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Vivian Xie
7 Nov 2022

Blood cancer drug from GSK fails main goal of trial

GSK has released a statement on the failure of Blenrep in achieving the main goals of a late-stage study for the blood cancer therapeutic, raising concerns of regulatory approval being rescinded.

Blenrep, GSK’s blood cancer drug, has failed the main of its late-stage study designed to demonstrate the primary endpoint of ‘progression-free survival’ - the period in which a patient with relapsed or refractory multiple myeloma lives with the disease without worsening after treatment.  

An antibody–drug conjugate, Blenrep joins a number of engineered antibodies with the ability to bind to tumour cells and release cell-killing chemicals. The drug was given accelerated approval by US authorities in 2020 for the indication of relapsed or refractory multiple myeloma in patients who had received a minimum of four prior therapies. In this late-stage trial, Blenrep was compared with a combination of pomalidomide and dexamethasone. Developed by Celgene, now a part of Bristol-Myers Squibb, pomalidomide was approved in 2013 for the treatment of multiple myeloma. From the trial, the data may result in Blenrep’s existing approvals being rescinded. 

J.P. Morgan analysts commented that “Overall, with this data calling into question Blenrep’s approvability in the existing setting and the chances of success in earlier treatment lines, we therefore expect the market to price in a risk that Blenrep’s approval is rescinded.” 

Additional trials of Blenrep are currently continuing as planned while GSK states that data from this particular trial will be shared with health authorities. 

Source: GSK's blood cancer drug fails main goal of trial, shares fall | Reuters 

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