we gathered data across our three separate regional cancer centers from March 2017 to 2019 and looked at these outcomes,” said study author Dr. Jonathan Heseltine, of the Clatterbridge Cancer Centre, in the United Kingdom, while presenting the findings at the 2022 ASCO Genitourinary Cancers Symposium.

The Food and Drug Administration approved Fotivda in March of last year for the treatment of adults with relapsed or refractory renal cell carcinoma who previously had two or more systemic therapies, based on findings from the phase 3 TIVO-3 trial, which included heavily treated patients. This study, however, is looked at patients who have not been given drugs to treat their cancer. Heseltine discussed these data.

The study included 113 patients with metastatic renal cell carcinoma (RCC), who were divided into prognostic risk per the International Metastatic RCC Database Consortium. Fifty-two percent of patients were determined to be at intermediate risk, while 22% were at favorable risk and 26% were determined to be poor prognosis. The majority (66%) of patients had undergone a nephrectomy (surgical removal of the kidney).

The researchers noted that, 88.5% of patients started Fotivda at the full dose, with 67% maintaining that dosage. Meanwhile, 11.5% started treatment with a dose reduction because of prior TKI-related toxicities of comorbidities. The average number of Fotivda cycles was seven, though this number ranged from one to 33 cycles.

At an average follow-up of 25.9 months, 29% of patients responded to the treatment, meaning that their disease shrunk as a result of being given Fotivda. There were no complete responses (where doctors cannot see any remaining signs of cancer); 29% of patients had a partial response (a decrease in tumor size or the amount of cancer in the body as a response to treatment); 39% had stable disease; 26% experienced disease progression; and 6% of patients’ disease was not evaluable.

Average progression-free survival (PFS; time from the start of treatment to a patient’s disease getting worse) was nine months, but varied among IMDC risk groups:

  • The favorable-risk group had an average PFS of 23 months
  • The intermediate-risk group had an average PFS of 10 months
  • The poor-risk group had an average PFS of three months

A total of 77% of patients experienced treatment-related side effects from Fotivda, with 14% being severe (grade 3). Common side effects included: fatigue (42% of patients; no grade 3), diarrhea (19%; less than 1% grade 3), mouth sores and inflammation, known as mucositis (24%; 2% grade 3), anorexia (12%; <1% grade 3) and high blood pressure (7%; 2% grade 3).

The researchers mentioned that notable grade 3 side effects included abnormal liver function (3%), vascular events (2%) and seizure (<1%).

“The safety data was interesting in that we found that there were fewer patients reporting a grade 3 toxicity. There were no grade 4 or 5 toxicities,” Heseltine said.

No patients died as a result from treatment with Fotivda, but 18% stopped treatment because of side effects.

“The key outcome from our work is that the real-world data demonstrates a similar progression-free survival and overall survival to the pivotal clinical trial, and that’s even with our population having a high proportion of poor-risk patients,” Heseltine said.

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