The addition of bevacizumab to erlotinib failed to improve progression-free survival (PFS), among other outcomes, in patients with EGFR-mutant non-small cell lung cancer (NSCLC), according to data from a phase 2 randomized clinical trial (ClinicalTrials.gov Identifier: NCT01532089). The trial results were published online August 8, 2019, in JAMA Oncology.1
The trial was conducted at 17 academic and community medical centers in the United States and included 88 patients with stage IV NSCLC that harbored an EGFR exon 19 deletion or exon 21 L858R mutation. Patients were randomly assigned to receive treatment with erlotinib alone or erlotinib in combination with bevacizumab.
The study population was a median age of 63 years (range, 31-84 years), and the majority of participants were female (70%) and white (85%). Approximately two-thirds of patients had an EGFR exon 19 deletion and 55% were never-smokers.
Patients who received erlotinib plus bevacizumab did not have a significantly improved PFS compared with patients who received erlotinib alone (hazard ratio [HR], 0.81; 95% CI, 0.50-1.31; P =.39). Furthermore, no improvement in overall response rate (81% vs 83%; P =.81) or overall survival (HR, 1.41; 95% CI, 0.71-2.81; P =.33) was seen.
“Our study, unlike previous randomized clinical trials, did not reveal a significant improvement in PFS with the combination of erlotinib and bevacizumab,” the study authors wrote in conclusion.
The study authors explained that there is “interest” in adding bevacizumab to a different agent, osimertinib. Currently, a single-arm phase 1/2 trial is evaluating bevacizumab plus osimertinib (ClinicalTrials.gov Identifier: NCT02803203) and a randomized phase 2 trial is evaluating osimertinib with or without bevacizumab (ClinicalTrials.gov Identifier: NCT03133546).
“It will be interesting to observe whether bevacizumab is tolerable and efficacious in combination with osimertinib,” the study authors wrote.
- Stinchcombe TE, Jänne PA, Wang X, et al. Effect of erlotinib plus bevacizumab vs erlotinib alone on progression-free survival in patients with advanced EGFR-mutant non-small cell lung cancer: A phase 2 randomized clinical trial [published online August 8, 2019]. JAMA Oncol. doi: 10.1001/jamaoncol.2019.1847