GSK wants to present Blenrep to regulatory bodies sooner.
The UK pharma will submit Blenrep in second-line multiple myeloma to US, European and Japanese authorities in the second half of 2024, which is earlier than the original 2025 guidance, according to its first-quarter earnings report. The filings will be based on positive outcomes from the Phase 3 DREAMM-7 and DREAMM-8 studies reported earlier this year.
Emma Walmsley“We’re encouraged by the data from DREAMM-7, which showed a tripling of progression-free survival,” CEO Emma Walmsley said on an investor call Wednesday. Nonetheless, “we’ve obviously got a journey to go on with the regulators,” she said, adding that more detail on a path forward will be provided once DREAMM-8 data are presented at this year’s ASCO meeting.
Blenrep won FDA accelerated approval as a single agent for fifth-line or later multiple myeloma in 2020, but was pulled from the US market in 2022 following a confirmatory trial disappointment.
The DREAMM studies are part of GSK’s plans to bring Blenrep back to market as the company now focuses on combination approaches in earlier lines of the disease. DREAMM-7 tested Blenrep versus Darzalex on top of bortezomib and dexamethasone in multiple myeloma patients who had at least one prior line of therapy. DREAMM-8, meanwhile, is looking at Blenrep versus bortezomib plus pomalidomide and low-dose dexamethasone in the same setting.
Prior to the market withdrawal, GSK had projected £3 billion ($3.7 billion) in Blenrep peak sales. In March, Citi analysts assigned the drug risk-adjusted sales of £2.5 billion ($3.19 billion) in 2035.
Luke MielsMeanwhile, GSK also detailed on Wednesday that its intermediate- or high-risk myelofibrosis drug Ojjaara achieved first-quarter sales of £52 million ($64 million). “Ojjaara is establishing market share in both the first-line and second-line settings and we’ve seen encouraging data suggesting physicians are anticipating increasing their use of Ojjaara in the coming months,” chief commercial officer Luke Miels said.
The JAK inhibitor, which received US approval in September, was added to GSK’s portfolio via its $1.9 billion buyout of Sierra Oncology in 2022.
On the R&D side, GSK dropped a CRK12 inhibitor for visceral leishmaniasis from Phase 1 development as part of general pipeline prioritization activities. It also added a Phase 1 solid tumor program in the form of a B7-H3 targeting antibody-drug conjugate that it licensed from Hansoh Pharma for $185 million upfront in December.
GSK also said it incurred restructuring costs of £49 million ($61 million) in Q1, including £28 million ($34 million) spent on supply chain-related costs as it spins off Haleon. The pharma company sold a partial stake in Haleon for $1.2 billion at the start of the year.