Dr. Robert Metcalf from The Christie NHS Foundation Trust stated that the high response rate from this novel immunotherapy combination surpasses other non-chemotherapy treatments and matches chemotherapy-based response rates without the toxicities. This is significant for head and neck squamous cell carcinoma patients with a CPS of less than one, where chemotherapy is currently the first-line treatment. Achieving complete responses in this group suggests strong future potential for the immunotherapy combination, warranting further investigation of eftilagimod plus pembrolizumab.
The durability of responses is tracking well, as seen in other clinical trials when efti is combined with KEYTRUDA. Over 50% of patients in Cohort B received treatment for at least six months, with three additional patients nearing this threshold at the time of data cut-off (11 March 2024). The combination continues to have a favorable safety profile with no new safety signals observed. This new data adds to the body of evidence that efti’s novel activation of antigen-presenting cells enhances the potential of immune checkpoint inhibitors like KEYTRUDA. As the only MHC Class II agonist in clinical development today, efti is generating a broad anti-cancer immune response uniquely and safely across all levels of PD-L1 expression, especially in patients with negative expression (CPS <1).
Based on the encouraging efficacy and high unmet medical need, Immutep will discuss the path forward with regulatory agencies. Efti has received FDA Fast Track designation in 1L HNSCC regardless of PD-L1 expression. The prevalence for CPS <1, CPS 1-19, and CPS >20 PD-L1 expression levels are approximately 20%, 30%, and 50% of the HNSCC patient population, respectively.
Pfizer Makes Strides in Developing Once-Daily Oral GLP-1 Agonist Danuglipron
Pfizer Inc. has announced the selection of its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, based on results from the ongoing pharmacokinetic study (NCT06153758). The company plans to conduct dose optimization studies in the latter half of 2024, evaluating multiple doses of this formulation to guide registration-enabling studies.
“Obesity is a key therapeutic area for Pfizer, and we have a robust pipeline with three clinical and several pre-clinical candidates. Our most advanced candidate, danuglipron, has shown good efficacy in a twice-daily formulation, and we believe a once-daily formulation could be highly competitive in the oral GLP-1 space,” said Mikael Dolsten, MD., PhD., Chief Scientific Officer & President, Pfizer Research and Development. “Following a thorough analysis of our previous Phase IIb data and trial design, we are confident that with the preferred modified release formulation and optimized future trial design, we can advance a competitive oral GLP-1 molecule into registration-enabling studies to meet the ongoing medical needs of people living with obesity.”
The ongoing open-label, randomized study is assessing the pharmacokinetics and safety of immediate- and modified-release formulations of danuglipron administered orally in healthy adults aged 18 years or older. Results so far have shown a pharmacokinetic profile supportive of once-daily dosing, with a safety profile consistent with previous danuglipron studies, including no liver enzyme elevations in over 1,400 study participants.
FDA Issues Complete Response Letter to Novo Nordisk for Once-Weekly Basal Insulin Icodec
Novo Nordisk has recently achieved a leading position in Europe’s market cap rankings through a sustained period of success. However, the FDA has put a brake on the Danish company’s momentum by rejecting its application for once-weekly insulin icodec, intended for patients with both Type 1 and Type 2 diabetes.
Recently, Novo Nordisk announced that the FDA has issued a Complete Response Letter regarding the Biologics License Application for once-weekly basal insulin icodec intended for diabetes mellitus treatment.
In the CRL, the FDA has specified requests concerning the manufacturing process and the inclusion of type 1 diabetes as an indication, which need to be addressed before the application review can be finalized. Novo Nordisk is currently evaluating the CRL’s contents and plans to collaborate closely with the FDA to meet these requests. The company anticipates that these requirements will not be fulfilled within 2024.
Martin Lange, Executive Vice President for Development at Novo Nordisk, stated, “We remain committed to the potential of once-weekly basal insulin icodec for individuals managing diabetes who require basal insulin therapy. We will work closely with the FDA to determine the necessary next steps to complete the review process, aiming to offer this innovative treatment option to adults with diabetes.”
Novo Nordisk submitted the insulin icodec application to the FDA in April 2023. In May 2024, an FDA Advisory Committee meeting discussed the benefit-risk profile of once-weekly basal insulin icodec specifically for type 1 diabetes. The panel of independent experts concluded that the available data were insufficient to support a positive benefit-risk assessment for type 1 diabetes. The Advisory Committee did not review the use of once-weekly insulin icodec for type 2 diabetes.
Insulin icodec is currently marketed as Awiqli® in the EU, Canada, Australia, Japan, and Switzerland to treat both type 1 and type 2 diabetes and in China to treat type 2 diabetes.
Arcutis’ ZORYVE® Cream 0.15% Gains FDA Approval for Atopic Dermatitis Treatment in Adults and Children Aged 6 and Up
Arcutis Biotherapeutics, Inc. has announced that the FDA has approved the supplemental new drug application (sNDA) for ZORYVE (roflumilast) cream, 0.15%, to treat mild to moderate atopic dermatitis in adults and children aged 6 years and older. ZORYVE is a steroid-free cream applied once daily, designed to quickly clear the disease and significantly reduce itch, offering a long-term treatment option.
The label expansion for atopic dermatitis was originally scheduled for June 7, 2024, but Arcutis announced on June 9 that the regulator had not requested additional information, causing a delay in the decision.
The approval is backed by positive findings from three Phase III trials, a Phase II dose-ranging study, and two Phase I pharmacokinetic studies. Arcutis disclosed aggregated results from the Phase III INTEGUMENT-1 and INTEGUMENT-2 trials in January 2024, revealing that 91.5% of atopic dermatitis patients treated with the drug showed measurable improvement in the Eczema Area and Severity Index (EASI) score after four weeks.
Lawrence F. Eichenfield, MD, a professor of dermatology and pediatrics at UC San Diego School of Medicine, emphasized the chronic nature of atopic dermatitis (AD) and the relief ZORYVE provides in controlling disease and itch, which is often the most troubling symptom. Clinical trials showed that 9 out of 10 patients experienced improvement within 4 weeks, with 69% achieving at least a clinically significant reduction in symptoms. This steroid-free option is seen as a positive advancement in dermatology, offering effectiveness without some of the risks associated with traditional steroids.
Atopic dermatitis affects millions in the US, with itching being the most burdensome symptom due to skin barrier issues and neuroimmune factors. In 7MM, the US accounted for ~33,000 atopic dermatitis prevalent cases, as per DelveInsight.
ZORYVE cream, a next-generation topical phosphodiesterase 4 (PDE4) inhibitor, demonstrated rapid and sustained itch reduction from the first application, targeting itch-signaling nerves and inflammatory pathways.
Frank Watanabe, president and CEO of Arcutis, expressed pride in ZORYVE’s approval as a steroid-free solution for AD, marking the third FDA approval for Arcutis in two years. The company aims to make ZORYVE cream 0.15% widely available by the end of July through various distribution channels, ensuring accessibility and affordability through patient support programs.
Arcutis plans to launch ZORYVE cream 0.15% as a new treatment option through major wholesalers and dermatology pharmacies by the end of July, ensuring consistent access for its product portfolio with a streamlined copay and fulfillment process. The ZORYVE® Direct Program supports patients in obtaining their prescribed medication, guiding them through insurance procedures, promoting adherence, and offering the ZORYVE Direct Savings Card Program to reduce out-of-pocket expenses for eligible commercially insured patients. Additionally, Arcutis will continue to provide the Arcutis CaresTM patient assistance program, supplying ZORYVE at no cost to financially eligible uninsured or underinsured patients.
NICE Recommends Ebglyss For Managing Moderate To Severe Atopic Dermatitis in NHS England’s Eligible Adolescent and Adult Population
Almirall S.A. has announced that the National Institute for Health and Care Excellence (NICE) is recommending the use of Ebglyss (lebrikizumab) within NHS England for patients with moderate to severe Atopic Dermatitis.
Lebrikizumab is approved for treating moderate-to-severe Atopic Dermatitis in adults and adolescents aged 12 years and older, weighing at least 40 kg, who require systemic therapy. It received approval from the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in December 2023.
In the United Kingdom, approximately 5.2 million adults (7.7%, aged 18-74) and 2.5 million children (18%, aged 0-17) are affected by moderate or severe atopic dermatitis, also known as atopic eczema. The NICE recommendation is expected to benefit many patients who struggle significantly daily with this condition.
Andrew Proctor, Chief Executive of the National Eczema Society, highlighted, “Atopic eczema can profoundly impact patients and their families, influencing everyday decisions from clothing choices to participation in activities due to its physical symptoms of itching, soreness, and skin irritation. The Society welcomes NICE’s endorsement of lebrikizumab as an additional treatment option for eligible individuals with moderate to severe atopic eczema, emphasizing the importance of providing diverse treatment choices to match patients’ needs.”
Jorgen Damsbo, General Manager at Almirall, UK, remarked, “The NICE recommendation for lebrikizumab reflects its proven effectiveness with 4-weekly maintenance dosing and a favorable safety profile, aligning with our commitment to improving patients’ lives by helping them achieve better health.”
Professor Tony Bewley, Consultant Dermatologist at Barts Health NHS Trust and Honorary Professor of Dermatology at QMUL, emphasized the significant psychosocial burden of atopic dermatitis, noting that lebrikizumab’s approval marks a crucial advancement that is welcomed by both patients and clinicians.
Professor Richard Weller, Professor of Medical Dermatology at the University of Edinburgh and Honorary Consultant Dermatologist, added, “Atopic dermatitis, a lifelong condition without a cure, greatly benefits from the expanding range of biologic treatments like lebrikizumab, now reimbursed by NICE, thereby enhancing treatment options for patients.”
NICE’s endorsement of lebrikizumab represents a pivotal development in the treatment landscape for moderate to severe Atopic Dermatitis, offering hope for improved quality of life for many affected individuals.
