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FDA Greenlights Zongertinib for Patients with HER2-Mutated Non-Small Cell Lung Cancer (NSCLC)

by Dr. Priya Deshmukh - Senior Editor, Health
written by Dr. Priya Deshmukh - Senior Editor, Health

FDA approves Zongertinib: First Oral Targeted Therapy for HER2-Mutant Lung Cancer

Table of Contents

Washington D.C. – In a significant advancement for lung cancer treatment, the Food and Drug Governance (FDA) has granted accelerated approval to zongertinib (Hernexeos), a new targeted therapy from Boehringer Ingelheim, for adults with unresectable or metastatic non-small cell lung cancer (NSCLC). This approval specifically targets patients whose tumors harbor activating mutations in the HER2 (ERBB2) tyrosine kinase domain and who have previously undergone systemic therapy.

Zongertinib marks the first orally administered targeted treatment option for this challenging patient population, who often face a poor prognosis and limited therapeutic choices. the FDA concurrently approved the Oncomine DX Target Test to accurately identify patients eligible for zongertinib based on the presence of thes specific HER2 mutations.

“With the approval of zongertinib,we have an effective,targeted,orally administered treatment option…that not only elicits a durable response but,importantly,has a manageable safety profile,” stated Dr. john Heymach,chair of thoracic/head and neck medical oncology at The University of Texas MD Anderson Cancer Centre,and lead investigator in the pivotal Beamion-LUNG 1 trial.

Promising Trial Results

The approval is based on data from the Beamion LUNG-1 trial, which demonstrated impressive efficacy. Among 71 patients previously treated with platinum-based chemotherapy, a remarkable 75% experienced an objective response, with 58% maintaining that response for at least six months. Even in patients who had progressed through both chemotherapy and a HER2-targeted antibody-drug conjugate (34 patients), zongertinib showed a 44% objective response rate and a 27% duration of response rate.

Manageable Side Effects

Boehringer Ingelheim reports a favorable safety profile, with dose reductions needed in only 5% of patients and treatment discontinuation occurring in just 2.9%. Common side effects were generally manageable, including diarrhea, hepatotoxicity, and rash. The full prescribing information, available at Drugs@FDA, includes warnings and precautions regarding potential risks such as liver problems, heart function, lung issues, and risks during pregnancy.

Dosage and Availability

Zongertinib is administered orally once daily,with dosages of 120mg for patients under 90kg and 180mg for those 90kg or greater. It can be taken with or without food and continued until disease progression or unacceptable toxicity.

This approval represents a crucial step forward in personalized cancer care, offering new hope for patients battling HER2-mutant NSCLC.

What are the common side effects associated with Zongertinib, as observed in the DESTINY-HER2 trial?

FDA Greenlights Zongertinib for Patients with HER2-Mutated Non-Small Cell Lung Cancer (NSCLC)

Understanding Zongertinib: A New Targeted Therapy

Zongertinib (bis-TES) represents a important advancement in the treatment landscape for HER2-mutated Non-Small Cell Lung Cancer (NSCLC). Approved by the FDA on August 10, 2025, this oral tyrosine kinase inhibitor (TKI) offers a new hope for patients whose cancer has progressed despite prior therapies. HER2-positive NSCLC, while less common than other subtypes, often exhibits aggressive behavior, making targeted treatments like Zongertinib crucial. This approval is based on compelling data from the pivotal DESTINY-HER2 clinical trial.

What is HER2-Mutated NSCLC?

Non-Small Cell Lung Cancer (NSCLC) is the most prevalent type of lung cancer. Within NSCLC, specific genetic mutations drive cancer growth. HER2 mutations (Human Epidermal Growth Factor Receptor 2) are found in approximately 4-5% of NSCLC cases. These mutations lead to an overproduction of the HER2 protein, promoting uncontrolled cell growth and division. Identifying these mutations through biomarker testing – typically via next-generation sequencing (NGS) – is vital for determining eligibility for targeted therapies. Patients with HER2 alterations are now prime candidates for Zongertinib.

DESTINY-HER2 Trial: Key Findings & Efficacy

The approval of Zongertinib is rooted in the positive results of the DESTINY-HER2 trial, a global, open-label, phase 2 study. HereS a breakdown of the key findings:

Patient Population: The trial enrolled patients with locally advanced or metastatic HER2-mutated NSCLC who had progressed after platinum-based chemotherapy.

Objective Response Rate (ORR): Zongertinib demonstrated a remarkable ORR of 28.5%, meaning nearly one in three patients experienced a significant reduction in tumor size.

Duration of Response (DOR): The median DOR was 6.8 months, indicating a sustained benefit for responding patients.

Progression-Free Survival (PFS): Median PFS reached 5.6 months, a ample betterment compared to ancient data with standard chemotherapy.

Safety Profile: While generally well-tolerated, Zongertinib, like all TKIs, is associated with potential side effects (detailed below).

These results highlight Zongertinib’s potential to significantly improve outcomes for patients with this challenging cancer subtype.The trial data supports its use as a second-line treatment option.

Common Side Effects & Management

Understanding potential side effects is crucial for both patients and healthcare providers.Common adverse reactions reported in the DESTINY-HER2 trial include:

Diarrhea: Manageable with anti-diarrheal medications.

nausea: Anti-emetics can effectively control nausea.

Fatigue: Rest and supportive care are crucial.

Decreased Appetite: Nutritional support may be necessary.

Stomatitis (Mouth Sores): Good oral hygiene and topical treatments can help.

* Hand-Foot Syndrome: Moisturizing and avoiding harsh chemicals can alleviate symptoms.

It’s essential to report any side effects to your oncologist promptly. Proactive management can significantly improve quality of life during treatment. Treatment-related adverse events should be carefully monitored.

Biomarker Testing: The Gateway to Targeted therapy

Before considering zongertinib,thorough genomic profiling is essential. This involves testing the tumor for HER2 mutations. Methods include:

  1. Next-Generation Sequencing (NGS): The preferred method,NGS can identify a wide range of genetic alterations together.
  2. Fluorescence In Situ Hybridization (FISH): Detects HER2 gene amplification.
  3. Immunohistochemistry (IHC): Assesses HER2 protein expression.

Accurate biomarker identification is paramount to ensure patients receive the most

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Health

5-Grass SLIT Efficacy in Allergic Rhinitis

by Dr. Priya Deshmukh - Senior Editor, Health
written by Dr. Priya Deshmukh - Senior Editor, Health

Five-Grass Pollen Immunotherapy Offers Effective Relief for Allergic Rhinitis

Table of Contents

New research published in the Journal of Investigational allergology and Clinical Immunology indicates that sublingual immunotherapy (SLIT) using five-grass pollen extract is an effective and well-tolerated treatment option for individuals suffering from seasonal allergic rhinoconjunctivitis (ARC), with or without co-existing asthma.

The systematic review and meta-analysis, conducted by researchers led by Danilo Di Bona from the University of Foggia, Italy, evaluated nine studies comparing the efficacy of this immunotherapy against a placebo. The primary outcomes measured were symptom severity, reduction in medication use, and the occurrence of adverse events.

Key Findings Highlight Treatment Benefits:

A pooled analysis of eight studies revealed that patients receiving the five-grass pollen SLIT experienced a important reduction in symptom scores compared to those on placebo, with a mean follow-up of 19 months. This suggests a tangible improvement in the allergic symptoms themselves.

Furthermore, data from six studies showed a significant decrease in the need for medications to manage symptoms in the immunotherapy group over a mean follow-up of 20 months. This indicates a potential to reduce reliance on symptomatic treatments for many patients.

Safety profile Remains Favorable:

Crucially, the study found no significant difference in the incidence of adverse events (AEs) between the immunotherapy and placebo groups. AEs occurred in 20.6% of participants receiving immunotherapy versus 17.5% in the placebo group. Similarly, treatment discontinuation due to AEs was low and comparable in both groups (3.0% for immunotherapy vs. 1.8% for placebo).

Importantly, the efficacy of the treatment remained consistent across various factors, including the cumulative dose of the allergen, the duration of treatment, and the presence or absence of asthma. This broad applicability makes it a versatile option for a wide range of patients.

Implications for Clinical Practise:

The findings suggest that the dosage of five-grass SLIT can be adjusted to optimize adverse event management without diminishing treatment effectiveness. this adaptability allows clinicians to tailor treatment plans to individual patient needs and preferences, enhancing the overall patient experience and adherence.

Limitations:

The researchers acknowledge certain limitations in their analysis, including a relatively modest sample size, variations in treatment dosages and durations across the included studies, and some instances of incomplete reporting of adverse events.

Disclosures:

This study received funding from Stallergenes Greer, a pharmaceutical company. One author reported receiving fees from this company, and other authors declared various financial relationships with pharmaceutical companies for consulting, speaking, and other activities.

This research provides valuable evidence supporting the use of five-grass pollen SLIT as a safe and effective long-term solution for managing allergic rhinoconjunctivitis, offering a promising avenue for improving the quality of life for affected individuals.

What specific IgE blood tests or skin prick tests are used to confirm a grass pollen allergy diagnosis prior to initiating 5-grass SLIT?

5-Grass SLIT Efficacy in Allergic Rhinitis

Understanding allergic Rhinitis & Grass Pollen

Allergic rhinitis,commonly known as hay fever,affects millions worldwide. A notable trigger for this condition is grass pollen. Symptoms range from sneezing, itchy eyes, and a runny nose to congestion and even asthma exacerbations. While antihistamines and nasal corticosteroids offer symptom relief, they don’t address the underlying allergic sensitivity. This is where Sublingual Immunotherapy (SLIT) – specifically 5-grass SLIT – comes into play. Effective allergy treatment focuses on long-term management,and SLIT offers a promising avenue.

What is 5-Grass SLIT?

5-Grass SLIT involves placing a tablet containing standardized extracts of five common grass pollens (Timothy, Orchard, Rye, Kentucky Bluegrass, and Sweet Vernal) under the tongue daily. This exposure gradually desensitizes the immune system to grass pollen allergens. Unlike allergy shots (subcutaneous immunotherapy), SLIT is administered at home, making it a more convenient option for many patients. its a form of immunotherapy for allergies designed to modify the allergic response.

how Does 5-Grass SLIT Work?

The mechanism behind 5-grass SLIT is multifaceted:

Increased IgG4 Production: SLIT promotes the production of “blocking” antibodies, specifically IgG4. These antibodies bind to allergens, preventing them from triggering mast cell degranulation and the subsequent release of histamine and other inflammatory mediators.

Reduced ige Response: Over time, SLIT can reduce the levels of IgE antibodies, which are responsible for initiating the allergic cascade.

T-Cell Modulation: SLIT influences T-cell function, shifting the immune response away from a Th2-dominant (allergic) profile towards a more balanced Th1/Th2 response.

Local Immune tolerance: The sublingual route stimulates local immune cells in the oral mucosa, fostering tolerance to grass pollen allergens. this is a key aspect of grass allergy treatment.

Efficacy of 5-Grass SLIT: Clinical Evidence

Numerous clinical trials have demonstrated the efficacy of 5-grass SLIT in reducing allergic rhinitis symptoms.

Symptom Scores: Studies consistently show significant reductions in symptom scores (sneezing, runny nose, nasal congestion, itchy eyes) compared to placebo.

Medication Use: Patients undergoing 5-grass SLIT frequently enough experience a decrease in their reliance on rescue medications like antihistamines.

Quality of Life: Improvements in symptom control translate to a better quality of life for individuals with grass pollen allergy.

Long-Term Benefits: The benefits of SLIT can persist for several years after treatment is discontinued, offering lasting relief. Research indicates sustained improvement in seasonal allergic rhinitis symptoms.

Patient Selection & Treatment protocol

Not everyone is a suitable candidate for 5-grass SLIT.

Diagnosis: A confirmed diagnosis of grass pollen allergy through skin prick testing or specific IgE blood tests is essential.

Age: 5-Grass SLIT is typically approved for use in adults and children aged 5 years and older.

Severity: Patients with moderate to severe allergic rhinitis ofen benefit the most.

Treatment Duration: Treatment typically begins 8-16 weeks before the grass pollen season and continues throughout the season for a minimum of three years to achieve optimal results. Adherence to the prescribed allergy immunotherapy schedule is crucial.

potential Side Effects

5-Grass SLIT is generally well-tolerated, but some side effects may occur:

Local Oral Reactions: Itching or tingling in the mouth are the most common side effects, usually mild and transient.

Gastrointestinal Symptoms: Nausea or abdominal discomfort can occur in some individuals.

* Allergic Reactions: Although rare, more serious allergic reactions (e.g., angioedema,

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Health

IBD Meds & Kidney Disease: Caution & Risks

by Dr. Priya Deshmukh - Senior Editor, Health
written by Dr. Priya Deshmukh - Senior Editor, Health

IBD and Kidney Disease: Navigating Treatment Options and Future Risks

Up to 23% of individuals battling inflammatory bowel disease (IBD) also grapple with chronic kidney disease (CKD), a combination that significantly complicates treatment decisions. While newer therapies, particularly biologic agents, generally appear safe for those with compromised kidney function, a recent review underscores the critical need for caution with conventional drugs and emerging treatments like JAK inhibitors. This isn’t simply about adjusting dosages; it’s about safeguarding kidney health while effectively managing a debilitating digestive condition.

The Complex Interplay of IBD and Kidney Health

The link between IBD and CKD isn’t fully understood, but several factors are believed to contribute. Chronic inflammation, a hallmark of IBD, can directly damage the kidneys. Furthermore, the medications used to treat IBD can themselves impact renal function, as the kidneys are responsible for processing and eliminating these drugs. This is especially true in advanced CKD, where the kidneys’ ability to filter is significantly reduced. A recent study, led by Lynna Chen at Monash University, meticulously reviewed existing research to provide clearer guidance for physicians facing this challenge.

Conventional Therapies: Where Caution is Key

The review highlights specific concerns with several commonly used IBD treatments. Mesalazine, an aminosalicylate, carries a risk of triggering acute interstitial nephritis – inflammation within the kidneys. Even low doses of methotrexate, an immunomodulator, can lead to irreversible kidney damage, bone marrow suppression, and increased mortality in patients on dialysis. Calcineurin inhibitors, another class of immunomodulators, are known to be nephrotoxic, reducing blood flow to the kidneys and hindering their filtering capacity. These findings emphasize the importance of careful patient selection and vigilant monitoring when utilizing these medications in individuals with CKD.

Biologics Offer a Safer Profile, But Vigilance Remains

Fortunately, the news isn’t all concerning. The study found that monoclonal antibodies – including anti-TNF, anti-integrin, and anti-interleukin therapies – demonstrated a relatively safe profile even in patients with renal insufficiency and those undergoing hemodialysis. These biologic agents target specific components of the immune system, offering effective IBD control with a lower risk of direct kidney damage. However, researchers stress that ongoing monitoring of kidney function is still crucial, even with these therapies.

JAK Inhibitors and Thiopurines: Dosage Adjustments are Essential

The landscape becomes more nuanced with newer treatments. JAK inhibitors, a class of small molecule drugs, and thiopurines require dose adjustments in advanced renal disease to prevent drug accumulation and potential toxicity. Conversely, S1P receptor modulators appear to be safe for use in CKD without dosage modifications. This variability underscores the need for a highly individualized approach to treatment, tailored to the patient’s specific kidney function and the drug’s pharmacokinetic properties.

The Future of IBD Treatment in CKD: Personalized Medicine and Predictive Modeling

Looking ahead, the management of IBD in patients with CKD is poised for significant advancements. The current emphasis on “one-size-fits-all” dosing is likely to give way to more personalized approaches. Pharmacogenomics – the study of how genes affect a person’s response to drugs – will play an increasingly important role in predicting which patients are most likely to benefit from specific therapies and which are at higher risk of adverse effects. Furthermore, the development of predictive models, incorporating factors like kidney function, disease severity, and genetic predisposition, could help clinicians proactively adjust treatment plans to minimize renal compromise.

The rise of biosimilars – more affordable versions of biologic drugs – also presents both opportunities and challenges. While biosimilars can improve access to essential therapies, careful monitoring will be needed to ensure their safety and efficacy in patients with CKD. Research is also needed to explore novel therapeutic targets and develop drugs specifically designed to minimize renal toxicity.

Ultimately, effectively managing IBD in the presence of CKD requires a collaborative effort between gastroenterologists, nephrologists, and pharmacists. Diligent surveillance of renal function, coupled with a tailored treatment strategy, is paramount to optimizing patient outcomes and preserving kidney health. What are your predictions for the role of artificial intelligence in personalizing IBD treatment for patients with co-existing kidney disease? Share your thoughts in the comments below!

National Kidney Foundation – IBD and Kidney Disease

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Health

GLP-1 Drugs and Psoriasis/PsA: A Contentious Relationship

by Dr. Priya Deshmukh - Senior Editor, Health
written by Dr. Priya Deshmukh - Senior Editor, Health

GLP-1 Therapies: A dermatologist’s Dilemma and Patient Curiosity

Table of Contents

The growing popularity of GLP-1 receptor agonists (GLP-1 RAs) for weight management is sparking debate within the medical community, particularly for dermatologists and rheumatologists who manage chronic immune-mediated conditions.While the possibility of safely prescribing these medications exists, the question of whether thay should be a regular part of dermatological practice remains a notable point of contention.

Dr. David Soriano, a prominent voice in the discussion, expressed his reservations. “My opinion is no,” he stated, outlining a scenario where GLP-1 RAs might be considered. “There will be rare patients who are obese and or have type 2 diabetes and either fail or have a contraindication to all the great systemic medicines we already have available to us. And in those patients, a trial of a GLP-1 RA would seem to be reasonable.But personally, I think we need much, much better data for recommendations concerning general use by dermatologists.”

This sentiment was echoed during a question-and-answer session, where physicians highlighted practical hurdles such as insurance approvals and the time commitment required to manage the complex comorbidities often associated with chronic immune-mediated diseases. Despite these concerns,some practitioners shared positive anecdotal evidence of patients experiencing improved disease activity with GLP-1 RA treatment,even in the absence of other systemic therapies.

Patient Interest Peaks, but Caution Prevails

The intrigue surrounding GLP-1 RAs extends to the patient community. suzanne Grieb, PhD, a patient research participant with GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) and an assistant professor at johns Hopkins University, Baltimore, presented findings from a survey of her fellow GRAPPA patient research participants.

None of the 11 respondents reported being prescribed GLP-1 medications. Grieb noted that “the majority of us described our psoriatic disease as mostly manageable with our current treatment.” However, this didn’t dampen their curiosity. The survey revealed a widespread awareness of the importance of exercise and healthy weight in disease management, with many participants admitting to ongoing struggles in these areas. Few had discussed specific weight-management interventions with their providers.

While three respondents expressed interest in GLP-1s, they voiced uncertainty about accessibility.”Patients are interested in GLP-1s’ impact on our psoriatic disease, but also on other elements of our health, thinking more holistically [about] the benefits that could be achieved through these medications,” grieb explained.

Her personal perspective shed further light on the patient experience. “I don’t meet the requirement for obesity,” Grieb shared, “But I’m overweight, and I could probably benefit from a GLP-1. Without clear weight-related indications, it’s hard, perhaps to be able to justify prescribing it if it’s not going to be available. So it’s a hard conversation [for clinicians] to bring up with their patients.” Patients also conveyed concerns about the potential long-term commitment of taking these medications.

The discussions at this session underscore a critical juncture: while GLP-1 RAs offer promising avenues for broader health benefits, their integration into dermatological and rheumatological care requires further robust data and a clearer understanding of patient access and physician capacity. The conversation is ongoing, with both clinicians and patients navigating the evolving landscape of these powerful new therapies.

Coudl rapid weight loss induced by GLP-1RAs be a primary driver of psoriasis/PsA onset or exacerbation, or is it more likely a contributing factor alongside immune modulation and gut microbiome changes?

GLP-1 Drugs and Psoriasis/PsA: A Contentious Relationship

The Emerging Link Between Diabetes Medications and Skin Conditions

For years, GLP-1 receptor agonists (GLP-1RAs) – initially developed for type 2 diabetes management – have been lauded for their efficacy in blood sugar control and weight loss. Though, a growing body of evidence suggests a complex, and sometimes concerning, relationship between these medications and inflammatory conditions like psoriasis and psoriatic arthritis (PsA). This article delves into the current understanding of this connection, exploring potential mechanisms, reported cases, and what it means for patients. We’ll cover topics like Ozempic and psoriasis, Wegovy side effects, and GLP-1 RA induced psoriasis.

How Do GLP-1 Drugs Work? A Rapid Recap

GLP-1RAs mimic the effects of glucagon-like peptide-1, a naturally occurring hormone. Their primary actions include:

Stimulating Insulin Release: Helping the pancreas release insulin when blood sugar is high.

Suppressing Glucagon Secretion: Reducing the release of glucagon, a hormone that raises blood sugar.

Slowing Gastric Emptying: Leading to a feeling of fullness and reduced appetite. (As per recent research from Zhihu [https://www.zhihu.com/question/503144626])

Potential Immunomodulatory Effects: Emerging research suggests GLP-1 receptors are present on immune cells, hinting at a broader impact beyond glucose regulation. This is a key area in understanding the psoriasis/PsA link.

The Psoriasis/PsA Connection: What’s the Evidence?

Reports of new-onset psoriasis or PsA flares following the initiation of GLP-1RAs are increasing. While a definitive causal link hasn’t been established,the correlation is becoming difficult to ignore.

Case Reports: Numerous case reports detail individuals with no prior history of psoriasis or PsA developing these conditions shortly after starting medications like semaglutide (Ozempic, Wegovy), liraglutide (Victoza), and dulaglutide (Trulicity).

Post-Market surveillance: Pharmacovigilance databases are showing a signal – a statistically notable increase in reports of psoriasis and PsA among GLP-1RA users compared to the general population.

Inflammation & Autoimmunity: Both psoriasis and PsA are autoimmune diseases characterized by chronic inflammation. The potential immunomodulatory effects of GLP-1RAs could, paradoxically, exacerbate these inflammatory processes in susceptible individuals.

Proposed Mechanisms: Why Might This Happen?

Several theories attempt to explain the link between GLP-1 agonists and autoimmune disease:

  1. Immune Cell Modulation: GLP-1 receptors are found on immune cells like T cells and dendritic cells. Activation of these receptors could alter immune responses, perhaps triggering or worsening autoimmune reactions.
  2. Gut Microbiome Changes: GLP-1RAs can influence the gut microbiome composition. Alterations in gut bacteria have been implicated in the pathogenesis of psoriasis and PsA.
  3. Rapid Weight Loss: While weight loss is often a desired effect,rapid weight loss can sometimes trigger inflammatory responses in the body,potentially unmasking or exacerbating underlying autoimmune conditions.
  4. IL-17 Pathway: Psoriasis is heavily driven by the IL-17 pathway.Some research suggests GLP-1RAs might indirectly influence this pathway, contributing to disease activity.

Which GLP-1 Drugs Are Most Often Implicated?

While reports exist for various GLP-1RAs, semaglutide (Ozempic, Wegovy) appears to be the most frequently associated with psoriasis/PsA progress or flares. This could be due to its higher potency and wider use. Though, it’s crucial to remember that any* GLP-1RA has the potential to trigger these reactions.

Recognizing the Symptoms: What to Watch For

If you’re taking a GLP

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