GSK's blood cancer drug Blenrep, has failed to meet the main goal of a late-stage study designed to show it was superior to an existing treatment on the market.
The multinational pharmaceutical company revealed this in a statement on Monday, 7 October, 2022, while stating that additional trials of Blenrep will proceed as planned.
In the trial, dexamethasone and pomalidomide were combined, and Blenrep was put up against them. Pomalidomide was created by Celgene, a company that is now a part of Bristol-Myers Squibb, and it was authorised as a therapy for multiple myeloma in 2013.
According to a note by J.P. Morgan analysts, “Results from the so-called superiority study known as DREAMM-3 may call into doubt Blenrep's current clearance. Other regulatory options include regulators revoking existing licenses or delaying decisions until more data is available.”
To supplement GSK's Blenrep and obtain access to its primary investigational therapy for a rare blood cancer, Sierra Oncology, a U.S. pharmaceutical business, was acquired by the corporation in April.
It was recommended as a therapy for patients with relapsed or refractory multiple myeloma who have had at least four previous regimens. The medication was awarded an expedited approval by U.S. regulators in 2020.
Sequel to its remarks, which prompted worries that Blenrep's regulatory license may be revoked, its shares dropped to 3 per cent.
Overall, this data raises concerns about Blenrep's approval in the current environment and the likelihood of success with earlier treatment lines. As a result, we anticipate that the market will price in a risk that Blenrep authorization may be revoked,” J.P. Morgan analysts said.
GSK said data from the trial will be shared with health authorities and discussions are currently ongoing.
