- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Cost to Medicare from bone modifying agent overuse in castration-sensitive prostate cancer. (3rd Floor, Back Bay Hall; Poster Bd #: A7) - Oct 13, 2023 - Abstract #ASCOQC2023ASCO_QC_90;
Our sensitivity analyses suggest we may overestimate costs if denosumab dosing frequency is now lower than during our observation period (eg., if more providers now use 3-month dosing), and we may underestimate costs if patients now experience CSPC for a longer duration (a plausible consequence from the introduction of ARSi therapy for CSPC in the post-LATITUDE era). Avoidable costs and toxicity may be reduced by greater adherence to guideline-concordant use of BMAs.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
New P4 trial: A Study of Romosozumab (EVENITY (clinicaltrials.gov) - Oct 12, 2023
P4, N=100, Not yet recruiting,
- |||||||||| Lumakras (sotorasib) / Amgen
Journal: Molecular docking analysis of KRAS inhibitors for cancer management. (Pubmed Central) - Oct 12, 2023
Through virtual screening and visual inspection, it was observed that these hits effectively interacted with the essential residues located within the active site of KRAS. Based on the findings of this study, it can be inferred that these compounds may have the potential to be employed in the treatment of cancer by targeting KRAS.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal, Minimal residual disease: Survival outcomes in patients with relapsed/refractory or MRD-positive B-cell acute lymphoblastic leukemia treated with blinatumomab. (Pubmed Central) - Oct 12, 2023
The median RFS and OS from RWE studies in adults with R/R B-cell ALL were numerically longer than the median RFS and OS from pivotal studies (MT-103-211, TOWER, and ALCANTARA); however, this trend was not observed in pediatric patients with R/R B-cell ALL. In conclusion, this analysis identified first salvage adults with Ph-negative R/R B-cell ALL as particularly well-suited for treatment with blinatumomab since survival outcomes from retrospective analyses reported in this patient subgroup were numerically better compared with those from pivotal studies without additional safety signals.
- |||||||||| AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
Trial completion date: Multicenter Study in Postmenopausal Women with Osteoporosis, ALVOBOND (clinicaltrials.gov) - Oct 12, 2023
P3, N=532, Active, not recruiting,
In conclusion, this analysis identified first salvage adults with Ph-negative R/R B-cell ALL as particularly well-suited for treatment with blinatumomab since survival outcomes from retrospective analyses reported in this patient subgroup were numerically better compared with those from pivotal studies without additional safety signals. Trial completion date: Apr 2025 --> Oct 2024
- |||||||||| AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
Enrollment closed, Phase classification: AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov) - Oct 12, 2023
P1, N=209, Active, not recruiting,
Trial completion date: Apr 2025 --> Oct 2024 Recruiting --> Active, not recruiting | Phase classification: PN/A --> P1
- |||||||||| AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
Enrollment closed: AVT03 With Xgeva in Healthy Male Subjects (clinicaltrials.gov) - Oct 12, 2023
P1, N=208, Active, not recruiting,
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||||||||| Vectibix (panitumumab) / Amgen, Takeda
Journal, HEOR, Real-world evidence, Cost-effectiveness, Cost effectiveness, Real-world, Metastases: Real-World Cost Effectiveness of a Policy of KRAS Testing to Inform Cetuximab or Panitumumab for Third-Line Therapy of Metastatic Colorectal Cancer in British Columbia, Canada. (Pubmed Central) - Oct 11, 2023
Reduction in drug costs, through price discounts or potential future biosimilars, would make anti-EGFR therapy considerably more cost effective. By using real-world data for a large cohort with long follow-up we can assess the value of a policy of KRAS testing and anti-EGFR therapy achieved in practice.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen, zeluvalimab (AMG 404) / Amgen
Trial completion date: AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Oct 11, 2023
P1b, N=23, Active, not recruiting,
These results emphasize the variety of circumstances of patients taking IIAs. Trial completion date: Jan 2026 --> Jan 2025
- |||||||||| Journal, Metastases: CDK4/6 inhibitors for hormone receptor-positive/human epidermal growth factor receptor 2 negative advanced breast cancer: A rapid health technology assessment. (Pubmed Central) - Oct 10, 2023
By means of an integrated analysis encompassing bulk transcriptomics, single-cell RNA sequencing, and spatial transcriptomics, we have discerned genes and clusters of fibroblasts that potentially contribute to the pathogenesis of psoriasis. Until the clinical studies, guideline recommendations, prices, and many other aspects of this assessment are updated, abemaciclib and palbociclib, which have the top 2 scores, can be used as a priority recommendation for Chinese medical institutions to select CDK4/6 inhibitors and optimize the use of the drug catalog based on the scoring results of this assessment.
- |||||||||| Ibrance (palbociclib) / Pfizer, Herceptin (trastuzumab) / Roche
Enrollment closed, Trial completion date, Trial primary completion date: PATRICIA: Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer (clinicaltrials.gov) - Oct 10, 2023
P2, N=102, Active, not recruiting,
Until the clinical studies, guideline recommendations, prices, and many other aspects of this assessment are updated, abemaciclib and palbociclib, which have the top 2 scores, can be used as a priority recommendation for Chinese medical institutions to select CDK4/6 inhibitors and optimize the use of the drug catalog based on the scoring results of this assessment. Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Dec 2023 | Trial primary completion date: Aug 2023 --> Dec 2023
- |||||||||| Ibrance (palbociclib) / Pfizer
Trial completion, Combination therapy, Metastases: Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors (clinicaltrials.gov) - Oct 10, 2023
P1, N=71, Completed,
Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Dec 2023 | Trial primary completion date: Aug 2023 --> Dec 2023 Active, not recruiting --> Completed
- |||||||||| Prolia (denosumab) / Amgen
Trial completion: PROUD: Preventing Osteoporosis Using Denosumab (clinicaltrials.gov) - Oct 10, 2023
P4, N=201, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| AMG 794 / Amgen
Enrollment open, Trial completion date, Trial primary completion date: A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications (clinicaltrials.gov) - Oct 10, 2023
P1, N=98, Recruiting,
Male gender, lower baseline disease activity and fewer comorbidities, characterize a favourable outcome in terms of disease burden accrual and TNFi survival. Active, not recruiting --> Recruiting | Trial completion date: Jun 2027 --> Feb 2028 | Trial primary completion date: Dec 2025 --> Apr 2026
- |||||||||| Sylvant (siltuximab) / Jazz, Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment open, Trial initiation date: Screening Trial for Pain Relief in Schwannomatosis (STARFISH) (clinicaltrials.gov) - Oct 9, 2023
P2, N=40, Recruiting,
Active, not recruiting --> Recruiting | Trial completion date: Jun 2027 --> Feb 2028 | Trial primary completion date: Dec 2025 --> Apr 2026 Not yet recruiting --> Recruiting | Initiation date: Mar 2023 --> Aug 2023
- |||||||||| Journal: Biotherapies in severe childhood asthma (Pubmed Central) - Oct 9, 2023
Such treatments mainly include biotherapies, and, in children, four monoclonal antibodies are presently available to treat severe asthma: omalizumab, mepolizumab, dupilumab and tezepelumab. These biotherapies have demonstrated short- and medium-term efficacy and safety in both adults and children.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: A Case of Testicular Cancer with Solitary Iliac Bone Metastasis (Pubmed Central) - Oct 9, 2023
After one cycle of a bleomycin, etoposide and cisplatinum (BEP) regimen, he was referred to our hospital...Denosumab was also administered monthly...Because extirpation of the remaining mass would require resection of the left part of the pelvic bone with significant functional loss of the left limb, we performed close follow-up after an additional 2 courses of the etoposide and cisplatin regimen. The patient is currently alive without recurrence at 45 months after the last systemic chemotherapy.
- |||||||||| Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Review, Journal: Positioning of Tezepelumab in severe asthma. (Pubmed Central) - Oct 9, 2023
Therefore, tezepelumab can be used in the whole spectrum of patients with severe uncontrolled asthma, especially in T2-high patients. This review includes a positioning statement by the authors, members of the SEAIC Asthma Committee.
- |||||||||| Tepezza (teprotumumab) / Roche, Amgen, Actemra IV (tocilizumab) / Roche, JW Pharma, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Review, Journal: Roles of four targets in the pathogenesis of graves' orbitopathy. (Pubmed Central) - Oct 9, 2023
However, as a second-line treatment for GO, targeted drugs such as tocilizumab and rituximab have very limited therapeutic effects and may be accompanied by side effects. The introduction of Teprotumumab, which targets IGF-IR, has made significant progress in the clinical management of GO...In this discussion, we explore the pathogenesis of GO and relevant work, and highlight four potential targets for GO: Interleukin-23 receptor (IL-23
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Anabolic and Antiresorptive Osteoporosis Treatment: Trends, Costs, and Sequence in a Commercially Insured Population, 2003-2021. (Pubmed Central) - Oct 9, 2023
The introduction of Teprotumumab, which targets IGF-IR, has made significant progress in the clinical management of GO...In this discussion, we explore the pathogenesis of GO and relevant work, and highlight four potential targets for GO: Interleukin-23 receptor (IL-23 New anabolic medications (abaloparatide and romosozumab) were recently approved for osteoporosis, and data suggest that prescribing antiresorptive medications after a course of anabolic medications offers better outcomes..
- |||||||||| ivabradine / Generic mfg.
Review, Journal: Ivabradine in patients with heart failure: a systematic literature review. (Pubmed Central) - Oct 9, 2023
Ivabradine on top of background therapy is beneficial for heart rate, hospitalization risk for HF, mortality, EF, and patients' QoL. Moreover, these benefits were achieved with no significant increase in the overall risk of total adverse events.
- |||||||||| Ibrance (palbociclib) / Pfizer, Orpathys (savolitinib) / AstraZeneca, Hutchmed
Journal, IO biomarker: Construction of Lung Adenocarcinoma Prognosis Model and Drug Sensitivity Analysis Based on Cuproptosis Related Genes (Pubmed Central) - Oct 9, 2023
Moreover, these benefits were achieved with no significant increase in the overall risk of total adverse events. The risk model constructed based on 13 CRGs has good prognostic value, which can assist LUAD patients in individualized treatment, and provides an important theoretical basis for the treatment and prognosis of LUAD.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Stivarga (regorafenib) / Bayer
P2 data, Clinical Trial,Phase III, Journal, Metastases: First-line regorafenib with nivolumab and chemotherapy in advanced oesophageal, gastric, or gastro-oesophageal junction cancer in the USA: a single-arm, single-centre, phase 2 trial. (Pubmed Central) - Oct 9, 2023
P2
Regorafenib can be safely combined with nivolumab and chemotherapy and showed promising activity in HER2-negative metastatic oesophagogastric cancer. A randomised, phase 3 clinical trial is planned.
- |||||||||| Ravicti (glycerol phenylbutyrate) / Immedica, Amgen
Journal: Treatment and management for children with urea cycle disorder in chronic stage. (Pubmed Central) - Oct 9, 2023
Gene therapy, stem cell therapy, enzyme therapy and other novel technologies may offer options for treatment in UCD patients. The regular biochemical assessments like blood ammonia, liver function and plasma amino acid profile are needed, and physical growth, intellectual development, nutritional intake should be also evaluated for adjusting treatment in time.
- |||||||||| Repatha (evolocumab) / Amgen, Astellas
Journal, Real-world evidence, Real-world: Real-World Insights into Evolocumab Use in Patients with Hyperlipidemia Across Five Countries: Analysis from the ZERBINI Study. (Pubmed Central) - Oct 7, 2023
These findings provide real-world evidence that evolocumab use is in accordance with its international guideline-recommended place in dyslipidemia therapy, as well as confirmation of its effectiveness and safety in a heterogeneous population. Evolocumab can address a healthcare gap in the management of dyslipidemia by increasing the proportion of patients achieving LDL-C goals recommended to lower cardiovascular risk.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Evaluation of the effectiveness of denosumab therapy giant cell tumor of the pelvis (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_917;
Conclusions Long-term denosumab therapy can be considered with curative intent for pelvic and sacrum GCTB. If surgical intervention is required wide resection may be advisable to reduce the risk of recurrence.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Stivarga (regorafenib) / Bayer
Sidedness and survival of chemo-refractory metastatic colorectal cancer treated with lonsurf or regorafenib: A nationwide population-based study in Taiwan (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_689;
For patients with left side colon, median TTF and OS were 1.9 months versus 2.0 months (p = 0.178) and 10.2 months versus 7.8 months (p = 0.006) in lonsurf and regorafenib, respectively, while for patients with right side colon, median TTF and OS were 1.8 months versus 1.8 months (p = 0.390) and 7.8 months versus 6.0 months (p = 0.011) in lonsurf and regorafenib, respectively. Conclusions Lonsurf provided a longer survival over regorafenib in mCRC patients regardless of sidedness of primary tumor location.
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