Übersicht des Medical Affairs Portal
Mode of Action Video zu Cobolimab
GSK is exploring different clinical assets aimed at augmenting the immune response, reducing immune suppression, and modulating the tumor microenvironment
Videovortrag von Prof. Reis zur Biomarkertestung beim OC
•In the phase 3 SIMPLIFY-1 trial, spleen and symptom benefits with momelotinib vs ruxolitinib were generally consistent in patients with anemia (baseline Hb levels <10 or <12 g/dL) compared with the ITT population • TI rates at week 24 in patients with anemia were nearly doubled with momelotinib vs ruxolitinib (eg, >1.7-times higher in the <10 g/dL subgroup, at 47% vs 27%), including higher rates of both maintenance of TI and achievement of new TI •No new momelotinib safety signals were identified in patients with anemia, and rates of grade ≥3 hematologic treatment-emergent adverse events during the double-blind period were lower than those observed with ruxolitinib • Overall, these descriptive analyses highlight the favorable benefit-risk profile of momelotinib in JAK inhibitor–naive patients with myelofibrosis and anemia, thus representing a potential treatment option for this population
• Lower HRQOL and functioning at baseline were reported in patients with MF in the phase 3 SIMPLIFY trials of momelotinib compared with the general population, highlighting the detrimental impact of MF on PROs regardless of transfusion status • Lower mean scores across all SF-36v2 domains were reported in patients who were TD than in those who were TI, either at baseline or at week 24 in the SIMPLIFY trials, suggesting that transfusion dependence in MF has a further negative impact on multiple aspects of patient quality of life • Associations between baseline transfusion status and PROs were observed in the physical functioning, role-physical, and general health SF-36v2 domains in SIMPLIFY-1 • These results were supported by associations between transfusion status and the physical functioning and fatigue domains of the EORTC QLQ-30 in MOMENTUM • Greater improvement across the SF-36/2 physical functioning, role-physical, general health, social functioning, and mental health domains was reported in patients who were TD at baseline in the SIMPLIFY trials but became TI at week 24 compared with those who remained TD, supporting the importance of transfusion independent status for physical functioning. general health, mental health, and overall quality of life • Mean changes for patients who became Tl exceeded the MID for groups with low baseline scores in all domains except role-physical (MID, 3.0; mean change, 2.212 • Hb levels at both baseline and week 24 in the SIMPLIFY trials may be incrementally associated with SF-36v2 physical functioning score, although the association was modest • These analyses highlight the detrimental impact of transfusion dependence on several HRQOL domains, most notably those related to physical functioning and fatigue, and the benefits of achieving transfusion independence at week 24, supporting further research into the effects of transfusions and anemia on quality of life in MF
• In a phase 2 study of 41 RBC TD patients treated with momelotinib, 85% (35/41) achieved a numeric reduction in RBC transfusion requirements on treatment compared with baseline • Using ordinal bins to group patients based on baseline-period and treatment-period intensity of RBC units transfused per 28 days, 90% (37/41) experienced a decline or stabilization of transfusion requirements on treatment; no patients were RBC transfusion-free at baseline, but 9 (22%) had no RBC transfusions over the entire treatment period • Mean change in transfusion intensity from baseline was −1.5 RBC units per 28 days, a decrease from baseline of ≈50% • Overall, these novel transfusion burden analyses demonstrate that binary transfusion independence response/nonresponse (34% transfusion independence responders in this study) may not fully capture the anemia benefits of momelotinib, which was associated with reduced RBC transfusion burden in the majority ofpatients (85%) • The RBC TD population and frequent assessments in this phase 2 study were advantageous to the present analysis, but limitations include the small sample size and lack of a comparator arm • With this phase 2 study providing proof of concept for the novel RBC transfusion burden analyses described here, similar analyses in the larger, randomized controlled phase 3 studies of momelotinib are ongoing
• Momelotinib showed a favorable safety profile vs fedratinib in both JAK inhibitor—experienced and —naive patients during a 24-week treatment window from phase 2 or3 trials involving momelotinib and fedratinib • There wasa significantly lower risk of key hematologic AEs, including anygrade and grade 3/4 anemia in both patient populations • The risk of key gastrointestinal AEs such as nausea and diarrhea was significantly reduced with momelotinib vs fedratinib • The favorable safety profile is consistent with what has been observed vs ruxolitinib in SIMPLIFY-1 and SIMPLIFY-2, particularly with respect to rates of anemia • These data support the use of momelotinib as a safe and tolerable treatment option for JAK and JAK inhibitor—naive patients with MF
Myelofibrose: Sorge von Betroffenen und Optionen für die Behandlung der Anämie
Anämie- Ein Schwerpunkt in der Behandlung der Myelofibrose
Videointerview mit Prof. Sehouli zu den Highlights zum Ovarialkarzinom vom ASCO 2023
Videointerview mit Prof. Thillr zu den Highlights zum Ovarialkarzinom vom ASCO 2023
Videointerview mit Prof. Hanker zur Präsentation der RUBY-Daten beim SGO 2023
Dostarlimab demonstrated durable antitumor activity in both dMMR/MSI-H and MMRp/MSS advanced or recurrent EC ▪ Median follow-up time is 27.6 (dMMR/MSI-H) and 33.0 (MMRp/MSS) months • Cohort A1 is the largest cohort of patients with dMMR/MSI-H EC studied with an anti–PD-1 monotherapy to date ▪ The probability of remaining in response at 24 months was 83.7% • Dostarlimab is the only PD-1 therapy clinically tested with a Q6W dosing schedule in endometrial cancer ▪ The safety profile was manageable ▪ The majority of TRAEs were grade 1 or 2 ▪ Discontinuation rates were low o 8.6% of patients discontinued treatment because of a TRAE
Prof. Schmalfeldt berichtet von den wichtigsten Studien zum Ovarialkarzinom, die beim SGO 2023 präsentiert wurden
Prof. Stefan Kommoss diskutiert die Relevanz der Biomarkertestung bei Primärdiagnose für die Behandlung des Endometriumkarzinoms
Videointerview mit Prof. Wölber zu den Highlights zum Endometriumkarzinom vom ASCO 2023
Zytopenien im Verlauf der MF Erkrankung, Patientenorientierte Therapieentscheidung, Kongresshighlights EHA 2023.
Unmet medical need: Zytopenien, Herausforderung Fatigue, Kongresshighlights EHA 2023.
PARP inhibitor Learn about the Poly ADP ribose polymerases (PARPs) family of enzymes which are involved in many functions, including DNA repair, gene expression, cellular signaling, and base excision repairs. PARP inhibition induces cell death through synthetic lethality.
Videointerview mit Prof. Mahner zur Präsentation der RUBY-Daten beim ASCO 2023
Videointerview mit PD Dr. Bronger zu den RUBY- und GY-018-Daten vom SGO 2023
Prof. Buderath berichtet von den wichtigsten Niraparib-Studien, die beim SGO 2023 präsentiert wurden
Myelofibrose: Fatigue und Anämie im Schwerpunkt
Myelofibrosis: Mechanism of Disease (Video)
•Among patients with MF who required RBC transfusions at baseline, treatment with momelotinib demonstrated an ability to deliver higher SVR, transfusion independence, and TSS response rates compared with BAT/RUX •With momelotinib, 25 patients in this baseline non-TI subgroup (35%) became TI (terminal 12-week criteria) at week 24 vs only 1 patient (3%) with BAT/RUX •Durability of transfusion independence with momelotinib is suggested by the similar TI response rates per terminal and rolling 12-week criteria (35% and 40%, respectively) •Mean Hb levels in this subgroup improved rapidly with momelotinib and remained higher than in those treated with BAT/RUX through week 24, despite the momelotinib arm having a lower median transfusion rate than the BAT/RUX arm during that period •Safety results in this subgroup were consistent with those previously reported for the ITT population •Collectively, these data suggest that in patients who need RBC transfusions, outcomes—notably anemiabenefits, including week 24 transfusion independence rate, median transfusion rate through week 24, and mean Hb levels over time—are improved by switching to momelotinib rather than continuing RUX and using ESAs or other supportive therapies to manage anemia
•Across 3 phase 3 trials, patients treated with momelotinib spent less time reliant on RBC transfusions and more time free from transfusions and anemia events compared with those treated with ruxolitinib, BAT, or danazol •The largest differences were observed with momelotinib vs ruxolitinib (SIMPLIFY-1) or BAT (88.5% ruxolitinib; SIMPLIFY-2) •However, momelotinib was also associated with less time reliant on RBC transfusions than danazol, a guideline-recommended supportive therapy for anemia managment in MF, in MOMENTUM •Incorporating anemia events into the TWiTR-An analyses had minimal impact on health state durations vs the TWiTR analyses. particularly in the JAK inhibitor-experienced setting (SIMPLIFY-2, MOMENTUM). consistent with the fact that more patients were TD at baseline in those trials •Given the negative QOL and prognostic impact of RBC transfusion dependence and achievement of transfusion independence with momelotinib may lead to improved quality of survival for patients with MF
•These data demonstrate that when accounting for differences in known prognostic factors and effect modifiers as well as changes in RBC transfusion status over time, a consistent and statistically significant relationship was observed between transfusion independence and OS across all 3 phase 3 momelotinibtrials •Consistent with inclusion of transfusion status in DIPSS-plus risk assessment,11these data support maintenance or achievement of TI status as a clinically relevant and meaningful endpoint that is prognostic for survival in JAK inhibitor–naive and –experienced disease settings, irrespective of other covariates •While factors such as sample size and follow-up that vary across trials impact the observed probability estimates for survival, the differing magnitudes of the separation between the TI and non-TI populations in each trial suggest that earlier initiation of momelotinib(eg, the JAK inhibitor–naive setting of SIMPLIFY-1) to maintain TI status or achieve it earlier may lead to more pronounced effects on OS •A limitation of these analyses is that evaluation of any potential differential impacts of these covariates on OS between momelotiniband comparator arms was not possible due to the crossover design of all 3 trials; all patients who remained in the trial after week 24 received momelotinib, confounding assessment of survival by treatment arm •Sensitivity analyses incorporating other time-dependent variables (eg, ferritin levels, platelet counts) and subgroup analyses (eg, baseline transfusion status) are being explored and may identify additional longitudinal changes that, along with transfusion status, impact OS in patients with MF
•Momelotinib was associated with improvements in RBC transfusion intensity and zero RBC transfusion status vs ruxolitinib in JAK inhibitor–naive patients with MF (SIMPLIFY-1) •Momelotinib treatment was associated with a reduction in mean RBC transfusion burden, while ruxolitinib was associated with increased mean RBC transfusion burden •Most patients who crossed over from ruxolitinib to momelotinib during the open-label phase experienced improved or maintained RBC transfusion burden vs baseline •These data suggest that increases in transfusion burden were delayed or prevented in patients treated with momelotinib compared with those treated with ruxolitinib •In JAK inhibitor–experienced patients with MF (MOMENTUM), momelotinib showed greater reduction in RBC transfusion burden from baseline vs danazol, which is a standard anemia therapy •Across both trials, ≥85% of patients treated with momelotinib either maintained or experienced improved transfusion intensity compared with baseline, highlighting that momelotinib provides consistent anemia benefit for the majority of patients
•Reductions in the need for transfusions associated with momelotinib are projected to result in meaningful healthcare system and patient savings in medical and transfusion-related costs relative to RUX in JAK-inhibitor-naive patients with MF. These findings were sonsistent in patients aged => 65years and patients with TD or TI/TR status at baseline •Patients with anemia (Hb <10g/dlL at baseline) had higher projected medical and transfusion-related cost savings with momelotinib compared with RUX •Momelotinib is also projected to provide time savings for patients on transfusion-related travel, procedure and recovery, and preparation and waiting compared with RUX •Future studies of real-world data are warranted to further ecaluate the impact of momelotinib on the clincial and economic, and humanistic burden in patients with MF
Aktuelle Fragen im Endometriumkarzinom - Aktuelle Zulassungs- und Studienübersicht im EC
Videointerview mit Prof. Rom zu den Studienhighlights im Ovarialkarzinom vom ESMO 2023
Videointerview mit PD Dr. Bronger zu den RUBY- und GY-018-Daten vom SGO 2023
Videointerview mit Prof. Hartkopf - Studien zur Immuntherapie beim Ovarialkarzinom vom ESMO 2023
Videovortrag von Prof. Pietzner zu PARPi bei BRCAm und NPlus
Scratch-Video zum Wirkmechanismus von Niraparib
Videointerview mit Prof. Lux zu den Studienhighlights im Endometriumkarzinom beim ESMO 2023
Videointerview mit Prof. Wölber - Neue Ergebnisse aus der RUBY-Studie zum Endometriumkarzinom beim ESMO 2023
Interaktive Infografiken zur 1L-Erhaltungstherapie beim OC mit zahlreichen Links zu weiterführenden Materialien
Erklärfilm zur Rolle der Immuntherapie für Patientinnen mit dMMR/MSI-H Endometriumkarzinom
Results from pooled phase 3 studies with momelotinib demonstrating association of Hb improvement with clincially meaningful improvements in symptoms
Results from pooled phase 3 studies with momelotinib demonstrating association of Hb improvement with clincially meaningful improvements in symptoms
Results from pooled phase 3 studies with momelotinib demonstrating association of Hb improvement with clincially meaningful improvements in symptoms
Modulares Webinar zum Ovarialkarzinom "State of the Art - von der Diagnose bis zur Rezidivtherapie" (4 CME Punkte). Zertifiziert bis 09/2023.
Interaktive Infografiken zur 1L-Erhaltungstherapie beim OC mit zahlreichen Links zu weiterführenden Materialien
Conclusions - In patients with advanced OC, 1L niraparib maintenance treatment was associated with a significant gain in QA-PFS compared with placebo, indicating a patient-relevant improvement in PFS. ● Niraparib increased restricted mean PFS without significantly increasing TOX time (duration of symptomatic grade ≥2 AEs prior to disease progression). The significant gain in TWiST demonstrates that niraparib-treated patients remained symptom-free for longer than those who received placebo. ● Collectively, the significant gains in QA-PFS and QA-TWiST demonstrate that niraparib maintenance treatment is associated with a PFS improvement whilst preserving patients’ HRQoL.
ZEAL-1L (NCT04475939) is a Phase 3, randomised, double-blind trial in patients with advanced or metastatic NSCLC without known driver mutations that will compare efficacy and safety of nira + pembro with placebo + pembro
These results showed that patients with advanced or recurrent EC received variable active treatment following PBCT – Overall, a large percentage of patients received no active therapy at index and, for those who did, the most common was doxorubicin monotherapy; this trend was similar across all countries • More than half (56% [151/271]) of patients did not respond to post-platinum treatment and, for those who progressed, treatment options were limited, suggesting that effective treatments are still needed – Patient response rates to CT reported here are higher than clinical trial rates. 6 This may be due to the majority of patients being ECOG 0/1 and/or physician selection bias of selecting responders • This study found that MSI or MMR testing is not common in clinical practice in the EU and varies between countries, highlighting the need to increase biomarker testing • As this was a chart abstraction, some limitations exist, including that data were originally collected for clinical practice and not research purposes, differences in data collection and reporting may exist between participating physicians and countries, and there may be patient selection bias by the physicians
• Improved OS was observed with dostarlimab compared with doxorubicin in pts with A/R EC • Dostarlimab and doxorubicin safety profiles were consistent with previous studies • There are inherent limitations with this type of comparison. IPTW is not a replacement for direct head-to-head comparison in a randomized controlled trial. Despite mASM, inter-study differences in assessment timing may impact results. A lower number of pts received dostarlimab compared with doxorubicin. There could also be an unknown impact of doxorubicin on MMR/MSI status • Overall, this ITC suggests a favorable benefit:risk profile for dostarlimab in pts with dMMR/MSI-H A/R EC
Safety with dostarlimab was consistent with the anti– PD-1 drug class ● Safety was consistent across tumor types ● Most treatment-related adverse events (TRAEs) were low grade, with few leading to interruption or discontinuation ● No overall increase in the rate of TRAEs was seen after transitioning to the 1000-mg Q6W dosing schedul
In the phase 3 MOMENTUM study, all prespecified primary and key secondary endpoints were met − Significant improvements in symptoms, spleen size, and anemia measures were observed with momelotinib vs danazol − Momelotinib was associated with a favorable safety profile and trend towards improved overall survival Momelotinib is the first and only JAK1 and JAK2 inhibitor that also decreases hepcidin through ACVR1 inhibition − This may contribute to rapid and sustained improvements in hemoglobin levels and transfusion requirements Momelotinib exhibits a consistent profile across thrombocytopenic subgroups, as described on a separate poster at this meeting Momelotinib exhibits a consistent profile across thrombocytopenic subgroups, as described on Poster 117 These findings support the future use of momelotinib as an effective treatment in MF patients, especially those with anemia
These data represent the most extensive BMF assessment in patients with MF to date (>300 paired biopsies and mature clinical data across distinct JAKi in treatment-naïve patients) Approximately 20% of JAKi-naïve patients experienced ≥1 grade BMF improvement within 24 weeks of either momelotinib or ruxolitinib treatment However, BMF changes from baseline to week 24 did not correlate with week 24 symptom or spleen response, anemia improvement, or long-term OS Given the lack of association with OS, these findings indicate the need to better understand BMF changes by week 24 as a surrogate for clinical benefit and disease modification
Patients receiving momelotinib in the MOMENTUM study demonstrated greater and consistent improvement in symptoms compared with danazol, using responder analysis, longitudinalresponder analysis, and time to event analyses Momelotinib showed significantly greater symptom and quality oflife improvement compared with danazol at week 24 for fatigue,abdominal discomfort, night sweats, pain, physical function, socialfunctioning, role functioning, insomnia, and global HRQOL asmeasured by MFSAF, EORTC QLQ-C30, and PROMIS questionnaires Consistent with the primary end point of MOMENTUM, the higher magnitude of response and faster response demonstrate that momelotinib provides progressive and durable symptom benefit (also shown in MOMENTUM week 48 oral presentation 627
In thrombocytopenic, symptomatic, and anemic patients with MF, including those with platelet counts as low as 25×10^9/L, momelotinib was administered safely and demonstrated improvements in symptom responses, transfusion independence rates, and spleen responses as compared with danazol Consistent with the overall intent-to-treat MOMENTUM population, platelet counts remained stable over time, and a trend toward improved overall survival versus danazol was maintained, in thrombocytopenic MF patients treated with momelotinib Momelotinib, which is the first and only JAK1 and JAK2 inhibitor that decreases hepcidin through ACVR1 inhibition, may address a critical unmet need particularly in symptomatic MF patients with anemia and thrombocytopenia
In this updated analysis, OL momelotinib maintained week 24 symptom, TI, and spleen responses with continued favorable survival and safety Momelotinib is the first and only JAK1 and JAK2 inhibitor that also decreases hepcidin through ACVR1 inhibition, thus providing benefit for patients with MF and anemia, which is an unmet need in MF treatment These findings support the potential use of momelotinib as an effective treatment in patients with MF, particularly in patients with anemia and thrombocytopenia
In MOMENTUM, in symptomatic and anemic patients with myelofibrosis, momelotinib showed significant benefit with higher TI response rates and lower transfusion burden compared with DAN In patients achieving week 24 TI-R, OS was significantly improved compared with patients who were non-TI Both MOMENTUM and the SIMPLIFY studies suggest that achieving week 24 TI-R on momelotinib may be a potential surrogate for improved OS TD patients not achieving TI on-study were still more likely to have reduced transfusion burden (become TR) on momelotinib when compared with DAN TD patients becoming TR by week 24 also demonstrated a significant improvement in OS Given the association of improved OS with reduced transfusion burden, this provides a potential signal of disease modification
TD in patients with myelofibrosis led to significantly higher rates of health care resource utilization and costs compared with non-TD patients, even after controlling for differences in age, gender, and baseline comorbidity The higher economic and clinical burden of TD is driven only in part by the higher number of transfusions Only a small proportion of patients with myelofibrosis diagnoses across all risk and disease durations within the IBM MarketScan Commercial Claims and Encounters Database are transfusion dependent. These results warrant the ongoing investigation in older populations This study highlights the need for additional therapeutic options to limit progression to TD and offset costs for patients with myelofibrosis
This study reports the largest clinical trial safety database to date in patients with JAKi-naive or -experienced myelofibrosis Most patients tolerated continuous treatment with momelotinib without cumulative toxicity Consistent with the lack of increasing hematologic AEs over time, hemoglobin and platelet values improved or remained consistent, respectively Peripheral neuropathy was mostly mild/moderate and noncumulative The risk of second primary malignancies and AML were not increased for a myelofibrosis population This integrated analysis demonstrated the long-term safety of momelotinib in patients with myelofibrosis from early to late stages, and with varying degrees of anemia
Momelotinib has undergone unique and extensive analysis in patients who transitioned from RUX without tapering or washout of RUX Transitioning to momelotinib from RUX can rapidly improve anemia and shift patients to TI without compromising splenic control Momelotinib requires once-daily dosing, infrequent dose modifications, and is very well tolerated during the transition after RUX and beyond No symptoms associated with withdrawal were observed when patients transitioned from RUX, which is often a clinical issue when transitioning between JAKis Administering momelotinib immediately after RUX, without tapering or washout, is safe, maintains symptom benefit and spleen volume, and improves anemia in patients with myelofibrosis
TMB-high (TMB-H) status and dMMR/MSI-H status show substantial overlap in the patient populations with EC ● TMB-H and dMMR/MSI-H EC have similar response rates ● Notably, the objective response rate (ORR) of patients with mismatch repair proficient (MMRp) and TMB-H EC was comparable to the ORR of patients with dMMR/MSI-H and TMB-H EC – TMB-H status in the patients with MMRp EC was not due to MSI-H (hypermutated) or POLε-mutated (ultramutated) status ● The study was not powered to assess antitumor activity by TMB status, and interpretation is limited by the small number of patients in each subgrou
This preliminary data suggests a manageable safety profile with low-dose belamaf (0.95 mg/kg Q3W) + nirogacestat (100 mg BID continuously) combination in patients with heavily pretreated RRMM. • Reduced ocular events, particularly Grade ≥3, 12.5% (2/10 in DE and 1/14 in CE) were observed in patients dosed with low dose belamaf + nirogacestat. • The ORR in belamaf + nirogacestat combination cohorts was 38% (9/24) and 17% achieved VGPR (4/24). • New sub-studies will evaluate belamaf + nirogacestat with standard of care treatments (Rd, Pd) as a quadruplet regimen to improve efficacy and reduce ocular events in patients with RRMM.1
Safety with dostarlimab was consistent with the anti– PD-1 drug class ● Safety was consistent across tumor types ● Most treatment-related adverse events (TRAEs) were low grade, with few leading to interruption or discontinuation ● No overall increase in the rate of TRAEs was seen after transitioning to the 1000-mg Q6W dosing schedul
Unsere Highlights vom DGP Kongress 2024 in Mannheim
Best of DGP Kongress 2023 - Highlights COPD
Online CME Fortbildung: Orale Kortikosteroide beim schweren Asthma bronchiale?
Wissenschaftliches Medizin-Portal für die Behandlung von schwerem eosinophilen Asthma. Nur für Angehörige der medizinischen Fachkreise in Deutschland.
Filterkriterien in der Praxissoftware: Schweres Asthma
Veranstaltungsseite zum PneumoCLUB meets Nexus 2024
Zusammenfassungen medizinischer Veranstaltungen
Unsere beiden Atemwegs-Flagship Veranstaltungen nächstes Jahr im Doppelpack - Sichern Sie sich jetzt ihren Platz!
EMAX-Studie: Direkter Vergleich von UMEC/VI vs. UMEC vs. SAL bei COPD
Prof. Dr. Claus Vogelmeier, Universitätsklinikum Gießen und Marburg. Mindestens 70 % der COPD-Exazerbationen haben einen infektiösen Ursprung, wobei in etwa 30 % der Fälle Atemwegsviren nachgewiesen werden. Könnte man daher viral-bedingte Exazerbationen durch eine Impfung gegen bekannte Erreger vermindern? Welche Impfungen sind für COPD-Patienten essenziell?
Prof. Dr. Michael Kreuter, Universitätsmedizin Mainz. Die Symptome einer IPF, vor allem der chronische Husten, sind für Patienten sehr schwer zu ertragen. Inwiefern kann die heutige Therapie diese Symptome beeinflussen und was erwartet uns in der Zukunft?
Prof. Dr. Stefan Andreas, Lungenfachklinik Immenhausen. Der Gebrauch von E-Zigaretten nimmt seit ihrer Einführung stetig zu und leider auch besonders in den jüngeren Altersgruppen beziehungsweise bei Jugendlichen. Es gibt ein hartnäckiges Gerücht, dass E-Zigaretten gesünder wären als richtige Zigaretten, doch stimmt das wirklich? Gibt es mittlerweile Langzeitdaten zu deren Verwendung?
Prof. Dr. Guy Brusselle, University Hospital Ghent (Video in englischer Sprache). Aktuelle Biologika im schweren Asthma sind zugelassen für die Add-on Therapie neben inhalativen Medikamenten. Es gibt allerdings eine Anzahl an sogenannten Super-Respondern, die durch die Biologika Gabe eventuell keine inhalative Medikation mehr benötigt. Prof. Brusselle spricht hier über neue Daten bezüglich der Sicherheit und Konsequenzen des Absetzens der inhalativen Therapie.
Prof. Dr. Michael Dreher gibt einen Überblick über die derzeit wichtigsten Atemwegserreger und wichtige Impfempfehlungen u.a. auch zum Schutz vor dem Respiratorischen Synzytial-Virus bei Erwachsenen und komorbiden Patienten.
Prof. Dr. Claus Vogelmeier, Universitätsklinikum Gießen und Marburg (NP-DE-FVU-VID-230004) Ist der Schwellenwert von ≥ 2 Exazerbationen pro Jahr, wie er zum vbei GOLD verwendet wird, in der Zukunft haltbar?
Prof. Dr. Marek Lommatzsch, Universitätsmedizin Rostock. Seit wenigen Jahren gibt es den Begriff klinische Remission als Therapieziel beim schweren Asthma, doch wie unterscheidet sich die neue Definition zu der bisher angestrebten Asthmakontrolle? Prof. Lommatzsch erklärt die wesentlichen Unterschiede und geht auf die Erreichbarkeit der Remission bei Patienten mit schwerem Asthma ein.
Prof. Dr. Tobias Welte, Medizinische Hochschule Hannover. Prof. Welte ist auf dem ERS-Kongress 2023 als erster Infektiologe mit der Sadoul Lecture ausgezeichnet worden. Diese Auszeichnung ist benannt nach dem französischen Wissenschaftler Paul Sadoul und ist quasi eine Art Nobelpreis der ERS.
In diesem Video erklärt Herr Prof Vogelmeier den Unterschied zwischen COPD-Patienten mit Typ 2 Inflammation und COPD-Patienten mit komorbidem Asthma - welche Konsequenzen hat das für die Therapie
Prof. Dr. Tobias Welte, Medizinische Hochschule Hannover. Gibt es neue Erreger von Atemwegsinfektionen, die eventuell auch wieder eine Pandemie auslösen könnten? Was erwartet uns und sind wir diesmal darauf vorbereitet?
Prof Dr. Mareike Lehmann, Universitätsklinikum Gießen und Marburg. Die aktuelle Behandlung der COPD besteht aus der inhalativen Therapie, die allerdings rein symptomatisch ist und nicht die Ursache der Erkrankung bekämpft. Doch was ist das Problem an diesem Ansatz? Prof. Lehmann geht darauf ein, welche neuen Therapieoptionen es in der nahen Zukunft geben könnte, wie z.B. die frühzeitige Zellalterung bei der COPD anzugehen.
Prof. Dr. Claus Vogelmeier, Universitätsklinikum Gießen und Marburg. Mindestens 70 % der COPD-Exazerbationen haben einen infektiösen Ursprung, wobei in etwa 30 % der Fälle Atemwegsviren nachgewiesen werden. Könnte man daher viral-bedingte Exazerbationen durch eine Impfung gegen bekannte Erreger vermindern? Welche Impfungen sind für COPD-Patienten essenziell?
Das RS-Virus ist allem bekannt für seine schweren Verläufen bei Säuglingen und Kleinkindern. Professor Joos erklärt hier, warum aber besonders ältere Erwachsene ab 60 Jahren und jene mit Grunderkrankungen gefährdet sind und wie eine neu zugelassene Impfung ältere Erwachsene über 60 Jahre wirksam schützen kann.
Prof. Dr. Tobias Welte, Medizinische Hochschule Hannover. Infektionen der Atemwege durch verschiedene Erreger wie z.B. Influenza oder RSV sind u.a. die wichtigsten Risikofaktoren für die Morbidität und Mortalität von Patienten mit chronischen Atemwegserkrankungen. Prof. Welte erklärt in diesem Video das Potential von Impfungen als Schutz für diese Hochrisikopatienten.
Prof. Dr. Stephanie Korn, IKF Pneumologie Mainz. In diesem Video diskutiert Frau Professor Korn inwieweit das Rauchen sich auf die Wirksamkeit von Biologika bei schwerem Asthma auswirken. Weiterhin geht es um neue Biomarker für sowohl die Auswahl als auch das Versagen der Biologika Therapie.
Prof. Dr. Guy Brusselle, University Hospital Ghent (Video in englischer Sprache). Gibt es Daten, ob die klinische Remission in der echten Behandlungsrealität tatsächlich erreichbar ist? Bei wieviel Prozent der Patienten ist dies möglich und wovon hängt das ab?
PD Dr. Henrik Watz, Lungenklinik Großhansdorf (NP-DE-FVU-VID-230002) Exazerbationen spielen eine wichtige Rolle in der Progression der COPD und dadurch auch in der Therapieentscheidung nach z.B. GOLD.
Die Eosinophilen gewinnen auch in der COPD immer mehr an Bekanntheit. So werden sie z.B. mittlerweile als Biomarker empfohlen für Patienten mit einem hohen Exazerbations-Risiko. Aber was passiert mit den Patienten, die keine erhöhten Eosinophilen Werte haben? Was sind hier die therapeutischen Optionen?
Prof. Dr. Michael Kreuter, Marienhaus Klinikum Mainz. Prof. Kreuter geht in diesem Video auf die Gemeinsamkeiten und die Abgrenzung der beiden progressiven Lungenfibrosen IPF und PPF ein und erläutert neue Daten, die auf dem ERS-Kongress vorgestellt wurden. Wird es in der Zukunft auch inhalative Therapien geben?
Prof. Dr. Michael Kreuter, Marienhaus Klinikum Mainz. Auf dem ERS-Kongress 2023 wurden neue Daten zur Sarkoidose vorgestellt. Konkret geht es um eine Reduktion der üblichen Kortison-Dosis. Prof. Kreuter diskutiert hier die positiven Aspekte dieser Studie aber auch die Limitationen.
Prof. Dr. Guy Brusselle, University Hospital Ghent (Video in englischer Sprache). Nicht bei jedem Patienten führen Biologika zu dem erwarteten Erfolg einer verbesserten Asthmakontrolle. Wie geht man mit diesen Patienten um? Um wieviel Prozent handelt es sich und gibt es Risikofaktoren?
Prof. Dr. Claus Vogelmeier zeigt neue Evidenzen inwiefern COPD-Patienten in Deutschland unterversorgt sind und diskutiert wie diese Situation in der Zukunft verbessert werden könnte.
Prof. Dr. Claus Vogelmeier, Universitätsklinikum Gießen und Marburg (NP-DE-FVU-INTF-230001) Vor einem Jahr ist in den GOLD Leitlinien eine neue Einteilung der initialen Patientengruppen vom ABCD- auf das ABE-Schema eingeführt worden.
Prof. Dr. Guy Brusselle, University Hospital Ghent (Video in englischer Sprache). Professor Brusselle zieht Bilanz: was wissen wir aus klinischen Studien und neuerdings auch aus real-world Studien über die Effektivität und Sicherheit von Biologika im schweren Asthma im alltäglichen Klinikeinsatz?
Foliensätze und Speakerslidedecks
Presentation of Tedi Soule for the Webinar "Research Session: CD226 Achse – Neue Ansätze in der Immunonkologie bei soliden Tumoren" from November 2023
Whiteboard video explaining the CD226 axis
5th Presentation of Prof. Martin Schuler for the Webinar "Research Session: CD226 Achse – Neue Ansätze in der Immunonkologie bei soliden Tumoren" from November 2023
Presentation of Tobias Pukrop for the Webinar "Research Session: CD226 Achse – Neue Ansätze in der Immunonkologie bei soliden Tumoren" from November 2023
Mode of Diseases Video zur CD226 Achse
Presentation of Konrad Klinghammer for the Webinar "Research Session: CD226 Achse – Neue Ansätze in der Immunonkologie bei soliden Tumoren" from November 2023
Presentation of Tobias Pukrop for the Webinar "Research Session: CD226 Achse – Neue Ansätze in der Immunonkologie bei soliden Tumoren" from November 2023
Aufzeichnungs des AIO-Symposiums in 2023: Erster Teil des Vortrags von Herrn Dr. Gießen-Jung zum Kolonkarzinom
Aufzeichnungs des AIO-Symposiums in 2023: Erster Teil des Vortrags von Herrn Dr. Gießen-Jung zum Kolonkarzinom
Presentation of Ivan Diaz-Padilla for the Webinar "Research Session: CD226 Achse – Neue Ansätze in der Immunonkologie bei soliden Tumoren" from November 2023
Aufzeichnungs des AIO-Symposiums in 2023: Zweiter Teil des Vortrags von Herrn Dr. Gießen-Jung zum Rektumkarzinom
Aufzeichnungs des AIO-Symposiums in 2023: Erster Teil des Vortrags von Herrn Dr. Gießen-Jung zum Kolonkarzinom
CONCLUSIONS In Chinese patients from the NORA study • Compared to fixed starting dose in NOVA, niraparib with ISD in NORA showed improved safety and comparable efficacy in the overall study population.1,3 • Platelet count decrease and neutrophil count decrease were the major haematologic TEAEs necessitating niraparib dose modification, the frequency of which decreased substantially three months after niraparib initiation. • Upon achieving stable, optimised doses in majority of patients, the PFS was comparable between subgroups receiving niraparib MT at 200-mg and 100-mg dose levels
Der Biomarker dMMR/MSI-H erklärt - für Patientinnen und ihre Angehörigen
No new safety signals were detected with dostarlimab compared to other anti–PD-1 inhibitors ● Most treatment-related adverse events (TRAEs) were low grade and occurred in the first 4 cycles (the first 12 weeks of treatment) — Some cases occurred later, suggesting a need for ongoing monitoring — The irTRAE hypothyroidism peaked during cycle 4 and occurred throughout the study period ● Few increases in the incidence of TRAEs were seen during cycle 5, following the transition to the 1000 mg every 6 weeks (Q6W) dosing schedule — The TRAEs with increased incidence after transition were fatigue and lipase increased ● Across the categories of grade ≥3 TRAEs observed, the majority resolved with a median time to resolution ranging from 1 to 30 days
Dostarlimab has an acceptable safety profile with manageable adverse events when analysed over the dMMR and mismatch repair proficient (MMRp) EC safety population of the GARNET trial ● Only 5.5% of patients discontinued treatment because of treatment related adverse events (TRAEs) ● TRAEs and immune-related TRAEs (irTRAEs) were seen in a low percentage of patients ● TRAEs and irTRAEs were seen more frequently earlier in the time course of dostarlimab treatment – irTRAEs were infrequent but could be seen throughout the course of treatment, so careful monitoring is necessary ● No increase in the rate of TRAEs or irTRAEs was seen when changing to the 1000-mg Q6W dosage of dostarlima
C High expression of programmed death ligand 1 (PD-L1–H) and high TMB (TMB-H) are more common in dMMR tumors; however, a subset of mismatch repair proficient (MMRp) tumors are PD-L1–H and/or TMB-H – Most dMMR tumors are also TMB-H (≈80%). Some MMRp tumors (6%) are also TMB-H – PD-L1–H occurs in ≈50% of dMMR tumors and in ≈40% of MMRp tumors ● In dMMR tumors there is considerable overlap of PD-L1–H and TMB-H; however, most PD-L1–H MMRp tumors are not TMB-H – Most TMB-H tumors are PD-L1–H, regardless of MMR status – In the MMRp patients, the sample size is not sufficient to determine if TMB alone, or TMB and PD-L1–H together, may predict response ● Differences in the distribution of TMB and CPS scores by cohort existed, and future research may refine the optimal cutoff points for each tumor type or an overall cutoff ● In summary, patients with high neoantigen production (TMB-H) and/or inflamed microenvironment (PD-L1–H) have increased objective response rate (ORR) compared to tumors with an absence of these features
● Dostarlimab’s antitumor activity and safety for patients with dMMR/MSI-H EC and mismatch repair proficient (MMRp)/microsatellite stable (MSS) EC were generally comparable across age groups – Objective response rates were similar across age groups for patients in both the dMMR/MSI-H EC and the MMRp/MSS EC cohorts – Incidences of grade ≥3 treatment-related adverse events (TRAEs) were low across all subgroups ● Older patients with advanced/recurrent dMMR/MSI-H EC experienced broadly similar treatment benefits as younger patients ● Dostarlimab can be used safely in older patients with advanced/recurrent dMMR/MSI-H EC
Conclusions - This real-world analysis shows that adoption of PARPi monotherapy in the 1L maintenance setting in patients with newly diagnosed advanced ovarian cancer has increased between 2017 and 2021 - PARPi use, when compared with active surveillance, was associated with significantly improved median progression-free survival (PFS) and was an independent predictor of improved PFS in patients with BRCAm or BRCA wild-type (BRCAwt) as well as patients with HRd or homologous recombination proficient (HRp)/homologous recombination deficiency (HRD) unknown statu
Conclusions The ORR observed with niraparib in combination with dostarlimab did not reach the threshold for second stage accrual, highlighting that PROC is difficult to treat and there remains an unmet need for effective treatments for patients with PROC and no known BRCAm, and prior bevacizumab treatment. Although DCR was 29.3%, futility was declared based on low ORR. PD-L1 status did not predict response, highlighting the need for robust biomarkers to predict response in PROC. The safety of the combination was simil
Conclusions OVARIO enrolled a high-risk population • 63% received NACT/IDS; 42% had PR following 1L platinum-based therapy in combination with bevacizumab • In the overall population, more than half (53%) of patients remained progression free at 24 months • 63% remained progression free in the HRd subgroup, and 42% in the HRp subgroup • Median TFST was 17.5 months, and median TSST was not reached in the overall population • PFS analysis suggests that the combination of niraparib and bevacizumab maintenance is efficacious; clinical benefit was observed in the overall population, and across biomarker subgroups in a continuum • Overall: mPFS of 19.6 months (95% CI 16.5–25.1) • HRd subgroup: mPFS of 28.3 months (95% CI 19.9–NE) and not yet reached in the BRCAm subgroup • HRp subgroup: mPFS of 14.2 months (95% CI 8.6–16.8) • There was no clinically meaningful impact on QoL as assessed by change in FOSI score • Safety of niraparib in combination with bevacizumab was consistent with the known side effects of each treatment as monotherapy, and no new safety signals were observed • Rate of treatment discontinuation is higher for combination therapy than for monotherapy alone, consistent with other PARPi + bevacizumab studies
In 341 patients with dMMR solid tumors, dostarlimab demonstrated durable antitumor activity and consistent response rate across 16 tumor types with extended follow-up of 2 or more years – Objective response rate (ORR) was 44%, with the majority of patients having reduction in tumor volume – Median duration of response was not reached (range, 1.18+ to 47.21+ months) – 72.2% of responders had a response lasting ≥12 months The safety profile was acceptable with manageable toxicities, with only 7.3% of patients discontinuing treatment because of a treatment-related adverse event (TRAE
Medizinisches Fachwissen aus dem Bereich der Rheumatologie
Interactive experience: review the expert statements and share your opinion on decision making in OC
Interview mit Prof. Ian Bruce auf dem ELM 2024 über die Beurteilung von Organschäden beim SLE
Interview mit Ashira Blazer MD, MSCI zu den neuen 2023 EULAR Empfehlungen zum SLE und wie Patienten von T2T und Disease Modification profitieren
Interview mit Prof. Dimitrios T. Boumpas zu den neuen 2023 EULAR Empfehlungen zum SLE mit den wichtigsten Neuerungen zu den Behandlungszielen, Management und Monitoring
Interview mit Prof. George Bertsias zu den neuen 2023 EULAR Empfehlungen zum SLE und wie diese die Patientenerfahrung beeinflussen können
Interview mit Ashira Blazer MD, MSCI zu den neuen 2023 EULAR Empfehlungen zum SLE und dem Stellenwert des früheren Einsatz von Biologika
Interview mit Prof. Zahir Amoura auf dem ELM 2024 über Strategien zur Minimierung der Glukokortikoid-Exposition bei der Behandlung des SLE
Vortrag von Prof. Ulf Müller-Ladner auf dem DGIM Symposium 2024 über die Epidemiologie, Symptomatik und Manifestationen des SLE
Gesamtvortrag von Prof. Ulf Müller-Ladner und Prof. Christof Specker auf dem DGIM Symposium 2024 über die Hintergründe und Herausforderungen beim SLE sowie den Stellenwert der neuen EULAR Empfehlungen
Vortrag von Prof. Christof Specker auf dem DGIM Symposium 2024 über die EULAR Empfehlungen zum Management des SLE und den Stellenwert von Impfungen
Interview mit Prof. Thomas Dörner auf dem ELM 2024 über die Gegenwart und Zukunft der B-Zell-Therapie beim SLE
Interview mit Alvaro Gomez Gonzalez auf dem ELM 2024 über neue Therapieoptionen und Guidelines zur Behandlung des SLE
Interview mit Prof. Martin Aringer auf dem ELM 2024 über die Klassifikation und Diagnose des SLE
Interview mit Dr. Isabell Haase auf dem ELM 2024 über die Nutzung von ChatGPT zur Beantwortung von Patientenfragen (ChatSLE)
Interview mit Prof. Dr. med. Jürgen Floege auf dem EULAR 2023 über die neuen KDIGO Leitlinien 2023 zur Behandlung der Lupusnephritis
Interview mit PD Dr. med. Uta Kiltz auf dem EULAR 2023 über die Neuerungen der EULAR Empfehlungen 2023 zur Behandlung des SLE
Interview mit Prof. Dr. med. Gerhard Krönke auf dem EULAR 2023 über Funktion und Bedeutung von CAR-T-Zellen bei der Behandlung des SLE
Animationsvideo zur Pathophysiologie des SLE mit den wichtigsten zellulären und löslichen Bestandteilen
Interview mit Prof. Dr. med. Martin Kriegel auf dem EULAR 2023 über die aktuellen Erkenntnisse und Entwicklungen im Bereich der Mikrobiomforschung bei rheumatischen Erkrankungen
Interview mit Prof. Dr. med. Torsten Witte auf dem EULAR 2023 über aktuelle Studienergebnisse zur Behandlung des Sjögren-Syndroms und Diagnostik
Interview mit Prof. Maria Dall'Era MD zu den neuen 2023 EULAR Empfehlungen zum SLE und dem Stellenwert des früheren Einsatz von Biologika
Interview mit Prof. Dr. med. Bimba Hoyer auf dem EULAR 2023 über die Wichtigkeit von Impfungen unter Immunsuppression
Interview mit Prof. Maria Dall'Era MD zu den Konzepten der neuen 2023 EULAR Empfehlungen zum SLE und dem Stellenwert des individualisierten Managements
Interview mit Prof. Roger Levy auf dem ELM 2024 über die Einsparung von Glukokortikoiden in der Real-World Behandlung des SLE
61-jähriger männlicher Patient mit RSV-Pneumonie und bakterieller Superinfektion
Schwerer Verlauf einer RSV Infektion bei einer Patientin mit COPD und kardiologischen Komorbiditäten
20. - 23. März 2024, Mannehim
DGRh Kongress 2024 Experteninterviews und GSK Highlights
Erklärvideo: Mode of Action AS01
Nicht nur bei unseren zahlreichen Veranstaltungen können Sie CME-Punkte sammeln, sondern auch über diese unabhängigen und zertifizierten Online-Fortbildungsmodule zu verschiedensten Fachgebieten – jederzeit und zu 100% digital.
Platform for comprehensive continuing education in the healthcare sector. Our website has been specifically designed to offer both CME training and general knowledge transfer in GSK’s indications
Allgemeines, Aktuelles und Informationen zu impfpräventablen Erkrankungen.
Videointerview mit Prof. Hanker zu den Studienhighlights im Endometriumkarzinom beim ESGO und SGO 2024
Videointerview mit Prof. Kommoss zu den Studienhighlights im Ovarialkarzinom beim ESGO und SGO 2024
Erklärfilm zur Kombinationstherapie aus Immuntherapie + Chemotherapie für Patientinnen mit dMMR/MSI-H Endometriumkarzinom
Erklärfilm zur klinischen Relevanz der Primärtestung auf dMMR/MSI-H bei Patientinnen mit Endometriumkarzinom
Erklärfilm zur Rolle der Immuntherapie für Patientinnen mit dMMR/MSI-H Endometriumkarzinom
Erklärfilm zur klinischen Relevanz der Primärtestung auf dMMR/MSI-H bei Patientinnen mit Endometriumkarzinom
Übersicht zum Atemwege Portal
DREAMM-7 Subgruppenanalyse für Hochrisiko und Lenalidomid refraktäre Patienten
Patient reported outcomes aus DREAMM-7
Initiale Daten der DREAMM-8 Studie: BPd vs PVd
Filterkriterien in der Praxissoftware: Chronische Rhinosinusitis mit Nasenpolypen (CRSwNP)