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The phase 3 ATLAS clinical trial to assess axitinib as an adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy has been stopped early. An interim analysis showed that it was highly unlikely that axitinib would offer any benefit for these patients.
The interim analysis failed to demonstrate a clear improvement in the primary endpoint of extending disease-free survival for patients treated with axitinib compared to those given a placebo.
“We are disappointed by the outcome of this study as we had hoped the efficacy that Inlyta [axitinib] has demonstrated as a second-line treatment in patients with advanced renal cell carcinoma would carry over to patients with earlier stage disease, where it would delay or prevent disease relapse. That goal was not achieved,” said Mace Rothenberg, chief development officer, Oncology, Pfizer Global Product Development.
Other ongoing studies with axitinib in combination with immunotherapy will continue.
Axitinib is an oral tyrosine kinase inhibitor (TKI) designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors, which play a role in tumour growth, development of tumour blood vessels, and progression of cancer. Adjuvant sunitinib (another TKI) is available in the USA for patients at high risk of recurrent RCC; however, adjuvant sunitinib is yet to be recommended by the European authorities. Two other clinical trials have failed to show a benefit for adjuvant TKIs (ASSURE for sunitinib and sorafenib and PROTECT for pazopanib).
Hope lies with immunotherapy for adjuvant treatment of RCC at high risk of recurrence.