AL102 / Immunome 
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  • ||||||||||  nirogacestat (PF-03084014) / SpringWorks Therap, AL102 / Ayala Pharma
    Review, Journal:  The Notch signaling pathway in desmoid tumor: Recent advances and the therapeutic prospects. (Pubmed Central) -  Nov 13, 2023   
    The updated findings from the phase III randomized controlled trial (DeFi trial) demonstrated that nirogacestat exerts significant benefits in terms of disease control and symptom resolution in patients with progressive DT. Therefore, this review provides a comprehensive overview of the present understanding of Notch signaling in the pathogenesis of DT, with a particular emphasis on the prospective therapeutic application of ?-secretase inhibitors in the management of DT.
  • ||||||||||  WVT078 / Novartis
    Initial Results from a Phase 1 Dose-Escalation Study of WVT078, a BCMA (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_6205;    
    P1
    Therefore, this review provides a comprehensive overview of the present understanding of Notch signaling in the pathogenesis of DT, with a particular emphasis on the prospective therapeutic application of ?-secretase inhibitors in the management of DT. Introduction: WVT078, a potent anti
  • ||||||||||  AL102 / Ayala Pharma, Novartis
    RINGSIDE phase 2/3 trial of AL102 for treatment of desmoid tumors (DT): Phase 2 results. (On Demand | S404; Poster Bd # 449) -  Apr 26, 2023 - Abstract #ASCO2023ASCO_2855;    
    P2/3
    The safety profile was consistent with the GSI class of drugs. Tumor response, volume reduction and T2 signal reduction were observed earlier in the 1.2 mg QD group, with deeper and maintained treatment responses.
  • ||||||||||  AL102 / Ayala Pharma, Novartis
    INITIAL RESULTS OF PHASE 2/3 TRIAL OF AL102 FOR TREATMENT OF DESMOID TUMORS (DT) () -  Sep 9, 2022 - Abstract #CTOS2022CTOS_340;    
    RINGSIDE Phase 3 Study EndpointsObjectivesEndpointsPrimaryEvaluate effects of AL102 on disease progressionPFS defined as time from randomization until date of assessment of progression (assessed by BICR based on RECIST v1.1) or death by any causeSecondaryEvaluate additional effects of AL102 on tumor response Conclusions of Part A of the study will be presented at the meeting.
  • ||||||||||  nirogacestat (PF-03084014) / SpringWorks Therap, AL102 / Ayala Pharma, Novartis
    Review, Journal:  Molecular pathogenesis of desmoid tumor and the role of γ-secretase inhibition. (Pubmed Central) -  Sep 8, 2022   
    Two GSIs, nirogacestat (PF-03084014) and AL102 are in later-stage clinical development; nirogacestat is being evaluated in a phase 3, randomized, placebo-controlled trial while AL102 is being evaluated in a phase 2/3, dose-finding (part A) and placebo-controlled (part B) trial. This review summarizes current understanding of the molecular pathogenesis of DT focusing on dysregulation of the Wnt signaling pathway, crosstalk with the Notch pathway, and the potential therapeutic role for GSIs in DT.
  • ||||||||||  AL102 / Ayala Pharma, Novartis
    Initial results of phase II/III trial of AL102 for treatment of desmoid tumors (DT) (7.3.U - Urval Auditorium) -  Jul 25, 2022 - Abstract #ESMO2022ESMO_1815;    
    P2/3
    Table: 1488MO Summary of Treatment-emergent Adverse Events (TEAEs) by Patient *Deemed unrelated to study drug by investigator Conclusions Safety findings to date show no indication for discontinuing any of the three dosing cohorts. Efficacy, patient reported outcome and additional safety data will be presented at the conference.
  • ||||||||||  Review, Journal:  Current management and recent progress in desmoid tumors. (Pubmed Central) -  May 18, 2022   
    P3
    In addition to nirogacestat, the gamma-secretase inhibitor AL102 is being investigated for the treatment of patients with progressing desmoid tumors in the phase II/III RINGSIDE trial. Finally, the beta-catenin inhibitor Tegavivint (BC2059) is being investigated in a phase 1 open-label trial in patients with a proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive.
  • ||||||||||  AL101 / Ayala Pharma, nirogacestat (PF-03084014) / SpringWorks Therap, AL102 / Ayala Pharma, Novartis
    AL102, ORAL GAMMA-SECRETASE INHIBITOR FOR THE TREATMENT OF DESMOID TUMORS ([VIRTUAL]) -  Nov 26, 2021 - Abstract #CTOS2021CTOS_333;    
    An oral GSI (PF-03084014) was effective in treating desmoid tumors with an objective response rate (ORR) of 71.4% in a Phase 1 study with 7 patients (Villalobos, 2018)...In a Phase 1 study with AL101 (formerly known BMS-906024; study CA216001), another GSI developed by Ayala, 2 participants with DT had confirmed partial response (PR) lasting either >3.5 years or >1 year; and an additional participant with extremity DT had stable disease lasting 1 year before discontinuing treatment (El-Khoueiry, 2018).RINGSIDE is a Phase 2/3, randomized study in patients with progressive DT... There are no results or conclusions to present at this time.
  • ||||||||||  AL101 / Ayala Pharma
    Clinical, Journal:  Activity of the Gamma Secretase Inhibitor AL101 in Desmoid Tumors: A Case Report of 2 Adult Cases. (Pubmed Central) -  Oct 29, 2021   
    Also, in a phase 1 study of AL102, a potent orally administered gamma secretase inhibitor that shares structural features with AL101, a patient with a desmoid tumor was noted to have tumor shrinkage. Formal clinical testing of AL102 for the treatment of patients with desmoid tumors that are not amenable to surgery or are refractory to/recurrent from other prior therapies is currently underway.
  • ||||||||||  AL102 / Ayala Pharma
    Enrollment open:  RINGSIDE: A Study of AL102 in Patients With Progressing Desmoid Tumors (clinicaltrials.gov) -  May 25, 2021   
    P2/3,  N=192, Recruiting, 
    It also provides a promising approach for expansion to other cancer indications in which the Notch pathway is dysregulated. Not yet recruiting --> Recruiting
  • ||||||||||  AL102 / Ayala Pharma, Novartis
    Trial completion, Trial primary completion date, Metastases:  Phase I Ascending Multiple-Dose Study of BMS-986115 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) -  Aug 30, 2016   
    P1,  N=36, Completed, 
    Completed --> Terminated; (Non-safety reason, business objectives have changed) Active, not recruiting --> Completed | Trial primary completion date: Jun 2016 --> Mar 2016