Latest news with #EHA
Egypt Independent
2 days ago
- Health
- Egypt Independent
Egypt's Healthcare Authority, Arab Emergency Union discuss strategic cooperation
Head of the Egypt Healthcare Authority (EHA) Ahmed al-Sobky had talks with Advisor Mishaal bin Al-Daihani, Chairman of the Arab Union for Emergency and Disaster Management, to prepare for a cooperation protocol focused on health emergencies and disaster response. The agreement will include joint training, crisis management, and business continuity, with certified programs for EHA staff and participants from other Arab countries. EHA will offer its field hospitals as training sites. The two sides also discussed collaboration in reconstruction, public awareness campaigns, and sharing Egypt's health system experience across the region. For his part, al-Sobky said that the partnership reflects Egypt's direction toward Arab cooperation in health and emergency preparedness. Meanwhile, Al Daihani praised Egypt's experience and confirmed plans for field-based programs and certified training across the Arab region.
Yahoo
4 days ago
- Business
- Yahoo
Adaptive Biotechnologies Highlights New Data at 2025 ASCO Annual Meeting and EHA 2025 Congress Demonstrating How clonoSEQ® MRD Assessment is Optimizing Patient Care and Drug Development in Lymphoid Cancers
30 scientific abstracts will be presented using clonoSEQ for MRD assessment across multiple types of blood cancers SEATTLE, May 30, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in 30 presentations, including a total of 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago and the European Hematology Association (EHA) Congress taking place June 12-15 in Milan. These presentations include notable new data supporting the clinical actionability of clonoSEQ in both multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). "The breadth of new MRD evidence being shared across various blood cancer types at ASCO and EHA this year highlights the transformative impact MRD is having on clinical care and drug development," said Susan Bobulsky, Chief Commercial Officer, MRD, Adaptive Biotechnologies. "These data presentations are a testament to the central role that clonoSEQ MRD testing now plays in clinical management and drug development across lymphoid cancers, particularly when combined with several clonoSEQ data presentations in diffuse large B-cell lymphoma (DLBCL) anticipated at the 18th International Conference on Malignant Lymphoma (iCML) on June 17-21, 2025 in Lugano, Switzerland." Selected presentations include:Results from MIDAS, a phase 3 randomized study of 718 transplant-eligible, newly diagnosed multiple myeloma (NDMM) patients, demonstrate the use of MRD status to guide therapy post-induction. (ASCO Abstract 7500, June 3, 9:45-9:57 a.m. CDT, S100bc, McCormick Place Convention Center) Interim data from ADVANCE, a phase 2 randomized study of 306 transplant-eligible patients with NDMM shows the impact of MRD-guided assessments post-induction (ASCO Abstract 7503, June 3, 10:21-10:33 a.m. CDT, S100bc, McCormick Place Convention Center) Interim results from VENETOSTOP, a phase 2 study of 66 CLL patients, report the use of MRD status to shorten duration of venetoclax-based therapy. (EHA Abstract PS1568, June 14, 6:30 p.m. CEST, Poster Hall, Milano Convention Centre)Results from the phase 3 IsKia study of 151 transplant-eligible NDMM patients demonstrates increased rates of sustained MRD negativity at 10-6 with isatuximab plus carfilzomib, lenalidomide, and dexamethasone. (ASCO Abstract 7502, June 3, 10:09-10:21 a.m. CDT, S100bc, McCormick Place Convention Center) Follow-up data from PERSEUS, a phase 3 trial of 709 transplant-eligible patients with NDMM reports the impact of sustained MRD negativity status on progression free survival (PFS) with subcutaneous daratumumab plus bortezomib, lenalidomide and dexamethasone (D-VRd) induction and DR maintenance. (ASCO Abstract 7501, June 3, 9:57-10:09 a.m. CDT, S100bc, McCormick Place Convention Center) Results from DREAMM-8, a Phase 3 study in 302 patients with relapsed or refractory multiple myeloma, found superior PFS and higher MRD negativity rates in patients treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) as compared to standard-of-care pomalidomide, bortezomib, and dexamethasone (PVd). (ASCO Abstract 7515, June 2, 9:00-9:06 a.m. CDT E450b, McCormick Place Convention Center) Data to be presented at ASCO: Presentation Type and Number Title Presentation Timing B-Cell Acute Lymphoblastic Leukemia Poster Presentation6540 Initial results from a phase II study of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) ± rituximab (R) + tafasitamab (tafa) for adults with newly-diagnosed (ND) Philadelphia chromosome negative (Ph-) B lymphoblastic leukemia (B-ALL) Sunday, June 19 a.m.-12 p.m. CDT Poster Presentation6543 Brexucabtagene autoleucel (Brexu-cel) as consolidation treatment in adults with B-cell acute lymphoblastic leukemia Sunday, June 19 a.m.-12 p.m. CDT Multiple Myeloma Oral Presentation7500* MRD-driven strategy following IsaKRD induction in transplant-eligible NDMM: Primary endpoints of the phase 3 MIDAS trial Tuesday, June 39:45-9:57 a.m. CDT Oral Presentation7501 Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trial Tuesday, June 39:57-10:09 a.m. CDT Oral Presentation7502 Sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial) Tuesday, June 310:09-10:21 a.m. CDT Oral Presentation7503* Randomized, multi-center study of carfilzomib, lenalidomide, and dexamethasone (KRd) with or without daratumumab (D) in patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trial Tuesday, June 310:21-10:33 a.m. CDT Oral Presentation7507* Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM) Tuesday, June 311:57 a.m.-12:09 p.m. CDT Oral Presentation7515 Minimal residual disease (MRD) negativity (neg) in patients (pts) with relapsed or refractory multiple myeloma (RRMM) treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) vs pomalidomide, bortezomib, and dexamethasone (PVd): Analysis from the DREAMM-8 trial Monday, June 29-9:06 a.m. CDT Oral Presentation7516 Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS study Monday, June 29:06-9:12 a.m. CDT ASCO Oral Presentation7517* Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): Outcomes in patients with 1q21+ status in the phase 3 IMROZ study Monday, June 29:12-9:18 a.m. CDT Poster Presentation7529 Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): Phase 3 CEPHEUS trial cytogenetic subgroup analysis Sunday, June 19 a.m.-12 p.m. CDT Poster Presentation7535 Carfilzomib, lenalidomide, and dexamethasone (KRd) as maintenance therapy after autologous stem-cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma (NDMM) Sunday, June 19 a.m.-12 p.m. CDT ASCO Poster Presentation7551* Positron emission tomography with computed tomography (PET/CT) and minimal residual disease (MRD) for efficacy assessment in transplant-ineligible newly diagnosed myeloma (Ti NDMM) patients (pts): IMROZ analysis Sunday, June 19 a.m.-12 p.m. CDT Data to be presented at EHA: Presentation Type and Number Title Presentation Timing B-Cell Acute Lymphoblastic Leukemia Oral PresentationS112 Safety and efficacy of single-agent subcutaneous blinatumomab in adults with relapsed/refractory (R/R) b-cell acute lymphoblastic leukemia (B-ALL): results from a phase 1/2 dose expansion study Sunday, June 1511:30-11:45 a.m. CEST Oral PresentationS117 Safety and efficacy of AZD0486 in adolescent and adult patients with relapsed or refractory b-cell acute lymphoblastic leukemia: early results from the phase 1/2 SYRUS study Friday, June 135:30-5:45 p.m. CEST Poster PresentationPF372 Donor-derived, allogeneic CD19/CD22-CAR T cells with myeloablative graft-engineered Allo-HCT for high-risk B-ALL Friday, June 136:30 p.m. CEST Chronic Lymphocytic Leukemia Poster PresentationPF575 Preliminary results of the ongoing multicenter, phase 2 study of retreatment with venetoclax plus obinutuzumab (ReVenG) in patients with recurrent chronic lymphocytic leukemia (CLL) Friday, June 136:30 p.m. CEST Poster PresentationPS1568 Using minimal residual disease status to guide venetoclax treatment duration in patients with chronic lymphocytic leukemia: interim results from the phase II VENETOSTOP study Saturday, June 146:30 p.m. CEST Follicular Lymphoma Poster PresentationPF881 Epcoritamab monotherapy demonstrates deep and durable responses at 3-year follow-up in patients with relapsed/refractory follicular lymphoma Friday, June 136:30 p.m. CEST Poster PresentationPS2150 4-year update of phase 2 ELARA trial: clinical outcomes of tisagenlecleucel in patients (pts) with high-risk relapsed/refractory follicular lymphoma (R/R FL) Saturday, June 146:30 p.m. CEST Mantle Cell Lymphoma Poster PresentationPF882 Minimal residual disease with bendamustine-rituximab with or without acalabrutinib in patients with previously untreated mantle cell lymphoma: results from the phase 3 ECHO trial Friday, June 136:30 p.m. CEST Multiple Myeloma Oral PresentationS201 Phase 2 registrational study of anitocabtagene autoleucel for relapsed and/or refractory multiple myeloma (RRMM): updated results from IMMAGINE-1 Saturday, June 145:15-5:30 p.m. CEST Oral PresentationS205* Minimal residual disease-driven strategy following isatuximab-carfilzomib-lenalidomide-dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma: Primary endpoints of the phase 3 MIDAS trial Sunday, June 1511:00-11:15 a.m. CEST Oral Presentation S207* A randomized, multi-center study of carfilzomib, lenalidomide and dexamethasone (KRd) with or without daratumumab (D) for the treatment of patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trial Sunday, June 1511:30-11:45 a.m. CEST Oral PresentationS208* Analysis of sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial) Sunday, June 1511:45 a.m.-12 p.m. CEST Poster PresentationPF727 Isa-vrd improves outcomes in high-risk (HR) newly diagnosed transplant-ineligible multiple myeloma (NDMM TI) using the IMS/IMWG consensus HR definition: results from the BENEFIT phase 3 trial (IFM 2020-05) Friday, June 136:30 p.m. CEST Poster Presentation PF729* Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): outcomes in patients with 1q21+ status in the phase 3 IMROZ study Friday, June 136:30 p.m. CEST Poster PresentationPF750 Isatuximab, bortezomib, lenalidomide, dexamethasone (Isa-VRd) in patients with transplant-ineligible (TI) newly diagnosed myeloma (NDMM) and plasmacytomas: IMROZ subgroup analysis Friday, June 136:30 p.m. CEST Poster PresentationPF754 Interim analysis of MRD-guided maintenance therapy with belantamab mafodotin and lenalidomide after Auto-HCT in newly diagnosed multiple myeloma Friday, June 136:30 p.m. CEST Poster Presentation PS1722* Positron emission tomography with computed tomography and minimal residual disease for efficacy assessment in transplant-ineligible newly diagnosed myeloma patients: IMROZ analysis Saturday, June 146:30 p.m. CEST *Indicates data to be presented at both ASCO and EHA. About clonoSEQ clonoSEQ® is the first and only FDA-cleared in vitro diagnostic (IVD) test for detecting and tracking minimal (or measurable) residual disease (MRD) in patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) using bone marrow, and in patients with chronic lymphocytic leukemia (CLL) using blood or bone marrow. clonoSEQ is also available in diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). clonoSEQ is covered by Medicare for MM, CLL, ALL, DLBCL and MCL. clonoSEQ identifies and quantifies DNA sequences in malignant cells—detecting one cancer cell in one million healthy cells—to help clinicians and researchers assess and monitor MRD with precision over time. It delivers standardized, sensitive results that inform treatment decisions, predict outcomes, and detect relapses earlier. clonoSEQ is CE-marked under the EU In Vitro Diagnostic Regulation (IVDR). For intended use details in the EU, see the instructions for use, available on request. To review the FDA-cleared uses of clonoSEQ, visit About Adaptive Biotechnologies Adaptive Biotechnologies ("we" or "our") is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature's most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. Forward Looking Statements This press release contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections regarding the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. ADAPTIVE INVESTORS Karina Calzadilla, Vice President, Investor Relations and FP&A 201-396-1687 investors@ ADAPTIVE MEDIAErica Jones, Associate Corporate Communications Director206-279-2423media@ in to access your portfolio
Al-Ahram Weekly
25-05-2025
- Health
- Al-Ahram Weekly
Egypt launches 5th Check on Your Child campaign under universal insurance plan - Health
Egypt has launched the fifth phase of its Check on Your Child campaign, a free medical screening programme targeting more than 250,000 students in public schools across five governorates covered by the Universal Health Insurance System (UHIS). The Egyptian Healthcare Authority (EHA), which is overseeing the programme, said the screenings will run through October and cover pupils entering kindergarten, sixth grade, and tenth grade in the 2025–26 academic year. The campaign is being rolled out in Port Said, Luxor, Ismailia, South Sinai, and Suez—the first five governorates included in the UHIS since its gradual rollout began in 2018. Students in all public education streams, including Al-Azhar and technical and sports schools, will be eligible. The exams include general medical check-ups, eye and skin assessments, dental exams, and visual, hearing, and mental health impairments screenings. Older students entering preparatory and secondary school will also be tested for Hepatitis C and undergo comprehensive blood tests and early screenings for chronic illnesses. Students with health issues will be referred to UHIS-affiliated health centres and units for further testing and treatment, free of charge. All results will be digitally stored in each student's electronic health record to allow for long-term monitoring through the Family Medicine Units. Students can schedule appointments through the national hotline 15344. EHA chairman Ahmed El-Sobky said the screenings are critical to supporting children's physical and mental development and detecting health problems early. He added that the initiative aligns with broader government efforts to improve public health and invest in the country's younger generations. As part of the UHIS expansion, the authority recently added two new hospitals in Dahab and Nuweiba in South Sinai. Earlier this month, the Egyptian cabinet approved the system's rollout in Aswan, which will begin full operations on 1 July 2025—making it the sixth governorate to join the programme. The UHIS aims to provide universal healthcare coverage for all Egyptians by 2030. Follow us on: Facebook Instagram Whatsapp Short link:
Yahoo
23-05-2025
- Business
- Yahoo
PMV Pharmaceuticals to Participate at Upcoming Investor Conferences
PRINCETON, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. ('PMV Pharma'; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today announced that David H. Mack, Ph.D., President and Chief Executive Officer and Deepika Jalota, Pharm. D., Chief Development Officer, will participate at the following investor conferences. Management will also participate in one-on-one investor meetings. TD Cowen 6th Annual Oncology Innovation Summit: Insights for ASCO & EHA Date: Tuesday, May 27, 2025Time: 11:30 AM EDT Jefferies Global Healthcare Conference Date: Thursday, June 5, 2025Time: 3:45 PM EDT A live audio webcast of the events will be available online at Events & Presentations. An archived replay of PMV Pharma's presentations will be available for 90 days following the webcast at Events & Presentations. About PMV Pharma PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. TP53 mutations are found in approximately half of all cancers. Our co-founder, Dr. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with a pharmaceutical development focus. PMV Pharma is headquartered in Princeton, New Jersey. For more information, please visit Investors Contact:Tim SmithSenior Vice President, Head of Corporate Development and Investor Relationsinvestors@ Media Contact:Kathy VincentGreig Communicationskathy@ 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
Yahoo
22-05-2025
- Business
- Yahoo
Rigel Announces Poster Presentations at the 2025 ASCO Annual Meeting and EHA2025 Congress
Final data from the GAVRETO® (pralsetinib) Phase 1/2 ARROW study in RET fusion-positive NSCLC and other solid tumors Supportive data for REZLIDHIA® (olutasidenib) utilization in patients with mIDH1 R/R AML SOUTH SAN FRANCISCO, Calif., May 22, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced seven upcoming poster presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) 2025 Congress. The ASCO Annual Meeting is being held in Chicago, Illinois and virtually from May 30 to June 3, 2025. The EHA2025 Congress is being held in Milan, Italy and virtually from June 12 to June 15, 2025. Rigel's poster presentations will include data for GAVRETO® (pralsetinib) for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), including final data from the Phase 1/2 ARROW study, and REZLIDHIA® (olutasidenib) for the treatment of relapsed or refractory (R/R) mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML). "We look forward to several posters highlighting the strength of our hematology and oncology product portfolio at ASCO and EHA, including the final efficacy and safety data from the Phase 1/2 ARROW study of GAVRETO. The study data continue to demonstrate GAVRETO's clinically meaningful and durable responses in patients with RET fusion-positive NSCLC, regardless of prior therapies, with a manageable safety profile. The study also showed promising anti-tumor activity in patients with various RET fusion-positive solid tumors, suggesting the potential for GAVRETO to address these unmet needs," said Raul Rodriguez, Rigel's president and CEO. "In addition, the collective data being presented on REZLIDHIA support its duration of response and potential clinical benefit when used in earlier lines of treatment for R/R AML patients and in primary refractory patients who are traditionally difficult to treat." ASCO Annual Meeting abstracts may be accessed online via Details of the poster presentations are as follows: ASCO Poster Presentations Saturday, May 31, 2025, 1:30pm to 4:30pm CTAbstract #: 8644Title: Efficacy and Safety of Pralsetinib in Patients with Advanced RET-fusion-positive NSCLC: Final Data from the Phase 1/2 ARROW StudyPresenter: Gilberto de Lima Lopes, M.D., MBA Final top-line efficacy and safety in RET fusion-positive NSCLC patients produced clinically meaningful and durable responses regardless of prior therapies, with a manageable safety profile. These results support the findings in previously published results, with a longer follow up period. Overall response rate (ORR) was 70.3% and median duration of response (DOR) was 19.1 months in the measurable disease population (n=259). In the efficacy population (n=281), median overall survival (OS) was 44.3 months with median follow up of 47.6 months. Median progression-free survival (PFS) was 13.1 months overall but was longer in the United States (25.9 months) vs. Asia (12.6 months) or Europe (12.9 months). Sunday, June 1, 2025, 9:00am to 12:00pm CTAbstract #: 6545Title: A Phase 2 Study of Olutasidenib in Relapsed/Refractory AML: Outcomes by Number of Prior Treatment RegimensPresenter: Eunice S. Wang, M.D. A post-hoc analysis of the pivotal cohort from the Phase 1/2 study evaluated outcomes in patients with R/R mIDH1 AML who received olutasidenib after either 1-2 or ≥3 prior lines of therapy. Patients in the 1-2 prior regimens group showed higher ORR and complete response (CR) / complete response with hematologic improvement (CRh) rates and longer median OS than those with ≥3 prior lines of therapy, providing a rationale for initiating olutasidenib earlier in the R/R treatment paradigm. Abstract #: 6546Title: Matching-adjusted Indirect Comparison (MAIC) of Olutasidenib and Ivosidenib in IDH1-mutated Relapsed/Refractory AMLPresenter: Justin M. Watts, M.D. In the absence of a head-to-head trial, a matching-adjusted indirect comparison (MAIC) analysis compared relative treatment effects of olutasidenib vs. ivosidenib in mIDH1 R/R AML, leveraging registrational data for olutasidenib and ivosidenib to match patients using key baseline clinical variables. Naïve and adjusted rates of response for olutasidenib vs. ivosidenib were comparable (adjusted point estimate favored olutasidenib for CR and ivosidenib for CR+CRh), while a longer duration of CR+CRh was observed with olutasidenib. Adjusted OS was similar between the two groups, although the hazard ratio (HR) favored olutasidenib. Results rely on the assumption of no unmeasured confounders, which reflects a limitation of the methodology. Monday, June 2, 2025, 1:30pm to 4:30pm CTAbstract #: 3116Title: Efficacy and Safety of Pralsetinib in RET Fusion-positive Solid Tumors: Final Data from the ARROW TrialPresenter: Vivek Subbiah, M.D. Final results from the Phase 2 portion of ARROW in patients with RET fusion-positive solid tumors other than NSCLC and thyroid cancer showed an ORR of 46.4% (13/28), including an ORR for pancreatic cancer of 100% (5/5). Overall, 10.7% (3/28) achieved complete response (pancreatic cancer, n=2; cancer of unknown primary, n=1) and 35.7% (10/28) achieved partial response. Median PFS was 7 months and median DOR was 11.1 months. Median OS was 10.3 months. Pralsetinib demonstrated robust and durable anti-tumor activity, with responses observed in many tumor types. These data validate RET fusions as a tissue-agnostic target with sensitivity to RET inhibition and activity beyond NSCLC and thyroid cancer, further supporting the promising potential of pralsetinib to address the unmet medical need in these patients. EHA2025 Congress abstracts may be accessed online via the EHA Library. Details of the poster presentations and publications are as follows: EHA Poster Presentations Friday, June 13, 2025, Time 18:30 to 19:30 CESTAbstract #: PF511Title: Efficacy and Safety of Olutasidenib Monotherapy in Primary Refractory AML: A Post Hoc Analysis of a Phase 2 StudyPresenter: Antonio Curti, M.D., Ph.D. In the pivotal cohort of R/R AML patients, 46 were primary refractory to first line treatment or subsequent induction therapy. With olutasidenib therapy, the ORR was 50% (23/46) and 30% (14/46) achieved a CR/CRh, with a mediation duration of CR/CRh of 17.6 months. The most commonly occurring treatment-emergent adverse events (AEs) were nausea (41%), vomiting (30%), and an increase in white blood cells (30%), with no new safety signals observed. Olutasidenib as a single agent demonstrated clinically meaningful activity and a durable response in patients with primary refractory AML, with an acceptable tolerability profile, suggesting it may be an effective therapeutic option for this patient population with a traditionally poor prognosis. Abstract #: PF516Title: Effect of Mutation Type and Co-mutations on Response to Olutasidenib in Patients With R/R Mutated IDH1 AMLPresenter: Stéphane de Botton, M.D., Ph.D. In the final five-year analysis of the registrational trial, mutational analysis showed durable responses across IDH1-R132 mutation types, particularly in the absence of RTK pathway co-mutations. Response rates were lower in patients with ≥4 co-mutations. Results show that it is possible for patients with deleterious co-mutations (i.e., FLT3, TP53, etc.) to respond favorably to olutasidenib, although the sample sizes are small for some co-mutations. Abstract #: PF530Title: Olutasidenib as Maintenance Therapy after Treatment Response in Mutated IDH1 Acute Myeloid LeukemiaPresenter: Andrew H. Wei, MBBS, Ph.D. In a separate cohort (n=18) of the Phase 2 trial, olutasidenib was evaluated as maintenance therapy in patients who achieved minimal residual disease (MRD)-positive CR or CR with incomplete blood count recovery (CRi) with prior treatment. The 4-month relapse-free survival (RFS) was 83% with a median RFS of 18.4 months. At 12 months, RFS was 71% and OS was 89%. RFS at 2 years was 48%. Two patients who had received prior venetoclax therapy entered with a CRi, improved to a CRh and ultimately a CR during the study. Most common treatment-emergent AEs were fatigue (33%), headache (33%) and nausea (28%), with no new safety signals. Olutasidenib as a single agent demonstrated clinically meaningful activity as a maintenance strategy in a subset of AML patients with CR/CRi and persistent MRD ≥0.01% after prior therapy. The analysis supports the potential benefit of switching to olutasidenib upon response to therapy. EHA Publications Abstract #: PB2499Title: Comparative Effectiveness of Olutasidenib and Ivosidenib in mIDH1 Relapsed or Refractory Acute Myeloid Leukemia Patients Post-Venetoclax: Insights From 2102-HEM-101 and a Real-World External ControlAuthors: Catherine Lai, M.D., MPH, Thomas Leahy, Ph.D., CStat, Alex Turner, Ph.D., Amber Thomassen, AGNP-BC, AOCNP, Lixia Wang, Ph.D., Aaron D. Sheppard, Ph.D., Jorge E. Cortes, M.D. Abstract #: PB2492Title: A Phase 2 Study of Olutasidenib in Relapsed/Refractory AML: Outcomes by Number of Prior Treatment RegimensAuthors: Eunice S. Wang, M.D., Jorge E. Cortes, M.D., Andrew H. Wei, M.D., Stéphane de Botton, M.D., Ph.D., Antonio Curti, M.D., Ph.D., Pau Montesinos, M.D., Ph.D., Karen W.L. Yee, M.D., Joseph G. Jurcic, M.D., William B. Donnellan, M.D., Jay Yang, M.D., Brian A. Jonas, M.D., Ph.D., Aaron D. Sheppard, Ph.D., Hua Tian, M.D., Justin M. Watts, M.D. Abstract #: PB2528Title: Matching-adjusted Indirect Comparison (MAIC) of Olutasidenib (OLU) and Ivosidenib (IVO) in isocitrate dehydrogenase-1 (IDH1)-mutated Relapsed/Refractory (R/R) AMLAuthors: Brian A. Jonas, M.D., Ph.D., Justin M. Watts, M.D., Eunice S. Wang, M.D., Florence R. Wilson, MSc, Julie Park, MMath, Shannon Cope, MSc, Aaron D. Sheppard, Ph.D., Jorge E. Cortes, M.D., Stéphane de Botton, M.D., Ph.D. About NSCLCIt is estimated that over 226,000 adults in the U.S. will be diagnosed with lung cancer in 2025. Lung cancer is the leading cause of cancer death in the U.S, with non-small cell lung cancer (NSCLC) being the most common type accounting for 85-90% of all lung cancer diagnoses.1 RET fusions are implicated in approximately 1-2% of patients with NSCLC.2 About AMLAcute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,010 new cases in the United States, most in adults, in 2025.3 Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.4,5 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.6 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need. About GAVRETO® (pralsetinib) INDICATIONS GAVRETO (pralsetinib) is indicated for the treatment of: Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)* *This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). IMPORTANT SAFETY INFORMATION Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis can occur in patients treated with GAVRETO. Pneumonitis occurred in 12% of patients who received GAVRETO, including 3.3% with Grade 3-4, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD. Hypertension: Occurred in 35% of patients, including Grade 3 hypertension in 18% of patients. Overall, 8% had their dose interrupted and 4.8% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity. Hepatotoxicity: Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 49% of patients, including Grade 3 or 4 in 7% and increased alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%. The median time to first onset for increased AST was 15 days (range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity. Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred in 4.1% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage. Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated. Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established. Embryo-Fetal Toxicity: Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the last dose. Common adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and increased bilirubin. Avoid coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong or moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose. Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose. Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur. Click here for Important Safety Information and Full Prescribing Information. To report side effects of prescription drugs to the FDA, visit or call 1-800-FDA-1088 (800-332-1088). About REZLIDHIA® INDICATIONREZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. IMPORTANT SAFETY INFORMATION WARNING: DIFFERENTIATION SYNDROME Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution. WARNINGS AND PRECAUTIONS Differentiation SyndromeREZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients, with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA initiation and has been observed with or without concomitant leukocytosis. If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold dose of REZLIDHIA and consider dose reduction based on recurrence. HepatotoxicityREZLIDHIA can cause hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The median time to onset of hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day to 17.5 months) after REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin. Monitor patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once in the fourth month, and once every other month for the duration of therapy. If hepatic dysfunction occurs, withhold, reduce, or permanently discontinue REZLIDHIA based on recurrence/severity. ADVERSE REACTIONSThe most common (≥20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and transaminitis. DRUG INTERACTIONS Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers. Avoid concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise instructed in the substrates prescribing information. If concomitant use is unavoidable, monitor patients for loss of therapeutic effect of these drugs. LACTATIONAdvise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose. GERIATRIC USENo overall differences in effectiveness were observed between patients 65 years and older and younger patients. Compared to patients younger than 65 years of age, an increase in incidence of hepatotoxicity and hypertension was observed in patients ≥65 years of age. HEPATIC IMPAIRMENTIn patients with mild or moderate hepatic impairment, closely monitor for increased probability of differentiation syndrome. Click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING. To report side effects of prescription drugs to the FDA, visit or call 1-800-FDA-1088 (800-332-1088). GAVRETO and REZLIDHIA are registered trademarks of Rigel Pharmaceuticals, Inc. About RigelRigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit The American Cancer Society. Key Statistics for Lung Cancer. Revised January 16, 2025. Accessed March 31, 2025: Kato, S. et al. RET Aberrations in Diverse Cancers: Next-Generation Sequencing of 4,871 Patients. Clin Cancer Res. 2017;23(8):1988-1997 doi: 10.1158/ The American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Revised March 4, 2025. Accessed March 31, 2025: Patel, A, et al. Outcomes of Patients With Acute Myeloid Leukemia Who Relapse After 5 Years of Complete Remission. 2021 Sep 7;28(7):811-814. doi: Thol F, Ganser, A. Treatment of Relapsed Acute Myeloid Leukemia. Curr. Treat. Options on Oncol. (2020) 21: 66. doi: Thol F, Schlenk RF, Heuser M, Ganser A. How I treat refractory and early relapsed acute myeloid leukemia. Blood (2015) 126 (3): 319-27. doi: Forward-Looking StatementsThis press release contains forward-looking statements relating to, among other things, the potential for the referenced clinical trials or trial results to strengthen our commercial portfolio, GAVRETO's success in treating both RET fusion-positive NSCLC and RET fusion-positive solid tumors, and the benefit of REZLIDHIA as an earlier line treatment for R/R AML. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "anticipates", "plan", "outlook", "potential", "may", "look to", "expects", "will", "initial", "promising", and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of fostamatinib, olutasidenib and pralsetinib; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding fostamatinib, pralsetinib or olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that fostamatinib, pralsetinib or olutasidenib may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, and subsequent filings, including Quarterly Reports on Form 10-Q. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law. Contact for Investors & Media: Investors:Rigel Pharmaceuticals, Inc.650.624.1232ir@ Media:David RosenArgot View original content to download multimedia: SOURCE Rigel Pharmaceuticals, Inc. Error 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
