Dive Brief:

• GSK on Monday said its drug Blenrep outperformed Johnson & Johnson’s Darzalex in a clinical trial of people with the blood cancer multiple myeloma, potentially cracking open the door to Blenrep’s relaunch one year after the company pulled the treatment from the U.S. market.
• Combined with Takeda’s Velcade and a steroid, Blenrep helped trial participants who had already received one line of treatment live longer without dying or their disease progressing than Darzalex plus Velcade and the steroid. Clinical trial monitors detected the benefit on progression-free survival — the trial’s main goal — at an interim data check.
• Blenrep consists of a cancer-seeking antibody paired to a tumor-killing chemotherapy. It was the first so-called BCMA-targeting drug to reach market with a Food and Drug Administration approval in 2020. However, confirmatory trial results failed to show a survival benefit, leading GSK to withdraw it.

Dive Insight:

A brighter future for Blenrep could provide some measure of good news for GSK’s small oncology business. Through the first nine months of the year, the company reported cancer drug sales of 487 million pounds, or $614 million, about one-fifth of what GSK earned from its top-selling shingles vaccine.

GSK’s cancer business is led by ovarian cancer drug Zejula, which sold 371 million pounds through Sept. 30, 2023, while the bulk of its remaining oncology sales comes from the immunotherapy Jemperli. By comparison, in the first nine months of 2022, Blenrep had sales of 91 million pounds.

Although first to market, Blenrep was viewed as a less effective BCMA-targeting agent because of its relatively low response rate compared to “bispecific” antibodies and cell therapies that also zero in on BCMA. Additionally, treatment was associated with a high rate of eye-related side effects.

When GSK decided to withdraw it, executives pointed to this trial, called DREAMM-7, and another called DREAMM-8 as providing potential validation of Blenrep’s effectiveness. (DREAMM-8 tests Blenrep plus Bristol Myers Squibb’s Pomalyst and a combination of other drugs against a Pomalyst-led combination.)

When reporting third quarter earnings on Nov. 1, GSK Chief Scientific Officer Tony Wood said “our expectations remain low” for the two trials. The company didn’t expect to see data until early 2024 because of a “slower than anticipated” rate of disease progression events that trial researchers use to measure efficacy. The trial will continue to measure whether Blenrep helps people live longer overall.

GSK said it plans to present the data at an upcoming medical meeting and discuss them with regulators, although it didn’t detail any plans to resubmit Blenrep for re-approval.