GSK on Monday announced that its blood cancer drug Blenrep failed the main goal of a late-stage study designed to show it was better than an existing treatment on the market.
While announcing DREAMM-3, the phase III open-label, randomised head-to-head superiority trial, the pharma company said that drug did not meet its primary endpoint of progression-free survival (PFS).
As oncology is a key area of focus for GSK as a standalone prescription medicine and vaccine business, the company’s share fell after its statement which reportedly raised concerns that regulatory approval of Blenrep may be rescinded.
The company also informed that the safety and tolerability profile of belantamab mafodotin was consistent with the known safety profile, and no new safety signals were identified. Overall rates of grade 3 keratopathy are consistent with prior reported data, it stated on Monday.
In the trial, Blenrep was compared with a combination of pomalidomide and low doses of the steroid dexamethasone. Pomalidomide was developed by Celgene, now part of Bristol-Myers Squibb , and was approved in 2013 as a treatment for multiple myeloma.
“At the time of the primary analysis, the OS data had only achieved 37.5% overall maturity. The median OS was 21.2 and 21.1 months for belantamab mafodotin and PomDex, respectively, with an HR of 1.14 (95% CI: 0.77, 1.68),” the company stated on Monday.
Blenrep was granted accelerated approval by the US Food and Drug Administration (FDA) as a monotherapy for treating adult patients with RRMM who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
“The accelerated approval was based on the results of the DREAMM-2 overall response rate, DOR and contingent upon a confirmed clinical benefit from a randomised phase III clinical trial. Data from DREAMM-3 is in the process of being shared with health authorities. Discussions with health authorities are currently ongoing,” the company stated.
GSK also informed that additional trials within the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme will continue.
“These trials are designed to demonstrate the benefit of Blenrep in combination treatment with novel therapies and standard-of-care treatments in earlier lines of therapy and dosing optimisation to maintain efficacy while reducing corneal events,” it stated.
According to reports, the drug belongs to a promising category of treatments called antibody drug conjugates, which are engineered antibodies that bind to tumour cells and then release cell-killing chemicals. Meanwhile, data from the DREAMM-7 and DREAMM-8 phase III trials are anticipated in the first half of 2023.