Novartis has announced positive findings from its the Phase 3 trial assessing the efficacy and safety of Beovu (brolucizumab) to treat diabetic macular edema (DME).
KESTREL is the second pivotal Phase 3 study of Beovu (3 mg and 6 mg) in DME.
According to Novartis, the trial met its primary endpoint of non-inferiority in change in best corrected visual acuity (BCVA) from baseline of Beovu 6 mg to aflibercept (Eylea) 2 mg at year one.
The trial also met its key secondary endpoint of non-inferiority in average change in BCVA of Beovu 6 mg to aflibercept 2 mg over week 40 through week 52.
More than half of patients in the Beovu 6 mg arm were maintained on a three-month dosing interval through year one, following the loading phase. Patients treated with Beovu 6 mg reportedly experienced significant improvement in change of central subfield thickness (CST) from baseline over the period of week 40 through week 52.
The company said the positive results from KESTREL support favourable findings from another pivotal Phase 3 study, KITE, in September 2020, reinforcing Beovu as a potential new treatment option for DME patients.
Mr Dirk Sauer, global head development of Novartis Pharma Ophthalmology, said the KESTREL results demonstrated Beovu had the potential, if approved, to offer DME patients better disease management.
“Based on these data and the strong results we saw earlier this year from the KITE clinical study, we look forward to working with regulatory authorities to bring Beovu to DME patients,” he said.
The data from KITE and KESTREL will be submitted to upcoming medical meetings and for peer-review publication.
In Australia, the Therapeutic Goods Administration (TGA) approved Beovu (brolucizumab) for the treatment of neovascular (wet) age-related macular degeneration (AMD) earlier this year, but it is not currently listed on the Pharmaceutical Benefits Scheme (PBS).
In July, Novartis made its third resubmission to the Pharmaceutical Benefits Advisory Committee (PBAC) to request Beovu to be PBS-listed for the treatment of patients with subfoveal choroidal neovascularisation (CNV) due to AMD.
In a document dated July 2020 outlining PBAC’s decisions not to recommend specific treatments, the authority said that while Novartis’ claim of Beovu’s non-inferior effectiveness compared with aflibercept was reasonable, it did not accept that the evidence supported less frequent dosing.
“The PBAC considered [Beovu] is likely inferior to aflibercept in terms of comparative safety, based on the clinical trial evidence of a significant difference in serious adverse events between brolucizumab and aflibercept, and changes made to the approved Product Information to reflect an emerging safety signal of retinal vasculitis and/or retinal vascular occlusion.”
Novartis said it disagrees with PBAC’s decision not to recommend the listing of Beovu on the PBS for the treatment of wet AMD.
“Beovu has now been approved in more than 30 countries, including all major markets, and Novartis and Australian clinicians believe that Beovu represents an important treatment option for patients with wet AMD, with an overall favourable benefit-risk profile,” Novartis said in response to PBAC’s latest decision.
Novartis stated it would continue to work collaboratively with the PBAC, the Department of Health and the Federal Government to ensure Australians with wet AMD receive access to Beovu through the PBS “at the earliest opportunity”.