Amgen News - LARVOL Sigma

|||||||||| Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Targeting Brain Metastasis: The Success of Trastuzumab-Deruxtecan in HER2+ Cancers: A Case Report (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_489;

|||||||||| A statistical model for integration of on-treatment circulating tumor DNA dynamics and prediction of outcomes in patients with ER+/HER2- metastatic breast cancer (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_409;

|||||||||| Circulating Tumor DNA as a Prognostic Biomarker for CDK 4/6 Inhibitor Therapy in Metastatic Breast Cancer (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_398;

|||||||||| Ibrance (palbociclib) / Pfizer
Targeting RANK pathway in combination with CDK4/6 inhibitors decreases the growth of palbociclib-resistant breast tumors via cancer cells and tumor microenvironment-mediated effects (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_319;

|||||||||| Prolia (denosumab) / Amgen
Rediscovering Denosumab: Immunomodulation of the Tumor Microenvironment in Early-Stage Breast Cancer through RANK Pathway Inhibition (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_307;

|||||||||| Rate of Fracture After Discontinuation of Bone Modifying Agents in Patients with Early-Stage Breast or Prostate Cancer on Hormonal Therapy (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_304;

|||||||||| Genomic comparison of rapid vs. typical progressors on CDK4/6 inhibitor treatment in advanced breast cancer (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_284;

|||||||||| Long-Term Follow-up and updated analysis from S0221, Comparing Alternative Dose-Schedules of Adjuvant Anthracycline/Taxane Therapy in High-Risk Early Breast Cancer. (Hall 1) - Nov 1, 2024 - Abstract #SABCS2024SABCS_259;

|||||||||| Ibrance (palbociclib) / Pfizer, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Palbociclib plus letrozole versus weekly paclitaxel, both in combination w/ trastuzumab plus pertuzumab, as neoadjuvant treatment for patients w/ HR+/HER2+ early breast cancer: primary results from the randomized phase II TOUCH trial (IBCSG 55-17). (Hall 1) - Nov 1, 2024 - Abstract #SABCS2024SABCS_257;

|||||||||| camizestrant (AZD9833) / AstraZeneca, Kisqali (ribociclib) / Novartis
Results from SERENA-1 Parts K/L: A Phase 1 study of the next-generation oral selective estrogen receptor degrader (SERD) camizestrant (AZD9833) in combination with ribociclib in women with ER-positive, HER2 negative advanced breast cancer. (Hemisfair Ballroom 1-2) - Nov 1, 2024 - Abstract #SABCS2024SABCS_241;

|||||||||| Orserdu (elacestrant) / Menarini
Elacestrant combinations in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a phase 1b/2, open-label, umbrella study. (Hemisfair Ballroom 1-2) - Nov 1, 2024 - Abstract #SABCS2024SABCS_239;

|||||||||| BBO-10203 / BridgeBio Oncology Therap
BBO-10203, a first-in-class, orally bioavailable, selective blocker of the PI3K?:RAS interaction inhibits tumor growth alone and in combination with standard of care therapies in breast cancer models without inducing hyperglycemia. (Hemisfair Ballroom 1-2) - Nov 1, 2024 - Abstract #SABCS2024SABCS_237;

|||||||||| Prolia (denosumab) / Amgen
Osteonecrosis of the jaw (ONJ) in patients with metastatic breast cancer treated with denosumab in a randomized phase III trial comparing 4 vs. 12 weekly administration (REDUSE, SAKK 96/12) (Hemisfair Ballroom 3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_225;

|||||||||| Keytruda (pembrolizumab) / Merck (MSD)
Anti-RANKL bone resorptive therapy increases immune-related adverse events (irAE) in breast cancer patients (pts) treated with pembrolizumab. (Hemisfair Ballroom 3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_223;

|||||||||| Ibrance (palbociclib) / Pfizer
Primary results of the randomised Phase III trial comparing first-line ET plus palbociclib vs standard mono-chemotherapy in women with high risk HER2-/HR+ metastatic breast cancer and indication for chemotherapy - PADMA study. (Stars at Night 1-2) - Nov 1, 2024 - Abstract #SABCS2024SABCS_174;

|||||||||| Review, Journal: PCSK9 Monoclonal Antibodies Have Come a Long Way. (Pubmed Central) - Nov 1, 2024
This review highlights the benefits of PCSK9 Mabs in high cardiovascular risk patients. Despite their efficacy and safety, these therapies are hindered by limited access, and require broader integration into clinical practice to optimize therapeutic outcomes.

|||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Romosozumab following denosumab improves lumbar spine bone mineral density and trabecular bone score greater than denosumab continuation in postmenopausal women. (Pubmed Central) - Nov 1, 2024
Despite their efficacy and safety, these therapies are hindered by limited access, and require broader integration into clinical practice to optimize therapeutic outcomes. For 12

|||||||||| Praluent (alirocumab) / Sanofi, Regeneron, Repatha (evolocumab) / Amgen, Astellas
Review, Journal: Rationale for Early Administration of PCSK9 Inhibitors in Acute Coronary Syndrome. (Pubmed Central) - Nov 1, 2024
Monoclonal antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), such as evolocumab and alirocumab, offer a potential strategy to reduce LDL-C levels further and mitigate this residual risk. This review delves into the molecular mechanisms, effects on cholesterol metabolism, inflammatory modulation, and clinical outcomes associated with early administration of PCSK9 inhibitors following ACS.

|||||||||| Repatha (evolocumab) / Amgen, Astellas
Clinical, Observational data, Retrospective data, Journal: A retrospective analysis on optimal medical therapy for patients with symptomatic lower extremity peripheral artery disease: a French observational study. (Pubmed Central) - Nov 1, 2024
A majority of LEAD patients did not reach the LDLc goals. LEAD patients with a vascular surgery history did not experience a better management whereas they had a more consistent follow-up.

||||||||||  atenolol / Generic mfg., ivabradine / Generic mfg.
New trial:  Comparison Between Atenolol,Propnalol and Ivabradine (clinicaltrials.gov) -  Nov 1, 2024
P=N/A, N=120, Completed,  Sponsor: Menoufia University

||||||||||  Epogen (epoetin alfa) / Amgen
New P4 trial:  EpoAid: Use of Epoetin Alfa and Iron Derisomaltose in Treatment of Anemia in Patients with Sepsis or Septic Shock: a Randomized Controlled Trial (clinicaltrials.gov) -  Oct 31, 2024
P4, N=200, Not yet recruiting,  Sponsor: Medical University of Silesia

||||||||||  AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
Trial completion:  Multicenter Study in Postmenopausal Women with Osteoporosis, ALVOBOND (clinicaltrials.gov) -  Oct 31, 2024
P3, N=532, Completed,  Sponsor: Alvotech Swiss AG
LEAD patients with a vascular surgery history did not experience a better management whereas they had a more consistent follow-up. Active, not recruiting --> Completed

|||||||||| warfarin / Generic mfg.
Preclinical, Journal: In Vitro Assessment of Inhibitory Effects of Kinase Inhibitors on CYP2C9, 3A and 1A2: Prediction of Drug-Drug Interaction Risk with Warfarin and Direct Oral Anticoagulants. (Pubmed Central) - Oct 31, 2024
Our results suggest that several kinase inhibitors, including vatalanib and linsitinib, can cause CYP-mediated drug-drug interactions with warfarin and, to a lesser extent, with apixaban and rivaroxaban. The work provides mechanistic insights into the risk of DDIs between kinase inhibitors and anticoagulants, which can be used to avoid preventable DDIs in the clinic.

|||||||||| Review, Journal: Treatment of Reactive Arthritis with Biological Agents. (Pubmed Central) - Oct 31, 2024
Biological agents, including anti-TNF, anti-IL17, and anti-IL6 therapies, can be safely and effectively used in the treatment of ReA when conventional therapies fail. It further emphasizes the need for a well-designed controlled trial to provide scientific basis for better informed clinical decisions in cases not responding to conventional treatment.

||||||||||  Vectibix (panitumumab) / Amgen
Trial completion date, Trial primary completion date:  Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) -  Oct 31, 2024
P2, N=60, Not yet recruiting,  Sponsor: Andrei Iagaru
It further emphasizes the need for a well-designed controlled trial to provide scientific basis for better informed clinical decisions in cases not responding to conventional treatment. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025



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