Osimertinib Plus Bevacizumab Fails to Improve PFS Among Patients With NSCLC Harboring EGFR Mutations

In a phase 2 study, osimertinib plus bevacizumab failed to demonstrate improvement in progression-free survival (PFS) for previously untreated patients with advanced nonsquamous non-small cell lung cancer (NSCLC) harboring EGFR mutations.

Dr Hirossugu Kenmotsu, Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan and colleagues conducted this multicenter, randomized controlled trial which evaluated the efficacy and safety of osimertinib plus bevacizumab for previously untreated patients with advanced nonsquamous NSCLC.

The phase 2 study was conducted at 21 institutions in Japan. In the study, 122 patients were randomized to receive either osimertinib plus bevacizumab (n = 61) or osimertinib monotherapy (n = 61). Patientswere classified according to gender, stage, and EGFR mutation status.

The primary end point was PFS defined as the time from randomization to disease progression or death, whichever occurred first, assessed according to RECIST version 1.1 by means of a blinded, independent, central review. The secondary end points were PFS assessed by investigators, overall survival (OS), overall response rate assessed according to RECIST version 1.1, and the incidence of adverse events.

At a median follow-up duration of 19.8 months, the median PFS was 22.1 months for osimertinib plus bevacizumab and 20.2 months for osimertinib monotherapy, with a hazard ratio of 0.862 (60% confidence interval [CI], 0.700 to 1.060; 95% CI, 0.531 to 1.397, one-sided stratified log-rank P = .213).

Adverse events of grade 3 or worse were observed in 34 patients (56%) in the osimertinib plus bevacizumab arm and 29 (48%) in the osimertinib monotherapy arm. In addition, 2 (3%) and 11 patients (18%) experienced any grade pneumonitis, respectively, and grade 3 pneumonitis was observed in 1 patient (2%) in each arm.

The researchers concluded, “This randomized phase 2 study failed to exhibit the superiority of osimertinib plus bevacizumab to osimertinib monotherapy for improving the PFS in untreated patients with nonsquamous NSCLC harboring EGFR mutations.”

Source:

Kenmotsu H, Wakuda K, Mori K, et al. Randomized phase II study of osimertinib plus bevacizumab versus osimertinib for untreated patients with non-squamous non-small cell lung cancer harboring EGFR mutations; WJOG9717L study. J Thorac Oncol. 2022;S1556-0864(22)00265-9. doi:10.1016/j.jtho.2022.05.006