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Yahoo
4 hours ago
- Business
- Yahoo
Daiichi Sankyo Continues to Transform Treatment Landscape for Patients with Cancer with Practice-Changing Data at ASCO
Late-breaking data from DESTINY-Breast09 and DESTINY-Gastric04 phase 3 trials showcase how ENHERTU will potentially redefine standard of care for first-line HER2 positive metastatic breast cancer and second-line HER2 positive metastatic gastric cancer Investor meeting to discuss ASCO presentations and oncology development updates BASKING RIDGE, N.J., May 22, 2025--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 20 abstracts in multiple cancers at the 2025 American Society of Clinical Oncology Scientific Program (#ASCO25). Data at ASCO showcasing the company's progress towards creating new standards of care for patients with cancer will include two late-breaking oral presentations. The first will feature results of the DESTINY-Breast09 phase 3 trial (LBA #1008) where ENHERTU® (trastuzumab deruxtecan) in combination with pertuzumab demonstrated superior progression-free survival compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment in patients with HER2 positive metastatic breast cancer. The second will highlight results of the DESTINY-Gastric04 phase 3 trial (LBA #4002) where ENHERTU demonstrated superior overall survival compared to ramucirumab and paclitaxel as a second-line treatment in patients with HER2 positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Data from DESTINY-Breast09 and DESTINY-Gastric04 will be featured in ASCO press briefings. "This year's ASCO marks the fourth in a row where potential practice-changing ENHERTU data will be showcased," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "With the results of DESTINY-Breast09 and DESTINY-Gastric04, we now have six breast and two gastric cancer randomized trials that have demonstrated significant survival improvements with ENHERTU. These data, along with other updates across our industry-leading oncology portfolio, underscore our commitment to pushing the boundaries of science to create new medicines or combination strategies that improve outcomes for patients with cancer." Other ENHERTU data at ASCO will include an oral presentation featuring an exploratory circulating tumor DNA analysis of the DESTINY-Breast06 phase 3 trial (#1013) evaluating ENHERTU compared to physician's choice of chemotherapy in hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) metastatic breast cancer. Updated results from the PRO-DUCE study (#1545) examining vital sign monitoring compared to usual care in patients with metastatic breast cancer receiving ENHERTU also will be highlighted as a poster presentation. A trials-in-progress poster presentation will feature the DESTINY-Gastric05 phase 3 trial (TPS4207) evaluating ENHERTU in combination with a fluoropyrimidine-based chemotherapy and pembrolizumab compared to trastuzumab in combination with platinum-based chemotherapy and pembrolizumab in previously untreated patients with unresectable, locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or GEJ cancer. Progress in Lung Cancer Across Daiichi Sankyo's DXd ADC PortfolioUpdated DATROWAY® (datopotamab deruxtecan) combination data across three early-phase trials will be highlighted in patients with early or advanced non-small cell lung cancer (NSCLC). Updated results from the TROPION-Lung02 phase 1b trial (#8501) evaluating DATROWAY plus pembrolizumab with or without platinum-based chemotherapy in patients with previously untreated advanced NSCLC without actionable genomic alterations will be featured as an oral presentation. This will include results from an exploratory analysis using quantitative continuous scoring (QCS), AstraZeneca's proprietary computational pathology platform. Poster sessions will highlight the first presentation of data of DATROWAY and rilvegostomig, AstraZeneca's PD-1/TIGIT bispecific antibody, from the TROPION-Lung04 phase 1b trial (#8521) cohort evaluating the combination in patients without actionable genomic alterations who have advanced or metastatic NSCLC, and the final pathologic complete response and major pathologic response data from the NeoCOAST-2 phase 2 trial (#8046) evaluating DATROWAY with durvalumab, AstraZeneca's anti-PD-L1 therapy, and chemotherapy as neoadjuvant treatment followed by adjuvant treatment with durvalumab in patients with resectable early-stage (IIA to IIIB) NSCLC. Additional lung cancer data at ASCO will include an oral presentation of the HERTHENA-Lung02 phase 3 trial (#8506) of patritumab deruxtecan (HER3-DXd) versus platinum doublet chemotherapy in patients with locally advanced or metastatic EGFR-mutated NSCLC with disease progression following the use of an EGFR tyrosine kinase inhibitor (TKI). Trials-in-progress poster presentations in lung cancer across the DXd ADC portfolio will include the TROPION-Lung14 phase 3 trial (TPS8647) evaluating DATROWAY combined with osimertinib, AstraZeneca's EGFR TKI, compared to osimertinib alone in the first-line setting of patients with locally advanced or metastatic EGFR-mutated NSCLC and a substudy of KEYMAKER-U01, a phase 1/2 trial (TPS8652), evaluating pembrolizumab plus ifinatamab deruxtecan (I-DXd) or patritumab deruxtecan with or without chemotherapy in patients with untreated advanced NSCLC. Additional Data and Trials-in-Progress Across Daiichi Sankyo's Oncology Portfolio at ASCOOral presentations also will highlight initial results from the TUXEDO-3 phase 2 trial (#2005) evaluating patritumab deruxtecan in patients with metastatic breast cancer or advanced NSCLC and active brain metastases and in patients with leptomeningeal carcinomatosis/disease from advanced solid tumors, as well as results from a phase 1 trial (#10003) evaluating valemetostat, a dual EZH1 and EZH2 inhibitor, in pediatric patients with malignant solid tumors. Additional DXd ADC trials-in-progress poster presentations include the REJOICE-PanTumor01 phase 2 trial (TPS3158) evaluating raludotatug deruxtecan (R-DXd) in patients with locally advanced or metastatic gynecologic or genitourinary cancers, IDeate-PanTumor02 phase 1b/2 trial (TPS3157) evaluating ifinatamab deruxtecan in patients with recurrent or metastatic solid tumors and a substudy of KEYMAKER-U06, a phase 1/2 trial (TPS4209) evaluating ifinatamab deruxtecan in combination with pembrolizumab with or without chemotherapy in patients with advanced esophageal squamous cell carcinoma. Other trials-in-progress posters include the QuANTUM-Wild phase 3 trial (TPS6580) evaluating VANFLYTA® (quizartinib) in combination with chemotherapy in patients with FLT3-ITD negative acute myeloid leukemia and a first-in-human phase 1 trial of DS-2243 (TPS2668), a potential first-in-class bispecific T-cell engager targeting HLA-A*02/NY-ESO in patients with advanced solid tumors. Daiichi Sankyo will hold a virtual conference call for investors on Monday, June 2, 2025 from 6:00 to 7:15 pm CDT / Tuesday, June 3, 2025 from 8:00 to 9:15 am JST. Executives from Daiichi Sankyo will provide an overview of the ASCO research data and address questions. Details of the two late-breaking ENHERTU oral presentations at ASCO 2025 include: Presentation Title Author Abstract Presentation (CDT) LBAs Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for first-line treatment of patients with human epidermal growth factor receptor 2 positive (HER2+) advanced/metastatic breast cancer: interim results from DESTINY-Breast09 S. Tolaney LBA1008 Special LBA Session Oral Presentation Monday, June 2 7:30 – 8:00 am Trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with human epidermal growth factor receptor 2 positive (HER2+) unresectable/metastatic gastric cancer or gastroesophageal junction adenocarcinoma: primary analysis of the randomized, phase 3 DESTINY-Gastric04 study K. Shitara LBA4002 Oral Presentation Saturday, May 31 3:00 – 6:00 pm Highlights of additional clinical data and trials-in-progress from Daiichi Sankyo's oncology pipeline include: Presentation Title Author Abstract Presentation (CDT) Breast Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician's choice of chemotherapy in HER2 low/ultralow, hormone receptor-positive (HR+) metastatic breast cancer in DESTINY-Breast06 R. Dent 1013 Oral Presentation Saturday, May 31 1:15 – 4:15 pm HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2- breast cancer J. O'Shaughnessy TPS629 Poster Session Monday, June 2 9:00 am – 12:00 pm Electronic patient-reported outcomes with vital sign monitoring versus usual care during trastuzumab deruxtecan treatment for metastatic breast cancer: updated results from the PRO-DUCE study Y. Kikawa 1545 Poster Session Sunday, June 1 9:00 am – 12:00 pm Lung TROPION-Lung02: datopotamab deruxtecan (Dato-DXd) plus pembrolizumab with or without platinum chemotherapy as first-line therapy for advanced non-small cell lung cancer B. Levy 8501 Oral Presentation Sunday, June 1 8:00 – 11:00 am Patritumab deruxtecan (HER3-DXd) in resistant EGFR-mutated advanced non-small cell lung cancer after a third-generation EGFR TKI: the phase 3 HERTHENA-Lung02 study T. Mok 8506 Oral Presentation Sunday, June 1 8:00 – 11:00 am First-line datopotamab deruxtecan (Dato-DXd) + rilvegostomig in advanced or metastatic non-small cell lung cancer: results from TROPION-Lung04 (cohort 5) S. Waqar 8521 Poster Session Saturday, May 31 1:30 – 4:30 pm TROPION-Lung14: a phase 3 study of osimertinib ± datopotamab deruxtecan (Dato-DXd) as first-line treatment for patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer S. Lu TPS8647 Poster Session Saturday, May 31 1:30 – 4:30 pm Neoadjuvant durvalumab + chemotherapy + novel anticancer agents and adjuvant durvalumab ± novel agents in resectable non-small cell lung cancer: updated outcomes from NeoCOAST-2 T. Cascone 8046 Poster Session Saturday, May 31 1:30 – 4:30 pm KEYMAKER-U01 substudy 01A: phase 1/2 study of pembrolizumab plus ifinatamab deruxtecan (I-DXd) or patritumab deruxtecan (HER3-DXd) with or without chemotherapy in untreated stage IV non-small cell lung cancer C. Aggarwal TPS8652 Poster Session Saturday, May 31 1:30 – 4:30 pm Gastric An open-label, randomized, multicenter, phase 3 study of trastuzumab deruxtecan (T-DXd) + chemotherapy ± pembrolizumab versus chemo + trastuzumab ± pembro in first-line metastatic HER2+ gastric or gastroesophageal junction cancer: DESTINY-Gastric05 K. Shitara TPS4207 Poster Session Saturday, May 31 9:00 am – 12:00 pm Esophageal KEYMAKER-U06 substudy 06E: phase 1/2 open-label, umbrella platform study of ifinatamab deruxtecan in combination with pembrolizumab with or without chemotherapy for first-line treatment of advanced esophageal squamous cell carcinoma K. Kato TPS4209 Poster Session Saturday, May 31 9:00 am – 12:00 pm AML QuANTUM-Wild: a phase 3, randomized, double-blind, placebo-controlled trial of quizartinib in combination with chemotherapy and as single-agent maintenance in FLT3-ITD negative acute myeloid leukemia P. Montesinos TPS6580 Poster Session Sunday, June 1 9:00 am – 12:00 pm Pan-Tumor Patritumab deruxtecan (HER3-DXd) in active brain metastases from metastatic breast and non-small cell lung cancers, and leptomeningeal disease from advanced solid tumors: results from the TUXEDO-3 phase 2 trial M. Preusser 2005 Oral Presentation Friday, May 30 2:45 – 5:45 pm IDeate-PanTumor02: a phase 1b/2 study to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with recurrent or metastatic solid tumors T. Kogawa TPS3157 Poster Session Monday, June 2 1:30 – 4:30 pm REJOICE- PanTumor01: a phase 2 signal-seeking study of raludotatug deruxtecan (R-DXd) in patients with advanced or metastatic gynecologic or genitourinary tumors L. Albiges TPS3158 Poster Session Monday, June 2 1:30 – 4:30 pm A phase 1, first-in-human study of DS-2243, an HLA-A*02/NY-ESO directed bispecific T‑cell engager, in patients with advanced solid tumors S. D'Angelo TPS2668 Poster Session Monday, June 2 1:30 – 4:30 pm Pediatric Safety and efficacy of the EZH1/2 inhibitor valemetostat tosylate (DS-3201b) in pediatric patients with malignant solid tumors (NCCH1904): a multicenter phase 1 trial A. Arakawa 10003 Oral Presentation Saturday, May 31 3:00 – 6:00 pm About the ADC Portfolio of Daiichi SankyoThe Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo's DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi SankyoDaiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 125 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit View source version on Contacts Media Contacts: Global/US Media: Jennifer BrennanDaiichi Sankyo, + 1 908 900 3183 (mobile) Japan: Daiichi Sankyo Co., Investor Relations Contact: DaiichiSankyoIR_jp@ 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
Daily Mail
7 hours ago
- Business
- Daily Mail
Thousands of women with incurable breast cancer thrown a lifeline - doctors say hope is now possible
A first-of-its-kind daily pill that slows the spread of aggressive breast cancer is set to revolutionise the treatment of thousands, experts say. A trial has found that the drug, vepdegestrant, is twice as effective as existing treatments at extending the lives of patients with incurable breast cancer—buying them precious time with loved ones. Experts say that vepdegestrant also has far fewer side effects than medicines used on the NHS, and can be taken at home. One in seven women in the UK are diagnosed with breast cancer in their lifetime—around 56,000 a year—making it the most common cancer in the UK. While nine out ten patients survive, the disease still claims the lives of more than 11,000 annually. Around two-thirds of breast cancer patients in the UK have a form of the disease called ER positive HER-2 negative breast cancer. Of these, up to half with an advanced form can develop a genetic mutation which makes their cancer resistant to treatment. Patients who get this mutation—called ESR1—typically have less than two years to live. Currently, these patients receive a once-a-month injection called fulvestrant, which stops cancer cells from feeding off oestrogen, the female sex hormone that research shows helps tumours to grow. However, fulvestrant, which has to be adminstered by a healthcare professional, has a number of uncomfortable side effects including hot flushes, nausea and muscle pain. In some cases, it can also damage the liver. Even then, the injection can only keep the disease at bay for, on average, two months, the trial showed. And only a fifth of fulvestrant patients go six months without their cancer spreading. But the vepdegestrant trial, presented at the American Society for Clinical Oncology conference in Chicago, found that the tablet halted the spread of breast cancer for, on average, five months. Moreover, nearly half of the 300 patients given vepdegestrant went six months without their cancer spreading. The study found that the drug, which also blocks cancer cells from consuming oestrogen, has no major side effects. Experts say it is too soon to say exactly how much longer vepdegestrant patients live than those on fulvestrant, but they expect the difference to be significant. The drug is already being fast-tracked for use in the US and has been sent for approval in the UK. Experts believe it could get the greenlight in the UK because it is so much better than the existing options. 'Fulvestrant is incredibly painful and uncomfortable for patients, the majority of whom are forced to have to come to the clinic for it,' says Professor Komal Jhaveri, an oncologist at the Memorial Sloan Kettering Cancer Centre in New York. 'Oral tablets can be taken at home.' Dr Jane Meisel, a medical oncology professor at Emory University in Georgia, said: 'This drug will be a very exciting option for patients that could transform treatment.' Given it can be taken at home, does not leave patients suffering debilitating side effects, 'it's definitely the first of its kind', she added.
National Post
7 hours ago
- Business
- National Post
BeOne Medicines Presents New SEQUOIA Study Results Reinforcing BRUKINSA's Differentiated Profile with or without Venetoclax in Frontline CLL at ASCO 2025
Article content BRUKINSA plus venetoclax demonstrated high response rates and a favorable safety profile across CLL patient types in SEQUOIA Arm D, including those with high-risk del(17p) mutational status Article content Article content At 5-year follow-up of SEQUOIA Arm C, BRUKINSA monotherapy showed sustained OS and PFS benefit in hard-to-treat del(17p) CLL patients versus historical data Article content SAN CARLOS, Calif. — BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today will present new data from the Arm C and D cohorts of the pivotal, global Phase 3 SEQUOIA trial of BRUKINSA ® (zanubrutinib). The findings underscore the strong and consistent efficacy of BRUKINSA across CLL patient types, including high-risk mutation status. These data will be presented in two rapid oral presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Article content Data from the Arm D of SEQUOIA demonstrate that treatment with BRUKINSA plus venetoclax has the potential to drive progression-free survival and overall deep and durable responses across the frontline CLL patient spectrum, including patients with high-risk mutational status. The best undetectable minimal residual disease (uMRD) rate in peripheral blood at a sensitivity level 10 -4 was 59%. These efficacy responses observed in Arm D, despite the high proportion of high-risk patients enrolled, are in line with recent fixed-duration studies in fitter, healthier patient populations. Additionally, 11 patients in Arm D were able to discontinue treatment early due to meeting uMRD-guided stopping criteria, and 9 patients remain in ongoing clinical remission with sustained uMRD (1 patient discontinued study while in clinical remission), allowing them to remain treatment-free. In patients without del(17p) and TP53 mutations, 43% achieved uMRD by cycle 16 and 60% by cycle 28. These data were published today in the Journal of Clinical Oncology. Article content 'While many first-line CLL studies have excluded patient populations with high-risk disease features, BeOne included those patients in SEQUOIA,' said Lai Wang, Ph.D., Global Head of R&D at BeOne. 'Nearly 88% of patients with del(17p) and /or TP53 treated with BRUKINSA plus venetoclax remain progression-free at 36 months, which represents an unprecedented outcome for a doublet regimen in this difficult-to-treat patient population. These new SEQUOIA data reinforce BRUKINSA's versatility across the spectrum of CLL patients and reflect BeOne's commitment to progressing a pipeline built to meet unmet patient needs and elevate the standard of care.' Article content Arm D Highlights (Abstract 7009) SEQUOIA Arm D investigated BRUKINSA plus venetoclax in 114 patients with treatment-naïve (TN) CLL / small lymphocytic lymphoma (SLL) with or without del(17p) and/or TP53 high-risk mutations. At a median follow-up of 31.2 months, the combination induced a high 24-month progression-free survival (PFS) rate of 92% (95% CI, 85-96%) and an impressive overall response rate (ORR) of 97%. The 24-month overall survival (OS) rate was 96% (95% CI, 90%-98%). Of those patients with del(17p) and/or TP53 mutations, 94% were progression-free at 24 months and 87.6% were progression-free at 36 months. Article content The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. Article content 'The zanubrutinib and venetoclax combination achieved deep, durable responses across risk groups, including patients with TP53 mutations, with a generally manageable safety profile. Notably, several patients were able to discontinue treatment and maintain remission, highlighting the potential for time-limited therapy with meaningful disease control,' said Mazyar Shadman, M.D., M.P.H., Associate Professor and Innovators Network Endowed Chair, Medical Director, Cellular Immunotherapy and the Bezos Family Immunotherapy Clinic at Fred Hutch Cancer Center. 'Generating data to inform future CLL treatment strategies that allow for both continuous therapy and planned time off treatment is essential, particularly for high-risk patients who are the most likely to succumb to this disease.' Article content Arm C Highlights (Abstract 7011) Arm C of the SEQUOIA study investigated BRUKINSA monotherapy in patients with TN CLL / SLL and del(17p) mutations and is the largest prospective cohort of CLL/SLL patients with del(17p). At a median follow-up of over 5.5 years (65.8 months), most patients remained progression-free. Notably, at 60 months, 72.2% of patients who received BRUKINSA remained progression-free (95% CI, 62.4, 79.8). When adjusted for the impact of the COVID-19 pandemic, 73.0% of patients in the cohort remained progression-free (95% CI, 63.3, 80.6) at 60 months. The 60-month OS rate was 85.1% (95% CI, 76.9, 90.6) and 87.0% (95% CI, 79.0, 92.1) when adjusted for COVID-19. At the time of data cut-off, the ORR was 97.3%, and 62.2% of patients were still receiving treatment with BRUKINSA. Article content The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. Article content For additional information about our presence at the 2025 ASCO Annual Meeting, please visit our meeting hub: Article content About Chronic Lymphocytic Leukemia Chronic lymphocytic leukemia (CLL) is a life-threatening cancer of adults. It is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow, and lymphoid tissues. 1,2 CLL is the most common type of leukemia in adults, accounting for about one-third of new cases. 2,3 Approximately 20,700 new cases of CLL will be diagnosed in the U.S. in 2024. 3 Article content About 50% of CLL patients have high-risk genetic features – including del(17p), TP53 or unmutated IGHV – that may limit the effectiveness of some treatments (e.g. chemotherapy) and increase the likelihood of disease progression. 4,5 Article content About SEQUOIA SEQUOIA ( NCT03336333) is a randomized, multicenter, global Phase 3 trial designed to evaluate the efficacy and safety of BRUKINSA in patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial consists of three cohorts: Article content Cohort 1 (n=479): randomized 1:1 to receive BRUKINSA (n=241) or bendamustine plus rituximab (n=238) until disease progression or unacceptable toxicity, in patients not harboring del(17p); data from this group comprise the primary endpoint; Cohort 2/Arm C (n=110): patients with del(17p) receiving BRUKINSA as a monotherapy; and Cohort 3/Arm D (n=114): 66 patients with del(17p) and/or pathogenic TP53 mutation and 47 patients without del(17p) or TP53 were enrolled, with 110 patients receiving BRUKINSA in combination with venetoclax. Article content The results of Cohort 1 of the SEQUOIA study led to the regulatory approval of BRUKINSA monotherapy in the treatment of TN CLL in many countries across the world, including approvals by the U.S. Food and Drug Administration and the European Medicines Agency. The primary endpoint of the trial is progression-free survival (PFS), as assessed by an independent review committee (IRC). Secondary endpoints include investigator-assessed PFS, IRC- and investigator-assessed overall response rate (ORR), overall survival (OS), and safety, as well as PFS and ORR in patients with del(17p). Article content About BRUKINSA ® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton's tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. Article content BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is also the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets, and more than 200,000 patients have been treated globally. Article content Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Waldenström's macroglobulinemia (WM). Mantle cell lymphoma (MCL) who have received at least one prior therapy. Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. Article content The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Article content Hemorrhage Article content Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients. Article content Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Article content Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding. Article content Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Article content Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Article content Cytopenias Article content Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. Article content Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed. Article content Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Article content Cardiac Arrhythmias Article content Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients. Article content Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment. Article content Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA. Article content Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA. Article content Embryo-Fetal Toxicity Article content Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Article content Adverse Reactions Article content The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Article content Drug Interactions Article content CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers. Article content About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Article content Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne's ability to deliver advanced and effective treatments for a broad range of cancer patients; BRUKINSA's role across CLL patients; the ability of BeOne's pipeline to meeting evolving patient needs and elevate the standard of care; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne's ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. Article content _______________________________ 1 National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)–Patient Version. Accessed November 2024. 2 American Cancer Society. What is Chronic Lymphocytic Leukemia? Updated May 10, 2018. Accessed November 2024. 3 American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Updated July 1, 2024. Accessed November 2024. 4 Leukemia and Lymphoma Society. Chronic Lymphocytic Leukemia. Revised June 2021. Accessed November 5, 2024. Article content Article content Article content Article content Article content Contacts Article content Article content Article content
Yahoo
8 hours ago
- Business
- Yahoo
ConcertAI Provides Intelligent Automation of ASCO® Guidelines into its Generative and Agentic AI Precision Suite™ and CancerLinQ® SmartLinQ™ Solutions
Powered by CARAai, ASCO® Guideline-concordant care recommendations will be automatically provided to CancerLinQ Network medical oncologists through SmartLinQ, and for biopharma research through Precision Explorer and Trials CAMBRIDGE, Mass., May 31, 2025--(BUSINESS WIRE)--ConcertAI, a leader in oncology generative and agentic AI SaaS and multi-modal data (MMD) solutions for healthcare and life sciences, today announced the integration of the American Society of Clinical Oncology® (ASCO®) Guidelines through the CARAai platform for its Precision Suite and CancerLinQ® SmartLinQ solutions™. Now, the power of the Precision Suite's low-latency and high-recency data can be used by biopharma researchers to assess Guideline-concordant care and outcomes at any point in time or reviewing changes over time. Members of the CancerLinQ® network using SmartLinQ solutions will now have ASCO Guideline-concordant recommendations for their individual patients as an augmentation of their assessment of treatment options. This published information will be integrated with other SmartLinQ features that can help oncologists consider a complete set of treatment options for optimized patient outcomes. In December of 2023, ASCO and ConcertAI announced the acquisition of CancerLinQ and ongoing network operations as a ConcertAI initiative. Over the last year and a half, ConcertAI has advanced the SmartLinQ application for QOPI® applications as well as advanced notifications of potentially beneficial diagnostics and newly approved therapeutics for a provider's patients. SmartLinQ works directly within the workflows of Epic and other EMRs. ASCO Guidelines will be augmenting the SmartLinQ solution by June 15th as part of the company's effort to assure that all network practices have that informational resource. On May 30th, ConcertAI announced its oncology Precision Suite™ of generative and agentic AI solutions for advancing analytics and inferences, and for clinical trial design and optimization. The ASCO Guidelines will be available within these solutions by June 30th for assessment of Guideline-concordant care across the widest array of settings, and to inform the design of clinical trial controls according to published clinical recommendations. "Through CancerLinQ, ConcertAI has an almost decade-long history of collaborating with ASCO," said Jeff Elton, Ph.D., Vice Chairman of ConcertAI. "This license of ASCO Guidelines represents a new opportunity to harness the latest generative and agentic AI technologies to promote high-quality cancer care, evidence generation, and advanced care insights." The CancerLinQ SmartLinQ deployment of these guidelines will be available to demonstrate at the 2025 ASCO Annual Meeting in Chicago. About ConcertAI: ConcertAI is the leader in predictive and generative AI SaaS and real-world data research solutions for healthcare and life sciences. Our mission is to accelerate insights and outcomes for patients through research-ready data, CARAai™ technologies, and scientific expertise in partnership with over 46 leading biomedical innovators, 2,000 healthcare providers, and medical societies. TeraRecon provides advanced radiological image visualizations and clinical AI decision augmentation solutions for MRI and CT. CancerLinQ® is an initiative of ConcertAI, providing oncology providers with ASCO-aligned automated QOPI and ASCO Certified® quality solutions and SmartLinQ™ analytic services. Headquartered in Cambridge, Massachusetts, ConcertAI has offices in Bangalore, Frankfurt, Philadelphia, Raleigh-Durham, and Tokyo. For more information, visit us at View source version on Contacts Media ContactTreble McKenzie Covellconcertai@ 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
Yahoo
11 hours ago
- Business
- Yahoo
Bio-Techne Corporation (TECH): A Bull Case Theory
We came across a bullish thesis on Bio-Techne Corporation (TECH) on scuttleblurb's Substack. In this article, we will summarize the bulls' thesis on TECH. Bio-Techne Corporation (TECH)'s share was trading at $47.93 as of 28th May. TECH's trailing and forward P/E were 57.75 and 22.03 respectively according to Yahoo Finance. A close-up of a biotechnology machine working on an oncology therapy. Bio-Techne has built a diverse and complex business centered on its strong legacy in recombinant proteins, expanding downstream into antibodies, assays, and instrument platforms, while also moving into cell and gene therapy (CGT) solutions. Its revenue is split roughly between Protein Sciences and Diagnostics, which are closely linked—diagnostics identify disease biomarkers that then become therapeutic targets developed using Bio-Techne's proteins and antibodies. Despite about 20 acquisitions over the past decade, its core legacy products still contribute 56% of total revenue, with the remainder coming from faster-growing, less penetrated markets. Around half of Bio-Techne's revenue comes from commercial R&D, now dominated by smaller, venture-funded biotechs rather than big pharma, making this segment more cyclical. Academia accounts for another 20%, a price-sensitive group vulnerable to budget swings. The company is gaining ground in GMP protein production for clinical and commercial use, a highly regulated and lucrative niche, though it trails established leaders like Miltenyi and Cellgenix. Bio-Techne has also expanded into proteomics and spatial biology through acquisitions. While the company once forecasted nearly $2 billion in revenue by 2026, growth slowed due to several factors: COVID-related demand spikes followed by inventory destocking, a 20-30% revenue decline in China, fading COVID testing tailwinds, and cautious FDA oversight of CGTs that hurt growth expectations. Despite these setbacks causing a nearly 50% stock price decline, recent signs point to recovery with organic growth rebounding to 9% and instrument sales improving. Bio-Techne's broad strategy reflects its efforts to protect core franchises while expanding into new growth areas, including becoming an instrument provider to capture more downstream value. Bio-Techne Corporation (TECH) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 34 hedge fund portfolios held TECH at the end of the first quarter which was 24 in the previous quarter. While we acknowledge the risk and potential of TECH as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than TECH but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey.
