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  • ||||||||||  vepdegestrant (ARV-471) / Arvinas, Pfizer, Ibrance (palbociclib) / Pfizer
    Vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, plus palbociclib in ER (Stars at Night Ballroom 1-2) -  Nov 4, 2023 - Abstract #SABCS2023SABCS_395;    
    P1/2, P3
    The safety profile of vepdegestrant plus palbo was generally consistent with the known safety profiles of the 2 agents except for an increased occurrence of grade 3/4 neutropenia, which was readily managed with laboratory monitoring and dose reductions of palbo. There is an ongoing study lead-in to the global VERITAC-3 study (NCT05909397) that is evaluating 2 doses of palbo (100 mg and 75 mg) in combination with vepdegestrant 200 mg QD to determine the recommended phase 3 combination to compare with letrozole plus palbo as first-line treatment for ER+/HER2- advanced breast cancer.
  • ||||||||||  Verzenio (abemaciclib) / Eli Lilly, Tecentriq (atezolizumab) / Roche
    MORPHEUS Hormone Receptor-Positive Breast Cancer: interim analysis of a Phase Ib/II, study of fulvestrant  (Stars at Night Ballroom 1-2) -  Nov 4, 2023 - Abstract #SABCS2023SABCS_376;    
    P1/2
    * Patient was treated in the second line and incorrectly included in this group. Abema, abemaciclib; AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; atezo, atezolizumab; CDK4/6, cyclin-dependent kinase 4/6; CI, confidence interval; ful, fulvestrant; irAE, immune-related adverse event; L, line; ORR, objective response rate; PFS, progression-free survival; TRAE, treatment-related adverse event.
  • ||||||||||  Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
    Inhibition of GPX4 enhances CDK4/6 inhibitor activity in breast cancer. (Stars at Night Ballroom 1-2) -  Nov 4, 2023 - Abstract #SABCS2023SABCS_373;    
    Background: Cyclin D-dependent kinases 4 and 6 (CDK4/6) inhibitors (CDK4/6i) including palbociclib, ribociclib and abemaciclib in combination with endocrine therapy are the standard of care for patients with estrogen receptor-positive (ER+). Our studies demonstrate that quiescence induced by palbociclib results in a ferroptosis-vulnerable state that could be exploited through combination with GPX4 inhibitors to enhance sensitivity to CDK4/6 inhibition in breast cancer.
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Protocol-defined biomarker analysis in the PALLAS (AFT-05) adjuvant trial: Genomic subtype derived from RNA sequencing of HR+/HER2- early breast cancer. (Hall 1) -  Nov 4, 2023 - Abstract #SABCS2023SABCS_260;    
    P3
    The phase 3 PALLAS trial (NCT02513394) compared two years of the CDK4/6 inhibitor palbociclib with endocrine therapy of provider choice, versus endocrine therapy alone, as adjuvant treatment for patients with Stage II-III hormone receptor-positive HER2-negative (HR+/HER2-) breast cancer...The planned analyses of prediction and prognosis are ongoing and those results will be presented at the time of the meeting. Support: AFT, ABCSG, Pfizer, ECOG-ACRIN, NSABP Foundation, GBG, BIG; Clinicaltrials.gov Identifier: NCT02513394; https://acknowledgments.alliancefound.org
  • ||||||||||  Ibrance (palbociclib) / Pfizer, Verzenio (abemaciclib) / Eli Lilly
    CDK4/6 inhibition is a potential vulnerability in NF1-depleted ER+ breast cancer (Hall 1) -  Nov 4, 2023 - Abstract #SABCS2023SABCS_244;    
    These data support a model whereby ER and RAS signaling converge upon CDK4/6, and CDK4/6 activation is a key survival mechanism when ER signaling is attenuated by treatment in NF1-depleted ER+ breast cancer cells. This apparent addiction for CDK4/6 activity makes NF1-depleted ER+ breast tumors vulnerable to CDK4/6 inhibition, thus creating a potential therapeutic opportunity to match CDK4/6 inhibition with patients who can benefit the most.
  • ||||||||||  Krystexxa (pegloticase) / Amgen, Kineret (anakinra) / SOBI, Ilaris (canakinumab) / Novartis
    Journal:  Drugs for gout. (Pubmed Central) -  Nov 3, 2023   
    This apparent addiction for CDK4/6 activity makes NF1-depleted ER+ breast tumors vulnerable to CDK4/6 inhibition, thus creating a potential therapeutic opportunity to match CDK4/6 inhibition with patients who can benefit the most. No abstract available
  • ||||||||||  Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Hukyndra (adalimumab biosimilar) / Cipla, Alvotech, Stada, Teva, JAMP Pharma, YAS Holding, Yuflyma (adalimumab-aaty) / Celltrion, Hikma
    Review, Journal:  Navigating adalimumab biosimilars: an expert opinion. (Pubmed Central) -  Nov 3, 2023   
    No abstract available The patent expiry of Humira in 2018 opened up the current European market to eight adalimumab biosimilars - (in alphabetical order) Amgevita, Amsparity, Hulio, Hukyndra, Hyrimoz, Idacio, Imraldi
  • ||||||||||  Stivarga (regorafenib) / Bayer
    Journal:  Targeting WNT/?-catenin via modulating EZH2 function - a new chapter in the treatment of ?-catenin mutant hepatocellular carcinoma? (Pubmed Central) -  Nov 3, 2023   
    In a recent study, Rialdi and colleagues identified a specific vulnerability in ?-catenin mutant hepatocellular carcinoma (HCC) via EZH2-mediated suppression of WNT signaling and revealed the selective anti-HCC activity of WNTinib, a chemical derivative of regorafenib and sorafenib in targeting this vulnerability. Their discoveries highlight the role of EZH2 in modulating WNT signaling and suggest an implication of WNTinihb as a small molecule inhibitor for the treatment of HCC with activated WNT/?-catenin.
  • ||||||||||  Praluent (alirocumab) / Sanofi, Regeneron, Repatha (evolocumab) / Amgen, Astellas
    Review, Journal:  Ups and downs in PCSK9 inhibition in the cardiovascular arena: a review. (Pubmed Central) -  Nov 3, 2023   
    Ongoing studies of PCSK9i in patients at lower risk and with acute myocardial infarction have the potential to broaden their indication. Alternative methods of PCSK9i are being evaluated and could provide easier and less expensive options for this important class of medication.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Denosumab for giant cell tumors of bone from 2010 to 2022: a bibliometric analysis. (Pubmed Central) -  Nov 3, 2023   
    Further research is required to analyze denosumab's safety and efficacy and understand its local recurrence of GCTB, to identify the optimal dose. Future progress in this field will likely focus on exploring new diagnostic and recurrence markers to monitor disease progression and examine new therapeutic targets and treatment strategies.
  • ||||||||||  Biomarker, Enrollment closed, IO biomarker:  UPSTREAM: Biomarker-based Study in R/M SCCHN (clinicaltrials.gov) -  Nov 3, 2023   
    P2,  N=340, Active, not recruiting, 
    QoL of ITP patients on TPO-RAs can be improved; the burden analyses presented can inform future efforts towards this. Recruiting --> Active, not recruiting
  • ||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen
    Lower Cumulative Incidence of Relapse but Higher Incidence of NRM in Patients with Poor Graft Function Following Allogeneic Stem Cell Transplantation (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_6372;    
    PGF was defined as follows: 1) =95% donor chimerism at last reading OR =95% CD3 negative chimerism; 2) =2 Lineage cytopenias defined as: Thrombocytopenia :=30x10 9 /L from D40-D60 OR =50 x10 9 /L from D60 onwards; neutropenia requiring filgrastim support at any time post D40; Hb <80g/L...Survival is inferior in patients with PGF particularly those with poor marrow recovery and this is mainly driven by non-relapse mortality. The lower CI of relapse in PGF is a novel finding of this study and may suggest a protective effect of PGF against the development of relapse but this finding requires further validation in external cohorts.
  • ||||||||||  Kepivance (palifermin) / SOBI, Amgen
    Preconditioning Single High-Dose Palifermin Alters the Posttransplant Inflammatory Cytokine Profile (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_6243;    
    P1/2, P2
    Pt 2 is a 68yo female with Ph-negative B-ALL who relapsed with CD19-low disease after multiagent chemotherapy, ino, and blina. This trial evaluates the incidence of severe CGVHD (primary objective of phase 2) following the addition of a single high dose of palifermin to GVHD prophylaxis with TMS (tacrolimus, methotrexate, sirolimus)...All patients received cyclophosphamide (total 4.8 g/m 2 ) and fludarabine (total 120 mg/m 2 ) as conditioning on days -6 to -3 followed by infusion of an 8/8 HLA-matched unrelated donor peripheral blood cell graft on day 0...The administration of a single high dose of palifermin (KGF) prior to conditioning treatment resulted in a notably distinct cytokine profile, characterized by a reduction in several GVHD associated pro-inflammatory cytokines, consistent with KGF
  • ||||||||||  navtemadlin (KRT-232) / Kartos Therap, M7583 / EMD Serono, Telios Pharma
    TL-895, a Highly Selective, Covalent Inhibitor of Bruton (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_5967;    
    P1/2, P2
    Our results indicate that BTKi therapy might increase susceptibility of MPN-BP SC to MDM2i therapy, by upregulating p53 activity and dampening NF-?B signaling, and also by disrupting protective TME interactions that sustain MPN-BP SC. This novel combination merits further clinical investigation in advanced phase MPN.
  • ||||||||||  Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
    Consolidation with Ponatinib Plus Sequential Blinatumomab and Chemotherapy after Low Intensity Dasatinib-Based Induction in Adults with Philadelphia Chromosome-Positive Acute Lymphoblastic L... (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_5680;    
    Introduction : Dasatinib plus prednisone is a standard induction approach for adults with Philadelphia Chromosome positive (Ph+) ALL known to result in high remission rates with minimal toxicity, however optimal post-remission therapy has not been determined...Concurrent with TKI, patients could also receive blina for one or two cycles (at discretion of treating clinician), followed by up to four cycles of consolidative chemotherapy alternating between high-dose methotrexate (1.5g/m 2 ) and intermediate-dose cytarabine (1g/m 2 x 6 doses)...The optimal number of blina cycles given post-remission is unclear, though we observed favorable outcomes in patients receiving a median of only 1 cycle, and maximum of 2 cycles. Favorable outcomes despite the low rate of allogeneic SCT (21%) seen in our cohort suggest that SCT may be safely avoided for some patients who receive ponatinib plus blina and chemotherapy-based consolidation.