- |||||||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma, SHR-A1921 / Jiangsu Hengrui Pharma
A phase II umbrella clinical trial of advanced salivary gland cancer based on molecular typing. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6678;
P2
This molecular subtype-guided precision therapy for advanced salivary gland cancer showed promising results with acceptable toxicity. Clinical trial information: NCT05924256.
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas
EMBARK post hoc analysis of sexual activity (SA) patient-reported outcomes (PROs) in patients (pts) who were sexually active or interested in sex at baseline (BL). (Hall A; Poster Bd #: 490) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2266;
P3
Among pts who were interested in sex or sexually active at BL, ENZ mono better preserved SA vs P + L in terms of SA domain, interest, activity, satisfaction, and maintaining erection. Adding ENZ to L had no impact on interest, activity, or satisfaction but may adversely affect erectile function, though differences in the median TTCD were clinically non-significant (0.06 months [1.8 days] and 0.09 months [2.7 days] in pts interested in sex and sexually active at BL, respectively).
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas
EMBARK post hoc analysis of impact of treatment suspension (TxS) on health-related quality of life (HRQoL). (Arie Crown Theater) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2195;
P3
Background: EMBARK (NCT02319837) showed enzalutamide (ENZ) + leuprolide (L) and ENZ mono delayed metastasis-free survival vs placebo (P) + L while maintaining high global HRQoL in high-risk biochemically recurrent nonmetastatic hormone-sensitive prostate cancer. This post hoc analysis confirmed that TxS, as expected, leads to clinically meaningful improvements in HRQoL.
- |||||||||| Opdivo (nivolumab) / BMS
Enrollment closed, Combination therapy, Metastases: Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov) - Apr 24, 2024
P2, N=60, Active, not recruiting,
Based on the 70-gene assay results from core needle biopsies, high-genomic-risk patients received NCT (anthracycline + cyclophosphamide for 4 cycles, followed by 4 cycles of docetaxel), while low-risk patients underwent 16 weeks of NET with letrozole ( Recruiting --> Active, not recruiting
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas
Trial completion date, Trial primary completion date, HEOR, Real-world evidence, Real-world, Metastases: Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (clinicaltrials.gov) - Apr 24, 2024
P=N/A, N=1, Completed,
Recruiting --> Active, not recruiting Trial completion date: Jun 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Apr 2024
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Preclinical, Journal: Puberty blocker, leuprolide, reduces sex differences in rough-and-tumble play and anxiety-like behavior in juvenile rats. (Pubmed Central) - Apr 23, 2024
Therefore, leuprolide treatment not only pauses sexual development of peripheral tissues, but also reduces sex differences in hormones, brain, and behavior: allowing for better harmonization of these systems following gender-affirming hormone treatment. These data contribute to the intended use of puberty blockers in stopping sex differences from developing further with the potential benefit of lowering anxiety-like behavior.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Journal: The effect of GnRH-a on the angiogenesis of endometriosis. (Pubmed Central) - Apr 19, 2024
P=N/A
GnRH-a administration does affect some pathways of angiogenesis in endometriotic lesions, but not all of them. Therefore, supplementary treatments that affect the SP1 pathway of angiogenesis should be developed to enhance the antiangiogenetic effect of GnRH-a in patients with endometriosis.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Preclinical, Journal: The effect of antiangiogenic agent aflibercept on surgically induced endometriosis in a rat model. (Pubmed Central) - Mar 31, 2024
Pretreatment menarche status or CA do not appear to predict onset of menses, but pre- and end-of-treatment BA/CA may be helpful in anticipating time to first menses after stopping treatment. Aflibercept is more successful than leuprolide acetate in the treatment of endometriosis.
- |||||||||| Herceptin (trastuzumab) / Roche
Journal: Immunoprofiles and Oncologic Outcomes of 15 Patients with Androgen Receptor-Positive Salivary Duct Carcinoma. (Pubmed Central) - Mar 28, 2024
Studies with larger patient numbers using tumor-specific molecular profiling and tumor heterogeneity analyses are justified to better understand the biology of these tumors. Molecularly informed treatment approaches, including the potential use of AR- and HER-2/Neu-directed therapies upfront in the definitive setting, may hold future promise to further improve outcomes for these patients.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., cyproterone acetate / Generic mfg.
Journal: Deep reinforcement learning identifies personalized intermittent androgen deprivation therapy for prostate cancer. (Pubmed Central) - Mar 21, 2024
Moreover, the adaptability of I$^{2}$ADT makes it a promising tool for other cancers with the availability of clinical data, where treatment regimens might need to be individualized based on patient characteristics and disease dynamics. Our research elucidates the application of deep reinforcement learning to identify personalized adaptive cancer therapy.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Preclinical, Journal: Transcriptome profiling reveals superovulation with the gonadotropin-releasing hormone agonist trigger impaired embryo implantation in mice. (Pubmed Central) - Mar 16, 2024
Mice in the superovulation (PG) group were administered 7.5 IU of PMSG, followed by the injection of 3.5 ?g of GnRHa (Leuprorelin) 48 h later, while mice in the control group (CTR) mated naturally...The transcriptome analysis showed that superphysiological estrogen led to a response of the uterus to a high estrogen signal, resulting in abnormal endometrium and extracellular matrix remodeling and up-regulation of ion transport and inflammation-related genes. Our findings suggest that a combination of PMSG and GnRHa trigger impaired embryo implantation in mice, as the excessive uterine response to superphysiological estrogen levels can lead to the change of gene expression related to endometrial remodeling, abnormal expression of uterine ion transport genes and excessive immune-related genes.
- |||||||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma, SHR-A1921 / Jiangsu Hengrui Pharma
Enrollment change, Metastases: A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - Mar 15, 2024
P2, N=88, Recruiting,
This significant increase in BMI z-score persisted at 24 months of observation. N=66 --> 88
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas
Prostate-specific antigen dynamics from the phase 3 EMBARK trial: A post hoc analysis (301A) - Mar 12, 2024 - Abstract #AUA2024AUA_939;
P3
and Astellas Pharma Inc INTRODUCTION AND OBJECTIVE: In the EMBARK trial, enzalutamide + leuprolide (enza combo) and enza monotherapy (mono) showed statistically superior and clinically meaningful improvements in metastasis-free survival (MFS) vs placebo + leuprolide (alone) while maintaining quality of life in patients (pts) with high-risk biochemically recurrent (BCR) prostate cancer. In pts with high-risk BCR, more pts who were treated with enza combo and enza mono reached undetectable PSA, they reached undetectable PSA sooner, had tx suspended at week 37, and achieved undetectable PSA following tx re-initiation vs leuprolide alone.
- |||||||||| Zilretta (triamcinolone acetonide ER) / Pacira, Bydureon (exenatide XR once-weekly) / AstraZeneca
Mapping the drug-loading design space of long-acting cross-linked microparticles (In-person; Galerie 6 (New Orleans Marriott)) - Mar 12, 2024 - Abstract #ACSSp2024ACS_Sp_11653;
In pts with high-risk BCR, more pts who were treated with enza combo and enza mono reached undetectable PSA, they reached undetectable PSA sooner, had tx suspended at week 37, and achieved undetectable PSA following tx re-initiation vs leuprolide alone. Polymeric microparticles (MPs) are clinically well-established formulations (e.g., Lupron Depot
- |||||||||| Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
Clinical, Journal, Metastases: Efficacy and Safety of Radiotherapy Plus Relugolix in Men With Localized or Advanced Prostate Cancer. (Pubmed Central) - Mar 7, 2024
This multicenter post hoc analysis of patients with localized and advanced prostate cancer receiving radiotherapy in 2 randomized clinical trials (a phase 2 trial of relugolix vs degarelix, and a subset of the phase 3 HERO trial of relugolix vs leuprolide acetate) included men who were receiving radiotherapy and short-term (24 weeks) ADT (n?=?103) from 2014 to 2015 and men receiving radiotherapy and longer-term (48 weeks) ADT (n?=?157) from 2017 to 2019...Patients receiving longer-term ADT received relugolix, 120 mg, orally once daily (360-mg loading dose) or leuprolide acetate injections every 12 weeks for 48 weeks, with up to 90 days of follow-up...The results of these 2 randomized clinical trials suggest that relugolix rapidly achieves sustained castration in patients with localized and advanced prostate cancer receiving radiotherapy. No new safety concerns were identified when relugolix was used with radiotherapy.
- |||||||||| Enrollment closed, Trial completion date, Trial primary completion date: Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis (clinicaltrials.gov) - Mar 5, 2024
P4, N=300, Active, not recruiting,
No new safety concerns were identified when relugolix was used with radiotherapy. Recruiting --> Active, not recruiting | Trial completion date: Sep 2022 --> Sep 2024 | Trial primary completion date: Aug 2022 --> Sep 2024
- |||||||||| bicalutamide / Generic mfg.
Journal: Reversibility of Bicalutamide PSMA PET-Positive Gynecomastia With Androgen Deprivation Therapy. (Pubmed Central) - Mar 4, 2024
This scan also demonstrated metastatic progression of his disease in bone and lymph nodes, and he was started on leuprolide injections. Three months after a decrease in his testosterone level, the radiotracer uptake in his breast tissue had resolved, demonstrating that PSMA-avid bicalutamide-induced gynecomastia is reversible.
- |||||||||| Sutent (sunitinib) / Pfizer
Journal: Systemic therapies for salivary gland carcinomas: an overview of published clinical trials. (Pubmed Central) - Mar 4, 2024
Despite all the advances in this field, there is yet no effective evidence-based regimen of ST, with all the clinical trials identified showing low rates of complete and partial responses. Further, translational studies are urgently required to characterize molecular targets and effective ST.
- |||||||||| Orilissa (elagolix) / AbbVie
Enrollment closed, Trial completion date, Trial primary completion date: Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis (clinicaltrials.gov) - Feb 28, 2024
P1, N=30, Active, not recruiting,
Further, translational studies are urgently required to characterize molecular targets and effective ST. Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
- |||||||||| neflamapimod (VX-745) / CervoMed, Tasigna (nilotinib) / Novartis, Inhibikase
Journal: Network analysis-guided drug repurposing strategies targeting LPAR receptor in the interplay of COVID, Alzheimer's, and diabetes. (Pubmed Central) - Feb 26, 2024
Through a combined network and targeted-based therapeutic intervention approach, this study has identified several drugs that could be repurposed for treating COVID-19 due to their expected interference with LPAR(1, 3, and 6) and spike protein complexes. In addition, it can also be hypothesized that the co-administration of these identified drugs during COVID-19 infection may not only help mitigate the impact of the virus but also potentially contribute to the prevention or management of post-COVID complications related to AD and DM.
- |||||||||| enzalutamide capsule / Generic mfg., leuprolide acetate for depot suspension / Generic mfg.
Journal, Metastases: Enzalutamide and leuprolide acetate in non-metastatic hormone-sensitive prostate cancer: the sooner the better? (Pubmed Central) - Feb 26, 2024
In addition, it can also be hypothesized that the co-administration of these identified drugs during COVID-19 infection may not only help mitigate the impact of the virus but also potentially contribute to the prevention or management of post-COVID complications related to AD and DM. No abstract available
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Observational data, Journal: Efficacy of leuprorelin in spinal and bulbar muscular atrophy: a 3-year observational study. (Pubmed Central) - Feb 24, 2024
However, those with a baseline SBMAFRS of???42 showed a mild decrease in scores, indicating a more favorable prognosis. These findings suggest that a higher baseline motor function was a key prognostic indicator in SBMA treatment and that initiating early leuprorelin treatment in patients with high baseline function may lead to good clinical outcomes.
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas
No Pressure: An Unusual Case of PFO Induced Hypoxia (San Diego Convention Center, Area I (Hall H, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_6424;
pneumonectomy, dilated descending aorta, compression from the abdomen, kyphosis) have been described. Knowledge of this phenomenon can be critical in making a diagnosis in an otherwise challenging case.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Trial completion date, Trial primary completion date: A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty (clinicaltrials.gov) - Feb 15, 2024
P4, N=80, Recruiting,
Trial primary completion date: Jul 2028 --> Sep 2029 Trial completion date: Apr 2024 --> May 2025 | Trial primary completion date: Jan 2024 --> May 2025
- |||||||||| Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
Enrollment open, HEOR: RecoverPC: Relugolix vs GnRH Agonist in Quality of Life (clinicaltrials.gov) - Feb 14, 2024
P2, N=110, Recruiting,
These consensus statements serve as a practical recommendation for clinicians in Hong Kong, and possibly the Asia-Pacific region, in the management of cardiometabolic toxicities of ADT or AR axis-targeted therapies in men with PCa. Not yet recruiting --> Recruiting
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