Inlyta Fails to Demonstrate Efficacy in Patients at High Risk of Recurrent Renal Cell Carcinoma


In its phase 3 trial, Pfizer’s axitinib (Inlyta) did not achieve disease-free survival in patients at high risk of recurrent renal cell carcinoma after nephrectomy.

Pfizer’s axitinib (Inlyta) failed to demonstrate improvement in the primary endpoint in its phase 3 ATLAS trial evaluating the drug as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy, according to a press release.

According to Pfizer, the independent Data Monitoring Committee recommended stopping the trial at a planned interim analysis due to futility.

Axitinib is an oral therapy designed to inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2, and 3. The drug is currently approved for the treatment of advanced RCC after failure of 1 prior systemic therapy.

RCC is the most common type of kidney cancer. Once a patient’s disease becomes metastatic, their long-term prognosis is poor in advanced RCC with a 5-year survival rate as low as 12%, according to Pfizer.

ATLAS is a phase 3 clinical trial that investigated the clinical efficacy and safety of adjuvant Inlyta (5 mg twice daily) compared with placebo in patients at a high risk of recurrent RCC following nephrectomy. In the trial, patients were dosed up to 3 years (for a minimum of 1 year) and the primary endpoint was disease-free survival.

The study did not show clear improvement in the primary endpoint for patients treated with axitinib compared with patients treated with a placebo, according to the press release.

“We are disappointed by the outcomes of this study as we had hoped the efficacy that Inlyta has demonstrated as a second-line treatment in patients with advanced RCC would carry over to patients with earlier stage disease, where it would or prevent relapse,” Mace Rothenberg, MD, chief development officer of oncology at Pfizer Global Product Development, said in the press release. “The goal was not achieved. We will conduct additional analyses on the data that may provide insight into this result.”

Axitinib will continue to be evaluated in combination with immune checkpoint inhibitors for patients with a variety of advanced stage cancers, including RCC, Dr Rothenberg added.


Pfizer Provides Update on Phase 3 Trial of Axitinib as Adjuvant Treatment for Patients at High Risk of Renal Cell Carcinoma Recurrence After Surgery [news release]. Pfizer’s website. Accessed April 13, 2018.

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