The following article features coverage from the European Society for Medical Oncology (ESMO) 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

The addition of bevacizumab to temozolomide-based therapy was associated with an improvement in overall response (OR) in children with relapsed/refractory neuroblastoma enrolled in the BEACON-Neuroblastoma clinical trial (ClinicalTrials.gov Identifier: NCT02308527), according to results reported at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain. 

It has been estimated that approximately one-half of patients treated for high-risk neuroblastoma will experience recurrence of disease. The absence of a standard treatment option for these patients represents an unmet medical need. 

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In this phase 2 study, patients with relapsed or refractory neuroblastoma aged 1 year to 21 years were randomly assigned to receive treatment with 1 active comparator arm (temozolomide) and 5 experimental arms: temozolomide-bevacizumab; irinotecan-temozolomide; irinotecan-temozolomide-bevacizumab; temozolomide-topotecan; and topotecan-temozolomide. 

The primary end point for part 1 of the study was best response, with at least 4 more responses in the bevacizumab plus chemotherapy arms compared with the chemotherapy alone arms set as the criterion for a positive result.

Of the 106 patients enrolled in part 1 of the study, 17 of 52 patients (33%) receiving chemotherapy plus bevacizumab and 8 of 54 patients (15%) receiving chemotherapy alone had an objective response to treatment, meeting the criterion for a positive study. 

Following an amendment of the BEACON-Neuroblastoma clinical trial protocol to include part 2 of the study, which involved enrollment of an additional 40 patients and inclusion of a coprimary end point of progression-free survival, available data again showed a positive result with respect to overall response, with responses observed in 21 of 77 patients (27%) and 13 of 77 (17%) of those patients receiving bevacizumab vs not, respectively. 

Longer follow-up will be necessary to determine whether addition of bevacizumab to temozolomide-based therapy has an impact on PFS or overall survival (OS). 

The rate of grade 3 or higher adverse events was 86% and 58% for patients receiving chemotherapy with or without bevacizumab, respectively. Of these, a decrease in platelet count and anemia were most common in patients treated with bevacizumab. 

Disclosure: This study was funded by Roche, and some of the authors disclosed payments from the pharmaceutical industry. For a full list of disclosures, please refer to the original abstract.

Read more of Cancer Therapy Advisor‘s coverage of the ESMO annual meeting by visiting the conference page.

Reference

Moreno L, Moroz V, Owens C, et al. Bevacizumab for children with relapsed & refractory high-risk neuroblastomoa (RR-HRNB): Results of the BEACON-neuroblastoma randomized phase II trial – A European ITCC-SIOPEN trial. Presented at: European Society for Medical Oncology (ESMO) Congress 2019; September 27-October 1, 2019: Barcelona, Spain. Abstract LBA64.