80 Clinical R&D CRCBIOSCREEN ANNOUNCES PUBLICATION OF CLINICAL VALIDATION DATA OF A MULTITARGET FECAL IMMUNOCHEMICAL TEST FOR COLORECTAL CANCER SCREENING CRCbioscreen, a Dutch diagnostics company, dedicated to developing a next generation stool test for population based ColoRectal Cancer or CRC screening, has announced the publication of promising results of a diagnostic accuracy study with a multitarget immunochemical test (mtFIT) for early detection of CRC. Data were published in the prestigious journal Annals of Internal Medicine. The researchers found that the combination of 3 biomarkers (hemoglobin, calprotectin and serpin F2) had significantly higher sensitivity compared with the standard FIT test, without compromising specificity. The mtFIT detects 35% more advanced adenomas, which could translate into 12% CRC incidence reduction and 8% CRC mortality reduction. The paper was authored by a team of researchers and clinicians from the Netherlands Cancer Institute, Amsterdam, in collaboration with researchers from AmsterdamUMC and ErasmusMC in Rotterdam, The Netherlands. The researchers used bio-banked residual FIT sample buffer from 1,284 patients to assess if the addition of protein biomarker quantification in stool could be used to improve the sensitivity of FIT, without sacrificing specificity. The patients were classified by their most advanced lesion – CRC, advanced adenomas, advanced serrated polyps, nonadvanced adenomas, and nonadvanced serrated polyps— and then classification and regression tree (CART) analysis was applied to biomarker concentrations in order to identify the optimal combination for detecting advanced neoplasia. Performance of this combination, the mtFIT, was cross-validated using a 'leave-one-out' approach and compared with FIT at equal specificity. The researchers found that the combination of 3 biomarkers (hemoglobin, calprotectin and serpin F2) had significantly higher sensitivity than FIT for advanced neoplasia (i.e. CRC and advanced precursor lesions) with equal specificity to FIT. The improvement was seen in the
advanced adenomas, for which sensitivity was increased by 35%, while sensitivity for CRC and advanced serrated polyps did not change. The improved sensitivity for advanced adenomas may prove critical to improving FIT's performance as a cancer prevention test. The authors estimate that when performed biennially and compared to traditional biennial FIT, mtFIT would reduce CRC incidence and mortality by 12% and 8%, respectively, assuming 73% adherence. Finally, the mtFIT was also deemed cost-effective. Funding has been secured to conduct a prospective screening trial to further validate mtFIT within the context of the Dutch CRC screening program. An independent editorial comment in the same issue of the journal commented on the study to be "important because the challenge of building a better screening test was approached from the perspective of an organized, population-based screening program, and it shows the potential of relatively inexpensive enhancements to the widely used FIT to improve sensitivity without sacrificing specificity" and "Ultimately, this study offers promise of incremental but important improvements in the effectiveness of population-based CRC screening through novel biomarker measurement using an existing screening platform." HANSA BIOPHARMA ANNOUNCES REIMBURSEMENT IN THE NETHERLANDS OF IDEFIRIX® (IMLIFIDASE) Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), the pioneer in enzyme technology for rare immunological conditions, has announced that its firstin-class treatment Idefirix® (imlifidase) is, as of August 1, reimbursable and available for use in the Netherlands. Idefirix® is the first and only treatment approved for use in the European Union for desensitization of highly sensitized patients prior to kidney transplantation, allowing them to be considered for a life-altering kidney transplantation from a deceased donor. “Highly sensitized patients have high levels of immunoglobulin G against many human leukocyte antigens that can cause tissue damage and potentially transplant rejection.” says Dr Annelies de Weerd, nephrologist at the Erasmus
SEPTEMBER - 2021 • HPN | HOSPITALPROFESSIONALNEWS.IE
Medical Center in Rotterdam. “Idefirix is the first medicine to desensitize immunized kidney transplant candidates. It works by inactivating immunoglobulin G, then reduces the risk of hyperacute rejection following transplantation.” Hansa Biopharma’s commercial launch activities throughout Europe are underway as planned. Pricing for Idefirix® has been published in the first markets[*] and the first commercial sales were reported in Q1 2021. The first agreements around reimbursement and funding access with healthcare providers and payers have been completed, and more are expected in the early-launch countries over the course of 2021. “At Hansa, our mission is to significantly improve the lives of rare disease patients with serious unmet medical needs, bringing highly innovative medicines from the laboratory to patients”, said Henk Doude van Troostwijk, Senior Vice President and Chief Commercial Officer, Hansa Biopharma. “We are excited to be able to partner with the healthcare community in the Netherlands to offer a new therapy option for highly sensitized patients waiting for a potentially life-saving kidney transplant. This reimbursement announcement shows how we are delivering on our commitment to improve the lives of patients with rare immunological conditions.” LEO PHARMA ANNOUNCES MHRA AND EC APPROVAL OF ADTRALZA (TRALOKINUMAB) LEO Pharma UK and Ireland, a leader in medical dermatology, has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) has approved tralokinumab for the treatment of moderate-tosevere atopic dermatitis in adult patients who are candidates for systemic therapy. The MHRA and EC approvals make tralokinumab the first and only approved biologic that specifically targets the IL-13 cytokine alone, a key driver of atopic dermatitis signs and symptoms.3,4 Tralokinumab is the first high affinity, human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine in adult patients with uncontrolled moderate-to-severe atopic dermatitis. 1,3,4 Tralokinumab will be available in a 150 mg/mL
prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week. Tralokinumab can be used with or without topical corticosteroids (TCS).5 “Atopic dermatitis can be an intensely itchy, challenging and unpredictable skin condition for some. As clinicians, we always want more options for patients and the approval of tralokinumab means that clinicians across the UK and Ireland now have an important new treatment option for patients with moderate-tosevere atopic dermatitis in adult patients” said, Professor Anthony Bewley, Consultant Dermatologist at Barts Health NHS Trust. The MHRA and EC approval of tralokinumab is a significant milestone for thousands of adults in Europe living with atopic dermatitis,” said Dr. Amit Aggarwal, Medical Director, LEO Pharma UK and Ireland. “Tralokinumab was developed based on the advanced understanding of the immune processes underlying atopic dermatitis, which is fundamental to our mission of pioneering medical dermatology” he continued. The approval is based primarily on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included more than 1,900 adult patients with moderate-to-severe AD. Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose ranging trial, and a vaccine response trial. LEO Pharma is working closely with key stakeholders to support access to tralokinumab for eligible patients. The MHRA and EC decisions are valid in the UK and all European Union Member States, Iceland, Norway, and Liechtenstein. Additional regulatory filings are underway with [the U.S. Food and Drug Administration (FDA) and other] health authorities worldwide. DUPIXENT® (DUPILUMAB) SIGNIFICANTLY IMPROVED ITCH AND HIVES IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA A pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU), an inflammatory skin disease, met its primary endpoints and all key secondary endpoints at