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New combination therapy shows promising results for prostate cancer

A novel combination prostate cancer therapy has been approved by the US Food and Drug Administration.
The new treatment combines two Pfizer-produced cancer drugs, Xtandi (also known as enzalutamide) and Talzenna (which also goes under the name talazoparib).
While Xtandi is a medication typically used for prostate cancer, the addition of Talzenna – an oral poly ADP-ribose polymerase (PARP) inhibitor – is new in patients with the disease.
The FDA approval specifically applies to adults with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
This type of cancer has spread beyond the prostate gland and progressed despite surgery and other treatment to lower testosterone.
Approximately 10%-20% of patients with prostate cancer develop mCRPC within five to seven years of diagnosis. HRR gene mutations are found in approximately 25% of tumours from men with mCRPC and have been associated with aggressive disease and poor prognosis.
In a phase 3 TALAPRO-2 trial, this drug combination was found to decrease the risk of cancer progression by 55%, compared to the standard treatment in these patients for whom the FDA approved the combination.

Neeraj Agarwal. Image: Huntsman Cancer Institute
Neeraj Agarwal, Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute at the University of Utah and global lead investigator for TALAPRO-2, said: “Despite treatment advancement in metastatic castration-resistant prostate cancer, the disease can progress quickly, and many patients may only receive one line of therapy.
“Therefore, new first-line treatment options are needed to reduce the risk of disease progression or death. For patients with mCRPC harbouring HRR genetic alterations, outcomes are even worse.
“The FDA’s approval of the talazoparib and enzalutamide combination is based on the findings from the pivotal TALAPRO-2 study, which demonstrated statistically significant and clinically meaningful reductions in the risk of progression or death among HRR gene-mutated tumours in patients with metastatic castration-resistant prostate cancer.
“It represents a treatment option deserving of excitement and attention.”
The approval came just days after he published the findings of the study in The Lancet, as the lead author, a first in institutional history.
The Phase 3 TALAPRO-2 trial is a two-part, two-cohort, multicentre, randomised, double-blind, placebo-controlled study that included two patient cohorts.
The safety of Talzenna and Xtandi in the TALAPRO-2 trial was generally consistent with the known safety profile of each medicine. Serious adverse reactions occurred in 30% of patients treated with Talzenna plus Xtandi. Serious adverse reactions reported in more than 2% of patients included anaemia (9%) and fracture (3%). Discontinuation of Talzenna occurred in 10% of patients.
A marketing authorisation application (MAA) for the Talzenna and Xtandi combination has been accepted for review by the European Medicines Agency. Pfizer has also shared data with other regulatory agencies to support regulatory filings.
Angela Hwang, chief commercial officer, president, global biopharmaceuticals business, Pfizer, said: “Pfizer has a legacy of bringing medicines to patients with genitourinary cancers and helping improve outcomes for patients suffering from advanced prostate cancer.
“As a global standard of care, Xtandi has shown efficacy in three types of prostate cancer, and the addition of Talzenna demonstrated significant improvements in delaying or preventing radiographic progression-free survival or death in patients with this type of advanced prostate cancer.”
She added that with the FDA’s approval of Talzenna plus Xtandi “we are proud to be able to offer this potentially practice-changing treatment to patients and add to their options in managing this aggressive disease.”
Prostate cancer is one of the most common types. Around one in eight men will be diagnosed with it in their lifetime.
According to the American Cancer Society, about six cases in 10 are diagnosed in men who are 65 or older, and it is rare in men under 40.
Neli Ulrich, chief scientific officer and executive director of the Comprehensive Cancer Center at Huntsman Cancer Institute, said: “This work, led by Dr Agarwal, with colleagues across the world, is absolutely ground-breaking. It will make a big difference in treatment options for many prostate cancer patients.”
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AI can predict Alzheimer’s with almost 93% accuracy, researchers say

Alzheimer’s AI can predict the disease with nearly 93 per cent accuracy using more than 800 brain scans, researchers say.
The system identified anatomical changes in the brain linked to the onset of the most common form of dementia, a condition that gradually damages memory and thinking.
The findings build on years of research suggesting AI could help spot early Alzheimer’s risk, predict disease and identify patients whose condition has not yet been diagnosed.
Benjamin Nephew, an assistant research professor at the Worcester Polytechnic Institute in Massachusetts, said: “Early diagnosis of Alzheimer’s disease can be difficult because symptoms can be mistaken for normal ageing.
“We found that machine-learning technologies, however, can analyse large amounts of data from scans to identify subtle changes and accurately predict Alzheimer’s disease and related cognitive states.”
The study used MRI scans, a type of detailed brain imaging, from 344 people aged 69 to 84.
The dataset included 281 scans showing normal mental function, 332 with mild cognitive impairment, an early stage of memory and thinking decline, and 202 with Alzheimer’s.
The scans covered 95 of the brain’s nearly 200 distinct regions and used an AI algorithm to predict patients’ health.
Being able to use AI to help diagnose Alzheimer’s earlier could give patients and doctors crucial time to prepare and potentially slow the progression of the disease.
The analysis showed that one of the top predictive factors was brain volume loss, or shrinkage, in the hippocampus, which helps form memories, the amygdala, which processes fear, and the entorhinal cortex, which helps provide a sense of time.
This pattern held across age and sex, with both men and women aged 69 to 76 showing volume loss in the right part of the hippocampus, suggesting it may be an important area for early diagnosis, the researchers noted.
However, the research also found that the way brain regions shrink differs by sex.
In females, volume loss occurred in the brain’s left middle temporal cortex, which is involved in language and visual perception. In males, it was mainly seen in the right entorhinal cortex
The researchers believe this could be linked to changes in sex hormones, including the loss of oestrogen in women and testosterone in men.
These conclusions could help improve methods of diagnosis and treatment going forward, Nephew said.
More than 7.2m Americans are living with Alzheimer’s, according to the Alzheimer’s Association.
More research is being done to reveal other impacting factors.
Nephew said: “The critical challenge in this research is to build a generalisable machine-learning model that captures the difference between healthy brains and brains from people with mild cognitive impairment or Alzheimer’s disease.”
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