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GSK/Merck KGgA cancer drug fails in third trial

Fusion protein, bintrafusp alfa – the centrepiece of the 2019 GSK/Merck partnership – has failed to meet its latest trial endpoint and the trial is to be discontinued

Merck has announced that its phase 2 INTR@PID BTC 055 study evaluating bintrafusp alfa with gemcitabine plus cisplatin in the first-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) is to be discontinued, after an independent data monitoring committee judged that it was unlikely to meet its primary objective of overall survival.

It has been bad year for bintrafusp alfa; it rang in the New Year glumly with news that it had failed to beat Merck/MSD’s Keytruda in non-small cell lung cancer, then announced its failure in a phase 2 trial in second-line treatment of locally advanced or metastatic BTC in March.

Bintrafusp alfa was the investigational compound at the centre of a deal potentially worth $4bn between Merck and GSK signed in 2019, with GSK paying $400m upfront. The latest results will inevitably cast doubt on the future of that deal.

The first-in-class drug is a bifunctional fusion protein immunotherapy that is designed to act on two immuno-inhibitory pathways that are commonly used by cancer cells to evade the immune system – TGF-β and PD-L1. This bifunctional approach is thought to control tumour growth by potentially restoring and enhancing anti-tumour responses.

In preclinical studies, bintrafusp alfa demonstrated activity both as a monotherapy and in combination with chemotherapy, leading Merck to focus on the underlying pathophysiology of difficult-to-treat cancers.

In announcing the discontinuation of the trial, Merck’s statement was short, offering no information on next steps with bintrafusp alfa, if indeed there are any. However, in earlier statements, Merck has detailed a strong clinical programme for bintrafusp alfa, including trials for breast cancer, urothelial cancer and cervical cancer, and the FDA’s clinical trials database lists more than 40 studies involving the experimental compound.

Earlier this summer, GSK CEO Emma Walmsley took time to reassure investors that the company’s new approach was bearing fruit. “We know this has been a company that has perennially disappointed when you look at the first half of the last decade,” she admitted, but promised that this was about to change.

After four years of strategic transformation and investment, her top team has been rejuvenated – 85% of GSK’s 125 leaders are new to their roles since 2017, and 30% were recruited externally. The team has also set the goal of delivering £33bn ($46bn) in annual sales by 2031, mostly driven by revenues from current late-stage projects under the stewardship of R&F chief, Hal Barron.

The goal is to revitalise the business around new vaccines and specialty medicines, combining prevention and treatment, and see GSK re-emerge as a powerhouse in infectious disease, HIV, oncology and immunology.

The Merck deal around bintrafusp alfa was a big-ticket items in that approach.

Article by
Hugh Gosling

25th August 2021

From: Research, Regulatory, Healthcare

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