AstraZeneca says new results reinforce Tagrisso as backbone therapy
New study results presented at the European Lung Cancer Congress 2025, March 26 to 29, demonstrate the role of AstraZeneca's (AZN) TAGRISSO, as monotherapy and as the backbone for novel combinations, across stages and settings of epidermal growth factor receptor-mutated non-small cell lung cancer. Highlights include: LAURA Phase III trial of TAGRISSO in unresectable, Stage III EGFRm NSCLC after chemoradiotherapy; SAVANNAH Phase II trial of TAGRISSO plus savolitinib in advanced EGFRm NSCLC with high levels of MET overexpression and/or amplification following disease progression on 1st-line TAGRISSO; ORCHARD Phase II platform trial of TAGRISSO plus datopotamab deruxtecan-dlnk in advanced EGFRm NSCLC following disease progression on 1st-line TAGRISSO; FLAURA2 Phase III trial of TAGRISSO plus chemotherapy as 1st-line treatment for advanced EGFRm NSCLC. Myung-Ju Ahn, MD, PhD, Professor of Hemato-Oncology at the Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, said: 'A critical goal in treating every patient with lung cancer is to not only extend a patient's life but also maintain quality of life while on treatment. The continued overall survival trend seen here at ELCC in the unresectable Stage III setting and the promising data for combinations that can address progression in the advanced setting, together reinforce osimertinib as an effective, safe and convenient treatment for patients with EGFR-mutated lung cancer across stages and lines of treatment.' Susan Galbraith, Executive Vice President, Oncology Hematology R&D, AstraZeneca, said: 'Having now treated more than one million patients around the world, TAGRISSO has repeatedly transformed expectations for patients with EGFR-mutated lung cancer by not only extending survival but also showing it is possible to maintain quality of life during cancer treatment. The breadth of data at ELCC reinforce TAGRISSO as the backbone therapy for patients with this disease and show that adding savolitinib or datopotamab deruxtecan-dlnk at the time of disease progression can help prolong patients' responses to treatment.'
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Vera Therapeutics Announces Atacicept Achieved 46% Proteinuria Reduction in ORIGIN Phase 3 Trial in Adults with IgA Nephropathy
Atacicept ORIGIN Phase 3 trial met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001) Other prespecified endpoints achieved similar or better results compared to the ORIGIN Phase 2b clinical trial — per FDA guidance, Vera is not sharing eGFR results at this time while the ORIGIN 3 placebo-controlled trial continues The safety profile of atacicept was favorable, and comparable to placebo Vera plans to meet with FDA in the coming weeks to discuss these results and the regulatory pathway; Vera currently plans to submit a Biologics License Application (BLA) for accelerated approval to the FDA in 4Q 2025; ORIGIN 3 trial continues with two-year results expected in 2027 Vera will host a conference call and webcast at 8:00 am ET on Monday, June 2 BRISBANE, Calif., June 02, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that the primary endpoint was met in the ORIGIN Phase 3 trial of atacicept for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) at week 36. For other prespecified endpoints, atacicept treatment also demonstrated results that were consistent with or better than those previously observed in the ORIGIN Phase 2b trial.1 The safety profile of atacicept in this analysis was favorable, and comparable to placebo. Vera plans to share these results with the FDA in the coming weeks, and full results will be submitted to the American Society of Nephrology Kidney Week. 'ORIGIN 3 is the first Phase 3 clinical trial in IgAN to demonstrate this magnitude of UPCR reduction compared to placebo at week 36. These results convincingly demonstrate the impact of atacicept to reduce proteinuria,' said Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Glomerular Disease Center at Stanford University Medical Center, and a primary investigator for both ORIGIN 2b and ORIGIN 3. 'If approved, we believe that atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor. We currently plan to submit a BLA for atacicept in IgAN to the FDA in the fourth quarter of this year, which may allow for US approval and commercial launch in 2026. We are grateful to the study participants, their families and caregivers, the study investigators and staff, our research partners, and the Vera team for their ongoing commitment and dedication to this important research,' said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. 'Vera aspires to evolve the practice of kidney medicine with the hope that, one day, patients may no longer face a future of dialysis or transplantation. Vera is poised for potential commercial launch of atacicept in 2026 and to pursue development in additional indications in other autoimmune kidney diseases and beyond.' 'Patients with IgA nephropathy, as well as their families and care partners, suffer from clinical uncertainty and the horrible outcome of kidney failure. In addition to clinical signs and symptoms, IgAN has a devastating impact on quality of life and mental wellbeing. I'm thrilled with the progress that is being made in developing new treatments for patients,' said Bonnie Schneider, Director and Cofounder of the IgA Nephropathy Foundation. ORIGIN 3 is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 431 adults with IgA nephropathy. Participants were randomized 1:1 to atacicept 150 mg, self-administered at home via once weekly subcutaneous injection, or placebo. The primary efficacy endpoint was the change in 24-hour UPCR compared to placebo at the 36-week interim analysis. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR and is expected to complete in 2027. For more information about the ORIGIN 3 clinical trial (NCT04716231), please visit The Company will host an investor call and webcast to discuss the data update at 8:00 AM ET on Monday, June 2. Investors Dial-in: 1-877-425-9470 Int'l Investors Dial-in: 1-201-389-0878 Conference ID: 13754147 Webcast: The live webcast will be available on the Company's Investor Calendar, with the recording and presentation available immediately following the event. References1. Barratt J, et al. JASN 2024 About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN, other autoimmune kidney diseases and lupus nephritis. The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA's determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different indications. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, atacicept's potential to be a best-in-class therapy for patients with IgAN, atacicept's potential as a treatment for indications beyond IgAN, Vera's expectations concerning other predefined endpoints in the Phase 3 ORIGIN trial, as well as the two-year data therefrom, Vera's plans to meet with, and submit a BLA for atacicept to, the FDA, and to potentially receive FDA approval for atacicept in IgAN and launch it commercially, and, in each case, the timing thereof, the potential for atacicept to bring value for patients and to the change the standard of care in IgAN, if approved, and other statements that are not historical fact. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'anticipate,' 'believe,' 'expect,' 'plan,' 'potential' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary or interim results may not be predictive of final study results, risks and uncertainties associated with Vera's business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@ Media Contact:Debra CharlesworthVera Therapeutics415-854-8051corporatecommunications@ 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
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Press Release Biocartis NV: Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test
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Associated Press
8 hours ago
- Associated Press
J INTS BIO to Present Global Clinical Results from JIN-A02, a Fourth-Generation EGFR-TKI, at ASCO 2025
Significant anti-tumor responses and reduction of brain metastases observed SEOUL, South Korea , June 1, 2025 /PRNewswire/ -- J INTS BIO, a company specializing in the development of therapeutics for cancer and rare diseases, officially announced interim results from the global Phase 1/2 clinical trial of JIN-A02, its fourth-generation EGFR-TKI drug candidate, at the American Society of Clinical Oncology 2025 (ASCO 2025), the world's largest oncology conference, held in Chicago, USA. JIN-A02 is an oral, fourth-generation EGFR-TKI designed to overcome resistance mutations (such as C797S) that develop after treatment failure with third-generation EGFR-TKIs, which are currently the first-line therapy for EGFR-mutant Non-small cell lung cancer (NSCLC). It is currently undergoing clinical trials in South Korea, the United States, Thailand, and other countries. Key efficacy and safety results from Part A (dose escalation) of the multi-center clinical trial (NCT05394831) were presented. 'Confirmed' clinical response observed in patients with disease progression after 3rd Generation EGFR TKI and chemotherapy One of the key findings of the ASCO presentation was that tumor responses were sustained in specific dose cohorts, with confirmed partial responses (PRs) verified by independent evaluation. Confirmed PRs were observed in 50mg,100mg and 300mg QD dose groups, providing clinical evidence of anti-tumor activity. In the 50 mg dose group, patients achieved a 77.3% reduction in tumor size, maintaining a PR over six consecutive treatment cycles (from cycle 3 to cycle 13). In the 300 mg dose group, a confirmed PR was observed with a 39.7% tumor size reduction, including a significant reduction in brain metastatic lesions. In the 100 mg dose group, a PR was also reported with a 35.3% reduction in tumor size, and brain metastatic lesions remained stable, further supporting the potential of JIN-A02 in treating brain metastases. Safety confirmed up to 300 mg, with therapeutic signals in brain metastases No dose-limiting toxicities (DLTs) or serious adverse events were observed with JIN-A02 at doses up to 300mg, which is six times the dose level when PR was first observed, demonstrating a favorable safety profile even at higher dose levels. The majority of adverse events reported at 300mg were mild (Grade 1-2) and included for the first time, Grade 1 skin rash, diarrhea, and skin desquamation in 3 out of 5 subjects – events commonly associated with EGFR inhibitors and generally considered clinically manageable. Importantly, there were no reports of systemic toxicities such as cardiovascular events or hepatotoxicity, supporting the drug's excellent safety profile. This safety and tolerability have translated into extended treatment durations in real-world settings, with a patient still on JIN-A02 after one year and seven months. In addition, the trial demonstrated notable responses in brain metastases first noted at 100mg, suggesting that JIN-A02 achieves therapeutically relevant concentrations in brain tissue. JIN-A02 gains national spotlight as government grants accelerate development In addition to the ASCO announcement, J INTS BIO continues to achieve noteworthy results in Korea. Recently, it was selected for the '2025 Baby Unicorn Fostering Project' by the Ministry of SMEs and Startups, officially recognizing both our scientific technology and commercialization potential. The 'Baby Unicorn Fostering Project' is a government project that focuses on developing promising startups with innovative technologies and growth potential in the global market as 'potential unicorns'. Companies selected for this project will receive full government support in recognition of their technological prowess and growth potential. With these accolades, JIN-A02 will receive dual funding for its Phase 2 trial and global expansion over the next two years, which is expected to be a decisive point to significantly accelerate the pace of clinical and commercialization in parallel with private investment. It is also significant as a case of securing confidence in the 3 arena of technology, marketability, and global scalability, as the recognition came from different government departments. Based on these achievements, we plan to initiate the Phase 2 clinical trial of JIN-A02 in before the end of this year, in discussions with the US FDA. 'The ASCO presentation of JIN-A02's ability to induce anti-cancer responses and its ability to respond to central nervous system metastatic lesions is of great significance,' said Dr. Anna Jo, CEO. 'The government's continued support is a recognition of our technical capabilities and potential for growth. We will take advantage of this opportunity to accelerate global clinical expansion, technology transfer, and indication expansion to realize our goal of early commercialization' View original content to download multimedia: SOURCE J INTS BIO
