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Clinical Trial News

ARANOTE Trial: Darolutamide Plus ADT Significantly Improves Outcomes in mHSPC

  • The Phase III ARANOTE trial investigated darolutamide plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC).
  • Darolutamide combined with ADT demonstrated a statistically significant improvement in outcomes compared to ADT alone in mHSPC patients.
  • Bayer presented comprehensive analysis from the ARANOTE trial at the European Society for Medical Oncology (ESMO) Congress 2024.
  • The ARANOTE trial's design and objectives were presented, highlighting the assessment of darolutamide and ADT versus ADT alone.

ESMO 2024: Novel Therapies and Individualized Treatments Highlighted for Lung Cancer

  • MARIPOSA-2 data is expected to confirm the benefits of novel targeted therapy combinations in lung cancer, showing consistent improvement across efficacy endpoints.
  • Ongoing advancements in targeted therapies, immunotherapy combinations, and antibody-drug conjugates are anticipated to be showcased at ESMO 2024.
  • Future directions in lung cancer treatment aim towards individualized therapies, focusing on both efficacy and improved quality-of-life for patients.

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/30/2020

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT04988295Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/17/2021

Adjuvant Durvalumab Fails to Improve DFS in Resected NSCLC, Regardless of PD-L1 Status

  • The phase 3 BR.31 trial showed adjuvant durvalumab did not improve disease-free survival (DFS) compared to placebo in resected NSCLC patients.
  • No significant DFS benefit was observed with durvalumab, irrespective of PD-L1 expression levels (≥25% or ≥1%), in EGFR/ALK-negative NSCLC.
  • The median DFS in the durvalumab arm was 69.9 months vs 60.2 months in the placebo arm for patients with PD-L1 expression of 25% or more.
  • Safety analysis revealed similar rates of any adverse events between durvalumab and placebo arms, but a higher rate of treatment discontinuation with durvalumab.

Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC

NCT02273375Active, Not RecruitingPhase 3
Canadian Cancer Trials Group
Posted 2/24/2015

Roche's Subcutaneous Tecentriq Approved; Gilead's HIV Shot Shows Promise

• The FDA approved Roche's Tecentriq Hybreza, the first checkpoint inhibitor available as a subcutaneous injection, offering a faster administration time of about seven minutes. • Gilead's twice-yearly lenacapavir HIV shot reduced infection risk by 96% in a Phase 3 trial, leading to halted trial and plans for regulatory filings and a potential 2025 launch. • Sanofi has secured rights to an experimental radiopharmaceutical drug for a rare form of cancer, marking its entry into the fast-growing field of radiopharmaceuticals. • Eli Lilly is investing $1 billion to expand its manufacturing site in Ireland to produce the active ingredient for its Alzheimer's drug Kisunla and other medicines.

ESSA Pharma's Masofaniten Shows Promise in Metastatic Castration-Resistant Prostate Cancer

  • Masofaniten, combined with enzalutamide, demonstrates durable PSA reductions in mCRPC patients, with 88% achieving PSA90 across all dose cohorts.
  • The combination therapy is well-tolerated, with most adverse events being Grades 1 and 2, primarily related to AR inhibition or gastrointestinal irritation.
  • Phase 2 dose expansion is underway, evaluating masofaniten plus enzalutamide versus enzalutamide alone, with sites active in the US, Canada, and Australia.
  • Median time to PSA progression and radiographic progression-free survival have not been reached after 15.2 months, suggesting potential long-term benefits.

EPI-7386 in Combination with Enzalutamide versus Enzalutamide alone in Metastatic Castration-Resistant Prostate Cancer

2023-509336-25-00CompletedPhase 1/2
Essa Pharma Inc.

Oral EPI-7386 in Patients with Castration-Resistant Prostate Cancer

NCT04421222TerminatedPhase 1
ESSA Pharmaceuticals
Posted 6/23/2020

Beyond Celiac Aims for Celiac Disease Cure by 2030

  • Beyond Celiac is accelerating its efforts to find a cure for celiac disease by 2030, addressing the unmet needs of 3.2 million affected individuals.
  • The organization's venture philanthropy program, Beyond Celiac Investments (BCI), has raised $1.5 million towards its $2 million goal to fund promising treatments.
  • A recent meeting between the Beyond Celiac Coalition and the FDA focused on making clinical trials more patient-centric to accelerate research.
  • Current celiac disease treatment relies on a strict gluten-free diet, which is often insufficient, highlighting the urgent need for alternative therapies.

Arizona Liver Health/Arizona Clinical Trials Opens State-of-the-Art ACT Medical Park

  • Arizona Liver Health/Arizona Clinical Trials (ALH/ACT) has opened ACT Medical Park, a 28,000 sq. ft. facility in Chandler, Arizona, featuring advanced medical and research services.
  • The ACT Phase 1 Unit includes 24 private rooms, a research pharmacy, and a lab capable of complex processing, supporting studies involving hepatic and renal impairments.
  • ACT Imaging, a premier research imaging center within the park, offers advanced diagnostics like 3T MRI, PET/CT, and specialized liver disease imaging technology.
  • The ACT Medical Park creates a comprehensive hub for healthcare, research, and wellness, also housing Phase 2-4 Trial Capabilities and the Arizona State Urological Institute.

Nerandomilast: A Novel PDE4B Inhibitor Shows Promise in Treating Idiopathic Pulmonary Fibrosis

• Nerandomilast (BI 1015550) is a potent and selective phosphodiesterase 4B (PDE4B) inhibitor demonstrating potential for treating idiopathic pulmonary fibrosis (IPF). • The drug's mechanism of action targets the reduction of inflammation and fibrosis, key pathological features of IPF, offering a novel therapeutic approach. • Preclinical and early clinical data suggest nerandomilast has a favorable safety profile and demonstrates target engagement, warranting further investigation. • Nerandomilast's oral bioavailability and demonstrated clinical potential position it as a promising candidate in the evolving treatment landscape for IPF.

PetVivo and Orthobiologic Innovations Partner to Advance Osteoarthritis Treatment for Pets

  • PetVivo and Orthobiologic Innovations (OBI) are collaborating to advance clinical trials for Spryng with OsteoCushion Technology, a treatment for osteoarthritis in animals.
  • The trials will focus on managing joint issues in the elbows and stifles of canine patients, evaluating the injection of collagen-elastin hydrogel microparticles.
  • OBI's expertise will support the development, marketing, and expansion of Spryng, aiming to provide long-term relief and improve joint function in pets.
  • Spryng is designed to replicate the function of natural cartilage, offering a shock-absorbing matrix for damaged joints.

Merck's Bomedemstat Shows Promise as Irreversible LSD1 Inhibitor for MPNs

  • Bomedemstat (MK-3543) is an irreversible inhibitor of lysine-specific demethylase 1 (LSD1), targeting myeloid malignancies like myeloproliferative neoplasms (MPNs).
  • The drug's mechanism involves covalent modification of LSD1, potentially offering a sustained therapeutic effect in MPN treatment.
  • Clinical trials are underway to evaluate bomedemstat's efficacy and safety in MPN patients, addressing a critical unmet need in hematologic oncology.
  • Bomedemstat's unique irreversible binding may provide advantages over reversible LSD1 inhibitors, warranting further investigation in MPN and related diseases.

A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis

NCT04308681CompletedPhase 2
Bristol-Myers Squibb
Posted 7/29/2020

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