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40 Diseases |  |
16 Trials |
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16 Trials |  |
530 News |  |
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- | Ogsiveo (nirogacestat) / SpringWorks Therap
Journal: Gamma-secretase inhibitors down-regulate the pro-fibrotic Notch signaling pathway in recessive dystrophic epidermolysis bullosa. (Pubmed Central) - Jun 22, 2024
Although less marked as compared to PF-03084014-treated cells, RDEB-FBs exhibited a reduction of fibrotic traits also upon DAPT treatment. This study provides new potential therapeutic strategies to antagonize RDEB fibrosis onset and progression.
- || 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.
- ||| Ogsiveo (nirogacestat) / SpringWorks Therap
P3 data, Journal: Onset and resolution of ovarian toxicity with nirogacestat treatment in females with desmoid tumors: Updated safety analyses from the DeFi phase 3 study. (Pubmed Central) - May 4, 2024
P3
Three recent randomized trials explored medical treatment for progressive or recurrent desmoid tumors, revealing promising clinical activities. Most FORP treated with nirogacestat experienced OT, with the majority resolving, including all who stopped treatment, suggesting that OT is transient.
- 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
Efficacy and safety of nirogacestat in patients with desmoid tumor and adenomatous polyposis coli (APC) mutation: Phase 3 DeFi analyses. (Hall A; Poster Bd #: 484) - Apr 24, 2024 - Abstract #ASCO2024ASCO_766;
P3
Improvement in PFS, ORR, tumor imaging characteristics and PROs was observed with niro compared to pbo in patients with DT harboring APC mutations. Efficacy and safety of niro in patients with APC mutations were generally consistent with findings for the overall DeFi population, suggesting that niro can provide clinically meaningful benefit to patients with progressing DT and APCmutations.
- Ogsiveo (nirogacestat) / SpringWorks Therap
Efficacy of nirogacestat in participants with poor prognostic factors for desmoid tumors: Analyses from the randomized phase 3 DeFi study. (Hall A; Poster Bd #: 482) - Apr 24, 2024 - Abstract #ASCO2024ASCO_764;
P3
Efficacy and safety of niro in patients with APC mutations were generally consistent with findings for the overall DeFi population, suggesting that niro can provide clinically meaningful benefit to patients with progressing DT and APCmutations. Niro demonstrated consistent improvement in PFS and ORR vs pbo in patients with characteristics implicated as poor prognostic factors for DT
- Ogsiveo (nirogacestat) / SpringWorks Therap
Monitoring ovarian function in oncology studies: Results and insights from the DeFi phase 3 study of nirogacestat in desmoid tumor. (S102) - Apr 24, 2024 - Abstract #ASCO2024ASCO_728;
P3
Niro demonstrated consistent improvement in PFS and ORR vs pbo in patients with characteristics implicated as poor prognostic factors for DT Investigator-identified OT and resolution in FORP were based on abnormal reproductive hormone values (increased follicle-stimulating hormone [FSH] or luteinizing hormone; decreased progesterone, anti-M
- ||| Elrexfio (elranatamab-bcmm) / Pfizer
Enrollment change, Combination therapy: MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma (clinicaltrials.gov) - Apr 11, 2024
P2, N=120, Recruiting, Sponsor: Pfizer
Investigator-identified OT and resolution in FORP were based on abnormal reproductive hormone values (increased follicle-stimulating hormone [FSH] or luteinizing hormone; decreased progesterone, anti-M N=92 --> 120
- | 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.
- | ABBV-383 IV / AbbVie
Trial completion date, Adverse events, Combination therapy: A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Mar 25, 2024
P1, N=270, Recruiting, Sponsor: TeneoOne Inc.
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. Trial completion date: Nov 2028 --> Jul 2031
- Ogsiveo (nirogacestat) / SpringWorks Therap
Nirogacestat for Desmoid Tumors (Arie Crown Theater) - Mar 11, 2024 - Abstract #ASCO2024ASCO_46;
- livmoniplimab (ABBV-151) / AbbVie, budigalimab (ABBV-181) / AbbVie
Livmoniplimab and budigalimab combination therapy in treating patients with metastatic ovarian granulosa cell tumors: Results from dose escalation in a first-in-human study (Section 48) - Mar 5, 2024 - Abstract #AACR2024AACR_5180;
Trial completion date: Nov 2028 --> Jul 2031 Abstract is embargoed at this time.
- || 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
Impact of nirogacestat (niro) on patient-reported outcomes (PROs) in adults with desmoid tumor with a best overall response (BOR) of stable disease (SD): Post hoc analysis from the DeFi study (Hall A) - Feb 20, 2024 - Abstract #SarcomaRC2024SARCOMA_RC_96;
- || 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.
- || Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial primary completion date: MajesTEC-2: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov) - Feb 15, 2024
P1, N=140, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Several new molecules are expected to be approved over the coming years. Trial primary completion date: Jun 2024 --> Oct 2024
- | Ogsiveo (nirogacestat) / SpringWorks Therap
Trial completion: Phase II Trial of the Gamma-Secretase Inhibitor PF-03084014 in Adults With Desmoid Tumors/Aggressive Fibromatosis (clinicaltrials.gov) - Feb 5, 2024
P2, N=17, Completed, Sponsor: National Cancer Institute (NCI)
Trial primary completion date: Jun 2024 --> Oct 2024 Active, not recruiting --> Completed
- || Elrexfio (elranatamab-bcmm) / Pfizer
Phase classification, Trial completion date, Trial primary completion date, Combination therapy: MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma (clinicaltrials.gov) - Jan 11, 2024
P2, N=92, Recruiting, Sponsor: Pfizer
Active, not recruiting --> Completed Phase classification: P1b/2 --> P2 | Trial completion date: Sep 2027 --> Jun 2027 | Trial primary completion date: Mar 2025 --> Jul 2025
- | Ogsiveo (nirogacestat) / SpringWorks Therap
Trial initiation date: Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study (clinicaltrials.gov) - Dec 10, 2023
P2, N=40, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
Phase classification: P1b/2 --> P2 | Trial completion date: Sep 2027 --> Jun 2027 | Trial primary completion date: Mar 2025 --> Jul 2025 Initiation date: Oct 2023 --> Oct 2024
- | Tecvayli (teclistamab-cqyv) / Genmab, J&J
Phase classification: MajesTEC-2: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov) - Dec 6, 2023
P1, N=140, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Initiation date: Oct 2023 --> Oct 2024 Phase classification: P1b --> P1
- | linvoseltamab (REGN5458) / Regeneron, Sanofi
Phase classification, Combination therapy: LINKER-MM2: A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments (clinicaltrials.gov) - Dec 5, 2023
P1, N=317, Recruiting, Sponsor: Regeneron Pharmaceuticals
Phase classification: P1b --> P1 Phase classification: P1b --> P1
- || 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
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: DREAMM 5: Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov) - Nov 7, 2023
P1/2, N=464, Recruiting, Sponsor: GlaxoSmithKline
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. Trial completion date: Feb 2028 --> Feb 2029 | Trial primary completion date: Feb 2025 --> Feb 2026
- || Ogsiveo (nirogacestat) / SpringWorks Therap, Blenrep (belantamab mafodotin-blmf) / GSK
Enrollment open, Combination therapy: A Study to Investigate Safety and Clinical Activity of Belantamab Mafodotin in Combination With Lenalidomide, Dexamethasone and Nirogacestat in Patients With Transplant Ineligible Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - Oct 24, 2023
P1/2, N=36, Recruiting, Sponsor: Hellenic Society of Hematology
Trial completion date: Feb 2028 --> Feb 2029 | Trial primary completion date: Feb 2025 --> Feb 2026 Not yet recruiting --> Recruiting
- | Ogsiveo (nirogacestat) / SpringWorks Therap
Trial completion date: Phase II Trial of the Gamma-Secretase Inhibitor PF-03084014 in Adults With Desmoid Tumors/Aggressive Fibromatosis (clinicaltrials.gov) - Oct 23, 2023
P2, N=17, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Trial completion date: Sep 2024 --> Dec 2023
- | Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial completion date: MajesTEC-2: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov) - Oct 11, 2023
P1b, N=140, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Sep 2024 --> Dec 2023 Trial completion date: Jun 2024 --> Feb 2025
- || Elrexfio (elranatamab-bcmm) / Pfizer
Trial completion date, Trial primary completion date, Combination therapy: MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma (clinicaltrials.gov) - Oct 5, 2023
P1b/2, N=105, Recruiting, Sponsor: Pfizer
Trial completion date: Jun 2024 --> Feb 2025 Trial completion date: Feb 2028 --> Sep 2027 | Trial primary completion date: Aug 2025 --> Mar 2025
- 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, Blenrep (belantamab mafodotin-blmf) / GSK
Low-dose belantamab mafodotin (belamaf) in combination with nirogacestat vs belamaf monotherapy in patients with relapsed/refractory multiple myeloma (RRMM): phase I/II DREAMM-5 platform sub-study 3 (Y2) - Sep 30, 2023 - Abstract #DGHO2023DGHO_552;
P1/2
Despite utilising a belamaf dose and schedule expected to have limited activity as a monotherapy, low-dose belamaf + nirogacestat demonstrated an encouraging ORR with a substantial reduction of high-grade ocular events, indicating an increase in BCMA target density by nirogacestat. Furthermore, the efficacy and safety data from the monotherapy arm were consistent with DREAMM-2, DREAMM-3 and real-world evidence observed to date.
- ||| PBCAR269A / Precision BioSci
Trial termination: A Dose-escalation Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Sep 21, 2023
P1/2, N=48, Terminated, Sponsor: Precision BioSciences, Inc.
Furthermore, the efficacy and safety data from the monotherapy arm were consistent with DREAMM-2, DREAMM-3 and real-world evidence observed to date. Completed --> Terminated; Study was terminated due to lack of sufficient therapeutic effect
- | 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.
- ||| nirogacestat (PF-03084014) / SpringWorks Therap
Clinical, P3 data, Journal: GOunder/Desmoid Tumor Research Foundation DEsmoid Symptom/Impact Scale (GODDESS): psychometric properties and clinically meaningful thresholds as assessed in the Phase 3 DeFi randomized controlled clinical trial. (Pubmed Central) - Sep 4, 2023
P3
GODDESS was found to be reliable, valid, responsive, and interpretable as a clinical trial endpoint in the pooled sample of DT/AF patients. Estimated MCTs can be used to define responders and assess group-level differences in future, unblinded, efficacy analyses.
- nirogacestat (PF-03084014) / SpringWorks Therap, Blenrep (belantamab mafodotin-blmf) / GSK
Low?Dose Belantamab Mafodotin (Belamaf) in Combination With Nirogacestat Versus Belamaf Monotherapy in Patients With Relapsed/Refractory Multiple Myeloma (RRMM): Phase 1/2 DREAMM?5 Platform Sub?Study 3 () - Aug 31, 2023 - Abstract #SOHO2023SOHO_621;
P1/2
Despite utilizing a belamaf dose and schedule expected to have limited activity as monotherapy, low-dose belamaf +nirogacestat demonstrated an encouraging ORR with a substantial reduction in high-grade ocular events, indicating an increase in BCMA target density by nirogacestat. These data support ongoing exploration of belamaf +nirogacestat + standard-of-care agents in patients with RRMM.
- || Elrexfio (elranatamab-bcmm) / Pfizer
Trial completion date, Trial primary completion date, Combination therapy: MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma (clinicaltrials.gov) - Aug 31, 2023
P1b/2, N=105, Recruiting, Sponsor: Pfizer
These data support ongoing exploration of belamaf +nirogacestat + standard-of-care agents in patients with RRMM. Trial completion date: Aug 2026 --> Feb 2028 | Trial primary completion date: Jul 2024 --> Aug 2025
- || Ogsiveo (nirogacestat) / SpringWorks Therap
Enrollment open: Study of Cryoablation and Nirogacestat for Desmoid Tumor (clinicaltrials.gov) - Aug 22, 2023
P2, N=23, Recruiting, Sponsor: Stanford University
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, Sponsor: Allogene Therapeutics
Not yet recruiting --> Recruiting Trial completion date: Dec 2027 --> Sep 2027 | Trial primary completion date: Dec 2022 --> Sep 2027 | Recruiting --> Active, not recruiting
- || Ogsiveo (nirogacestat) / SpringWorks Therap
New P2 trial: Study of Cryoablation and Nirogacestat for Desmoid Tumor (clinicaltrials.gov) - Jul 17, 2023
P2, N=23, Not yet recruiting, Sponsor: Stanford University
- | 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, Sponsor: SpringWorks Therapeutics, Inc.
No abstract available Recruiting --> Active, not recruiting
- | Ogsiveo (nirogacestat) / SpringWorks Therap, Blenrep (belantamab mafodotin-blmf) / GSK
Trial completion date, Trial primary completion date, Combination therapy: A Study of Belantamab Mafodotin in Combination With Nirogacestat and Pomalidomide in People With Multiple Myeloma That Has Not Responded to Treatment or Has Come Back After Treatment (clinicaltrials.gov) - Jul 3, 2023
P1, N=30, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Recruiting --> Active, not recruiting Trial completion date: Oct 2023 --> Oct 2026 | Trial primary completion date: Oct 2023 --> Oct 2026
- ||||| Tecvayli (teclistamab) / Genmab, J&J, nirogacestat (PF-03084014) / SpringWorks Therap
Clinical: @MileHighMyeloma presenting teclistamab plus GSi nirogacestat. RRMM mPLRx 4 TCR 71% HR20% 5 deaths in 28 pts… G3/4 neutropenia 75% CRS 75% G3/4 1%. Diarrhea common. Pneumonia 21% only 42% Ig replaced ORR 74% CrR 52% #EHA23RF #mmsm (Twitter) - Jun 10, 2023
- ||| #desmoid fibromatsis poster discussion #ASCO23 🤰pregnancy is safe 🩻MRI T2 hypersignal + volume related to response to NIROGACESTAT 💊AL102 (GSI) ph2 - 50% RR 💉💉nivo+ipi = 16%RR @Thalcin @FioreDoc @SelnetH2020 @acccancercenter @SBOC_Oncologia (Twitter) - Jun 4, 2023
- |||| nirogacestat (PF-03084014) / SpringWorks Therap
Clinical, P3 data: Happy to present at #ASCO23 data about MRI findings in desmoid tumors in a secondary analysis of the DeFi phase 3 trial comparing nirogacestat to placebo. Please come to the Sarcoma Poster Discussion! (Twitter) - May 30, 2023
- || Ogsiveo (nirogacestat) / SpringWorks Therap
New P2 trial: Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study (clinicaltrials.gov) - May 30, 2023
P2, N=40, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
- | 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.
- || linvoseltamab (REGN5458) / Regeneron, Sanofi
Trial completion date, Trial primary completion date, Combination therapy: LINKER-MM2: A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments (clinicaltrials.gov) - May 16, 2023
P1b, N=317, Recruiting, Sponsor: Regeneron Pharmaceuticals
These findings establish the rationale for therapeutic strategies aimed at targeting the oncogenic pathway activated in KLHL6- or NOTCH2-mutated DLBCL. Trial completion date: May 2032 --> Aug 2032 | Trial primary completion date: Oct 2026 --> Jan 2027
- ABBV-383 / AbbVie
ABBV-383 IN COMBINATION WITH ANTI-CANCER REGIMENS IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA: DOSE ESCALATION AND EXPANSION () - May 12, 2023 - Abstract #EHA2023EHA_2988;
P1
Efficacy endpoints include ORR, PFS, DOR, time to progression and minimal residual disease negativity. Summary/