- |||||||||| obicetrapib (TA-8995) / NewAmsterdam Pharma
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: VINCENT: Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels (clinicaltrials.gov) - Nov 13, 2024 P2, N=30, Recruiting, Not yet recruiting --> Recruiting | Trial completion date: Jul 2025 --> Dec 2025 | Initiation date: Aug 2024 --> Nov 2024 | Trial primary completion date: Mar 2025 --> Oct 2025
- |||||||||| Ibrance (palbociclib) / Pfizer, Balversa (erdafitinib) / J&J
Trial completion, Trial completion date: Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer (clinicaltrials.gov) - Nov 13, 2024 P1, N=35, Completed, Not yet recruiting --> Recruiting | Trial completion date: Jul 2025 --> Dec 2025 | Initiation date: Aug 2024 --> Nov 2024 | Trial primary completion date: Mar 2025 --> Oct 2025 Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Mar 2024
- |||||||||| Lumakras (sotorasib) / Amgen
Retrospective data, Journal, HEOR, Real-world evidence, Real-world: Real-World Evaluation of Treatment Patterns, Healthcare Costs, and Healthcare Resource Utilization Among Patients with Non-small Cell Lung Cancer in the US Receiving Sotorasib. (Pubmed Central) - Nov 13, 2024 Thus, clinically approved CDK4/6 inhibitors might have the potential to be repurposed for HHT. Patients in the US receiving sotorasib as 2L+ therapy for NSCLC in real-world clinical practice showed high adherence, TTNT comparable to progression-free survival observed in clinical trials, and HCC similar to those immediately prior to treatment demonstrating real-world benefits with no additional impact on healthcare resources with sotorasib.
- |||||||||| Nplate (romiplostim) / Amgen, Doptelet (avatrombopag) / SOBI, Promacta (eltrombopag) / Novartis
Journal, Real-world evidence, Real-world: Avatrombopag in immune thrombocytopenia: A real-world study of the Spanish ITP Group (GEPTI). (Pubmed Central) - Nov 13, 2024 Overall, 40/268 (14.9%) thrombocytosis and 12/268 (4.5%) thromboembolic events were reported. Our real-world cohort supports the use of avatrombopag to manage ITP, regardless of disease severity and treatment history.
- |||||||||| Journal: 'Efficacy of biologics in NSAID-ERD: United airways from the nose to the bronchi'. (Pubmed Central) - Nov 13, 2024
Herein we will review the currently available clinical trial and real-world evidence for biologic efficacy and safety patients with NSAID-ERD, discuss the mechanisms of biologic therapy specific to NSAID-ERD, and review evidence regarding the use of biologic therapy versus endoscopic sinus surgery therapy for CRSwNP and NSAID-ERD. We will propose a management approach for choosing biologic therapy or endoscopic sinus surgery with aspirin therapy after desensitization for patients with NSAID-ERD.
- |||||||||| Journal: Current goals of NSAID-ERD management: patient-centered approaches involving NSAID desensitization with and without biologics. (Pubmed Central) - Nov 13, 2024
So far, dupilumab demonstrated greater efficacy in patients with NSAID-ERD than in aspirin-tolerant patients with regard to several clinical outcomes...Additionally, there are conflicting studies as to whether patients on a T2 biologic become desensitized to NSAIDs, as omalizumab proved to restore tolerance to aspirin in only two thirds of patients. This goal of NSAIDs tolerance should be considered as part of disease control future approaches, representing one of many aspects in a patient-centered care approach.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon, Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap, Aimovig (erenumab-aooe) / Amgen, Novartis
Journal: Psychopathological variables in chronic migraine patients with different therapeutic approach: psychological profile differences and impact on therapeutic efficacy in real life. (Pubmed Central) - Nov 13, 2024 Our study highlighted more pronounced psychopathological comorbidities in patients in treatment with NON-SPECIFIC therapies in terms of impulsivity, alexithymia, and emotion regulation. Moreover, treatment efficacy overtime was more pronounced and stable over time in the SPECIFIC group, and psychopathological comorbidity did not influence it.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Journal, HEOR: Erenumab versus topiramate: migraine-related disability, impact and health-related quality of life. (Pubmed Central) - Nov 13, 2024 The current data support the assessment of TBL structures as a reliable prognostic tool in GCTB, potentially aiding in the development of personalized treatment strategies for patients. This post hoc analysis demonstrated that patients treated with erenumab had significant improvements in headache impact and quality of life as measured by patient-reported outcomes versus patients treated with topiramate.
- |||||||||| Leqvio (inclisiran) / Novartis
Journal: In-silico trial emulation to predict the cardiovascular protection of new lipid-lowering drugs: an illustration through the design of the SIRIUS programme. (Pubmed Central) - Nov 13, 2024 P It follows an idealized crossover design where each virtual patient is its own control, comparing inclisiran to 1) placebo as adjunct to high-intensity statin therapy with or without ezetimibe, 2) ezetimibe as adjunct to high-intensity statin therapy, 3) evolocumab as adjunct to high-intensity statin therapy and ezetimibe.The co-primary efficacy outcomes are based on time to the first occurrence of any component of 3P-MACE (composite of CV death, nonfatal MI or nonfatal IS) and time to occurrence of CV death over 5 years. The SIRIUS in-silico trial programme will provide early insights regarding a potential effect of inclisiran on MACE in ASCVD patients, several years before the availability of the results from ongoing CV outcomes trials (ORION-4 and VICTORION-2-P).
- |||||||||| Enrollment open: The Sagittarius Trial (clinicaltrials.gov) - Nov 12, 2024
P3, N=700, Recruiting, Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| Stivarga (regorafenib) / Bayer
Trial completion, Trial completion date, Trial primary completion date, Metastases: Regorafenib in Patients with Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma (clinicaltrials.gov) - Nov 12, 2024 P2, N=38, Completed, Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Nov 2024 | Trial primary completion date: Mar 2025 --> Nov 2024
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Yondelis (trabectedin) / PharmaMar, J&J, Opdivo (nivolumab) / BMS
TNT: A PHASE 2 STUDY USING TALIMOGENE LAHERPAREPVEC, NIVOLUMAB, AND TRABECTEDIN FOR ADVANCED LEIOMYOSARCOMA AND LIPOSARCOMA NCT # 03886311) () - Nov 9, 2024 - Abstract #CTOS2024CTOS_484; The use of pegfilgrastim and a modified 21-day schedule was successful in allowing for continued treatment despite myelosuppression. The data indicates that the combination regimen using Talimogene Laherparepvec, Nivolumab and Trabectedin may be more effective than Trabectedin alone (Median PFS 4.1 months) as treatment for previously treated patients with advanced leiomyosarcoma and liposarcoma with manageable toxicity.
- |||||||||| IDRX-42 / IDRx
IN VITRO PROFILING OF IDRX-42 AGAINST SECONDARY MUTATIONS FOUND IN TKI-RESISTANT GIST () - Nov 9, 2024 - Abstract #CTOS2024CTOS_409; Additionally, IDRX-42 has activity against all tested K11 + secondary/tertiary mutations with the exception of K14 T670I. It should be noted that T670I is an infrequently reported secondary mutation compared to V654A or AL secondary mutations, possibly due to diminished enzymatic activity compared with the parental K11 mutant kinase.
- |||||||||| EARLY ASSESSMENT OF DISEASE RESPONSE TO IMMUNOTHERAPY VIA CIRCULATING TUMOR DNA IN ADVANCED SOFT TISSUE SARCOMAS () - Nov 9, 2024 - Abstract #CTOS2024CTOS_380;
Other systemic therapies used concurrently with immunotherapy were cabozantinib (n = 6), temozolomide (n = 2), pazopanib (n = 2), palbociclib (n = 2), gemcitabine (n = 1), ivosidenib (n = 1), and carboplatin/paclitaxel (n = 1)... Decline in ctDNA demonstrates correlation with radiographic response to immunotherapy and improved survival and could be a potential early biomarker of therapeutic efficacy in advanced soft tissue sarcomas.
- |||||||||| Ibrance (palbociclib) / Pfizer, Verzenio (abemaciclib) / Eli Lilly
ACQUIRED CYCLIN D AMPLIFICATION IS A MECHANISM FOR RESISTANCE TO CDK4/6 INHIBITORS IN DEDIFFERENTIATED LIPOSARCOMA () - Nov 9, 2024 - Abstract #CTOS2024CTOS_359; Our analysis revealed that three patients with DDLPS acquired either cyclin D1 or cyclin D2 amplification in progressing samples following treatment with CDK4/6i. Unlike breast cancer, where cyclin E1 amplification is a well-established driver of resistance to CDK4/6i, these findings suggest a potential role for cyclin D amplification in acquired resistance in LPS.
- |||||||||| Prolia (denosumab) / Amgen
RANKL-INHIBITION FOR GIANT CELL LESIONS OF THE JAW: A RETROSPECTIVE COHORT ANALYSIS () - Nov 9, 2024 - Abstract #CTOS2024CTOS_283; High-dose denosumab is effective and safe in achieving a complete response in GCLJ within 12 months, but there is a significant risk of progression after treatment discontinuation. Therefore, using RANKL-inhibition according to the described protocol is only justified for cases where other treatments have failed, or disease may lead to disfiguring mutilating surgery.
- |||||||||| Prolia (denosumab) / Amgen
CURRENT INDICATIONS OF OPEN SURGERY IN PRIMARY APPENDICULAR/ PELVIC ANEURYSMAL BONE CYSTS () - Nov 9, 2024 - Abstract #CTOS2024CTOS_273; Percutaneous sclerotherapy alone is successful in 87% of primary ABCs in this series. We recommend extended curettage surgery, in large uncontained defects, pathologic fracture or risk of fracture in high stress high risk zones or cases with partial healing or in cases with rapid progression.
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