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Adding bevacizumab to erlotinib significantly improves progression-free survival (PFS) in patients with previously untreated, advanced, non-squamous non-small cell lung cancer (NSCLC), according to final results from the phase 3 BEVERLY trial.
The results were presented at the European Society for Medical Oncology (ESMO) Congress 2021 by Maria C. Piccirillo, MD, of the National Cancer Institute in Naples, Italy.
The phase 3 BEVERLY trial (ClinicalTrials.gov Identifier: NCT02633189) enrolled 160 adults with previously untreated, stage IIIB/IV, non-squamous NSCLC with activating EGFR mutations.
The patients’ median age at baseline was 67.0 years (range, 59.5-73.0 years), most were women (63.8%), and about half were never smokers (51.9%). Types of EGFR mutations included exon 19 deletion (55.0%), exon 21 L858R mutation (41.3%), and “other” (3.8%).
The patients were randomly assigned to receive erlotinib at 150 mg daily alone (80 patients assigned; 1 was non-evaluable) or combined with bevacizumab at 15 mg/kg intravenously every 21 days (80 patients) until disease progression, unacceptable toxicity, or withdrawal.
At a median follow-up of 36 months, bevacizumab significantly prolonged PFS.
Per investigator assessment, the median PFS was 15.4 months in the bevacizumab-erlotinib arm and 9.6 months in the erlotinib-alone arm (adjusted hazard ratio [aHR], 0.66; 95% CI, 0.47-0.92; P =.015).
Per blinded independent central review, the median PFS was 14.8 months in the bevacizumab-erlotinib arm and 9.6 months in the erlotinib-alone arm (aHR, 0.68; 95% CI, 0.48-0.96; P =.027).
Overall survival (OS) was similar between the treatment arms. The median OS was 33.3 months in the bevacizumab-erlotinib arm and 22.8 months in the erlotinib-alone arm (aHR 0.72; 95% CI, 0.47-1.10; P =.132).
A subgroup analysis suggested that bevacizumab plus erlotinib might work better among smokers, Dr Piccirillo said.
Compared with erlotinib alone, bevacizumab plus erlotinib led to more frequent grade 3 or higher hypertension (23.8% vs 5.1%; P =.001) and grade 3 or higher rash (33.8% vs 16.5%; P =.01).
There was 1 toxic death resulting from intracranial hemorrhage reported in the bevacizumab-erlotinib arm.
Based on these results, Dr Piccirillo concluded that bevacizumab plus erlotinib might be considered as a first-line treatment option for patients who cannot receive osimertinib.
Disclosures: This research was partially supported by Roche. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Piccirillo MC, Bonanno L, Garassino MCC, et al. Bevacizumab + erlotinib vs erlotinib alone as first-line treatment of pts with EGFR mutated advanced nonsquamous NSCLC: Final analysis of the multicenter, randomized, phase III BEVERLY trial. Presented at: European Society for Medical Oncology (ESMO) Congress 2021; September 16-21, 2021. Abstract 1207O.