GSK’s blood cancer treatment fails to meet its primary trial target, causing its stock to plummet2 min read
GSK’s blood cancer medicine Blenrep failed to meet the primary goal of a late-stage research designed to demonstrate that it was superior to an existing treatment on the market, the company announced on Monday.
GSK’s shares plummeted 3% after its comments, which raised concerns that Blenrep’s regulatory licence may be revoked. Oncology is a significant area of concentration for GSK as a separate prescription pharmaceutical and vaccine business.
GSK said that Blenrep did not reach the primary endpoint of “progression-free survival,” or the time a person lives with the disease without it worsening following therapy, in patients with relapsed or refractory multiple myeloma.
The business decided to buy Sierra Oncology in April, acquiring access to its primary experimental medicine for a rare blood cancer and complementing GSK’s Blenrep.
The medicine obtained accelerated approval in the United States in 2020 and is currently approved as a therapy for patients with relapsed or refractory multiple myeloma who have had at least four prior therapies.
Blenrep was compared in the experiment to a combination of pomalidomide and low doses of the steroid dexamethasone. Celgene, which is now part of Bristol-Myers Squibb, developed pomalidomide, which was authorised as a therapy for multiple myeloma in 2013.
J.P.Morgan analysts noted in a note that findings from the so-called superiority trial termed DREAMM-3 may put into doubt Blenrep’s existing approval, adding that several regulatory scenarios now exist, including existing licences being revoked or authorities waiting for additional evidence.
“Overall, given these evidence putting into doubt Blenrep’s approvability in the current environment and the likelihood of success in previous treatment lines, we expect the market to price in the possibility that Blenrep authorisation is revoked,” they said.
GSK stated that results from the trial will be shared with health authorities, and that conversations are presently underway, with future Blenrep trials continuing as scheduled.
The medicine is part of a promising class of treatments known as antibody drug conjugates, which are designed antibodies that bind to cancer cells and then release cell-killing chemicals.
(In Bengaluru, Pushkala Aripaka and Amna Karimi contributed reporting, and Rashmi Aich, Uttaresh.V, and Susan Fenton edited the piece.)
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