Articles from EMD Serono

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the presentation of longer-term results from the global Phase 3 MANEUVER trial evaluating pimicotinib, an investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., for the treatment of patients with tenosynovial giant cell tumor (TGCT). This latest analysis showed that, with a median follow-up of 14.3 months, the objective response rate (ORR) for people treated with pimicotinib from the beginning of the study increased considerably to 76.2% (95% CI: 63.8, 86.0) by blinded independent review committee (BICR) per RECIST v1.1, from 54% at Week 25. The study also showed continued clinically meaningful improvements in key secondary endpoints related to patient outcomes such as pain and function. The safety profile was consistent with previously reported data. The results are being presented today in the Sarcoma mini-oral session at the European Society for Medical Oncology (ESMO) Congress 2025 (Presentation # 2690MO).

EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, and President Donald J. Trump’s administration, today announced an agreement to expand access to the company’s portfolio of in vitro fertilization (IVF) therapies for the more than 10 million American women struggling to have a baby.

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the presentation of over 30 abstracts from its multiple sclerosis (MS) portfolio. New four-year data from two large Phase 4 studies highlight the long-term efficacy, favorable disability outcomes and durable impact of MAVENCLAD® (cladribine) tablets in people living with relapsing multiple sclerosis (RMS). These findings are to be presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held September 24-26 in Barcelona.

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EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the presentation of detailed positive results from Part 1 of the global Phase 3 MANEUVER trial evaluating pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., in the treatment of patients with tenosynovial giant cell tumor (TGCT). Once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo (p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT. These findings will be presented Sunday, June 1 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #11500).

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the presentation of new oncology data across more than 12 tumor types at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 to June 4 in Chicago. The presentations include the Phase 3 MANEUVER data for potentially best-in-class pimicotinib in the treatment of the rare tumor TGCT, as well as data from both company- and investigator-sponsored studies highlighting the company’s focus on advancing differentiated molecules to tackle some of the most challenging cancers.

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EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the appointment of Miguel Fernández Alcalde as President of EMD Serono.

Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that the Phase III MANEUVER trial of pimicotinib, an investigational medicine being developed by Abbisko Therapeutics Co., Ltd., met its primary endpoint, demonstrating significant improvement in objective response rate (ORR) in patients with tenosynovial giant cell tumor (TGCT). The ORR for pimicotinib at week 25 was 54.0% compared with 3.2% for placebo (p<0.0001).

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced presentations showcasing the long-term safety profile, sustained efficacy data, and durable effect of MAVENCLAD® (cladribine) tablets in individuals with relapsing multiple sclerosis (RMS). Among 34 total MAVENCLAD presentations are data from several MAGNIFY-MS sub-studies demonstrating the impact of MAVENCLAD on disability progression, central inflammation, and an oral presentation on immune reconstitution effects. These data, along with six other company abstracts, will be presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) taking place September 18-20 in Copenhagen.

Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced the first patient has been dosed in the Phase III MyClad trial (NCT06463587) evaluating the efficacy and safety of oral cladribine for the treatment of generalized Myasthenia Gravis (gMG). Cladribine capsules have the potential to be the first oral treatment for gMG patients. gMG is a rare, neuromuscular disorder causing muscle weakness that can be severe and have a significant impact on patients’ lives.

Merck KGaA, Darmstadt, Germany, a leading science and technology company that operates its Healthcare business as EMD Serono in the US and Canada, today shared updates on the company’s oncology pipeline and focused approach to the research and development of potential new medicines designed to improve the futures of people with cancer. This year, the company plans to open multiple new Phase Ib and II clinical studies for tuvusertib and M9466, key assets from its broad portfolio of DNA damage response (DDR) inhibitors; has advanced its lead antibody-drug conjugate (ADC), M9140, to Phase Ib based on positive signs of clinical benefit, and plans to expand to additional tumors; and progress M3554, its next ADC based on the company’s proprietary exatecan-payload platform, into clinical development. These and other updates were shared at the company’s Oncology R&D Update Call.

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced new research from the company’s diverse oncology portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 to June 4, Chicago. Data from company- and investigator-sponsored studies include 31 accepted abstracts across more than 10 tumor types, including seven oral presentations, highlighting the company’s innovative oncology pipeline encompassing potential first-in-class approaches designed to hit cancer at its core.

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the presentation of two new post-hoc analyses of tertiary endpoints from the MAGNIFY-MS study, a Phase IV, prospective, open-label study evaluating the efficacy and safety of MAVENCLAD® (cladribine) tablets in highly active relapsing multiple sclerosis (RMS). The first presentation examines the stability or improvement in cognitive processing speed over a two-year period, suggesting the potential of MAVENCLAD to maintain or improve cognitive function in patients with highly active RMS. Additionally, interim findings from year three of the MAGNIFY-MS extension trial underscore the continued efficacy and safety profile of MAVENCLAD, which is consistent with earlier safety data. These data are being presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024.

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced new real-world data that continue to reinforce the JAVELIN Bladder regimen of first-line platinum-based chemotherapy followed by BAVENCIO® (avelumab) maintenance as a standard of care for eligible patients with locally advanced or metastatic urothelial carcinoma (UC) who do not progress on first-line chemotherapy. Data include real-world studies that confirm median overall survival (OS) of approximately 30 months in patients without progression after first-line chemotherapy. Additional analyses offer insights into treatment sequencing outcomes in the real world, with the first analysis of OS by next-line treatment, including in patients who received an antibody-drug conjugate (ADC) such as enfortumab vedotin after the JAVELIN Bladder regimen. These and other analyses will be presented at the 2024 American Society of Clinical Oncology’s annual Genitourinary Cancers Symposium, January 25-27, in San Francisco.

Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced a licensing agreement with Inspirna, Inc. (New York, NY) for ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, and SLC6A8-targeting follow-on compounds. Ompenaclid is currently being evaluated in a Phase II study for the second-line treatment of RAS-mutated (RASmut) advanced or metastatic colorectal cancer (mCRC).

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that it plans to move its U.S. Healthcare headquarters, currently located in Rockland, Mass., to Boston’s Seaport district. ​

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that 28 abstracts featuring the latest research on the company’s oncology portfolio addressing unmet needs across bladder, head and neck, lung, colorectal and other cancers, will be presented at the 2023 European Society of Medical Oncology (ESMO) Annual Meeting, October 20-24, Madrid, Spain.

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced new five-year data from the open-label extension (OLE) of the Phase II clinical trial, which demonstrated that people with relapsing multiple sclerosis (RMS) treated with investigational BTK inhibitor (BTKi) evobrutinib continued to have low annualized relapse rates (ARR), with a high proportion of patients showing no evidence of clinical worsening. Additional patient-reported data from the study showed statistically significant and clinically meaningful improvements in mental health and vitality, which is closely related to fatigue. These data, presented at the 9th Joint ECTRIMS-ACTRIMS meeting, may indicate the long-term positive benefits of evobrutinib for people with RMS.

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the presentation of new analyses from the MAVENCLAD® (cladribine) tablets MAGNIFY-MS study, which demonstrated that patients with relapsing multiple sclerosis (RMS) experienced sustained reduction in serum neurofilament light chain (NfL), indicating that MAVENCLAD reduced neuronal injury over two years. Additional data include two real-world evidence (RWE) studies, which indicated an increase in the use of cladribine tablets in treatment-naïve patients and demonstrated low levels of switching to other disease-modifying therapies (DMTs) up to four years. These data were presented at the 9th Joint ECTRIMS-ACTRIMS meeting in Milan, Italy.

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced a new collaboration with the United Nations-Guided Global Initiative on Ageing (GIA) to provide a training course on critical skills for family caregivers. The course, consisting of 5 modules, provides professional instruction and guidance on essential topics in caregiving such as using medical equipment, creating safe environments and overcoming communication barriers. The course is available on EMD Serono’s Embracing Carers® website: EmbracingCarers.com.

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that 43 abstracts covering several modalities and mechanisms will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, June 2-6, Chicago. New data for the medicines BAVENCIO® (avelumab) and TEPMETKO® (tepotinib) and pipeline assets including the first-in-class investigational IAP (inhibitor of apoptosis protein) inhibitor xevinapant demonstrate the Company’s efforts to pioneer novel medicines intended to improve the lives of people living with cancer.

Merck KGaA, Darmstadt, Germany, which operates its Healthcare business as EMD Serono in the US and Canada, today announced it has strengthened its Oncology franchise by regaining exclusive worldwide rights to develop, manufacture, and commercialize anti-programmed death ligand-1 (PD-L1) antibody BAVENCIO® (avelumab) following the termination of its Alliance agreement with Pfizer.

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced updated long-term efficacy and safety data for investigational evobrutinib that continue to show a favorable safety and tolerability profile, consistent with what was seen earlier in the double-blind period (DBP) of the clinical trials. These data also continue to demonstrate its treatment benefit in reducing annualized relapse rates (ARR) over four years in people with relapsing multiple sclerosis (RMS). Data will be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023, taking place February 23-25.

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced findings of a new analysis of long-term follow-up data from the Phase III JAVELIN Bladder 100 trial. These analyses reinforce the proven survival benefits of BAVENCIO® (avelumab) in the first-line maintenance setting for patients with locally advanced or metastatic urothelial carcinoma (UC). With median follow-up of at least 38 months from randomization, patients who were progression-free following platinum-based chemotherapy who received BAVENCIO first-line maintenance plus best supportive care (BSC) had longer median overall survival (OS) than those who received BSC alone in the maintenance setting. This benefit was seen regardless of whether their initial chemotherapy regimens included cisplatin or carboplatin. This analysis, as well as multiple studies of BAVENCIO in the real-world setting, are being presented at the 2023 American Society of Clinical Oncology’s annual Genitourinary Cancers Symposium, February 16-18, 2023.

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced findings which demonstrated that annualized relapse rates (ARR) remained low and Expanded Disability Status Scale (EDSS) scores were stable in people with relapsing multiple sclerosis (RMS) treated with investigational evobrutinib through more than three and half years. Additionally, the number of T1 gadolinium-enhancing (Gd+) lesions and T2 lesion volume remained low for the duration of the open-label extension (OLE) of the Phase II clinical trial. These data, presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), suggest the long-term positive benefits of evobrutinib for people with RMS as a potential best-in-class therapy.

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the company will present 39 abstracts at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held October 26-28, 2022 in Amsterdam, the Netherlands. The breadth of data highlights the Company’s scientific leadership in multiple sclerosis (MS) and includes a presentation on a clinical trial with long-term data on Expanded Disability Status Scale (EDSS) scores in people with relapsing MS (RMS) treated with evobrutinib, an investigational agent, as well as new data demonstrating MAVENCLAD® (cladribine) tablets improved Quality of Life (QoL) in people with highly active RMS over two years. Additionally, a two-year follow-up study showed the onset of action on the reduction of MRI lesions with MAVENCLAD being maintained from Month 2 through two years.

EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, in the US and Canada, today announced that the IAP (inhibitor of apoptosis protein) inhibitor xevinapant (formerly known as Debio 1143) plus chemoradiotherapy (CRT) markedly improved long-term efficacy outcomes in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) compared with placebo plus CRT. The addition of xevinapant more than halved the risk of death over five years compared with placebo. These late-breaking data from the 96-patient Phase II trial will be presented during the mini-oral session on head and neck cancer on September 10, 2022 at 10:55 AM CEST (Abstract #LBA33) at the European Society of Medical Oncology Congress 2022.

EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, in the US and Canada, today announced the latest research from the Company’s oncology portfolio and pipeline to be presented at this year’s European Society of Medical Oncology (ESMO) Annual Meeting, September 9-13, 2022. A total of 29 abstracts, including 5 late-breaking oral presentations and 2 additional mini-oral presentations, will feature data from company- and investigator-sponsored studies across six approved or investigational medicines in multiple tumor types.

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Not intended for UK-based media

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced 13 abstracts from the Company’s multiple sclerosis (MS) portfolio will be presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, being held April 2-7. Data being presented include presentations on investigational Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib, including new 2.5-year efficacy and safety data in patients with relapsing multiple sclerosis (RMS) from a Phase II open-label extension study and a Phase II post-hoc analysis demonstrating that treatment with evobrutinib led to a reduction in slowly expanding lesions (SEL), which may be associated with chronic inflammation in the central nervous system (CNS). Additionally, retrospective real-world efficacy and safety data on MAVENCLAD® (cladribine) tablets will be presented, including relapse data compared to other oral disease modifying therapies (DMTs) as well as COVID-19 outcomes.

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced new real-world data from the MSBase Registry demonstrating MAVENCLAD® (cladribine) tablets had more favorable relapse outcomes and longer time to switch to another disease modifying therapy (DMT) compared to the oral DMTs fingolimod, dimethyl fumarate (DMF) and teriflunomide in relapsing multiple sclerosis (RMS) patients. A second study, analyzing real-world follow up of clinical trial patients with a first attack suggestive of MS, showed those treated with MAVENCLAD had a lower rate of conversion to clinically definite multiple sclerosis (CDMS), defined by further relapse or disability progression, and a lower risk of relapse than those not exposed to MAVENCLAD. These data will be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2022, taking place February 24-26, 2022.

EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the European Commission (EC) has approved once-daily oral TEPMETKO® (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced a strategically focused expansion of its neurology pipeline with the acquisition of the rights to develop cladribine for the treatment of generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). The company entered into an agreement to secure the global rights by acquiring Chord Therapeutics, a Swiss-based biotech company focused on rare neuroinflammatory diseases.

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of once-daily oral TEPMETKO® (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in the first quarter of 2022.

More than two-thirds (69%) of unpaid caregivers of people living with cancer in the United States say the pandemic has worsened their emotional and mental health, and a similar percentage (66%) say the pandemic has made caregiving harder overall. These are the findings of a new analysis of more than 100 U.S. cancer caregivers surveyed in the Carer Well-Being Index conducted by Embracing Carers®, an initiative led by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada, in partnership with nine global caregiving organizations.

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today shared data in an oral presentation from a Phase II post-hoc analysis, demonstrating that the oral, central nervous system (CNS)-penetrant, fully covalent Bruton’s tyrosine kinase inhibitor (BTKi) evobrutinib impacted brain lesions associated with chronic inflammation in the CNS, making it the first BTKi to show significant reductions in slowly expanding lesions (SEL). SELs are chronic, active, demyelinated multiple sclerosis (MS) lesions, which are thought to be an early indicator of disease progression in MS. These data were presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) days after the completion of enrolment into the Phase III EVOLUTION RMS program, in which evobrutinib is being investigated, was announced.

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced new interim real-world data on MAVENCLAD® (cladribine) tablets that show patients with relapsing multiple sclerosis (RMS) experienced a significant improvement in quality-of-life (QoL) scores after the first course of treatment in Year 1 with MAVENCLAD. Additionally, late-breaking real-world MAVENCLAD data evaluating long-term mobility and disability status suggested sustained benefit beyond the last treatment course and a reduced need for a wheelchair or ambulatory device among MAVENCLAD-treated patients. These data were presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced enrollment has been completed in the Phase III EVOLUTION RMS clinical trial program, which is evaluating the efficacy and safety of investigational Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib in patients with relapsing multiple sclerosis (RMS). This milestone comes just ahead of the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place virtually from October 13-15, 2021, where 39 abstracts from the Company’s multiple sclerosis (MS) portfolio will be presented. Data will include two oral presentations and a late-breaking ePoster on evobrutinib as well as late-breaking ePosters on MAVENCLAD® (cladribine) tablets including new interim data on patient-reported improvements in quality of life (QoL) and new independent data on MAVENCLAD patients who have received a complete course of an mRNA COVID-19 vaccine.

Not intended for UK-based media

Not intended for UK-based media

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced a new analysis from the MAGNIFY-MS sub-study showing a specific immune repopulation pattern in patients with relapsing multiple sclerosis (RMS) treated with MAVENCLAD® (cladribine) tablets, which may contribute to their ability to fight infections and develop protective antibodies from vaccines. The data were presented at the 2021 American Academy of Neurology (AAN) Annual Meeting that was held virtually April 17 – 22, 2021.

Not intended for UK-based media