RCC Risk Reduction of Disease Worsening, Death After Combination Therapy

Submitted by onc_editor on Wed, 12/13/2017 - 13:32

A phase III study found a combination therapy to reduce the risk of progression-free survival (PFS) as an initial treatment for certain patients with advanced kidney cancer.

The IMmotion 151 trial is a multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab (Tecentriq) and bevacizumab (Avastin) versus sunitinib alone in patients with inoperable, locally advanced or metastatic renal cell carcinoma (RCC) who have not received prior systemic active or experimental therapy. A total of 915 patients were enrolled globally and randomized (1:1) to receive either the combination therapy (atezolizumab 1200 mg, bevacizumab 15 mg/kg via intravenous infusion every 3 weeks) or monotherapy (50 mg orally once daily for 4 weeks followed by 2 weeks rest).

The co-primary endpoints of the study were PFS—as determined by RECIST v1.1 in patients whose tumors expressed PD-L1—and overall survival (OS) in the intention-to-treat population.

Results of the study demonstrated a statistically significant risk reduction of disease worsening or death for patients receiving atezolizumab plus bevacizumab compared with patients receiving sunitinib as initial treatment of advanced or metastatic RCC expressing PD-L1. Researchers reported that in patients whose disease expressed PD-L1, a numerical difference favoring atezolizumab plus bevacizumab was seen across all patient risk factor groups (ie, favorable, intermediate, and poor). However, the study design prohibited these data from being assessed for statistical significance.

Additionally, researchers reported that the assessment of secondary endpoints is ongoing and results will be presented at an upcoming oncology conference in 2018. Top-line results of OS are not mature. Nonetheless, safety for the atezolizumab plus bevacizumab combination appear consistent with the known safety profile of each individual medicine previously reported in the phase II IMmotion150 study. No new safety signals were observed with the combination regimen.

“We are encouraged by these results as they add to the emerging body of evidence that supports our rationale for this combination. We believe that the regimen of Tecentriq and Avastin may enhance the potential of the immune system in the initial treatment of advanced kidney cancer,” commented Sandra Horning, MD, chief medical officer and head of Global Product Development, Genentech, in a press release (December 11, 2017). “We will discuss these data with health authorities globally and hope to bring this combination forward as a potential new treatment option as soon as possible.”—Zachary Bessette