Fotivda improves survival and has an ‘interesting’ – and tolerable – safety profile for the treatment of kidney cancer

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

“We set out to assess the actual use of (Fotivda) because we had signals that it might be the drug of choice due to its toxicity profile. So, we collected data at our three separate regional cancer centers from March 2017 to 2019 and looked at those results,” said study author Dr Jonathan Heseltine, from Clatterbridge Cancer Centre, UK. Uni, during the presentation of the results at the 2022 ASCO Symposium on Genitourinary Cancers.

The Food and Drug Administration approved Fotivda in March last year for the treatment of adults with relapsed or refractory renal cell carcinoma who had previously received at least two systemic therapies, based on trial results. phase 3 TIVO-3, which included heavily treated patients. . This study, however, involves patients who did not receive medication to treat their cancer. Heseltine discussed this data.

The study included 113 patients with metastatic renal cell carcinoma (RCC), who were divided into prognostic risk by 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 of poor prognosis. The majority (66%) of patients had undergone nephrectomy (surgical removal of the kidney).

The researchers noted that 88.5% of patients started Fotivda on a full dose, with 67% maintaining that dose. Meanwhile, 11.5% started treatment with a dose reduction due to prior comorbidity TKI-related toxicities. Fotivda’s average number of cycles was seven, although this number ranged from one to 33 cycles.

After an average follow-up of 25.9 months, 29% of patients responded to treatment, meaning that their disease decreased following Fotivda administration. There were no complete responses (when doctors can’t see any remaining signs of cancer); 29% of patients had a partial response (decreased tumor size or amount of cancer in the body in response to treatment); 39% had stable disease; 26% experienced disease progression; and 6% of patients’ disease was not evaluable.

The mean progression-free survival (PFS; time from starting treatment to a patient’s disease getting worse) was nine months, but varied across IMDC risk groups:

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

A total of 77% of patients experienced treatment-related side effects with Fotivda, including 14% serious side effects (grade 3). Common side effects included: fatigue (42% of patients; not Grade 3), diarrhea (19%; less than 1% Grade 3), mouth sores and inflammation, known as mucositis (24%; 2% grade 3), anorexia (12%;

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

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

No patient died as a result of treatment with Fotivda, but 18% discontinued treatment due to side effects.

“The main result of our work is that the real-world data demonstrate progression-free survival and overall survival similar to the pivotal clinical trial, even with our population having a high proportion of low-risk patients,” Heseltine said.

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