GSK is strengthening its argument to resume selling its cancer drug Blenrep. Study results released Sunday show adding the therapy to two other backbone multiple myeloma medicines delayed disease progression better than Takeda’s Velcade and the same drug regimen.
Combined with publication Saturday of a similar trial that compared Blenrep to Johnson & Johnson’s Darzalex, GSK could have sufficient data to ask the Food and Drug Administration to reauthorize its use. GSK withdrew the drug in 2022 after it failed a trial designed to confirm its accelerated approval two years prior. But the U.K.-based pharmaceutical company kept studying Blenrep, a so-called antibody-drug conjugate, with the eventual goal of getting it back on the market.
If successful, GSK will face a changed treatment landscape that has seen the launch of cell therapies and dual-acting antibodies that target the same pathway as Blenrep, a protein flag called BCMA. Blenrep could also draw skepticism from doctors and patients over its side effects, which include vision loss and eye sores.
The newest data, presented at the American Society of Clinical Oncology, came from a GSK trial called DREAMM-8. The trial put Blenrep into combination with Bristol Myers Squibb’s Pomalyst and a steroid, and compared it to Velcade in the same combination. People enrolled in the trial had previously received at least one line of therapy, including Bristol Myers’ Revlimid, and relapsed after.
The Blenrep combination reduced the relative risk of disease progression or death, the trial’s primary measure, by 48% compared to the Velcade arm. More than half the people receiving Blenrep hadn’t died or had their disease worsen after nearly two years of follow-up, while those who received Velcade had a median progression-free survival of around 13 months.
Meanwhile, data published Saturday in The New England Journal of Medicine from the DREAMM-7 trial, success of which GSK announced in November, provided similar support. The trial tested Blenrep with Velcade and a steroid against Darzalex and the same two drugs.
The benefit was similarly strong versus Darzalex. Blenrep reduced the relative risk of progression by 59%, leading to a median progression-free survival of 37 months, compared to 13 months among those on the Darzalex regimen.
Suzanne Trudel, associate professor at the Princess Margaret Centre in Toronto, said doctors are learning how to manage the drug’s eye-related side effects better, which are caused by the chemotherapy that Blenrep delivers to diseased cells. Trudel was the lead author of the study and presented the data.
“I think ADCs are a difficult group of drugs to develop because of the toxicity you see,” Trudel said. “We’ve learned that from antibody-drug conjugates in [acute myeloid leukemia] you have to figure out how to dose-modify to reduce the toxicity. I think we’re getting that point across with [Blenrep] now that it is more manageable that all of the ocular events are reversible with dose reductions.”
Suzanne Trudel, associate professor at Princess Margaret Centre in Toronto, presents clinical trial data during a press conference held June 1, 2024, at the American Society of Clinical Oncology’s annual meeting in Chicago.
Jonathan Gardner/BioPharma Dive
Among the changes made in DREAMM-8 related to the amount and frequency of Blenrep used. As initially approved, Blenrep was administered once every three weeks at 2.5 milligrams per kilogram of body weight. In DREAMM-8, the initial dose was the same, but subsequent doses were reduced to 1.9 milligrams per kilogram and administered every four weeks.
Management of eye-related side effects has improved as physicians gained experience. Tulio Rodriguez, director of the hematology, bone marrow transplant and cellular therapy program at City of Hope Chicago, said physicians initially used steroids to treat eye problems because that was how they are managed with other cancer medications.
”Steroids don’t have a role here,” Rodriguez said, pointing to use of lubricating or moisturizing eye drops, and dose reductions when necessary.
Rodriguez said the new data should “resurrect” Blenrep and provide a BCMA-targeting alternative to CAR-T cell therapies like J&J’s Carvykti and Bristol Myers’ Abecma. Like all CAR-T therapies, both treatments have a lengthy manufacturing cycle, and also can cause an immune-related side effect that requires patients to stay in or near the hospitals where they receive their infusions.
“Bispecific” antibodies from J&J and Pfizer also target BCMA, meanwhile, have arrived on market since Blenrep was first introduced. So far, those drugs can only be used after multiple lines of therapy, but both J&J and Pfizer have plans to move their use earlier. While more convenient than CAR-T therapies, they also have immune response that require close monitoring.
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- Source: https://www.biopharmadive.com/news/gsk-blenrep-multiple-myeloma-asco-dreamm-8/717730/