Please login to the form below

Not currently logged in
Email:
Password:

Trial failure for bintrafusp alfa casts doubt on GSK/Merck KGaA’s cancer alliance

Bispecific antibody fails in non-small cell lung cancer trial

Bintrafusp alfa – the novel immunotherapy at the centre of a major alliance between GlaxoSmithKline (GSK) and Merck KGaA – has failed in a late-stage trial in difficult-to-treat cancers.

GSK and Merck entered the partnership in 2019 to jointly develop and commercialise bintrafusp alfa – previously known as M7824. At the time, the deal was said to be worth $4.2bn (€3.7 billion or £3.2bn) to the Darmstadt-headquartered Merck.

That includes an upfront payment paid by GSK to Merck of €300m – although the €500m earmarked for a milestone payment triggered by data from the lung cancer programme will now be lost.

The phase 3 INTR@PID Lung 037 study evaluated bintrafusp alfa as a first-line treatment for patients with stage IV non-small cell lung cancer (NSCLC) that have high expression of PD-L1.

In a statement, Merck said that the study’s Independent Data Monitoring Committee (IDMC) recommended that the trial should be discontinued, as it is ‘unlikely’ to meet the co-primary endpoint of progression-free survival.

“We have pioneered the science behind bintrafusp alfa, and now through a strategic alliance, multiple non-correlated parallel hypotheses are being evaluated across numerous indications in our extensive INTR@PID clinical program,” said Danny Bar-Zohar, global head of development for the healthcare business of Merck.

“We remain committed to further evaluation of bintrafusp alfa, and this data from INTR@PID Lung 037 will provide important insights that may be applied to future studies,” he added.

Despite failing in NSCLC, bintrafusp alfa will continue to be evaluated in a number of additional clinical trials across a range of cancer types.

This includes assessing the drug’s benefit in biliary tract cancer (BTC) and cervical cancer – top-line results for the BTC study are planned to be published in Q1, according to Merck.

The German pharma company also recently initiated monotherapy studies in triple-negative breast cancer and in locally advanced/metastatic urothelial cancer.

Bintrafusp alfa is part of a new wave of bispecific antibodies that are currently being developed by a number of companies as potential successors to the PD-1/PD-L1 inhibitor class.

The molecule is designed to simultaneously target two immuno-suppressive pathways, transforming growth factor-β (TGF-β) trap and an anti-programmed cell death ligand-1 (PD-L1), that are commonly used by cancer cells to evade the immune system.

Although GSK has not issued a press release regarding the NSCLC trial failure, a company spokesperson told Endpoints News: “No additional safety signals were observed by the IDMC. Development continues for bintrafusp alfa in several additional cancer indications.”

Article by
Lucy Parsons

21st January 2021

From: Research

Share

Tags

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
3 Monkeys Zeno

3 Monkeys Zeno is an award winning global creative communications consultancy – home to a collective of creative and strategic...

Latest intelligence

competitive intelligence
Integrating competitive intelligence into business development, licensing and M&A strategy
The advantages of partnering with a competitive intelligence or knowledge management team...
reaching HCPs during pandemic
Reaching patients and HCPs during the pandemic
COVID-19 has caused unprecedented disruption to drug launches, but some pharma companies avoided costly delays by quickly pivoting to digital channels...
#DemandDiversity: Black history in clinical trials: It's more than just Tuskegee [Infographic]
Take a look at this infographic showing some of the most notorious clinical trials and medical research in history....

Infographics