Pharmaceutical Market Europe • February 2025 • 8-9
NEWS
Pfizer shares phase 3 results for sasanlimab in bladder cancer
Pfizer has shared promising top-line results from a phase 3 study of sasanlimab as an induction therapy in bladder cancer.
The CREST trial has been evaluating the subcutaneously administered investigational anti-PD-1 monoclonal antibody in combination with standard-of-care Bacillus Calmette-Guérin (BCG), with or without maintenance, in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
Approximately 10,500 people are diagnosed with bladder cancer in the UK every year and NMIBC, in which the cancer cells are confined to the inner lining of the bladder, accounts for the majority of new cases.
CREST met its primary endpoint, with sasanlimab plus BCG demonstrating a clinically meaningful and statistically significant improvement in event-free survival compared to BCG alone.
The overall safety profile of the combination was also shown to be generally consistent with the known profile of BCG and with data reported from clinical trials of sasanlimab.
Pfizer said it is planning to discuss the results with global health authorities to support potential regulatory filings for sasanlimab in this indication, adding that it will continue to evaluate the drug in combination with its antibody drug conjugate portfolio.
Bayer’s menopause drug shows promise in phase 3 trial
Bayer has shared positive results from a late-stage study of its investigational non-hormonal drug in patients experiencing vasomotor symptoms (VMS) as a result of breast cancer treatment.
The OASIS 4 study has been evaluating elinzanetant as a treatment for moderate-to-severe VMS caused by adjuvant endocrine therapy in women with hormone receptor positive breast cancer or in those who are at high risk of developing breast cancer.
VMS, such as hot flashes, are reported by up to 80% of women at some point during the menopausal transition. Patients receiving adjuvant endocrine therapy, including aromatase inhibitors, for the treatment or prevention of breast cancer may also experience VMS.
OASIS 4 met its primary endpoint, with elinzanetant resulting in statistically significant mean reductions in the frequency of moderate-to-severe VMS from baseline to weeks four and 12 compared to placebo.
All key secondary endpoints were also achieved, demonstrating a reduction in severity of VMS at weeks four and 12, a reduction in frequency of VMS at week one, as well as improvements in sleep disturbances and menopause-related quality of life at week 12 compared to placebo.
Axsome announces
late-stage results for Alzheimer’s programme
Axsome Therapeutics has announced that it has successfully completed its late-stage clinical programme evaluating AXS-05 (dextromethorphan-bupropion) in Alzheimer’s disease (AD) agitation.
The company said it is planning to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) for the orally administered candidate in this indication later this year.
Up to 70% of AD patients report agitation, which is characterised by emotional distress as well as verbal and physical aggressiveness, and has been associated with accelerated cognitive decline.
Axsome reported that the 295-patient ACCORD-2 trial met its primary endpoint, with AXS-05 demonstrating a statistically significantly delay in the time to relapse of agitation, as assessed by the Cohen-Mansfield Agitation Inventory (CMAI) total score, compared to placebo.
AXS-05 also achieved ACCORD-2’s key secondary endpoint of relapse prevention, and was shown to reduce worsening for overall AD severity versus placebo.
The company noted that the late-stage ADVANCE-2 trial of 408 AD patients did not demonstrate statistical significance for change in the CMAI total score, but said the results for the primary and nearly all secondary endpoints “numerically favoured” AXS-05 over placebo.
WHO urges US to ‘reconsider’ withdrawal
US President Donald Trump has signed an executive order to withdraw the country from the World Health Organization (WHO).
Trump previously took steps to withdraw the US from the global health organisation in 2020, but the move was reversed by the Biden administration.
The order cites WHO’s “mishandling of the COVID-19 pandemic… and other global health crises, its failure to adopt urgently needed reforms, and its inability to demonstrate independence from the inappropriate political influence of WHO member states”.
It also states that WHO “continues to demand unfairly onerous payments from the US, far out of proportion with other countries’ assessed payments”.
The US was a founding member of WHO in 1948 and has participated in shaping and governing the organisation’s work ever since.
The country must complete a one-year notice period before it officially leaves the organisation.
Responding to the announcement, WHO said: “We hope the US will reconsider and we look forward to engaging in constructive dialogue to maintain the partnership between the [US] and WHO, for the benefit of the health and well-being of millions of people around the globe.”
Drug repurposing study identifies potential dementia treatments
A study led by researchers from the universities of Cambridge and Exeter has identified several approved drugs that could be repurposed to treat dementia.
The new research published in Alzheimer’s and Dementia: Translational Research & Clinical Interventions found that certain antibiotics, antivirals, vaccines and anti-inflammatory medications are associated with a reduced risk of developing the neurodegenerative disease.
Led by Ben Underwood and Ilianna Lourida, the UK team examined 14 previous studies that used large clinical data sets and medical records, and looked at data from more than 130 million individuals and one million dementia cases.
Among the drug classes associated with a reduced risk of dementia were antibiotics, antivirals and vaccines, supporting the theory that common forms of the disease may be triggered by viral or bacterial infections. Anti-inflammatory drugs such as ibuprofen were also found to be associated with a lower risk.
The researchers also found conflicting evidence for some drug classes, with certain antidepressants, blood pressure medications and diabetes treatments connected with a lower risk of dementia and others associated with a higher risk.
UK access pathway launched to accelerate medicines access
The Medicines and Healthcare products Regulatory Agency (MHRA) has published full details of a new end-to-end access pathway designed to help get new medicines to NHS patients in “the shortest time possible”.
The UK-wide Innovative Licensing and Access Pathway (ILAP) was first launched in 2021 to reduce the time to market for innovative medicines by offering drug developers a single platform to collaborate with the MHRA and UK health technology assessment bodies.
The pathway has now been refreshed to offer a more streamlined and integrated process to support the development of medicines that can be introduced into the NHS to address unmet clinical needs “at the earliest opportunity”.
The new ILAP boasts a number of key improvements compared to the original pathway. This includes involving the NHS as a “core partner” and focusing on operational planning and system preparedness, as well as providing a single point of contact for each product.
The updated pathway has also been designed to enhance bespoke services through more selective entry and dialogue between ILAP partner organisations and developers, and enable more effective planning by providing predictable delivery timelines.
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