- |||||||||| CC-3 / German Cancer Research Center, University of Tuebingen
Clinical development of an optimized bispecific B7H3xCD3 antibody for the treatment of colorectal carcinoma and other tumors (Darwin) - Oct 13, 2024 - Abstract #DGHO2024DGHO_351;
P1
CC-3 mediated pronounced antitumor activity in vitro and displayed the expected long half-life and potent antitumor activity in three different mouse models...Key eligibility criteria include diagnosis of progressive metastatic CRC, breast cancer or sarcoma after exhaustion of established treatment options, i.e. for CRC three-lines of therapy consisting of FOLFOX, FOLFIRI, FOLFOXIRI, TAS-102, or regorafenib if applicable, in combination with anti-Vascular Endothelial Growth Factor monoclonal antibody (mAb) and anti-EGFR mAb in RAS-wild-type and left-sided tumors...Secondary endpoints include overall safety, efficacy, survival, quality of life, and pharmacokinetics. Presently, the first three patients have been enrolled.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon, Ajovy (fremanezumab-vfrm) / Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Journal, Real-world evidence, Real-world: Blood pressure monitoring in elderly migraineurs starting an anti-CGRP monoclonal antibody: a real-world prospective study. (Pubmed Central) - Oct 12, 2024
The study concludes that treatment with anti-CGRP mAbs over one year does not significantly affect BP in patients aged???60, nor does it increase the incidence of hypertension compared to general population trends. Nonetheless, continuous monitoring and further long-term studies are necessary to fullya scertain the cardiovascular safety of these medications in the elderly.
- |||||||||| Krystexxa (pegloticase) / Amgen
GFR Recovery in a Patient with Stage 4 CKD and Chronic Uncontrolled Gout after Treatment with Intravenous (IV) Pegloticase () - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5494;
The findings of his case proposes that treatment with pegloticase IV could be beneficial for patients with uncontrolled gout in terms of eGFR recovery and also reduction in CKD progression by stabilizing chronic uncontrolled gout. Potentially this may leed to future controlled trials which may further evaluate pegloticase as a treatment for GFR recovery and GFR protection in patients with CKD and chronic gout..
- |||||||||| hydralazine hydrochloride / Generic mfg.
Hydralazine-Induced ANCA-Associated Vasculitis with Pulmonary Involvement () - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5344;
Diagnosis is made through history, serology for anti-histone antibodies, ANCA, low complement and biopsy of affected organs. Treatment includes discontinuation of hydralazine and immunosuppressive therapy with pulse steroids, rituximab and or cyclophosphamide..
- |||||||||| Tavneos (avacopan) / Amgen, Rituxan (rituximab) / Roche
Treatment of ANCA-Associated Glomerulonephritis in a Patient with Bacteremia and Vertebral Osteomyelitis: A Challenging Clinical Dilemma () - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5325;
Despite treatment with Rituximab and high-dose corticosteroids, he developed Enterobacter Cloacae bacteremia and vertebral osteomyelitis...The treatment of ANCA-associated small vessel vasculitis and glomerulonephritis primarily involves high-dose corticosteroids and cyclophosphamide...Lower dose steroid regimens and new agents like Avacopan may offer safer alternatives without compromising efficacy...7/30/20237/29/20236/12/2023Na134135138K4.24.44.3Cl10099105CO2222224Anion Gap12149BUN545636Creatinine6.155.911.62eGFR9944Calcium8.48.18.5Phosphorus 4.94.5. .
- |||||||||| Tavneos (avacopan) / Amgen
Avacopan as Adjuvant Therapy for ANCA-Associated Vasculitis: A Case Report () - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5319;
Standard treatment for ANCA vasculitis often includes high-dose steroids, rituximab, or cyclophosphamide...The patient received 60 mg prednisone and 1 g Rituximab...Despite the lack of case reports on avacopan as adjuvant therapy for partial responders to standard ANCA vasculitis treatment, our patient's positive outcome highlights its potential benefit. To date, the patient's kidney function remains stable, emphasizing avacopan's role in vasculitis management.
- |||||||||| Tavneos (avacopan) / Amgen, Rituxan (rituximab) / Roche
Decoding the Kidney Conundrum: Dive into the Glomerulonephritis Mystery! () - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5310;
Immune complex deposition in ANCA-associated vasculitis (AAV) GN is atypical, as AAV is typically "pauci-immune." Recent studies classify AAV/GN into "pauci-immune" (PI) and "immune complex" (IC) groups, with IC deposits potentially exacerbating ANCA effects and role of complement activation causing worsened proteinuria. Early recognition is crucial for preserving renal function, with rituximab and avacopan showing promise in treatment..
- |||||||||| Tavneos (avacopan) / Amgen, Rituxan (rituximab) / Roche
Granulomatosis with Polyangiitis: Role of Nephrologist in Management of a Rare Systemic Disease () - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5266;
Early recognition is crucial for preserving renal function, with rituximab and avacopan showing promise in treatment.. She received another cycle of pulse-dose steroids and two doses of cyclophosphamide, with improvement in eye and nasal symptoms...Continued immunosuppression with rituximab for 18
- |||||||||| Tavneos (avacopan) / Amgen
Avacopan beyond the 52-Week Treatment Course (Room 6D, Convention Center) - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4829;
Rituximab was used alongside AVP for remission maintenance in majority of patients. Infection complications were the most observed adverse effects.
- |||||||||| Prolia (denosumab) / Amgen
Journal: Dose-specific effects of denosumab on serum calcium levels in patients with osteoporosis and various renal functions. (Pubmed Central) - Oct 11, 2024
The primary end point for the study was not met; other clinical effects of avacopan to improve certain key kidney function parameters and slow disease progression were variable and require further evaluation. The magnitude of serum calcium decrease following subsequent dose(s) was smaller than that following the initial dose of denosumab among patients with osteoporosis and advanced CKD.
- |||||||||| Review, Journal: Expanding therapeutic options: overview of novel pharmacotherapies for dyslipidemia. (Pubmed Central) - Oct 11, 2024
Optimizing the use of available first- and second-line lipid-lowering drugs allows us to adequately control low-density lipoprotein cholesterol (LDL-C) levels, even in statin-intolerant individuals and in patients at high and very high risk of developing cardiovascular diseases who must reach more aggressive LDL-C targets. The drugs under development will further improve our ability to manage the overall lipid-related cardiovascular disease risk and target other dyslipidemia biomarkers.
- |||||||||| Retrospective data, Review, Journal: The efficacy and safety of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors combined with statins in patients with hypercholesterolemia: a network meta-analysis. (Pubmed Central) - Oct 10, 2024
Notably, evolocumab exhibited the most pronounced effect with a treatment difference of -63.67% (-68.47% to -58.87%) compared with placebo...Furthermore, the safety profile of PCSK9 inhibitors was favorable with no increase in the incidence of AE, SAE, or AE leading to treatment discontinuation; however, alirocumab, inclisiran, and tafolecimab may potentially entail a potential risk associated with injection-site reactions...Furthermore, PCSK9 inhibitors and ezetimibe exhibit similar safety profiles. [PROSPERO], identifier [CRD42023490506].
- |||||||||| Qinlock (ripretinib) / Ono Pharma, Stivarga (regorafenib) / Bayer, Ayvakit (avapritinib) / Blueprint Medicines
Review, Journal: Pan-Canadian consensus recommendations for GIST management in high- and low-throughput centres across Canada. (Pubmed Central) - Oct 10, 2024
This literature review, along with clinical expertise and opinion, was used to develop this concise and clinically relevant consensus paper to harmonize the knowledge and clinical practice on GIST management across Canada. The content presented here will help guide healthcare providers, especially in Canada, in terms of approaching and managing GIST.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Journal, IO biomarker: Case report: sub-clinical extramedullary B-ALL in the setting of relapse following targeted therapy. (Pubmed Central) - Oct 10, 2024
In the newly-emergent era of antigen-targeted immunotherapy, it is foundational that incidence and relapse patterns following targeted therapy are well-understood. Herein we contribute to a growing body of literature addressing this fundamental clinical gap and highlight a future role for formal prospective imaging studies to better establish response, toxicity and relapse patterns following CAR-T cell therapy in EM B-ALL.
- |||||||||| camizestrant (AZD9833) / AstraZeneca, saruparib (AZD5305) / AstraZeneca
Trial completion date, Metastases: EvoPAR-Breast01: Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer (clinicaltrials.gov) - Oct 10, 2024
P3, N=500, Recruiting,
Herein we contribute to a growing body of literature addressing this fundamental clinical gap and highlight a future role for formal prospective imaging studies to better establish response, toxicity and relapse patterns following CAR-T cell therapy in EM B-ALL. Trial completion date: Jul 2030 --> Oct 2030
- |||||||||| fludarabine IV / Generic mfg., cyclophosphamide / Generic mfg., busulfan / Generic mfg.
Trial completion date, Trial primary completion date: RAFA: HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy (clinicaltrials.gov) - Oct 9, 2024
P2, N=70, Recruiting,
Initiation date: Jul 2024 --> Feb 2025 Trial completion date: Jul 2026 --> Jul 2027 | Trial primary completion date: Jul 2024 --> Jul 2025
- |||||||||| Prolia (denosumab) / Amgen
Review, Journal: Diabetic Charcot neuroarthropathy: A threat to both limb and life. (Pubmed Central) - Oct 9, 2024
Denosumab is potentially an efficacious, if unproven, therapy to accelerate healing...Mortality is also increased with DCN, especially in the presence of a foot ulcer. To avoid the recurrence of DCN and especially to lower the risk of the recurrence of a foot ulcer recurrence reconstructive, surgery may be needed.
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Blincyto (blinatumomab) / Astellas, Amgen
Enrollment closed, Enrollment change: Provision of TCR?? T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Na (clinicaltrials.gov) - Oct 9, 2024
P2, N=170, Active, not recruiting,
Future studies, including prospective trials or updated retrospective analyses, focusing on cancers treated with first-line immunotherapy, could provide further insights into this therapeutic approach. Recruiting --> Active, not recruiting | N=52 --> 170
- |||||||||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Enrollment change, Trial withdrawal, HEOR, Real-world evidence, Real-world: CA056-1083: A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes (clinicaltrials.gov) - Oct 9, 2024
P=N/A, N=0, Withdrawn,
Expansion of IDE397 monotherapy is ongoing, as well as in combination with sacituzumab-govitecan (Trodelvy Not yet recruiting --> Withdrawn | N=86 --> 0
- |||||||||| Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
Trial completion date, Trial primary completion date: Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA (clinicaltrials.gov) - Oct 8, 2024
P=N/A, N=60, Recruiting,
Using pegfilgrastim after hyper-CVAD therapy was more effective than the short-acting G-CSF in terms of infection, neutropenia recovery, and hospitalization in patients with newly diagnosed ALL. Trial completion date: Aug 2032 --> Oct 2032 | Trial primary completion date: Aug 2032 --> Oct 2032
- |||||||||| Journal, Adverse events: Adverse event profiles of CDK4/6 inhibitors: data mining and disproportionality analysis of the FDA adverse event reporting system. (Pubmed Central) - Oct 8, 2024
Notably, our analysis found novel safety signals linked to CDK4/6 inhibitors, including nail-related disorders such as onychoclasis, nail disorder, and nail discoloration, and psychiatric concerns, including eating disorders and emotional disorder. Overall, the present study identified several new safety signals of CDK4/6 inhibitors, as well as differences among various drugs within the CDK4/6 category, through the use of the FDA FAERS, which deserve more careful monitoring in the clinic.
- |||||||||| Adcetris (brentuximab vedotin) / Takeda, Pfizer
Trial completion date, Trial termination: SGN35-027: Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma (clinicaltrials.gov) - Oct 8, 2024
P2, N=255, Terminated,
Trial completion date: Jun 2026 --> Aug 2024 | Active, not recruiting --> Terminated; The study was prematurely discontinued as the sponsor believes the data collected is enough to show the safety and efficacy of the combinations studied in all cohorts. The decision was not based on any safety and/or efficacy concerns.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen
Trial completion date, Trial primary completion date: Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC (clinicaltrials.gov) - Oct 7, 2024
P=N/A, N=300, Recruiting,
Not yet recruiting --> Recruiting Trial completion date: Aug 2038 --> Jan 2038 | Trial primary completion date: Aug 2038 --> Jan 2038
- |||||||||| Lumakras (sotorasib) / Amgen
Journal: The Retrofit: Lessons From Sotorasib's Dosing Conundrum. (Pubmed Central) - Oct 7, 2024
In DeLLphi-300 extended follow-up, tarlatamab demonstrated unprecedented survival and potential findings of intracranial activity in previously treated SCLC. No abstract available
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