|
|
|
|
||
More from the competitive landscape(when it rains it pours. Was tempted to put “FAIL” as the header but in deep sympathy to ummmbg request…) GSK reports PhIII flop for BCMA drug — raising questions about its future and upping the stakes on combos Amber Tong Senior Editor Two years after an accelerated approval, GSK’s BCMA-targeting antibody-drug conjugate has flunked a Phase III study in multiple myeloma, raising doubts about the pharma giant’s plan to move it up to earlier lines of treatment. The Monday update comes from DREAMM-3, a head-to-head trial pitting GSK’s Blenrep against PomDex, the standard-of-care combo of the chemotherapy pomalidomide and the steroid dexamethasone. Blenrep failed the primary endpoint of progression-free survival. In response to an Endpoints News inquiry, GSK spokesperson said that “DREAMM-3 was a confirmatory study for the current accelerated/conditional approval for Blenrep in the US and EU.” “While we are disappointed the study did not meet its primary endpoint, patients in the DREAMM-3 trial who responded to treatment with Blenrep achieved deep and durable responses,” the spokesperson wrote. “We remain confident in Blenrep and the potential to deliver meaningful results from combination trials in second line relapsed/refractory multiple myeloma and in on-going first line evaluation.” Blenrep was the first FDA-approved drug that targets BCMA, though it was soon followed by others, including CAR-Ts and bispecifics, that appeared to generate better efficacy. It was also the first in-house GSK drug to gain an OK since the British drugmaker sold almost all of its oncology assets to Novartis in a 2014 swap. Notwithstanding its toxicity profile — the drug was known to cause vision damage among patients — the FDA decided that the benefits among patients who are out of options outweighed the risks. DREAMM-3 enrolled patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapies, and randomized them 2:1 to receive either Blenrep or PomDex. It’s an earlier line of treatment than what Blenrep is currently approved for, but does come close to the group covered by the accelerated approval: patients who have received at least four prior therapies, including an anti-CD38 antibody, a proteasome inhibitor and an immunomodulatory agent. The two other ongoing Phase III trials listed by GSK both test Blenrep in combination with other drugs in the second line setting, meaning the patients would’ve received one prior drug. GSK said it will share and discuss the new data with health authorities. DREAMM-7 and DREAMM-8 are slated to read out in 2023. In the trial, investigators tracked a hazard ratio of 1.03 despite observing a longer median PFS for Blenrep (11.2 months) versus PomDex (7 months). Numerically, Blenrep also generated better numbers on the secondary endpoint of overall response rate — 41% compared to 36% for PomDex — and while the median duration of response for PomDex was about 8.5 months, it was not reached for Blenrep. While overall survival data were not yet mature (at only “37.5% overall maturity”), the median OS was 21.2 months and 21.1 months for the Blenrep and PomDex groups, respectively, with a hazard ratio of 1.14. Sales of Blenrep have been limited so far — £89 million in 2021 and £91 million in the first nine months of 2022 — likely due to the narrow indication. The pharma giant had hoped it would serve as an anchor for its myeloma portfolio; it’s also teamed up with SpringWorks to test Blenrep in combination with nirogacestat. AUTHOR Amber Tong Senior Editor |
return to message board, top of board |