MedicalResearch.com Interview with:
Tosh Butt, MBA
MedicalResearch.com: What is the background for this study? How is benralizumab different from more traditional treatments for asthma?
- BORA is a randomized, double-blind, parallel-group, Phase III extension, and is one of six Phase III trials in the WINDWARD program in asthma. The current analysis includes results for 1,926 patients from the two placebo controlled exacerbation trials, SIROCCO (48 week) and CALIMA (56 weeks). BORA provides evidence that add on maintenance treatment with FASENRA (benralizumab) resulted in a consistent safety profile over a second year of treatment, with no increase in the frequencies of overall or serious adverse events, and sustained efficacy in terms of reducing asthma exacerbations, and improving lung function and asthma symptoms. The BORA trial results could provide confidence to patients with severe eosinophilic asthma and physicians that the positive outcomes they may be seeing with benralizumab can be maintained over a second year of treatment.
- FASENRA, a different kind of respiratory biologic, has a strong clinical profile which includes the ability to show lung function improvement after the first dose, the potential to reduce – or even stop – oral steroid use, and the convenience of 8-week dosing (no other respiratory biologic offers this dosing). FASENRA is approved for add-on maintenance treatment of patients with severe asthma ages 12 years and older, and with an eosinophilic phenotype. FASENRA binds directly to the IL-5a receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis, or cell death. Other biologics currently available are anti-IL5s – a passive approach that primarily acts to block differentiation and survival of the eosinophil.
MedicalResearch.com: What are the main findings?
Response: Results from the BORA trial provide new evidence that add-on maintenance treatment with FASENRA (benralizumab) can provide long-term benefit in maintenance of reductions in exacerbations and improvements of lung function and asthma control, with a consistent safety profile in a second year of follow up. Specifically in the BORA trial, FASENRA (benralizumab) given for an additional 56 weeks showed a safety and tolerability profile similar to that observed in the placebo-controlled SIROCCO and CALIMA trials, with no increase in the frequencies of overall or serious adverse events. Near complete eosinophil depletion was maintained in patients who continuously received benralizumab. Improvements in exacerbation frequency, lung function and asthma symptoms observed with FASENRA in the predecessor trials were maintained through a second year in BORA and improved for patients who newly received FASENRA. In fact, nearly three quarters (74%) of patientswith a baseline blood eosinophil count of 300 cells per μL or greater who received FASENRA every eight weeks continuouslyfrom SIROCCO or CALIMA into BORA experienced no exacerbations in BORA.
MedicalResearch.com: What should readers take away from your report?
Response: Results from the BORA trial provide new evidence that add-on maintenance treatment with FASENRA (benralizumab) can provide long-term benefit in maintenance of reductions in exacerbations and improvements of lung function and asthma control, with a consistent safety profile in a second year of follow up. For patients and clinicians, BORA is really important – it could give them confidence that the safety and efficacy they see in the first year of treatment will be maintained, and support long-term use.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Additional analyses from the BORA trial, including treatment in adolescents up to 108 weeks, will be available in the second half of 2019 and a fully integrated efficacy and safety analysis, including patients from ZONDA, will be available in the first half of 2019. We continue to consider the development of benralizumab in the treatment of other diseases in which eosinophils play an important role.
MedicalResearch.com: Is there anything else you would like to add?
Response: Respiratory is one of AstraZeneca’s three main strategic areas of focus and we’re committed to advancing respiratory science to better understand the underlying causes and deliver new medicines to transform respiratory care. We have one of the most exciting respiratory pipelines in the industry and have increased R&D activity to deliver a portfolio of new medicines. There is high unmet need with both asthma and COPD patients and more needs to be done to deliver better treatment options to patients and physicians. We knew FASENRA had a strong clinical profile from the Phase III program, but what we’re now hearing back anecdotally from clinicians and patients is really striking and underscores our belief that FASENRA is a gamechanger for severe asthma. Nearly 10,000 patients are now on FASENRA.
Results from the Phase III extension BORA trial evaluating the long-term safety and efficacy of FASENRA™ (benralizumab) as an add-on maintenance treatment in patients with severe eosinophilic asthma who had previously completed one of the two pivotal SIROCCO or CALIMA Phase III trials.
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