Pfizer is set to discontinue its ATLAS trial, a Phase III study of adjuvant INLYTA (axitinib) versus placebo in patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy, after a recommendation by the data monitoring committee of the trial.
The committee has asked Pfizer to stop the trial after conducting a planned interim analysis that showed the futility of the study.
The analysis has also found that the trial was not successful in demonstrating a clear improvement in the primary endpoint of extending disease-free survival (DFS) for patients treated with INLYTA compared to patients treated with placebo.
However, no new safety signals were found, and the safety profile was consistent with the known profile of INLYTA in advanced RCC.
Pfizer Global Product Development Oncology chief development officer Mace Rothenberg said: “We are disappointed by the outcome of this study as we had hoped the efficacy that INLYTA 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. We will conduct additional analyses on the data that may provide insight into this result.
“Studies evaluating INLYTA in combination with immune checkpoint inhibitors for patients with a variety of advanced stage cancers, including RCC, will continue.”
The global, multi-centre, randomised double-blind ATLAS trial examined the clinical efficacy and safety of adjuvant INLYTA in comparison with placebo for the treatment of patients who are at high risk of recurrent RCC following nephrectomy.
A total of 724 patients were enrolled in the trial, which was performed in collaboration with SFJ Pharmaceuticals.
In a separate development, Pfizer has joined the TriNetX global health research network as a member.
The membership will allow the company to have access to clinical data from TriNetX's network of healthcare organisations. These will help develop clinical study and protocol design, as well as site identification and patient recruitment for clinical trials across a range of therapeutic areas and development stages.