20th Jan 2021 14:08
(Alliance News) - GlaxoSmithKline PLC said fellow drug maker Merck KGaA had opted to discontinue a clinical trial of bintrafusp alfa in patients with advanced non-small cell lung cancer.
The Intr@pid Lung 037 trial of the immunotherapy was in patients with stage 4 non-small cell lung cancer with high PD-L1 expression. PD-L1 is a protein found in cells which instructs the immune system's T cells not to attack; cancer cells with large amounts of this protein are harder for the immune system to detect and fight.
Glaxo and Merck entered a global strategic alliance to jointly develop and commercialise bintrafusp alfa in February 2019.
In March 2020, they agreed to amend the protocol of the Intr@pid Lung 037 study versus pembrolizumab, switching to an adaptive trial design based on pre-specified rules and a change to study endpoints to progression-free survival/overall survival from overall response rate/progression-free survival.
However, an independent data monitoring committee has now recommended that the trial be discontinued and this recommendation has been followed "as the study is unlikely to meet the primary efficacy endpoint".
The recommendation applies only to this specific clinical trial. Bintrafusp alfa is currently being investigated but is not approved for use anywhere worldwide.
Shares in Glaxo were down 1.8% at 1,385.80 pence in London on Wednesday afternoon. Shares in Merck were down 2.5% at EUR145.10 in Frankfurt.
By Anna Farley; [email protected]
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