After market withdrawal, GSK touts positive Blenrep combo trial in multiple myeloma

Is Blenrep back from the dead? After a positive trial readout, GSK sure hopes so.

GKS’s Blenrep significantly delayed disease progression or death compared with Johnson & Johnson’s Darzalex in their respective combinations with Takeda’s Velcade and the steroid dexamethasone (Vd) in multiple myeloma patients who had tried at least one prior line of treatment, GSK said Monday.

That means the phase 3 DREAMM-7 trial has met its primary endpoint of progression-free survival ahead of schedule. GSK previously projected a readout in the first half of 2024.

In a release, GSK highlighted a “strong and clinically meaningful” trend suggesting the Blenrep regimen could help patients live longer. The trial remains ongoing to follow up for mature overall survival data.

The trial success comes as a surprise, given that GSK last year pulled Blenrep from the U.S. market as a late-line multiple myeloma therapy. The decision followed a phase 3 flop in which Blenrep alone couldn’t beat a pairing of Bristol Myers Squibb’s Pomalyst and dexamethasone in patients who had failed on at leas two prior lines of therapy.

European regulators recently also recommended not renewing the drug’s conditional approval.

At the time of the withdrawal, GSK said it remained confident in delivering positive results from two Blenrep combo trials. The second one, DREAMM-8, compares a pairing of Blenrep, Pomalyst and dexamethasone (Pd) versus Pomalyst, Velcade and dexamethasone (PVd), also as a treatment for the second line or later. That study is expected to read out in the second half of 2024.

In contrast, industry watchers had all but written Blenrep off from GSK’s portfolio, especially after the huge clinical success of Johnson & Johnson and Legend Biotech’s CAR-T therapy Carvykti and the emergence of T-cell engagers like J&J’s Tecvayli. All these drugs target BCMA on multiple myeloma cells.

Still, investors and analysts will likely require more detailed data to reassign Blenrep any value. GSK said the DREAMM-7 data will be shared at a medical meeting and with drug regulators.

Blenrep has a high bar to meet. In the CARTITUDE-4 trial, Carvykti cut the risk of progression or death by 74% compared with standard combinations in myeloma patients who had tried one to three lines of therapy. The standard-of-care regimens used in that trial are PVd or Darzalex plus Pd.

Blenrep is part of GSK’s burgeoning oncology business. Thanks to the market withdrawal, the antibody-drug conjugate generated just 30 million pound sterling ($38 million) In the first nine months of 2023, down 67% year over year.

Despite the prior Blenrep setback, GSK has made some headway in oncology lately. The company's PD-1 inhibitor Jemperli recently generated favorable overall survival data in a head-to-head lung cancer trial against Merck’s market-leading Keytruda. Jemperli also beat Keytruda to the first FDA approval in newly diagnosed endometrial cancer, even though it’s for a limited patient subgroup.

In September, the FDA approved GSK’s JAK inhibitor Ojjaara, a potential competitor to Incyte’s Jakafi. In an unexpectedly broad label, the FDA allowed the GSK drug for myelofibrosis patients regardless of their treatment history.