Pharmaceutical Market Europe • June 2025 • 8-9
NEWS
AstraZeneca shares Imfinzi phase 3 results in bladder cancer
AstraZeneca (AZ) has shared promising results from a late-stage study of its immunotherapy Imfinzi (durvalumab) in non-muscle-invasive bladder cancer (NMIBC).
The phase 3 POTOMAC trial has been evaluating the drug in combination with standard-of-care Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk NMIBC who have undergone transurethral resection of a bladder tumour.
After one year, treatment with the Imfinzi regimen demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) compared to BCG induction and maintenance therapy alone.
A second arm assessing Imfinzi in combination with BCG induction-only therapy compared to BCG induction and maintenance therapy alone did not achieve the DFS endpoint, AZ said.
Bladder cancer is the ninth most common cancer globally and NMIBC, in which the cancer cells are confined to the inner lining of the bladder, accounts for over 70% of diagnoses.
AZ’s Imfinzi is designed to target the PD-L1 protein, which cancer cells use to evade the immune system, and was approved in the US at the end of March this year as part of a perioperative treatment regimen for adults with muscle-invasive bladder cancer.
Boehringer’s nerandomilast shows lung function benefit
Boehringer Ingelheim (BI) has unveiled results from two late-stage studies of nerandomilast in idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
The phase 3 FIBRONEER-IPF and FIBRONEER-ILD trials have been evaluating the candidate in patients with IPF and PPF, respectively, with and without background anti-fibrotic therapy.
IPF, which primarily affects adults aged over 50 years, is one of the more common progressive fibrosing interstitial lung diseases (ILDs). Patients with specific types of non-IPF fibrosing ILD may also go on to develop PPF, characterised by worsening respiratory symptoms.
Results presented at this year’s American Thoracic Society International Conference showed that the trials met their primary endpoint at both doses, with nerandomilast 9mg and 18mg significantly reducing decline in forced vital capacity, a measure of lung function, by absolute change from baseline at week 52 compared to placebo.
Neither study met the composite key secondary endpoint of time to first acute IPF/ILD exacerbation, first hospitalisation for respiratory cause or death, BI said. However, the company outlined that death occurred in a “numerically smaller” proportion of patients treated with nerandomilast than placebo in FIBRONEER-ILD.
Roche shares 96-week results for MS drug candidate
Roche has shared positive new 96-week data for its investigational fenebrutinib in patients with relapsing forms of multiple sclerosis (MS).
Results from the phase 2 FENopta open-label extension study, presented at this year’s Consortium of MS Centers annual meeting, showed that patients treated with fenebrutinib maintained no disability progression and low levels of disease activity for up to two years.
Affecting over 2.9 million people worldwide, MS is a chronic immune-mediated disease of the central nervous system that disrupts communication between the brain and the rest of the body.
Taken orally, fenebrutinib belongs to a class of drugs known as Bruton’s tyrosine kinase inhibitors, which work by selectively blocking the cells that drive the autoimmune reaction behind MS.
The results from FENopta demonstrated that patients treated with the candidate for up to 96 weeks had a low annualised relapse rate of 0.06 and, during this time, there was no disability progression, as measured by the Expanded Disability Status Scale.
Roche’s drug was also shown in MRI scans to suppress disease activity in the brain, with no new T1 gadolinium-enhancing lesions detected at 96 weeks.
BioNTech commits £1bn
to boost UK R&D presence
BioNTech has announced that it will be investing up to £1bn into the UK over the next ten years in an effort to widen its regional research and development (R&D) activities.
The UK government has also agreed to award the company up to £129m, representing one of the largest grants of its kind in UK history for a pharmaceutical company.
The agreement between BioNTech’s subsidiary BioNTech UK and the UK government is focused on accelerating clinical trials for the company’s oncology drug candidates, expanding its R&D footprint, and supporting research into areas such as structural biology, regenerative medicine and infectious disease vaccines.
The funds will go towards establishing two new R&D centres, one of which will be in Cambridge, as well as setting up a UK headquarters in London.
The company’s London office will also accommodate an artificial intelligence
(AI) hub led by InstaDeep, its wholly owned subsidiary.
The commitments are expected to create over 400 new highly skilled jobs over the next decade, including researchers in clinical and scientific drug development and bioinformatics.
FDA rolls out AI system to accelerate drug review process
The US Food and Drug Administration (FDA) has announced that all of its centres will operate on a common generative artificial intelligence (AI) system by 30 June this year.
The “aggressive” rollout timeline follows the successful completion of a new AI-assisted scientific review pilot, the regulator said.
The AI tools will be deployed immediately and will expedite the review process by enabling FDA scientists and subject-matter experts to spend less time on “tedious” and “repetitive” tasks.
“We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process,” said FDA commissioner, Martin Makary.
The rollout will be led by Jeremy Walsh, who was recently appointed as the regulator’s chief AI officer. He will be joined by Sridhar Mantha, director of the Center for Drug Evaluation and Research’s Office of Strategic Programs.
After the secure system is fully integrated, work will continue to improve the technology’s usability, expand document integration and adapt to the needs of each centre, while maintaining information security and compliance with FDA policy.
Researchers to evaluate neurodegenerative disease blood test
A team of researchers from the UK Dementia Research Institute (UKDRI) is evaluating whether a new blood test can diagnose neurodegenerative diseases at a much earlier stage.
It is hoped that the test, used for conditions such as Alzheimer’s and Parkinson’s disease, could be available for widespread use in healthcare settings across the UK in the coming years.
Protein aggregation and associated inflammation are key features of neurodegenerative diseases and occur early in disease progression; however, current diagnostic tools are not sensitive enough to detect them.
Based at the University of Cambridge, Sir David Klenerman’s team has developed ultra-sensitive tests that are able to detect blood-based disease markers, including harmful proteins that clump together into ‘aggregates’ in the brain and result in damage to brain cells, alongside signs of inflammation activation.
The researchers are now developing and validating the new blood test, following funding and support from medical research charity LifeArc. As well as aiding in early diagnosis, the test would offer a less invasive option compared to existing spinal fluid tests and would be cheaper than current brain imaging scans.
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