Crovalimab

Next-gen aHUS treatments are shifting from IV infusions to oral and subcutaneous options-offering new hope in safety, efficacy, and patient ease. The aHUS therapy landscape is on the cusp of disruption-with emerging oral drugs and biosimilars reshaping market dynamics and patient access.” — DataM Intelligence AUSTIN, TX, UNITED STATES, June 9, 2025 / EINPresswire.com / -- Atypical hemolytic uremic syndrome (aHUS) is a rare, life-threatening condition that has challenged clinicians for decades due to its complex pathophysiology and unpredictable relapses. Primarily caused by uncontrolled activation of the complement system-a vital part of immune defense-this disorder results in the body mistakenly attacking its own endothelial cells. This autoimmune-like attack leads to blood clots in small vessels, hemolytic anemia, low platelets, and acute kidney injury. The cascade of events often unfolds rapidly, leaving minimal room for therapeutic delay. Book Your Free CI Consultation Call: https://www.datamintelligence.com/strategic-insights/ci/atypical-hemolytic-uremic-syndrome-ahus Historically, the clinical landscape for aHUS treatment was limited and reactive. However, the emergence of complement inhibitors such as Soliris (eculizumab) and Ultomiris (ravulizumab) has dramatically transformed patient outcomes. These targeted therapies block the complement component C5, thereby halting the terminal pathway responsible for endothelial injury. Despite their efficacy, these treatments bring challenges-namely, high costs, intravenous dosing burdens, and long-term immunosuppression. Epidemiology and Disease Burden Though rare, aHUS is now recognized more frequently due to improved diagnostic capabilities and awareness. Incidence estimates suggest approximately 1 to 2 cases per million population annually, with a higher prevalence in pediatric patients and young adults. Despite being uncommon, the economic and clinical burden is significant. Frequent hospitalizations, renal replacement therapies, and lifelong medication usage make it a resource-intensive condition for both patients and health systems. Looking ahead, as diagnosis rates continue to rise and access to therapy improves globally, the treated patient population is expected to expand steadily over the next decade. Market Leaders: Soliris and Ultomiris Soliris, the first-in-class anti-C5 monoclonal antibody, has long been the backbone of aHUS management. Delivered via intravenous infusion every two weeks, it provides rapid disease control and kidney function stabilization. Ultomiris, a long-acting version of Soliris, offers dosing every eight weeks and has quickly gained traction due to its extended half-life and comparable efficacy. While both drugs offer life-altering benefits, their IV delivery model and high cost present logistical and economic hurdles-particularly in resource-limited settings. Furthermore, patients on chronic complement inhibition face elevated risks of infections, especially from encapsulated organisms like Neisseria meningitidis, requiring mandatory vaccination and close monitoring. Biosimilars Enter the Arena: Expanding Access To address cost constraints, biosimilars such as Bkemv and EPYSQLI have recently entered the market. Both mirror the efficacy and safety profile of Soliris but at reduced prices. This has significant implications for healthcare systems seeking cost-effective treatment options and for patients in emerging markets where branded biologics were previously out of reach. The entry of biosimilars is expected to trigger pricing pressure on originator brands and encourage broader adoption of complement blockade therapy in previously underserved regions. Emerging Innovations: Convenience Redefined The next wave of innovation in aHUS centers around patient-centric improvements-most notably the shift from intravenous to oral or subcutaneous delivery. Fabhalta (Iptacopan), an oral complement factor B inhibitor, represents a potentially game-changing option. By targeting the alternative pathway upstream of C5, Fabhalta may offer broader complement control. Its oral daily dosing also addresses the burden of frequent infusions, enhancing quality of life and adherence. Another frontrunner is Crovalimab (Piasky), a subcutaneous anti-C5 monoclonal antibody recently approved in several regions. Its monthly SC administration empowers patients with greater autonomy and reduces hospital visits-especially appealing for younger, working patients or those in remote areas. These innovations are not merely incremental-they have the potential to disrupt the current therapeutic paradigm, offering alternatives that align more closely with patient preferences. Pipeline Outlook: What’s Next? The aHUS pipeline includes promising assets in various stages of development, including novel monoclonal antibodies, small molecules, and even RNA interference (RNAi) therapies. These next-gen modalities aim to deliver differentiated value-whether through new mechanisms of action, improved safety profiles, or enhanced pharmacokinetics. Key targets include: - Complement factor B and C3, which offer upstream inhibition for more comprehensive control. - Gene therapies under preclinical evaluation, aiming for long-term or potentially curative outcomes. - Oral agents and self-administered injectables, reducing the logistical barriers of hospital-based care. While Soliris and Ultomiris set a high bar for efficacy and safety, pipeline therapies must offer clear advantages-either in administration, tolerability, or cost-effectiveness-to capture significant market share. Target Opportunity Profile (TOP): Where the Gaps Lie To secure a strong foothold in the evolving aHUS market, developers must address the following unmet needs: - Convenience: Intravenous dosing every two to eight weeks limits patient freedom. Oral or subcutaneous routes are increasingly preferred. - Affordability: The high cost of branded therapies restricts global access. Cost-effective alternatives or pricing models will be key. - Safety: While current therapies are generally well tolerated, they carry infection risks. Novel agents must aim to reduce immunosuppression-related complications. - Innovation in Mechanism: Moving beyond C5 to upstream targets may offer added efficacy in difficult or resistant cases. - Real-World Outcomes: Long-term data on kidney preservation, survival, and quality of life will influence payer decisions and treatment guidelines. Competitive Dynamics: A Market in Transition The market for aHUS treatment is no longer defined solely by biologics delivered via infusion centers. With oral small molecules like Fabhalta and subcutaneous agents like Crovalimab gaining traction, the competitive landscape is undergoing rapid transformation. Manufacturers must now compete not only on efficacy but also on convenience, safety, price, and patient experience. Biosimilars are squeezing margins while expanding access. Meanwhile, pipeline entrants promise to reset expectations entirely-with oral, gene-based, and potentially curative approaches in development. Download Free Sample Report: https://www.datamintelligence.com/strategic-insights/sample/atypical-hemolytic-uremic-syndrome-ahus Conclusion The treatment of atypical hemolytic uremic syndrome has come a long way-from managing life-threatening relapses with supportive care to providing targeted, disease-modifying therapy. But the next frontier is patient-centric: offering safe, effective, and affordable treatment that fits seamlessly into patients’ lives. Oral drugs like Fabhalta and injectables like Crovalimab mark a pivotal shift, challenging the status quo and opening the door to more personalized and accessible care. As biosimilars democratize access and innovation drives differentiation, the aHUS market is poised for significant evolution in the years ahead. Read Related CI Reports: 1. Eosinophilic Esophagitis | Competitive Intelligence 2. Warm Autoimmune Hemolytic Anemia | CI Insights Sai Kumar DataM Intelligence 4market Research LLP +1 877-441-4866 email us here Visit us on social media: LinkedIn X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Updated data from the pivotal phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant1 89% of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive and 82% showed no signs of cancer one year post-treatment1 Timely initiation of effective therapy at relapse or after initial therapy failure is critical for this aggressive, life-threatening disease Results demonstrate potential of the Columvi combination as a much-needed, off-the-shelf and fixed-duration treatment option Basel, 23 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today two-year follow-up data from the phase III STARGLO study. After a median follow-up of 24.7 months, data showed a 40% improvement in overall survival (OS) for patients treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) and OS was not reached, compared to 13.5 months for MabThera®/Rituxan® (rituximab) plus GemOx (R-GemOx).1 These updated data continue to demonstrate the statistically significant and clinically meaningful survival benefit of this off-the-shelf, fixed-duration Columvi combination for people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT).1 Data will be presented in an oral session at the 61st American Society of Clinical Oncology (ASCO), 30 May – 3 June 2025. “We are encouraged that the two-year follow-up data for Columvi reinforces its potential to extend the lives of many patients where prognosis has historically been poor,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “These findings demonstrate the potential lasting benefits of early and effective treatment initiation with a bispecific antibody for people with relapsed or refractory disease.” "When cancer comes back or doesn’t respond to treatment, it’s devastating for patients with DLBCL given the aggressive nature of the disease,” said Haifaa Abdulhaq, MD, Professor, University of California San Francisco (UCSF), Director of Hematology, UCSF Fresno. “In my community practice, I’ve seen the potential of this Columvi combination to help patients start treatment quickly - providing lasting remissions and more time without ongoing therapy.” The benefit across key secondary endpoints, including progression-free survival (PFS) and complete remission (CR), was maintained for patients treated with the Columvi combination.1 There was a 59% reduction in the risk of disease progression or death (hazard ratio = 0.41, 95% confidence interval: 0.29–0.58) and more than twice as many patients sustained a CR (58.5% vs. 25.3%).1 Among patients with a CR at the end of the treatment period, 89% were alive and 82% had maintained remission one year after treatment.1 Safety of the combination remained unchanged from the previous analysis and was consistent with the known safety profiles of the individual medicines.1,2 Patients received a higher median number of cycles of the Columvi combination (11 versus 4), due to disease progression in the R-GemOx arm.1,2 A higher rate of adverse events (AEs) was observed with the Columvi regimen. One of the most common AEs was cytokine release syndrome, which was generally low grade.1 Given the wide adoption of global treatment guidelines in real-world clinical practice, there are no biological or clinical differences in DLBCL management worldwide.3-6 While second-line therapies have advanced, DLBCL can progress rapidly and many people are not candidates for, cannot tolerate, or do not have access to latest therapies.7,8 There is an urgent need for treatments that are rapidly available upon a diagnosis of relapse, that can manage the disease and improve long-term outcomes. Based on the STARGLO data, this Columvi combination is approved in more than 30 countries for people with R/R DLBCL who are not candidates for ASCT, including countries throughout the EU. Columvi in combination with GemOx was added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as an NCCN category 1 preferred recommendation for the treatment of people with second-line DLBCL who are not intended to proceed to transplant.†3 Columvi monotherapy has been approved for use in R/R DLBCL after two or more prior lines of therapy in more than 60 countries worldwide. Columvi is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme. Together with the clinical development of off-the-shelf allogeneic CAR T-therapies, Roche aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. The STARGLO study [GO41944; NCT04408638] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability. Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma. As part of Roche’s efforts to elevate treatment standards in the earlier stages of DLBCL, where there is the best opportunity to improve long-term outcomes and prevent relapse, Columvi is also being investigated in combination with Polivy® (polatuzumab vedotin) and MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL in the phase III SKYGLO study [GO44145; NCT06047080]. DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and the most common form, accounting for about one in three cases of NHL.9 Approximately 160,000 people worldwide are diagnosed with DLBCL each year, with comparable incidence rates across regions.9,10 Medical practices, including pathological classification, diagnosis, staging, initial treatment and relapse management, are similarly approached worldwide.3-6 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.7,11 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. †NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. References [1] Abramson J, et al. Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year (yr) follow-up of STARGLO. Presented at: ASCO Annual Meeting; 2025 May 30 - Jun 3. Abstract #7015. [2] Abramson J, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. Lancet 2024; 404 (10466): 1940-1954. [3] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.1.2025. [4] Tilly H, et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26:v116-25. [5] Zhu J, et al. Union for China Lymphoma Investigators of Chinese Society of Clinical Oncology. Chinese Society of Clinical Oncology (CSCO) diagnosis and treatment guidelines for malignant lymphoma 2021 (English version). Chin J Cancer Res. 2021;30;33(3):289-301. [6] Wight J, et al. Diffuse large B-cell lymphoma: a consensus practice statement from the Australasian Lymphoma Alliance. Intern Med J. 2022;52(9):1609-1623. [7] Fabbri N, et al. Second-line treatment of diffuse large B-cell lymphoma: Evolution of options. Semin Hematol 2023; 60(5): 305–312. [8] Westin J, et al. CAR T cells as a second-line therapy for large B-cell lymphoma: A paradigm shift? Blood. 2022;139(18):2737–2746. [9] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited May 2025]. Available from: https://www.uptodate.com/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-thebasics. [10] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited May 2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-nonhodgkin-lymphoma-fact-sheet.pdf. [11] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. The content above comes from the network. if any infringement, please contact us to modify.