Pfizer Inc. (NYSE: PFE) shares were relatively muted after the pharma giant provided an update for its late-stage kidney trial. Unfortunately, the results were not up to par, and the independent Data Monitoring Committee has recommended stopping the trial.
Specifically, Phase 3 Atlas trial evaluating Inlyta (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy recommended stopping the trial at a planned interim analysis due to futility.
The recommendation was based on the study failing to demonstrate a clear improvement in the primary endpoint of extending disease-free survival for patients treated with Inlyta compared with patients treated with a placebo. No new safety signals were observed, and the safety profile was consistent with the known profile of Inlyta in advanced RCC.
Inlyta has had a significant impact on the treatment of patients with advanced RCC worldwide in its currently approved indications. More than 66,000 patients have been treated with Inlyta to date.
Mace Rothenberg, M.D., Chief Development Officer, Oncology, Pfizer Global Product Development, commented:
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.
Shares of Pfizer were last seen down fractionally on the day to $35.88, with a consensus analyst price target of $40.11 and a 52-week range of $31.67 to $39.43.