- |||||||||| Ibrance (palbociclib) / Pfizer
Journal, Patient reported outcomes: Patient-reported outcomes in high-risk HR+ (Pubmed Central) - Dec 18, 2023
Patient-reported global QoL and fatigue did not substantially change in both treatment arms. Slight differences in GHS, physical functioning, and fatigue favored the placebo arm statistically without achieving clinically meaningful thresholds.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Micropetrosis: Osteocyte Lacunar Mineralization in Aging and Disease. (Pubmed Central) - Dec 18, 2023
Denosumab and bisphosphonates seem to affect lacunar mineralization differently, where specifically bisphosphonates have been shown to prolong osteocyte viability and reduce micropetrosis. Despite continuous proceedings in the field of osteocyte-lacunar-network characteristics, more studies are necessary to further clarify the mechanisms of lacunar mineralization, the inter-site variability of micropetrosis accumulation, the relevance of micropetrosis in various diseases and conditions, and whether micropetrosis could be an indicator of bone fragility or a target for treatment.
- |||||||||| brazikumab (AMG 139) / AstraZeneca
Biomarker, Journal: Combining Pharmacometric Models with Predictive and Prognostic Biomarkers for Precision Therapy in Crohn's Disease: A Case Study of Brazikumab. (Pubmed Central) - Dec 18, 2023
We demonstrated that model derived IB (baseline biomarker levels that achieve 50% of I ) of 22.8 pg/mL and 8.03 mg/L for BIL22 and BCRP as the cutoffs to select subpopulations can effectively identify high-response sub-group patients with improved separation of responders when compared to using the median values as the cutoff. This work exemplifies the utility of pharmacometrics to quantify biomarker-driven responses in biologic therapies and distinguish between predictive and prognostic biomarkers, complementing clinical efforts of identifying subpopulations with higher likelihood of response to brazikumab.
- |||||||||| Ibrance (palbociclib) / Pfizer
Enrollment closed, Surgery: WI223281: Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery (clinicaltrials.gov) - Dec 18, 2023
P2, N=17, Active, not recruiting,
This work exemplifies the utility of pharmacometrics to quantify biomarker-driven responses in biologic therapies and distinguish between predictive and prognostic biomarkers, complementing clinical efforts of identifying subpopulations with higher likelihood of response to brazikumab. Recruiting --> Active, not recruiting
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Journal: A Proximity-Dependent Biosensor System for Visualizing Cell-Cell Interactions Induced by Therapeutic Antibodies. (Pubmed Central) - Dec 17, 2023
The system was applied to quantitatively monitor cell-cell interactions between NK and target cells induced by rituximab and between T and target cells induced by blinatumomab in a 3D cell culture system. The biosensor system has the potential to characterize antibody pharmacology through a deeper understanding of antibody-mediated cell-cell interactions.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Journal, HEOR, IO biomarker: Leveraging health care technology to improve health outcomes and reduce outcome disparities in AYA leukemia. (Pubmed Central) - Dec 17, 2023
Currently, several up-front trials are looking to incorporate the use of inotuzumab, blinatumomab, and chimeric antigen receptor T-cell therapy into existing chemotherapy backbones for AYA patients, as well as tyrosine kinase inhibitors for both Philadelphia-positive (Ph+) and Ph-like B-ALL. In addition to ongoing attempts to improve up-front treatments by incorporating immunotherapy and targeted approaches, the increased use of next generation sequencing for measurable residual disease evaluation has led to superior risk-stratification and a decreased need to pursue consolidative hematopoietic stem cell transplantation during the first complete remission for many patients.
- |||||||||| Vectibix (panitumumab) / Amgen, Takeda, Lumakras (sotorasib) / Amgen
Journal, Metastases: Revolutionizing KRAS p.G12C therapy in metastatic colorectal cancer: The triumph of dual inhibition. (Pubmed Central) - Dec 17, 2023
In addition to ongoing attempts to improve up-front treatments by incorporating immunotherapy and targeted approaches, the increased use of next generation sequencing for measurable residual disease evaluation has led to superior risk-stratification and a decreased need to pursue consolidative hematopoietic stem cell transplantation during the first complete remission for many patients. The study by Fakih et
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Journal: CAR-T therapy for adult B-cell acute lymphoblastic leukemia (Pubmed Central) - Dec 17, 2023
We have already used tisagenlecleucel in clinical practice, but it is limited to patients up to 25 years of age. This review summarizes the most recent evidence on CAR-T therapy for relapsed or refractory adult B-ALL, which has a poor prognosis when assessed in younger patients.
- |||||||||| tarlatamab (AMG 757) / Amgen
Journal: Tarlatamab Shows Promise in SCLC. (Pubmed Central) - Dec 17, 2023
Tarlatamab, an investigational bispecific T-cell engager molecule that targets the cell surface protein delta-like ligand 3, has shown promising activity in patients with small cell lung cancer whose disease had progressed after receiving another therapy. Questions remain over whether clinicians and patients would use the drug given its challenging administration.
- |||||||||| AMG 193 / Amgen
Journal: AMG 193 Effective in Multiple Tumor Types. (Pubmed Central) - Dec 17, 2023
In a phase I trial of the MTA-cooperative PRMT5 inhibitor AMG 193, five of 39 patients with advanced MTAP-deleted solid tumors who had scans following initial treatment experienced partial responses. The responses occurred in five tumor types-esophageal, pancreatic, renal cell, gallbladder, and ovarian Sertoli-Leydig cell cancer.
- |||||||||| Lumakras (sotorasib) / Amgen
Journal: Modifying Trial Design May Be Key to Full Sotorasib Approval. (Pubmed Central) - Dec 17, 2023
The responses occurred in five tumor types-esophageal, pancreatic, renal cell, gallbladder, and ovarian Sertoli-Leydig cell cancer. Due to design flaws and disappointing progression-free survival data in CodeBreaK 200, a confirmatory phase III trial for the KRASG12C inhibitor sotorasib, the drug's full approval as a second-line option for metastatic KRASG12C non-small cell lung cancer may be delayed and will likely hinge on further studies.
- |||||||||| Uplizna (inebilizumab) / Mitsubishi Tanabe, Amgen
Journal: Inebilizumab reduces neuromyelitis optica spectrum disorder risk independent of FCGR3A polymorphism. (Pubmed Central) - Dec 17, 2023
Previously, the F allele polymorphism at amino acid 158 of the FCGR3A gene (F158) was shown to decrease IgG-binding affinity and reduce rituximab (anti-CD20) efficacy for NMOSD attack prevention. In contrast, our current findings from inebilizumab-treated NMOSD patients indicate similar clinical outcomes between those with F158 and V158 allele genotypes.
- |||||||||| Ibrance (palbociclib) / Pfizer, Tukysa (tucatinib) / Pfizer
Journal, Metastases: Can We De-escalate Therapy for HER2-Positive Metastatic Breast Cancer? (Pubmed Central) - Dec 17, 2023
A recent phase Ib/II trial evaluated the combination of tucatinib, letrozole, and palbociclib in patients with HR+/HER2+ metastatic breast cancer, demonstrating a manageable safety profile and encouraging efficacy data. An all-oral, chemotherapy-free regimen is an appealing strategy, and could be a possible maintenance or primary therapy option in select patients.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen, Takeda
Journal, IO biomarker, Metastases: Anti-EGFR Antibodies in the Management of Advanced Colorectal Cancer. (Pubmed Central) - Dec 17, 2023
Finally, we look towards the future and describe contexts in which these agents are currently being investigated clinically with a focus on combinations with MAPK-targeted therapies and immunotherapy. Overall, this review provides historical context, current clinical usage, and future directions for anti-EGFR antibodies in advanced colorectal cancer.
- |||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen, Takeda
Journal, Real-world evidence, Real-world, Metastases: Atypical (non-V600E) BRAF mutations in metastatic colorectal cancer in population and real-world cohorts. (Pubmed Central) - Dec 17, 2023
Nine patients with aBRAFmt received cetuximab/panitumumab without response...OS for patients with aBRAFmt tumours was slightly better than for BRAF-V600Emt, but worse than for RASmt and RAS&BRAFwt. aBRAFmt should not be a contraindication for metastasectomy.
- |||||||||| Praluent (alirocumab) / Sanofi, Regeneron, Repatha (evolocumab) / Amgen, Astellas
Journal, Adherence: Analysis of Adherence to anti-PCSK9 Antibody Therapy Among Patients from Italy. (Pubmed Central) - Dec 17, 2023
According to Italian Drug Agency (AIFA), poor therapeutic adherence is the main cause of ineffectiveness of drug therapies, and it is associated with increased hospitalizations, morbidity and mortality. Data obtained from this study allow to detect the categories of patients who need specific programs about the correct use of drugs, in order to increase therapeutic adherence and facilitate the achievement of the expected outcomes for treatment.
- |||||||||| Review, Journal: New biological therapies for low-density lipoprotein cholesterol. (Pubmed Central) - Dec 17, 2023
Vaccines and gene editing therapies in particular hold great potential to potentially confer active long-term or provide single-treatment life-long knock-down of PCSK9 or ANGPTL3 activity. Biologic therapies inspired by monogenic hypocholesterolemia states are becoming valuable tools to help protect against atherosclerotic cardiovascular disease.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Efficacy of denosumab in the treatment of hypercalcemic renal dysfunction in sarcoidosis: a case report. (Pubmed Central) - Dec 16, 2023
Serum creatinine and corrected serum calcium levels subsequently decreased. The prednisone dose could be reduced following repeated denosumab administration.Thus, denosumab can be a multifaceted, beneficial option for sarcoidosis-induced hypercalcemia, as it alleviates renal dysfunction indirectly by normalizing serum calcium levels, facilitates reduction of the glucocorticoid dose, and ameliorates glucocorticoid-induced osteoporosis.
- |||||||||| Ibrance (palbociclib) / Pfizer
Trial primary completion date: A Phase Ib/II Study Confirmed Inhibition of Autophagy Synergizes Anti-tumor Effect of High Dose CDK4/6i (clinicaltrials.gov) - Dec 15, 2023
P1/2, N=29, Recruiting,
The prednisone dose could be reduced following repeated denosumab administration.Thus, denosumab can be a multifaceted, beneficial option for sarcoidosis-induced hypercalcemia, as it alleviates renal dysfunction indirectly by normalizing serum calcium levels, facilitates reduction of the glucocorticoid dose, and ameliorates glucocorticoid-induced osteoporosis. Trial primary completion date: Jun 2024 --> Dec 2023
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Trial completion date, Trial primary completion date, Minimal residual disease: Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL (clinicaltrials.gov) - Dec 15, 2023
P2, N=2, Active, not recruiting,
Trial primary completion date: Jun 2024 --> Dec 2023 Trial completion date: Nov 2025 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Jun 2024
- |||||||||| Ibrance (palbociclib) / Pfizer, TT001 / Ting Therap
Journal: Design, synthesis, and biological evaluation of N-(pyridin-3-yl)pyrimidin-4-amine analogues as novel cyclin-dependent kinase 2 inhibitors for cancer therapy. (Pubmed Central) - Dec 14, 2023
Recruiting --> Active, not recruiting Among them, the most promising compound 7l presented a broad antiproliferative efficacy toward diverse cancer cells MV4-11, HT-29, MCF-7, and HeLa with IC50 values of 0.83, 2.12, 3.12, and 8.61
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Observational data, Journal: Repercussions of Denosumab in Patients With Giant Cell Tumor of Bone: An Observational Study. (Pubmed Central) - Dec 14, 2023
After receiving neoadjuvant denosumab for 24 weeks, the study participants' clinical symptoms and histological indicators improved. With the exception of the stromal cells, there was no statistically significant difference between the male and female participants.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen
Does Neupogen Increase the Risk of Rejection After Heart Transplant? (Promenade Lobby (Sunset Center)) - Dec 13, 2023 - Abstract #WRMC2024WRMC_105;
The development of leukopenia and subsequent administration of Neupogen does not appear to increase the risk of rejection after HTx. Therefore, use of this drug does not appear to be a contraindication for treatment of leukopenia post-HTx.
- |||||||||| Stivarga (regorafenib) / Bayer
Journal: Brain metastasis of hepatocellular carcinoma- single center experience. (Pubmed Central) - Dec 13, 2023
In this study, it was found that patients who were clinically eligible to receive tyrosine kinase inhibitors survived longer after the detection of brain metastasis. Our study shows that multidisciplinary evaluation of these patients is vital for treatment guidance, and survival outcomes can be improved with the advancements in surgical and radiotherapy techniques even in patients with poor prognosis.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal, Real-world evidence, Real-world: Effectiveness of romosozumab in patients with osteoporosis at high fracture risk: a Japanese real-world study. (Pubmed Central) - Dec 12, 2023
Our study shows that multidisciplinary evaluation of these patients is vital for treatment guidance, and survival outcomes can be improved with the advancements in surgical and radiotherapy techniques even in patients with poor prognosis. This large-scale, multicenter chart review provides clinically relevant insights into the profiles of patients initiating romosozumab, effectiveness of real-world romosozumab use, and sequential therapy in Japanese patients at high risk of fracture.
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