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  • ||||||||||  Incorporating Immunotherapy into Upfront ALL Therapy (LEVEL 3, GENERAL ASSEMBLY) -  Jul 5, 2024 - Abstract #SOHO2024SOHO_89;    
    The use of HSCT in this setting should be carefully evaluated. Treatment of B-lineage acute lymphoblastic leukemia (B-ALL) has seen notable improvement in outcomes in the past few years with the advent of the use of pediatric-intensive regimens for adolescents and young adults, the use of measurable residual disease (MRD) for risk assessment, and the introduction of potent immunotherapeutic agents, including blinatumomab (Blin), inotuzumab ozogamicin (InO), and chimeric-antigen receptor T-cell (CAR-T) therapy...8 The United States intergroup E1910 trial treated Ph-neg B-ALL adults (age range of 30
  • ||||||||||  Elderly ALL: Low-Dose Chemotherapy and Immunotherapy Combinations (Level 3, 351 BCEF) -  Jul 5, 2024 - Abstract #SOHO2024SOHO_49;    
    P2, P3
    However, with the advent of immunotherapy, implicating anti-B therapeutic monoclonal antibodies, such as blinatumomab, a bi-specific CD19/CD3 T-cell engager, and inotuzumab (InO), an anti-CD22 antibody-drug conjugate, has led to some important breakthroughs in this high-risk population.1 Philadelphia Chromosome-Positive (Ph+) B-Cell ALL Patients Combining low-dose chemotherapy and tyrosine kinase inhibitors (TKIs) has become a standard of care in elderly patients...3 Blinatumomab-Based Regimen for Older ALL Patients Considering blinatumomab, a Southwest Oncology Group study4 reported the use of blinatumomab in 29 patients (age ?64 years, median age: 75 years) as induction (1 or 2 cycles) and consolidation (3 cycles) therapy followed by POMP maintenance (prednisone, vincristine, 6-mercaptopurine, and methotrexate (MTX)).4 Results were disappointing with a complete remission rate of 66% and a 3-year OS rate of only 37%...A second study (INITIAL-1 trial) was published last year by the German Multicenter Study Group on Adult Acute Lymphoblastic Leukemia (GMALL).7 This study included 45 patients (age ?55 years, median age: 64 years) who received up to three induction cycles of InO (total dose of 4.8 mg/m2) with DEX, followed by 5 cycles of age-adapted chemotherapy consolidation and one cycle of re-induction therapy, each in combination with rituximab for CD20-positive ALL, then maintenance with purinetol plus MTX...Finally, the European Working Group on Adult ALL (EWALL) has recently reported8 the results of the phase 2 multicenter prospective Ewallino study testing InO (total dose 2.8 mg/m2) as part of two induction courses (one with vincristine/DEX and the second with cyclophosphamide/DEX), followed by six courses of consolidation therapy and maintenance with vincrsitine/purinethol/MTX over 18 months...No current immunotherapies have been proven effective in this setting (anti-CD38 therapy with daratumomab or isatuximab).9,10 However, hopes are already increasing with the demonstration of very promising early results of CAR T products against CD5 and CD7.11 Conclusion The treatment of older ALL patients remains challenging. However, the future is promising and new strategies, chemo-free regimens or a combination of attenuated chemotherapy with new targeted agents, are already optimizing results and providing better outcomes in this particular high-risk population.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Elderly ALL: Inotuzumab/Blinatumomab (Level 3, 351 BCEF) -  Jul 5, 2024 - Abstract #SOHO2024SOHO_48;    
  • ||||||||||  Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Elderly ALL: Inotuzumab as Induction (Level 3, 351 BCEF) -  Jul 5, 2024 - Abstract #SOHO2024SOHO_47;    
    However, the future is promising and new strategies, chemo-free regimens or a combination of attenuated chemotherapy with new targeted agents, are already optimizing results and providing better outcomes in this particular high-risk population. The first induction cycle (21 days) consisted of InO 0.8 mg/m2 on day 1 and 0.5 mg/m2 on day 8 and day 15 in combination with dexamethasone 10 mg/m2 (days 7
  • ||||||||||  Tepezza (teprotumumab-trbw) / Roche, Amgen
    Journal:  Teprotumumab for Thyroid Eye Disease-related Strabismus. (Pubmed Central) -  Jul 5, 2024   
    Extraocular motility in all 4 ductions also improved. A substantial minority of patients still required strabismus surgery following teprotumumab.
  • ||||||||||  Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Clinical, Retrospective data, Journal:  The effect of erythropoiesis?stimulating agents on lung cancer patients: a meta?analysis. (Pubmed Central) -  Jul 5, 2024   
    There was no statistically significant difference between the two groups in the incidence of adverse reactions (RR 0.98, 95% CI 0.95-1.00, P?=?0.10). In conclusion, ESAs does not increase the mortality of lung cancer patients or may reduce the risk of death, and can reduce the need for blood transfusion, although ESA can increase the incidence of thrombotic vascular adverse events.Registration PROSPERO CRD42023463582.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  Efficacy and safety of denosumab de?escalation in giant cell tumor of bone. (Pubmed Central) -  Jul 5, 2024   
    In conclusion, 12-weekly de-escalated denosumab treatment showed clinical benefits as a maintenance treatment in patients with unresectable GCTB, in addition to sustained stable tumor control and improved clinical symptoms with standard treatment. A 24-weekly treatment can also be administered, with careful attention paid to detecting local recurrence.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    Trial completion date, Metastases:  AMG 510 Ethnic Sensitivity Study (CodeBreaK 105). (clinicaltrials.gov) -  Jul 5, 2024   
    P1,  N=12, Active, not recruiting, 
    A 24-weekly treatment can also be administered, with careful attention paid to detecting local recurrence. Trial completion date: Jul 2024 --> Dec 2024
  • ||||||||||  AMB-05X / AmMax
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT (clinicaltrials.gov) -  Jul 4, 2024   
    P2,  N=20, Completed, 
    Active, not recruiting --> Completed Recruiting --> Completed | N=48 --> 20 | Trial completion date: Jan 2026 --> Jun 2024 | Trial primary completion date: Nov 2025 --> Jun 2024
  • ||||||||||  fludarabine IV / Generic mfg., thiotepa / Generic mfg.
    Trial completion, Trial completion date:  Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov) -  Jul 4, 2024   
    P2,  N=40, Completed, 
    Recruiting --> Completed | N=48 --> 20 | Trial completion date: Jan 2026 --> Jun 2024 | Trial primary completion date: Nov 2025 --> Jun 2024 Trial completion date: Jun 2025 --> Jun 2024 | Active, not recruiting --> Completed
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Trial completion date, Trial primary completion date:  A Study of MT-0551 in Patients With Systemic Sclerosis (clinicaltrials.gov) -  Jul 4, 2024   
    P3,  N=80, Recruiting, 
    Trial completion date: Jun 2025 --> Jun 2024 | Active, not recruiting --> Completed Trial completion date: Jul 2026 --> Apr 2027 | Trial primary completion date: Jun 2024 --> Mar 2025
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion date, Trial primary completion date:  BoneZone: Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults (clinicaltrials.gov) -  Jul 4, 2024   
    P2,  N=450, Recruiting, 
    Trial completion date: Jul 2026 --> Apr 2027 | Trial primary completion date: Jun 2024 --> Mar 2025 Trial completion date: May 2025 --> Feb 2027 | Trial primary completion date: Dec 2023 --> Feb 2027
  • ||||||||||  Neulasta (pegfilgrastim) / Roche
    Journal:  Artifactual hypoglycaemia may be common in patients with soft tissue sarcoma who received pegfilgrastim-supported chemotherapy. (Pubmed Central) -  Jul 4, 2024   
    Barriers to early HCT included infection, physician preference, lack of an HLA-matched donor, logistical delays, and disease progression, all of which may limit real-world uptake of such early-to-transplant protocols. If a lack of symptoms due to hypoglycemia and leukocytes is confirmed, physicians should wait and identify the normalization of the level of glucose according to the neutrophil nadir following temporal leukocytes, which prevents further invasive examination for hypoglycemia.
  • ||||||||||  Praluent (alirocumab) / Sanofi, Regeneron, Leqvio (inclisiran) / Novartis, Repatha (evolocumab) / Amgen, Astellas
    Journal:  Proprotein convertase subtilisin/kexin type 9-inhibition across different patient populations. (Pubmed Central) -  Jul 3, 2024   
    The impact of CYP3A4 inhibition was interrogated utilizing repeat doses of 200 PCSK9 inhibitors are safe, well tolerated, and effective in primary and secondary prevention in a wide range of patient populations.
  • ||||||||||  Journal:  Enhancing neutrophil cytotoxicity of a panel of clinical EGFR antibodies by Fc engineering to IgA3.0. (Pubmed Central) -  Jul 3, 2024   
    IgA3.0 matuzumab exhibited reduced receptor internalization compared to the other antibodies, possibly accounting for its superior in vivo Fc-mediated tumor cell killing efficacy. In conclusion, reformatting EGFR antibodies into an IgA3.0 format increased Fc-mediated killing while retaining Fab-mediated functions and could therefore be a good alternative for the currently available antibody therapies.
  • ||||||||||  Imdelltra (tarlatamab-dlle) / Amgen
    Review, Journal, Circulating tumor cells, PARP Biomarker, IO biomarker, Tumor cell:  Circulating tumor cells: advancing personalized therapy in small cell lung cancer patients. (Pubmed Central) -  Jul 3, 2024   
    Specific tumor biomarkers, such as delta-like ligand 3 (DLL3) and schlafen11 (SLFN11), may enable the selection of more efficacious, novel immunomodulating targeted treatments like bispecific T-cell engaging monoclonal antibodies (tarlatamab) and chemotherapy with PARP inhibitors...CTCs have been studied for their prognostic ability in SCLC; however, their value in guiding treatment decisions is yet to be elucidated. This review explores novel and promising targeted therapies in SCLC, summarizes current knowledge of CTCs in SCLC, and discusses how CTCs can be utilized for precision medicine.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Stivarga (regorafenib) / Bayer
    Enrollment open, Monotherapy:  REGPEM-CRC-01: Regorafenib in Combination with Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer (clinicaltrials.gov) -  Jul 3, 2024   
    P2,  N=154, Recruiting, 
    This review explores novel and promising targeted therapies in SCLC, summarizes current knowledge of CTCs in SCLC, and discusses how CTCs can be utilized for precision medicine. Not yet recruiting --> Recruiting
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) (clinicaltrials.gov) -  Jul 3, 2024   
    P1/2,  N=46, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Oct 2027 --> May 2024 Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
  • ||||||||||  Clinical, Journal:  Towards precision medicine in COPD: Targeting type 2 cytokines and alarmins. (Pubmed Central) -  Jul 2, 2024   
    300 eosinophils/?L treated with dupilumab (anti-IL-4R?)...Several ongoing RCTs are evaluating the efficacy and safety of anti-TSLP (tezepelumab), anti-IL-33 (itepekimab, tozorakimab), and anti-ST2 (astegolimab) in patients with COPD, who experience exacerbations. In conclusion, targeting T2 inflammation or epithelial-derived alarmins might represent a step forward in precision medicine for the treatment of a subset of COPD.
  • ||||||||||  Vyepti (eptinezumab-jjmr) / Teva, Lundbeck, Aimovig (erenumab-aooe) / Amgen, Novartis, Nurtec ODT (rimegepant ODT) / Pfizer
    Breaking New Ground in Vestibular Migraine Treatment with CGRP-Based Therapies (B7) -  Jul 2, 2024 - Abstract #EAN2024EAN_2995;    
    Interventions included Erenumab, Rimegepant, and Eptinezumab, with treatment tailored as per FDA- approved dosing guidelines. Present study reinforces the efficacy of CGRP- based therapies in treating VM, advocating for the inclusion of CGRP therapies in standard treatment protocols and highlighting need for further research in this area.