GSK blood cancer drug Blenrep, withdrawn from the U.S. market just 12 months ago, may see renewed interest thanks to positive data from a combination trial.

The Phase 3 study, dubbed DREAMM-7, showed that Blenrep, a BCMA-directed antibody drug conjugate (ADC), significantly extended the time to disease progression or death versus Genmab and Johnson & Johnson’s anti-CD37 medicine Darzalex as a second-line treatment for multiple myeloma. 

Both therapies were paired with a cocktail known as BorDex, which contains Takeda’s Velcade (bortezomib) and dexamethasone.

Given the results, the British drugmaker is “particularly encouraged” by the potential for Blenrep (belantamab mafodotin) plus BorDex to address high unmet need in relapsed/refractory multiple myeloma, said GSK’s Hesham Abdullah, SVP and global head oncology, R&D, in a press release announcing the results Monday morning.

The study, which has been unblinded early on the advice of an independent data monitoring committee, met its primary endpoint of progression-free survival (PFS). A “strong and clinically meaningful” overall survival (OS) trend was also seen and the trial continues to follow up for OS. No new safety signals were seen.

Results will be presented at an upcoming scientific meeting and shared with health authorities, GSK said. 

Blenrep resurrected 

At one time, Blenrep was seen as a key plank of GSK’s resurrected oncology aspirations. The company hived off its consumer health joint venture with Pfizer as Haleon during the summer of 2022, leaving a pure-play biopharma concentrated on drugs for cancer, among other disease areas. 

Having sold its oncology unit to Novartis for $16 billion in 2014, though, GSK had to start anew. Blenrep’s approval in 2020 as a fifth-line treatment for patients with multiple myeloma was a sign that the rebuild was off to a solid start. 

As the drug was greenlit via the Food and Drug Administration’s accelerated approval program, GSK was required to run a confirmatory trial. That trial (DREAMM-3) failed to meet its goal, however, and the pharma giant, on the urging of the FDA, withdrew Blenrep from the U.S. market in November 2022.

GSK continued the DREAMM trial program to see if it could demonstrate the ADC’s benefit in combination with other therapies in earlier lines of therapy. Whether GSK’s persistence will ultimately pay off remains to be seen, but the potential upside makes the bet worth trying. For instance, Darzalex generated nearly $8 billion in 2022 worldwide sales, predominantly in the multiple myeloma setting. 

In addition to DREAMM-7, an ongoing head-to-head Phase 3 trial (DREAMM-8) is evaluating Blenrep in combination with BMS drug Pomalyst (pomalidomide) and dexamethasone versus bortezomib in combination with Pomalyst and dexamethasone. DREAMM-8 data are expected in the second half of 2024.

For a February 2024 article on GSK reporting positive news on a trio of high-profile products, click here.