Sun Pharma reports positive results from Phase 3 trials for ILUMYA
The studies, named INSPIRE-1 and INSPIRE-2, tested ILUMYA over a 24-week period. Patients who received ILUMYA showed significant improvements in symptoms of psoriatic arthritis compared to those who received a placebo. Both trials successfully met their primary goal—a higher proportion of patients treated with ILUMYA achieved ACR20 responses, a standard measure used to assess improvement in joint disease, by Week 24. The results were statistically significant.
On the safety front, the drug performed as expected. There were no new safety concerns, and the data remained in line with ILUMYA's existing safety record. The drug is already approved to treat moderate-to-severe plaque psoriasis, and these latest findings suggest it may have potential in addressing PsA as well.
However, it's important to note that ILUMYA is not yet approved for psoriatic arthritis, and its use for this indication has not been reviewed or authorized by health regulators.
Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty Development at Sun Pharma, stated, 'We are excited to share that both the INSPIRE-1 and INSPIRE-2 clinical trials have successfully met their primary endpoints. These top-line results reinforce the therapeutic potential of ILUMYA as a treatment option for patients with active psoriatic arthritis. We extend our sincere gratitude to the patients, healthcare professionals and administrators whose contributions made the studies possible. We look forward to sharing the complete clinical data in the near future.'
Sun Pharma plans to present the full results from these studies at upcoming medical conferences and publish them in peer-reviewed journals.
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Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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About the AQUILA Study AQUILA (NCT03301220) is a randomised, multicentre Phase 3 study investigating daratumumab SC versus active monitoring in patients (n=390) with high-risk smouldering multiple myeloma (SMM).7 The primary endpoint is progression-free survival and secondary endpoints include time to progression, overall response rate and overall survival.7 Patients in the study were diagnosed with SMM in the last five years and were excluded if they had prior exposure to approved or investigational treatments for SMM or multiple myeloma.7 About Smouldering Multiple Myeloma SMM is an asymptomatic intermediate disease state of multiple myeloma where abnormal cells can be detected in the bone marrow.2,8 Patients living with SMM tend not to show signs or symptoms typically associated with active myeloma, such as bone pain, bone fractures, kidney problems, or anaemia, however as abnormal plasma cells are present, organ damage may begin and progress asymptomatically.1,9 Approximately 15 percent of all cases of newly diagnosed multiple myeloma are classified as SMM, and half of those diagnosed with high-risk SMM are estimated to progress to active multiple myeloma within two years.10 About Multiple Myeloma Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.11,12 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.11,12 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.13 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy while remissions become progressively shorter.14,15,16 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.17 About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 618,000 patients worldwide.18 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.19 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.19 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.19 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.19 Daratumumab may also have an effect on normal cells.19 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.20,21,22,23,24,25,26,27,28 For further information on daratumumab, please see the Summary of Product Characteristics at: About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow. and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc. and Janssen Research & Development, LLC are Johnson & Johnson companies. This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. *Professor Meletios A. Dimopoulos, M.D., National and Kapodistrian University of Athens School of Medicine, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Dimopoulos MA, et al. Phase 3 Randomized Study of Daratumumab Monotherapy versus Active Monitoring in Patients with High-risk Smoldering Multiple Myeloma: Primary Results of the AQUILA study. Oral presentation. American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024.2 Myeloma UK. Smouldering Myeloma. Available at: Last accessed: July 2025. 3 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. July 2025.4 Oben B, et al. Whole-Genome Sequencing Reveals Progressive Versus Stable Myeloma Precursor Conditions as Two Distinct Entities. Nature Communications. 2021; 12(1861).5 Maura F, et al. Targeting the Tumor and The Immune System in Smoldering Multiple Myeloma. The New England Journal of Medicine. 2025;392:1858-1860.6 Dimopoulos MA, et al. Phase 3 Randomized Study of Daratumumab Monotherapy Versus Active Monitoring in Patients With High-risk Smoldering Multiple Myeloma: Primary Results of the AQUILA Study. Abstract #773. American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024. 7 A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma. Available at: . Last accessed: July 2025.8 WebMD. Smoldering Multiple Myeloma. Available at: Last accessed: July 20259 American Cancer Society. About Multiple Myeloma. Available at: Last accessed: July 2025.10 Rajkumar SV, et al. Smoldering Multiple Myeloma Current Treatment Algorithms. Blood Cancer J. 2022;12(9):129.11 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207.12 American Society of Clinical Oncology. Multiple Myeloma: Introduction. Available at: Last accessed: July 2025.13 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: Last accessed: July 2025.14 Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347.15 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23.16 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430.17 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: Last accessed: July 2025.18 J&J Data on File (RF-452129). Number of Patients Treated with DARZALEX Worldwide as of December 2024.19 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: Last accessed: July 2025.20 Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38.21 Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. New England Journal of Medicine. 2019;380(22):2104-2115.22 Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395:132-141.23 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812.24 Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood 2020;2;136(1):71-80.25 Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981.26 Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884.27 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518.28 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. CP-529642 July 2025 CONTACT: Media contact: Jenni Mildon jmildon@ +44 7920 418 552 Investor contact: Lauren Johnson investor-relations@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
