- |||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal, IO biomarker: Diagnostic and therapeutic advances in adults with acute lymphoblastic leukemia in the era of gene analysis and targeted immunotherapy. (Pubmed Central) - Jan 20, 2024 Nevertheless, relapse of refractory ALL still occurs, and some poor ALL subtypes, such as Ph-like ALL and ETP-ALL, are unsolved problems for which novel agents and treatment strategies are needed. In this review, we summarize the currently applied diagnostic and therapeutic practices in the era of advanced genetic analysis and targeted immunotherapies in United States and Europe and introduce real-world Korean data.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Stivarga (regorafenib) / Bayer
Comparison between nivolumab and regorafenib after sorafenib failure for hepatocellular carcinoma (New Hall) - Jan 20, 2024 - Abstract #APASL2024APASL_2451; In this review, we summarize the currently applied diagnostic and therapeutic practices in the era of advanced genetic analysis and targeted immunotherapies in United States and Europe and introduce real-world Korean data. Clinical outcomes in patients treated with nivolumab and regorafenib after sorafenib failure did not differ significantly.
- |||||||||| Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Journal: Tezepelumab (Tezspire (Pubmed Central) - Jan 19, 2024 Tezepelumab proved a broad anti-inflammatory effect by blocking IL-4, IL-13 and IL-5 pathways, inducing a significant reduction in serum total IgE levels, FeNO, blood and sub-mucosal eosinophils, without affecting neutrophil level. Tezepelumab also reduced bronchial hyperresponsiveness and mucus plugs.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Severe Hypocalcemia With Denosumab Among Older Female Dialysis-Dependent Patients. (Pubmed Central) - Jan 19, 2024 Denosumab was associated with a markedly higher incidence of severe and very severe hypocalcemia in female dialysis-dependent patients aged 65 years or older compared with oral bisphosphonates. Given the complexity of diagnosing the underlying bone pathophysiology in dialysis-dependent patients, the high risk posed by denosumab in this population, and the complex strategies required to monitor and treat severe hypocalcemia, denosumab should be administered after careful patient selection and with plans for frequent monitoring.
- |||||||||| Journal, PD(L)-1 Biomarker, IO biomarker: Metabolic-Related Gene Prognostic Index for Predicting Prognosis, Immunotherapy Response, and Candidate Drugs in Ovarian Cancer. (Pubmed Central) - Jan 19, 2024
Meanwhile, we identified four candidate therapeutic drugs (ABT-737, crizotinib, panobinostat, and regorafenib) for patients with high MRGPI, and we evaluated the pharmacokinetics and safety of the candidate drugs. In summary, the MRGPI was a robust clinical feature that could predict patient prognosis, immunotherapy response, and candidate drugs, facilitating clinical decision making and therapeutic strategy of OC.
- |||||||||| Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Reimbursement, US reimbursement, Journal, HEOR, Medicare, Oncology care model, Cost of care: The Impact of Biosimilar Use on Total Cost of Care and Provider Financial Performance in the Medicare Oncology Care Model: A Population-Based Simulation Study. (Pubmed Central) - Jan 19, 2024 N/A. On the basis of our simulation study using observed Medicare claims and OCM criteria, we found that biosimilar substitution for reference products can significantly lower episode TCOC and improve provider financial performance under the terms of the largest value-based payment model implemented to date.
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Journal, Real-world evidence, Real-world: Real-World Experience of Adalimumab Biosimilar (ABP (Pubmed Central) - Jan 19, 2024 On the basis of our simulation study using observed Medicare claims and OCM criteria, we found that biosimilar substitution for reference products can significantly lower episode TCOC and improve provider financial performance under the terms of the largest value-based payment model implemented to date. Both patients with IBD and treating physicians reported high levels of satisfaction with ABP
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Blincyto (blinatumomab) / Astellas, Amgen
Enrollment closed: HAP2HCT: TCR??-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies (clinicaltrials.gov) - Jan 18, 2024 P2, N=140, Active, not recruiting, In conclusion, the present study offers a novel combination for prevention or treatment of bone metastasis of breast cancer. Recruiting --> Active, not recruiting
- |||||||||| Lumakras (sotorasib) / Amgen
Journal: Sotorasib is a pan-RASG12C inhibitor capable of driving clinical response in NRASG12C cancers. (Pubmed Central) - Jan 18, 2024 Structural and reciprocal mutagenesis studies suggested that differences in isoform-specific binding are mediated by a single amino acid: Histidine-95 in KRAS (Leucine-95 in NRAS). A patient with NRASG12C colorectal cancer treated with sotorasib and the anti-EGFR antibody panitumumab achieved a marked tumor response, demonstrating that sotorasib can be clinically effective in NRASG12C-mutated tumors.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen, Takeda
Preclinical, Journal: Exploring the Sensitivity of Antibody-Drug Conjugate Efficacy to the Selection of Payload, Antibody, and Cell line. (Pubmed Central) - Jan 18, 2024 Panitumumab, which had the second-highest anti-EGFR affinity, exhibited the least effective cytolysis across A431, A549, and MDA-MB-231 cells. By demonstrating that ADC potency toward a given target is dependent on both the antibody and drug chosen, these findings can guide the selection of ADCs for further in vivo analysis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment closed: MITO: Muscle Impact of Treating Osteoporosis (clinicaltrials.gov) - Jan 18, 2024 P4, N=20, Active, not recruiting, Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Sep 2025 Recruiting --> Active, not recruiting
- |||||||||| Lumakras (sotorasib) / Amgen, Tarlox (tarloxotinib bromide) / Pathos
Trial termination: Tarlox and Sotorasib in Patients With KRAS G12C Mutations (clinicaltrials.gov) - Jan 17, 2024 P1/2, N=5, Terminated, Trial completion date: Mar 2028 --> Jul 2028 Active, not recruiting --> Terminated; Study drug was discontinued by manufacturer for business reasons.
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Vectibix (panitumumab) / Amgen
Trial completion, Trial completion date, Trial primary completion date, Tumor mutational burden: Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin (clinicaltrials.gov) - Jan 17, 2024 P1, N=5, Completed, Active, not recruiting --> Terminated; lack of accrual Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Feb 2023 | Trial primary completion date: Sep 2024 --> Feb 2023
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Adverse events: Pharmacovigilance. Withdrawal and rebound effects: not just with psychotropic drugs (Pubmed Central) - Jan 17, 2024 This type of unintended effect, often underestimated, generally results from a drug-induced homeostatic imbalance that persists after the drug has been discontinued. Taking this risk into account right from the initial prescription should make it possible to prevent such complications, by encouraging intermittent use of the drug, or by applying a very gradual reduction in dosage when a regular treatment is stopped.
- |||||||||| Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: BIOTAPE: Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis (clinicaltrials.gov) - Jan 17, 2024
P4, N=15, Active, not recruiting, However, denosumab treatment did not affect coronary artery calcifications in these patients. Recruiting --> Active, not recruiting | N=156 --> 15 | Trial completion date: Mar 2024 --> Aug 2024 | Trial primary completion date: Dec 2023 --> Jul 2024
- |||||||||| Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Trial completion date, Trial primary completion date: Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype (clinicaltrials.gov) - Jan 17, 2024 P4, N=45, Not yet recruiting, Recruiting --> Active, not recruiting | N=156 --> 15 | Trial completion date: Mar 2024 --> Aug 2024 | Trial primary completion date: Dec 2023 --> Jul 2024 Trial completion date: Dec 2026 --> Mar 2027 | Trial primary completion date: Dec 2026 --> Mar 2027
- |||||||||| Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Observational data, Journal, Real-world evidence, Real-world: No wearing-off effect of erenumab or fremanezumab for chronic migraine prevention: a single-center, real-world, observational study. (Pubmed Central) - Jan 16, 2024 There was no wearing-off in treatment responders, which is in alignment with premarketing data from placebo-controlled phase III studies. These data suggest that patients should be informed upfront that no wearing-off effect is expected because anxiety for attacks at the end of the month per se may generate migraine attacks.
- |||||||||| Journal: Therapeutic TNF Inhibitors Exhibit Differential Levels of Efficacy in Accelerating Cutaneous Wound Healing. (Pubmed Central) - Jan 16, 2024
In line with histologic assessments, proteomics analyses from healing wounds exposed to various TNF inhibitors revealed distinct and differential wound-healing signatures that may underlie the differential efficacy of these inhibitors in accelerating cutaneous wound healing. Taken together, these data revealed that TNF inhibitors exhibited differential levels of efficacy in accelerating cutaneous wound healing in the impaired wound-healing model in
- |||||||||| Preclinical, Journal: In situ modeling of acquired resistance to RTK/RAS-pathway-targeted therapies. (Pubmed Central) - Jan 16, 2024
We additionally modeled resistance to targeted therapies including the KRAS inhibitors adagrasib and sotorasib, the MEK inhibitor trametinib, and the farnesyl transferase inhibitor tipifarnib. These studies highlight the tractability of in situ resistance assays to model acquired resistance to targeted therapies and provide a framework for assessing the extent to which synergistic drug combinations can target acquired drug resistance.
- |||||||||| humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial completion date, Metastases: Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - Jan 16, 2024 P2, N=153, Active, not recruiting, These studies highlight the tractability of in situ resistance assays to model acquired resistance to targeted therapies and provide a framework for assessing the extent to which synergistic drug combinations can target acquired drug resistance. Trial completion date: Dec 2023 --> Dec 2024
- |||||||||| Itovebi (inavolisib) / Roche
Enrollment closed, Metastases: INAVO120: A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Jan 16, 2024 P2/3, N=325, Active, not recruiting, Trial completion date: Dec 2023 --> Dec 2024 Recruiting --> Active, not recruiting
|