Researchers behind the Optima trial found that a genomic test called Prosigna can identify patients who are unlikely to benefit from chemotherapy after surgery. For many of these patients, hormone therapy alone produced similar outcomes.

The findings could help doctors personalize treatment decisions and reduce unnecessary exposure to chemotherapy and its side effects.

How the Study Was Conducted

The Optima trial enrolled 4,429 patients aged 40 and older with hormone receptor-positive breast cancer. This is the most common type of breast cancer worldwide.

Doctors typically recommend chemotherapy for patients in this group because they face a higher risk of recurrence. Researchers from institutions including University College London and the University of Glasgow used genomic testing to determine whether some patients could safely avoid the treatment.

The study focused on the Prosigna test, which examines the activity of 50 genes within a tumor. The test estimates the likelihood that cancer will return within 10 years and helps identify patients who may benefit most from chemotherapy.

Similar Outcomes Without Chemotherapy

Researchers reported that patients classified as lower risk achieved similar results whether they received chemotherapy or not.

Five years after treatment, 93.7% of patients who received hormone therapy without chemotherapy remained alive and free from breast cancer recurrence. Among those who underwent both chemotherapy and hormone therapy, the figure was 94.9%.

The researchers concluded that omitting chemotherapy did not significantly worsen outcomes for patients identified as lower risk through genomic testing.

Reducing Treatment Burden

Chemotherapy remains an important treatment for many breast cancer patients. However, it can cause significant side effects, including fatigue, nausea, hair loss, fertility complications and cognitive difficulties.

As a result, researchers have increasingly explored ways to identify patients who can safely avoid the treatment.

The Optima investigators estimated that more than two-thirds of patients in the study could potentially skip chemotherapy when doctors used genomic testing to guide treatment decisions.

The findings support the growing use of precision oncology, an approach that tailors treatment based on the biological characteristics of an individual’s tumor rather than relying solely on traditional risk factors.

Part of a Broader Shift in Breast Cancer Care

The results add to a growing body of evidence supporting genomic testing in breast cancer treatment.

Earlier studies involving genomic tools such as Oncotype DX also found that many patients with hormone receptor-positive, HER2-negative breast cancer can safely forgo chemotherapy when genetic testing indicates a low likelihood of benefit.

However, treatment recommendations still depend on several factors, including age, menopausal status, lymph node involvement and specific tumor characteristics.

Researchers stressed that the Prosigna test is not intended to replace chemotherapy altogether. Instead, it helps identify patients who are less likely to benefit from the treatment.

Potential Impact on Future Care

The Optima trial could influence future breast cancer treatment guidelines and help reduce unnecessary chemotherapy use.

Beyond improving patient quality of life, a more targeted treatment approach could lower healthcare costs by avoiding therapies that provide limited benefit.

Researchers said they will continue monitoring trial participants to assess long-term outcomes and confirm the durability of the findings.

The results highlight the increasing role of genomic medicine in cancer care and suggest that many patients may be able to receive effective treatment with fewer side effects.

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A promising new drug, tavapadon, has shown significant potential in treating Parkinson’s disease, offering relief from motor symptoms like tremors, stiffness, and coordination issues—without the common side effects associated with current treatments.

In clinical trials, tavapadon—a once-daily pill—has proven to be effective for patients already taking at least 400 mg of levodopa a day. It specifically benefits those experiencing “motor fluctuations,” a situation where levodopa’s effects wear off, causing symptoms to resurface. Researchers found that tavapadon provided more sustained “on time” (periods when symptoms are controlled) while reducing “off time” (when symptoms return), without the typical negative side effects that often accompany levodopa.

Levodopa has long been the standard treatment for Parkinson’s, but it can come with a range of side effects such as sleep disorders, hallucinations, and impulse control issues. Tavapadon works by mimicking dopamine in the brain and targeting different dopamine receptors (D1/D5), which offers the same symptom relief as levodopa but with fewer adverse effects.

Dr. Hubert H. Fernandez, the lead study author from the Cleveland Clinic, expressed optimism about tavapadon’s potential: “It provides patients with another option to alleviate motor fluctuations in the moderate to advanced stages of Parkinson’s. This is a promising step forward for both patients and doctors.”

The clinical trial, called TEMPO 3, was a multi-center, pivotal study that measured various side effects such as excessive daytime sleepiness, weight gain, and blood pressure changes. Remarkably, the side effects from tavapadon were no worse than those experienced by patients receiving a placebo.

Dr. Fernandez cautioned that while the results are promising, this study was short-term, and further long-term research is needed to fully confirm the drug’s benefits. Nonetheless, he remains hopeful, saying, “We’re very encouraged by these preliminary findings. Whether used at the beginning of treatment or alongside levodopa for more advanced cases, tavapadon represents a significant gain for Parkinson’s patients.”

For recently diagnosed patients with less severe symptoms, tavapadon may replace levodopa altogether, potentially reducing the need for frequent doses of the standard drug. This could minimize the risk of motor fluctuations and dyskinesia (involuntary movements), which are common side effects of levodopa use over time.

For more advanced Parkinson’s cases, tavapadon can be used in combination with levodopa, providing more consistent symptom relief without the typical side effects.

Parkinson’s disease is expected to become a global health crisis, with cases projected to increase to 25 million worldwide by 2050. The biggest surge is expected among people aged 80 and older, with the number of cases in that age group predicted to rise by 196%. This highlights the urgent need for improved treatments like tavapadon.

AbbVie, the pharmaceutical company behind tavapadon, is preparing to file for approval with the U.S. Food and Drug Administration (FDA). Once submitted, the FDA will review the application, which could lead to the drug being approved for widespread use. If approved, tavapadon could offer a new, more effective treatment option for people living with Parkinson’s disease, improving their quality of life and providing a much-needed alternative to existing therapies.

Dr. Mary Ann Picone, a medical director at Holy Name Medical Center, praised the trial results, calling the drug “very interesting and encouraging” for Parkinson’s patients. She highlighted that one of the major challenges of current Parkinson’s treatments is the wearing-off phenomenon, where the drug’s effects diminish over time, leading to “freezing” episodes and increased stiffness.

Tavapadon’s ability to target different dopamine receptors could extend the beneficial effects of treatment, offering patients more “on time” without the involuntary movements that often interfere with their ability to function. As Dr. Picone noted, this new therapy could be a game-changer in improving quality of life for those living with Parkinson’s.

As the long-term clinical trials continue, there’s growing hope that tavapadon will become a vital part of Parkinson’s treatment. With its potential to reduce motor symptoms and side effects, this new drug could offer a better, more sustainable treatment option for patients at every stage of the disease.

Stay tuned for further updates as the FDA review process moves forward, with the possibility of a new chapter in Parkinson’s disease treatment just around the corner.

Source: FOX News – New drug for Parkinson’s shown to be effective in clinical trials: ‘Very encouraged’

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China’s DeepSeek Sparks a Wave of Innovation Beyond Big Tech

China’s rise in innovation isn’t limited to technology—it’s quietly transforming the pharmaceutical industry as well. In a groundbreaking development, Akeso, a little-known Chinese biotech company, has delivered a lung cancer drug that outperformed the world’s best-selling medicine, Keytruda by Merck.

A Game-Changing Discovery

In September 2024, clinical trials conducted in China revealed that Akeso’s drug, Ivonescimab, delivered superior results compared to Keytruda, which has amassed over $130 billion in global sales.

Clinical Trial Results:

• Ivonescimab: Patients went 11.1 months before tumor progression.
• Keytruda: Patients saw progression in just 5.8 months.

The results, unveiled at the World Conference on Lung Cancer, marked a historic moment for Chinese biotech—but at the time, it went largely unnoticed outside the industry.

Stock Surge & Global Attention

That changed when DeepSeek, another Chinese firm, made headlines with its own medical breakthroughs, drawing global attention to China’s growing pharmaceutical power.

In early September, shares of Summit Therapeutics, Akeso’s U.S. partner, more than doubled, reaching record highs. The California-based company had secured the exclusive rights to commercialize Ivonescimab in North America and Europe, making it a major player in the global market.

“We believe the Chinese biotech industry will play an important role globally,” said Michelle Xia, CEO of Akeso, in an interview with BiotechTV.

Akeso also expressed its excitement in a statement to CNN, highlighting that its innovation comes from a deep understanding of disease biology and protein engineering, as well as China’s fast-paced development process and highly skilled talent pool.

China’s Biotech Boom: From Copycats to Innovators

For decades, China’s pharmaceutical industry focused on producing “me-too” drugs, essentially low-cost replicas of existing medications. That began to change over the last 10 years, with Chinese biotech firms now producing cutting-edge medications that compete with Western pharmaceutical giants.

Major Licensing Deals with Western Firms:

• AstraZeneca & CSPC Pharmaceutical Group – $1.92 billion deal for cardiovascular medication.
• Merck & Hansoh Pharmaceutical – $2 billion partnership for an experimental weight-loss drug.

Experts say the shift is undeniable.

“People knew China’s biotech industry was growing fast, but few saw it as a real threat to top U.S. innovators,” said Rebecca Liang, pharmaceuticals analyst at AB Bernstein. “Now, with next-generation drugs like Ivonescimab, that threat is getting real.”

China’s Rise as a Global Innovation Hub

According to HSBC Qianhai Securities, China has rapidly become an innovation hotspot for biotech:

Key Industry Growth Stats:

• Licensing deals: 46 in 2017 → 200+ in 2023
• Total deal value: $4 billion (2017) → $57 billion (2023)
• Large pharmaceutical transactions (above $50M) grew 30% in 2024 compared to 2023.

“Chinese biotech firms’ research capabilities and efficiency are catching up fast,” said Cui Cui, Managing Director of Healthcare Research at Jefferies. “Government support, foreign investment, and local talent are all fueling this growth.”

Doubts at Home: Can Chinese Drugs Win Over Local Patients?

While Akeso’s drug is making waves globally, many Chinese citizens remain skeptical about domestic pharmaceuticals.

Concerns over generic drug quality recently sparked a public outcry, leading to an official investigation into China’s pharmaceutical industry. The country’s health regulator later defended the safety of domestic medications, but doubts persist.

Public Opinion in China:

• Gu Zhihao, a Beijing resident: “To be honest, I prefer the more expensive imported medicine. After all, you get what you pay for.”
• US Investors & FDA Concerns: The FDA has previously rejected drugs developed in China, citing trial methodology concerns.

What’s Next for Akeso & Ivonescimab?

While China’s drug regulator has approved Ivonescimab for some lung cancer patients, it will take years before it reaches the U.S. market.

Upcoming Global Trial (2025): A new international clinical trial is planned, which could validate Ivonescimab’s efficacy on a global scale. If successful, it would cement China’s role as a biotech leader and challenge Western dominance in cancer treatment.

Conclusion: A New Era in Global Pharma

China’s biotech industry is no longer just catching up—it’s now a serious contender in global drug development. If companies like Akeso and DeepSeek continue delivering breakthrough treatments at lower costs, the entire pharmaceutical landscape could shift dramatically.

Is the world ready for Chinese-made, best-in-class medicines? The success of Ivonescimab may be the first major test.

Source

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Millions of teenagers in Africa are suffering from asthma with no formal diagnosis as the continent undergoes rapid urbanisation, researchers have found.

The study, published in the Lancet Child and Adolescent Health, involved 27,000 pupils from urban areas in Malawi, South Africa, Zimbabwe, Uganda, Ghana and Nigeria. It found more than 3,000 reported asthma symptoms, but only about 600 had a formal diagnosis.

Many of the children reported missing school or having their sleep disrupted by wheezing.

“If our data are generalisable, there are millions of adolescents with undiagnosed asthma symptoms in sub-Saharan Africa,” said Dr Gioia Mosler of Queen Mary University of London, the study’s research manager.

The team that led the study, whose research on the impact of pollution on lung health was instrumental in introducing the ultra low-emission zone (Ulez) in London, said there was an urgent need for medicines and diagnostic tests in the region.

Rates of asthma have increased in sub-Saharan Africa over the past few decades, a trend attributed to rapid urbanisation which exposes children to more risk factors such as air pollution. The climate crisis was also likely to have an impact, experts said.

The Achieving Control of Asthma in Children and Adolescents in Africa (Acacia) study recruited pupils aged between 12 and 14. Screening revealed that while 12% reported asthma symptoms, only 20% of that group had received a formal diagnosis of asthma.

Lung function tests suggested nearly half of undiagnosed participants with severe symptoms were “very likely” to have asthma.

Even among those who had received a formal diagnosis, about a third were not using any medicine to control their condition, according to the study.

Dr Rebecca Nantanda of Makerere University in Kampala, who led the research in Uganda, said: “Undiagnosed and poorly controlled asthma greatly impacts on the physical and psychosocial wellbeing of the affected children and their caregivers. The high burden of severe undiagnosed asthma revealed by the Acacia study requires urgent attention, including access to medicines and diagnostics.”

Prof Jonathan Grigg of Queen Mary University of London, said asthma was made worse by exposure to small particles of pollutants, with the impact of the climate crisis yet to become clear. “In some areas in sub-Saharan Africa, climate change is likely to result in increased exposure of these vulnerable children to dust and natural fires.

“On the other hand, climate change mitigation will, hopefully, reduce exposure to fossil fuel-derived particles in this region.

“The pharmaceutical industry has been hesitant to support asthma research and initiatives. For example, companies may feel that they cannot support research in countries where they do not intend to market their asthma product,” he said.

“Innovations such as handheld wheeze detectors and asthma clinics delivered at schools also have the potential to substantially reduce the burden of asthma.”

Source

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