- |||||||||| Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Journal: Quantification of Letrozole, Palbociclib, Ribociclib, Abemaciclib, and Metabolites in Volumetric Dried Blood Spots: Development and Validation of an LC-MS/MS Method for Therapeutic Drug Monitoring. (Pubmed Central) - Oct 16, 2024 Clinical validation supports DBS-based TDM as feasible, with conversion models developed for estimating plasma concentrations (the reference for TDM target values) of letrozole, abemaciclib, and its metabolites. Preliminary data for palbociclib and ribociclib are also presented.
- |||||||||| omecamtiv mecarbil (AMG 423) / Amgen, Servier
Journal: Dynamics of the Pre-Powerstroke Myosin Lever Arm and the Effects of Omecamtiv Mecarbil. (Pubmed Central) - Oct 16, 2024 Finally, we map out the distinct conformations and ligand-protein interactions adopted by OM. These results uncover some structural factors that govern the motor domain-tail orientations and the mechanisms by which OM primes the pre-powerstroke myosin heads.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Minimal residual disease: Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov) - Oct 16, 2024 P4, N=10, Terminated, The resulting preservation of vascular and bone health will be assessed for the first time by examining aortic and iliac artery calcifications and vertebral fractures, respectively. N=45 --> 10 | Trial completion date: Dec 2025 --> Sep 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Sep 2024; The decision to terminate is not based on safety or efficacy but due to slow enrollment impacting the ability to complete the study as planned.
- |||||||||| Prolia (denosumab) / Amgen
Trial completion date, Trial initiation date, Trial primary completion date: Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia (clinicaltrials.gov) - Oct 16, 2024 P3, N=440, Not yet recruiting, N=45 --> 10 | Trial completion date: Dec 2025 --> Sep 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Sep 2024; The decision to terminate is not based on safety or efficacy but due to slow enrollment impacting the ability to complete the study as planned. Trial completion date: Oct 2026 --> Oct 2027 | Initiation date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2026 --> Oct 2027
- |||||||||| Prolia (denosumab) / Amgen
Journal: Denosumab - protection for bone and beyond? (Pubmed Central) - Oct 15, 2024 The findings guide clinicians in selecting optimal treatments and underscore the need for further research to refine evidence-based approaches, ultimately enhancing patient outcomes and quality of life. No abstract available
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen, zeluvalimab (AMG 404) / Amgen
Phase classification: AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Oct 15, 2024 P1, N=23, Active, not recruiting, Trial completion date: Mar 2028 --> Jun 2029 | Trial primary completion date: Sep 2025 --> Jan 2027 Phase classification: P1b --> P1
- |||||||||| MASH 2B TRIALS- A SYSTEMATIC REVIEW () - Oct 15, 2024 - Abstract #AASLD2024AASLD_2363;
Lanifibranor and icosabutate showed promise, especially in T2D patients. FGF21 analogues like efruxifermin improved fibrosis, while FGF19 trials had variable results.
- |||||||||| Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
CHARACTERIZATION OF LIVER INJURY INDUCED BY CDK 4/6 INHIBITORS INDUCED LIVER INJURY () - Oct 15, 2024 - Abstract #AASLD2024AASLD_1960; CDKIs, especially ribociclib, are associated with hepatocellular hepatitis in MBC treatment. Corticosteroids appear beneficial when spontaneous improvement is absent, but further data are needed
- |||||||||| Orkedia (evocalcet) / Mitsubishi Tanabe, Upasita (upacicalcet) / Suzuken, Pathalys Pharma, Kissei, Parsabiv (etelcalcetide) / Amgen
Review, Journal: New calcimimetics for secondary hyperparathyroidism in CKD G5D: do they offer advantages? (Pubmed Central) - Oct 15, 2024 This agent has greater clearance by hemodialysis and shows no effect on gastric emptying. More studies are needed comparing the old calcimimetics to the new ones to establish their future role in the treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) G5D.
- |||||||||| Stivarga (regorafenib) / Bayer
Enrollment closed, Trial completion date, Trial primary completion date, Real-world evidence, Real-world, Metastases: COLONGER: An Observational Study to Learn More About the Long-Term Responses to Treatment With Regorafenib in Patients With Metastatic Colorectal Cancer in the United States (clinicaltrials.gov) - Oct 15, 2024 P=N/A, N=2326, Active, not recruiting, More studies are needed comparing the old calcimimetics to the new ones to establish their future role in the treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) G5D. Completed --> Active, not recruiting | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
- |||||||||| Ravicti (glycerol phenylbutyrate) / Immedica, Amgen
Journal: Perinatal management and follow-up in a child with a prenatal diagnosis of OTC deficiency: a case report. (Pubmed Central) - Oct 15, 2024 To date, after 3.5?years of follow up, growth and neurological development have been adequate, biochemical control has been appropriate except for a simple and mild decompensation during the course of a gastroenteritis. This case emphasises the importance of early diagnosis and treatment to avoid potential complications.
- |||||||||| zanzalintinib (XL092) / Exelixis
P3 data, Journal, Metastases: STELLAR-303: randomized phase III study of zanzalintinib (Pubmed Central) - Oct 15, 2024 P3 Presented is the design of STELLAR-303, a global, phase III, open-label, randomized study evaluating zanzalintinib plus atezolizumab versus regorafenib in patients with non-MSI-H mCRC who progressed during/after or are refractory/intolerant to standard-of-care therapy. The primary end point is overall survival in patients without liver metastases.Clinical Trial Registration: NCT05425940 (ClinicalTrials.gov).
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Blincyto (blinatumomab) / Astellas, Amgen
Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy: Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (clinicaltrials.gov) - Oct 15, 2024 P2, N=171, Not yet recruiting, The primary end point is overall survival in patients without liver metastases.Clinical Trial Registration: NCT05425940 (ClinicalTrials.gov). Trial completion date: Dec 2027 --> Dec 2028 | Initiation date: Oct 2024 --> Jan 2025 | Trial primary completion date: Dec 2027 --> Dec 2028
- |||||||||| Journal, Metabolomic study: Metabolic Response to Small Molecule Therapy in Colorectal Cancer Tracked with Raman Spectroscopy and Metabolomics. (Pubmed Central) - Oct 14, 2024
Cells treated with a combination of subtoxic doses of trametinib and BKM120, an inhibitor of the PI3K pathway, showed a synergistic response between the two pathways...RS metabolites were verified with mass spectrometry, and enrichment pathways were identified, including amino acid, purine, and nicotinate and nicotinamide metabolism that differentiated monotherapy from combination therapy. Our approach may ultimately be applicable to patient-derived primary cells and cultures of patient tumors to predict effective drugs for individualized care.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Clinical, Review, Journal: A practical approach for anabolic treatment of bone fragility with romosozumab. (Pubmed Central) - Oct 14, 2024 Our approach may ultimately be applicable to patient-derived primary cells and cultures of patient tumors to predict effective drugs for individualized care. Based on the available evidence, romosozumab could be proposed as ideal drug in several clinical settings, such as non-fractured post-menopausal women at very-high risk of fractures, patients with recent hip fracture, patients non responder to bisphosphonates and short-term denosumab therapy.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon, Ajovy (fremanezumab-vfrm) / Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Journal: Efficacy and Tolerability of Anti-CGRP Monoclonal Antibodies in Patients Aged ? 65 Years With Daily or Nondaily Migraine. (Pubmed Central) - Oct 14, 2024 This retrospective analysis provides real-world evidence that there is no difference in the efficacy and tolerability of treatment with erenumab, fremanezumab, and galcanezumab in patients O65 when compared with patients U65 both with daily or nondaily migraine. These data may help guide the choice of migraine treatment in older populations.
- |||||||||| Journal: Combined inhibition of CDK4/6 and AKT is highly effective against the luminal androgen receptor (LAR) subtype of triple negative breast cancer. (Pubmed Central) - Oct 13, 2024
The comparison between biosimilar and originator offers further evidence in support of the biosimilar to optimizing resources in healthcare. Herein, we investigated combined blockade of the CDK4/6 and PI3K signaling with palbociclib, alpelisib, and capivasertib, which inhibit CDK4/6, PI3K?, and AKT1-3, respectively...The AR antagonist enzalutamide was inactive against MDA-MB-453, MFM-223, and CAL148
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Blinatumomab as a novel therapeutic approach in systemic sclerosis: a case report (Osaka/Samarkand) - Oct 13, 2024 - Abstract #DGHO2024DGHO_1470; The treatment was safe, and the patient showed a substantial clinical benefit. The treatment strategy foresaw depleting the bulk of B-cells with an initial low dose and starting the higher dose at low B cell counts, this way CRS could be prevented.
- |||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Blincyto (blinatumomab) / Astellas, Amgen, Tasigna (nilotinib) / Novartis, Inhibikase
Importance of alloHSCT in Ph+ ALL in the era of targeted and immunotherapies (Shanghai) - Oct 13, 2024 - Abstract #DGHO2024DGHO_923; A phase 2 study using hyperCVAD and ponatinib reported a CR rate of 100%, a complete molecular remission (CMR) rate of 86%, and an estimated 6-year OS of 75%...The GIMEMA group explored a chemotherapy-free approach by combining dasatinib with blinatumomab, achieving a CR rate of 98%, a CMR rate of 55%, and an OS of 80.7% at 53 months follow-up...The GRAAPH 2014 phase 3 trial highlighted a higher relapse rate with reduced-intensity chemotherapy combined with nilotinib, emphasizing the importance of consolidation chemotherapy intensity...Additionally, the duration of TKI treatment and associated side effects, along with concerns about CNS relapses, suggest that some form of chemotherapy may still be necessary. Future trials, such as the upcoming GRAAPH randomized phase 3 trial, aim to determine whether patients in CMR can forgo alloSCT.
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