Quantcast
Channel: Endpoints News
Viewing all articles
Browse latest Browse all 2200

GSK readies Blenrep's commercial re-launch in the US, and a push in second line

$
0
0

GSK is gearing up for the revival of multiple myeloma drug Blenrep, having hung onto the salesforce that was assembled when the drug first nabbed accelerated approval in 2020, only to be pulled after a trial failure.

Chief commercial officer Luke Miels told reporters Monday that the company elected not to downsize the oncology sales unit after disappointing confirmatory trial results prompted the British pharma to pull the drug from the US market in late 2022.

“The calculated judgement we took at the time was that there would be a pathway back for Blenrep,” he said. Recent positive results in two late-stage trials have fueled that vision, with GSK now expected to submit approval applications to global regulators in the second half of 2024.

Miels said the sales team has paid the vote of confidence back “in spades,” citing the successful launch of myelofibrosis drug Ojjaara. The oncology sales team has about 75 employees in the US, and Miels expects it will grow slightly.

GSK has said Blenrep could exceed $3 billion in peak sales based largely on treating second-line patients, the indication being applied for this year. Miels believes GSK can replace Johnson & Johnson’s Darzalex as the standard of care for second-line patients, as Darzalex moves into first-line patients.

Miels said he thinks Blenrep could eventually target that population as well.

“We’ve just got to work out the dose and the design, but we think [Blenrep] is something that could be an opportunity to be used in the first-line setting,” Miels said.

Watching TIGIT

Blenrep, if approved as a second-line treatment, would likely become the bedrock of GSK’s oncology portfolio, a possibility that’s given the pharma more confidence about its oncology R&D efforts. But Miels was more measured about other early drugs, including an anti-TIGIT candidate called belrestotug that’s part of a partnership with iTeos Therapeutics.

“Our approach is really one of discipline, but [also] in being inquisitive,” Miels said. He added that GSK expects to present updated data on belrestotug at this year’s European Society for Medical Oncology annual meeting, results that will inform the future development plan.

ITeos announced earlier Monday that the two had launched a Phase 3 study testing a doublet therapy of belrestotug and Jemperli in PD-L1-selected patients with non-small cell lung cancer, comparing it to patients receiving Keytruda and placebo. Another Phase 2 study is testing the asset as part of a triple combo with Jemperli and an anti-CD96 antibody to treat squamous cell carcinoma of the head and neck.

Miels outlined that a bucket of assets including belrestotug, the anti-CD96 med and an anti-PVRIG candidate could exceed $2 billion in peak sales should they become commercial-stage products. But those projections rest largely on the fate of the TIGIT drug.

“If any one of these was to move forward, then we would rapidly increase the probability of success,” Miels said. “We’ll get that clarity in the second half of this year, whether we keep moving forward.”


Viewing all articles
Browse latest Browse all 2200

Trending Articles