- |||||||||| Ogsiveo (nirogacestat) / SpringWorks Therap
Clinical, Review, Journal: Current Management of Desmoid Tumors: A Review. (Pubmed Central) - Jun 20, 2024 The 2023 consensus guideline is informed by a number of new aspects, including data for local ablative therapies such as cryotherapy; other indications for surgery; and the ?-secretase inhibitor nirogacestat, the first representative of the newest class of medical agents and first approved drug for DT...The therapeutic armamentarium of DT therapy is continually expanding. It is imperative to carefully select the management strategy for each patient with DT to optimize tumor control and enhance quality of life.
- |||||||||| Ogsiveo (nirogacestat) / SpringWorks Therap
Review, Journal: Capturing Patient Voice to Improve Outcomes That Matter to Patients with Desmoid Tumor. (Pubmed Central) - Jun 12, 2024 Another DT-specific PRO measure, the Desmoid-Type Fibromatosis Quality of Life (DTF-QoL) questionnaire, has been developed but not validated. As novel DT therapies continue to be developed, incorporating DT-specific PRO measures into clinical trials will be key to capturing patient voice, improving outcomes of importance to this unique patient population, and assisting patients and providers in selecting optimal treatment.
- |||||||||| Votrient (pazopanib) / Novartis, BeiGene, Ogsiveo (nirogacestat) / SpringWorks Therap
Journal: Active surveillance and emerging medical treatment options for desmoid: when and for whom? (Pubmed Central) - May 10, 2024 Active surveillance has solidified its position as the primary management approach for desmoid tumors, validated by three robust prospective studies. Three recent randomized trials explored medical treatment for progressive or recurrent desmoid tumors, revealing promising clinical activities.
- |||||||||| sorafenib / Generic mfg.
Sorafenib treatment duration in desmoid tumors. (Hall A; Poster Bd #: 511) - Apr 24, 2024 - Abstract #ASCO2024ASCO_791; Still, most patients did not require additional therapy. This finding underscores the complexity of determining the optimal duration for sorafenib therapy, and multiple features should be considered, including side effects, symptom improvement, fertility planning, tumor cellularity (evaluated by T2 MRI signal), and physician-patient shared decision.
- |||||||||| Ogsiveo (nirogacestat) / SpringWorks Therap, Blenrep (belantamab mafodotin-blmf) / GSK
Biomarker, Journal, IO biomarker: Soluble B-cell maturation antigen in lacrimal fluid as a potential biomarker and mediator of keratopathy in multiple myeloma. (Pubmed Central) - Apr 4, 2024 Based on the proposed mechanism, pinocytosis-induced keratopathy can be prevented by lowering the entry of sBCMA into the lacrimal fluid. Future therapeutic concepts may therefore consist of belantamab-free debulking therapy prior to belantamab consolidation and/or concomitant use of gamma-secretase inhibition as currently evaluated for belantamab and nirogacestat in ongoing studies.
- |||||||||| Ogsiveo (nirogacestat) / SpringWorks Therap
Review, Journal: Nirogacestat: First Approval. (Pubmed Central) - Feb 27, 2024 In November 2023, nirogacestat was approved in the USA for use in adult patients with progressing desmoid tumours who require systemic treatment. This article summarizes the milestones in the development of nirogacestat leading to this first approval for the systemic treatment of desmoid tumours.
- |||||||||| Ogsiveo (nirogacestat) / SpringWorks Therap
Retrospective data, Review, Journal: Desmoid Tumors: Current Perspective and Treatment. (Pubmed Central) - Feb 19, 2024 The recent approval of nirogacestat has ushered in a new era of treatment for patients diagnosed with desmoid tumors. Several new molecules are expected to be approved over the coming years.
- |||||||||| 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.
- |||||||||| Blenrep (belantamab mafodotin-blmf) / GSK
Soluble BCMA in tear fluids: a potential mechanism of ocular toxicity caused by Belantamab mafodotin (Hall E) - Sep 30, 2023 - Abstract #DGHO2023DGHO_1511; The ongoing DREAMM-5 trial interrogates the addition of the gamma-secretase inhibitor Nirogacestat to minimize sBCMA levels in patients treated with Belamaf. Our novel finding of TFsBCMA suggests that it may be of additional value to also track TFsBCMA levels in these patients, and that such a strategy, lowering sBCMA levels, may not only increase treatment efficiency but may also hold potential to reduce ocular side effects under Belamaf therapy.
- |||||||||| nirogacestat (PF-03084014) / SpringWorks Therap
Journal, Epigenetic controller: Inhibition of Notch Signaling Enhances Antitumor Activity of Histone Deacetylase Inhibitor LAQ824. (Pubmed Central) - Sep 13, 2023 We also demonstrated that the combination of LAQ and a Notch signaling pathway inhibitor significantly inhibited the growth of tumor cells in vivo using an allograft tumor model. This study indicates that inhibition of the Notch signaling pathway provides a valuable strategy for enhancing solid tumor sensitivity to LAQ.
- |||||||||| linvoseltamab (REGN5458) / Regeneron
Trial in Progress: Linvoseltamab, a BCMAxCD3 bispecific antibody, in a Phase 1b multi-cohort study of combination regimens for patients with relapsed/refractory multiple myeloma (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_319; P1/2, P1b LINKER-MM2 (NCT05137054) is a global, Phase 1b, open-label, multi-cohort study designed to assess the safety, tolerability, and efficacy of linvoseltamab in combination with nine different agents (daratumumab, carfilzomib, lenalidomide, bortezomib, pomalidomide, isatuximab, fianlimab, cemiplimab, or nirogacestat) in separate cohorts of participants with RRMM. Analyses from the LINKER-MM2 study will provide important information on the tolerability and preliminary clinical efficacy of linvoseltamab when given in combination with other cancer therapies, aiming to improve care for patients with RRMM.
- |||||||||| Ogsiveo (nirogacestat) / SpringWorks Therap
Enrollment open: Study of Cryoablation and Nirogacestat for Desmoid Tumor (clinicaltrials.gov) - Aug 22, 2023 P2, N=23, Recruiting, Trial completion date: Aug 2026 --> Feb 2028 | Trial primary completion date: Jul 2024 --> Aug 2025 Not yet recruiting --> Recruiting
- |||||||||| ALLO-715 / Allogene Therap
Enrollment closed, Trial completion date, Trial primary completion date, CAR T-Cell Therapy, IO biomarker: Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL) (clinicaltrials.gov) - Aug 14, 2023 P1, N=132, Active, not recruiting, Not yet recruiting --> Recruiting Trial completion date: Dec 2027 --> Sep 2027 | Trial primary completion date: Dec 2022 --> Sep 2027 | Recruiting --> Active, not recruiting
- |||||||||| nirogacestat (PF-03084014) / SpringWorks Therap
Journal: Nirogacestat and Hypophosphatemia. (Pubmed Central) - Jul 13, 2023 Trial completion date: Dec 2027 --> Sep 2027 | Trial primary completion date: Dec 2022 --> Sep 2027 | Recruiting --> Active, not recruiting No abstract available
- |||||||||| Ogsiveo (nirogacestat) / SpringWorks Therap
Enrollment closed: Nirogacestat in Ovarian Granulosa Cell Tumors (clinicaltrials.gov) - Jul 12, 2023 P2, N=53, Active, not recruiting, No abstract available Recruiting --> Active, not recruiting
- |||||||||| ipatasertib (RG7440) / Roche, nirogacestat (PF-03084014) / SpringWorks Therap, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: DLBCL associated NOTCH2 mutations escape ubiquitin-dependent degradation and promote chemo-resistance. (Pubmed Central) - May 26, 2023 Targeting CHOP-resistant DLBCL tumors with the Phase 3 clinical trial molecules nirogacestat, a selective g-secretase inhibitor, and ipatasertib, a pan-AKT inhibitor, synergistically promotes DLBCL death. These findings establish the rationale for therapeutic strategies aimed at targeting the oncogenic pathway activated in KLHL6- or NOTCH2-mutated DLBCL.
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