CD Protein Inhibitors 

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  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Trial completion date, Trial primary completion date, Checkpoint inhibition, Checkpoint block:  BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy (clinicaltrials.gov) -  Sep 27, 2024   
    P1/2,  N=27, Recruiting, 
    Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
  • ||||||||||  BT5528 / Bicycle Therap
    Trial completion date, Trial primary completion date, Metastases:  Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression (clinicaltrials.gov) -  Sep 27, 2024   
    P1/2,  N=288, Recruiting, 
    Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025 Trial completion date: Dec 2024 --> Oct 2026 | Trial primary completion date: Dec 2023 --> Oct 2025
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Trial completion date, Trial primary completion date:  Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma (clinicaltrials.gov) -  Sep 27, 2024   
    P2,  N=69, Recruiting, 
    Trial completion date: Dec 2024 --> Oct 2026 | Trial primary completion date: Dec 2023 --> Oct 2025 Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
  • ||||||||||  xirestomig (ATG-101) / Antengene
    Journal:  The ULK1 effector BAG2 regulates autophagy initiation by modulating AMBRA1 localization. (Pubmed Central) -  Sep 26, 2024   
    To gain insights into functions of the holo-complex, we generated a deep interactome by combining affinity purification- and proximity labeling-mass spectrometry of all four complex members: ULK1, ATG13, ATG101, and RB1CC1/FIP200...In growth conditions, the unphosphorylated form of BAG2 sequesters AMBRA1, attenuating autophagy induction. In starvation conditions, ULK1 phosphorylates BAG2 on Ser31, which supports the recruitment of AMBRA1 to the ER membrane, positively affecting autophagy.
  • ||||||||||  Rituxan (rituximab) / Roche
    Journal:  Autologous stem cell transplant in fit patients with late relapsed diffuse large B-cell lymphoma that responded to salvage chemotherapy. (Pubmed Central) -  Sep 26, 2024   
    We retrospectively studied 151 patients with DLBCL that relapsed ?12 months after R-CHOP or R-CHOP-like frontline therapy who underwent ST and ASCT at Mayo Clinic between July 2000 and December 2017 or the University of Iowa between April 2003 and April 2020...Conversely, survival was favorable in patients who required only 1 line of ST, supporting the current clinical practice of ASCT consolidation in these patients. Moreover, outcomes were favorable in patients aged ?70-78 years at ASCT, similar to younger patients, highlighting the safety and feasibility of this approach in such patients.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Journal, Adverse events, CAR T-Cell Therapy:  Dermatologic adverse events associated with chimeric antigen receptor T-cell therapy: a pharmacovigilance analysis of the FDA reporting system. (Pubmed Central) -  Sep 26, 2024   
    This study reveals a significantly increased reporting rate of severe cutaneous eruptions and vascular cutaneous DAEs associated with CAR-T therapy, with both event groups associated with high mortality. These results emphasize the importance of monitoring dermatologic toxicities in clinical practice to ensure timely identification and management of potentially severe adverse events.
  • ||||||||||  Adcetris (brentuximab vedotin) / Takeda, Pfizer
    Review, Journal, PD(L)-1 Biomarker, IO biomarker:  Emerging immunotherapies in the Hodgkin Lymphoma Armamentarium. (Pubmed Central) -  Sep 26, 2024   
    Brentuximab vedotin and PD-1 inhibitors have improved outcomes for classic Hodgkin lymphoma (cHL), but better therapies are needed for patients who relapse after these agents...Rational combinations with existing agents and next generation antibody and CAR-T constructs may improve response rates and durability. Identifying biomarkers of response to these immunotherapies and using more sensitive tools to assess response, such as circulating tumor DNA, may further inform treatment decisions and enable a precision medicine approach in the future.
  • ||||||||||  Darzalex (daratumumab) / J&J
    Journal, HEOR, Real-world evidence, Real-world:  Real-world treatment patterns and outcomes in relapsed/refractory multiple myeloma (1-3 prior lines): Flatiron database. (Pubmed Central) -  Sep 26, 2024   
    In 561 patients with 1 prior LOT at inclusion, cumulative attrition rate from LOT 2-5 was 85%, which included 25% patients who died and 60% with no further treatment. Patients with lenalidomide-refractory MM who have received 1-3 prior LOT have poor outcomes and progress rapidly through available therapies, highlighting the need for more effective treatments early in the disease course, before patients are lost to attrition.
  • ||||||||||  Journal:  Access to expensive therapies and diagnostics for kidney care in Switzerland. (Pubmed Central) -  Sep 26, 2024   
    Patients with lenalidomide-refractory MM who have received 1-3 prior LOT have poor outcomes and progress rapidly through available therapies, highlighting the need for more effective treatments early in the disease course, before patients are lost to attrition. From the perspective of nephrologists, the pre-authorizations process in Switzerland is cumbersome, not transparent and inequitable, may result in denial or delays of important treatment for patients and contributes to moral distress.
  • ||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
    Journal, FDG PET:  18F-FDG PET/CT for Detection of Immunotherapy-Induced Hypophysitis-A Case-Control Study. (Pubmed Central) -  Sep 26, 2024   
    The 2nd-line TKI was effective for a small group of nccRCC patients previously treated with IO combination therapy, although this study was retrospectively analyzed with a small number of cases. Our findings suggest that, in patients undergoing ICI treatment for metastatic melanoma, a pituitary TBR of approximately 2.4 may indicate impending ICI-induced hypophysitis.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Clinical, Journal, Monotherapy, Metastases:  Cemiplimab monotherapy in Japanese patients with recurrent or metastatic cervical cancer. (Pubmed Central) -  Sep 26, 2024   
    Our findings suggest that, in patients undergoing ICI treatment for metastatic melanoma, a pituitary TBR of approximately 2.4 may indicate impending ICI-induced hypophysitis. While acknowledging limitations inherent to a small subgroup analysis, the HR of 0.86 observed in Japanese patients suggests an emerging survival benefit despite a 4.6-month shorter median duration of follow-up versus the overall study population.
  • ||||||||||  Avastin (bevacizumab) / Roche, Lenvima (lenvatinib) / Eisai, Merck (MSD), Tecentriq (atezolizumab) / Roche
    Journal, Combination therapy, Metastases:  Newly established borderline resectable 1 (BR1) (Pubmed Central) -  Sep 26, 2024   
    Future research could assess this practice in other oncology therapies. In patients with advanced HCC with intrahepatic target nodules the BR1 category is one of the favorable candidates for selecting those to be treated with MCT strategies.
  • ||||||||||  Tivdak (tisotumab vedotin-tftv) / Genmab, Pfizer
    Review, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases:  Antibody drug conjugates in recurrent or metastatic cervical cancer: a focus on tisotumab vedotin state of art. (Pubmed Central) -  Sep 26, 2024   
    However, several questions are still unresolved: (1) the identification of the most suitable timing for ADCs administration in the treatment sequence of advanced/recurrent CC; (2) the evaluation of combination therapies as a tool to minimize the emergence of resistant clones and to enhance overall effectiveness; and (3) the assessment of tolerability and correct management of special toxicities (e.g. ocular and neurological adverse events). In the near future, an improvement in patient selection via biomarker-driven strategies should be crucial for optimizing both treatment benefits and maintaining an acceptable toxicity profile.
  • ||||||||||  BH3120 / Hanmi
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) -  Sep 26, 2024   
    P1,  N=245, Recruiting, 
    IMM0306, a fusion protein of CD20 mAb with the CD47 binding domain of SIRP?, reverses the tumorpromoting effects of IL-16,which provides new insight into treatment strategy in ABC-DLBCL. Trial completion date: Jul 2027 --> Jan 2028 | Trial primary completion date: Feb 2027 --> Aug 2027
  • ||||||||||  Sarclisa (isatuximab-irfc) / Sanofi
    Subcutaneous administration of isatuximab by an on-body delivery system (OBDS) in multiple myeloma patients: results of a nurse survey (Exhibit Hall, Pavilion 3) -  Sep 26, 2024 - Abstract #IMW2024IMW_695;    
    P1
    Introduction: Intravenous (IV) isatuximab (Isa) in combination with pomalidomide-dexamethasone (Pd) is approved for the treatment of relapsed/refractory multiple myeloma (RRMM) patients...Extent of drug delivered not clear in case of interruption (83%) and need to press/hold a button to pause injection (67%) were agreed upon as potential disadvantages for HCPs; risk of allergy to the adhesive tape (50%) was reported as a potential disadvantage for patients, although no interruptions or allergy were observed in 581 administrations via OBDS in the Phase 1b study (IMS 2023; P-306). Findings from this nurse survey show a high level of confidence and preference for SC Isa treatment delivery using a hands-free OBDS vs IV administration, due to its ease of use, tolerability, and time savings, suggesting its applicability in routine clinical practice.
  • ||||||||||  Blenrep (belantamab mafodotin-blmf) / GSK
    Efficacy of Belantamab Mafodotin + Bortezomib + Dexamethasone (BVd) Compared to Alternative Regimens in 2L+ Relapsed/Refractory Multiple Myeloma (RRMM): A Network Meta-analysis of Randomized Trials (Exhibit Hall, Pavilion 3) -  Sep 26, 2024 - Abstract #IMW2024IMW_694;    
    P3
    The phase III DREAMM-7 study (NCT04246047) evaluated belamaf with bortezomib (V)+dexamethasone (d; BVd) vs daratumumab (D)+Vd (DVd) in patients with RRMM who had ?1 prior line of therapy (2L+)...All regimens compared to BVd included a proteasome inhibitor and were: cyclophosphamide (Cy)+Vd (CyVd), Cy + carfilzomib (K)+d (CyKd), DVd, elotuzumab (E)+Vd (EVd), D+K+d (DKd), isatuximab (Isa)+Kd (IsaKd), panobinostat (Pano)+Vd (PanoVd), pomalidomide (P)+Vd (PVd), selinexor (S)+Vd (SVd), Kd, and Vd... In the absence of any direct RCTs comparing BVd, this NMA indicated BVd offers the highest PFS, OS, and ORR of the included proteasome inhibitor-based regimens for 2L+ RRMM.
  • ||||||||||  Darzalex (daratumumab) / J&J
    A MULTICENTER OBSERVATIONAL RETROSPECTIVE STUDY OF SECOND-LINE TREATMENT WITH DARATUMUMAB  (Exhibit Hall, Pavilion 3) -  Sep 26, 2024 - Abstract #IMW2024IMW_693;    
    PFS was shorter than in the general population (27 mos), except for pts with ?VGPR, but two-fold longer than previously reported in the CASTOR study (7.8 mos), regardless of the number of prior lines of therapy. Overall, DaraVd remains an alternative option for len-ref pts at first relapse, especially for those ineligibles to receive pomalidomide-or carflizomib-based regimens.
  • ||||||||||  Tecvayli (teclistamab-cqyv) / Genmab, J&J
    Brazilian Single-Center Initial Experience and Safety of Teclistamab for Patients with Heavily Pretreated Relapsed/Refractory Multiple Myeloma (Exhibit Hall, Pavilion 3) -  Sep 26, 2024 - Abstract #IMW2024IMW_676;    
    This is a real-world initial experience of teclistamab in RRMM at a Brazilian single center and indicates that, after addressing 2 cases of grade 4 CRS in patients with very aggressive progressive disease, teclistamab was well-tolerated with the use of tocilizumab in grade 1 CRS. Despite the high incidence of extramedullary disease, and tocilizumab use in grade 1 CRS, early efficacy assessment of teclistamab in a real-world setting is encouraging.