Pharmaceutical Market Europe • March 2025 • 8-9
NEWS
AstraZeneca (AZ) has announced positive results from a late-stage trial of camizestrant in advanced breast cancer.
The phase 3 SERENA-6 study randomised patients with HR-positive, HER2-negative advanced breast cancer whose tumours had an emergent ESR1 mutation to receive either AZ’s candidate or an aromatase inhibitor (anastrozole or letrozole), both taken alongside a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib).
Patients with HR-positive breast cancer, the most common subtype of the disease, are frequently treated with endocrine therapies that target oestrogen receptor (ER)-driven disease in combination with CDK4/6 inhibitors.
However, many patients with advanced disease develop resistance to these medicines, and mutations in the ESR1 gene are a key driver of this.
The camizestrant combination demonstrated a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival compared to standard-of-care treatment with an aromatase inhibitor and CDK4/6 inhibitor, AZ said.
The key secondary endpoints of time to second disease progression (PFS2) and overall survival were immature at the time of the interim analysis, but the company noted that its camizestrant combination demonstrated a trend toward improvement in PFS2.
Boehringer Ingelheim (BI) has announced positive top-line results from a late-stage study of its investigational nerandomilast in progressive pulmonary fibrosis (PPF).
The phase 3 FIBRONEER-ILD trial randomised more than 1,170 PPF patients to receive one of two doses of the oral candidate or placebo twice daily for at least one year.
The study met its primary endpoint by demonstrating an absolute change from baseline in forced vital capacity (FVC), a measure of lung function, at week 52 versus placebo.
IPF is one of the more common progressive fibrosing interstitial lung diseases, affecting approximately three million people worldwide.
The results came five months after BI revealed that its phase 3 FIBRONEER-IPF of nerandomilast in idiopathic pulmonary fibrosis (IPF) met the same FVC primary endpoint.
BI said in the September announcement that it would be submitting a new drug application (NDA) for nerandomilast in IPF to the US Food and Drug Administration and other health authorities worldwide.
Based on the new results from FIBRONEER-ILD, the company will now also be submitting an NDA for the drug in PPF.
Johnson & Johnson (J&J) has shared positive results from a late-stage study evaluating a subcutaneous (SC) version of Tremfya (guselkumab) in ulcerative colitis (UC).
The phase 3 ASTRO trial has been investigating the use of Tremfya SC induction therapy in adults with moderately to severely active cases of the disease.
UC is one of the two main forms of inflammatory bowel disease, which affects almost one in every 100 people in the US.
Tremfya was recently approved by the US Food and Drug Administration for this patient population, administered via an IV induction regimen, followed by a SC maintenance regimen. It is hoped that a fully SC treatment regimen would offer increased flexility to patients.
Results showed that SC Tremfya 400mg induction led to statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures at week 12.
Clinical remission was achieved by 27.6% of SC Tremfya-treated patients versus 6.5% in the placebo group at week 12, while 65.6% of those in the SC Tremfya cohort had a clinical response compared to 34.5% in the placebo arm.
An international clinical trial aimed at preventing Alzheimer’s disease (AD) in young adults who are at risk of developing the neurodegenerative disorder has begun.
Led by Washington University School of Medicine, the Primary Prevention Trial will enrol approximately 240 individuals from families that carry mutations in one of the three key genes associated with early-onset AD.
Both genetic and non-genetic forms of AD start with the amyloid beta protein slowly collecting in the brain two decades before the onset of memory and thinking problems.
The study is part of the Knight Family Dominantly Inherited Alzheimer Network-Trials Unit and will evaluate whether remternetug, an investigational antibody being developed by Eli Lilly, can remove amyloid beta from the brain or block it from accumulating in the first place.
Participants will receive remternetug, administered via an injection under the skin, or placebo every three months for two years. At the end of the experimental period, those who carry a mutation will be eligible to receive Lilly’s drug for an additional four years as part of an open-label extension.
The UK government’s Department of Health and Social Care has announced that almost 700,000 women will be taking part in a “landmark” trial to evaluate how artificial intelligence (AI) can be used to detect breast cancer earlier.
The Early Detection using Information Technology in Health trial is backed by £11m of government support via the National Institute for Health and Care Research.
Approximately 55,000 cases of breast cancer are diagnosed every year in the UK.
Women who are already booked in for routine breast cancer screenings on the NHS will be invited to take part in the study, which will test five AI platforms across 30 sites.
Breast cancer screening is offered every three years to women aged between 50 and 71 years, and involves taking X-rays of the breasts, called mammograms. These are then used to identify changes in the breast tissue that could indicate early signs of cancer.
Two specialists are currently needed per mammogram screening, but it is hoped that the AI technology in the trial will enable just one to complete the same mammogram screening process safely and efficiently.
Eli Lilly has unveiled plans to invest at least $27bn in building four new pharmaceutical manufacturing sites in the US.
The investment, which Lilly claims is the largest pharmaceutical manufacturing investment in US history, raises the company’s total US capital expansion commitments to more than $50bn since 2020 and is aimed at increasing its domestic medicine production across therapeutic areas.
Lilly said it expects to begin construction on the four domestic manufacturing sites this year, adding that the facilities should begin making medicines for patients within five years.
Three of the locations will focus on manufacturing active pharmaceutical ingredients, as well as “reshoring critical capabilities” of small molecule chemical synthesis, while the fourth will extend Lilly’s network for future injectable therapies.
The plants are predicted to create over 3,000 jobs for highly skilled workers, including engineers, scientists, operations personnel and lab technicians. The company also anticipates that almost 10,000 construction jobs will be created during the development of the sites.
The announcement came less than three months after Lilly unveiled a $3bn expansion to the US manufacturing facility that it acquired from Nexus Pharmaceuticals.