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Clinical Trial News

TAK-906: Peripheral D2/D3 Antagonist Under Development for Gastroparesis

  • TAK-906, developed by Altos Therapeutics and Takeda, is a peripherally-restricted D2/D3 receptor antagonist designed to treat gastroparesis.
  • The drug does not penetrate the blood-brain barrier, targeting the stomach and vomiting center in the area postrema.
  • Gastroparesis, characterized by delayed gastric emptying, leads to symptoms like nausea, vomiting, pain, and anorexia.
  • TAK-906 aims to alleviate these symptoms by modulating dopamine receptors in the gastrointestinal tract without central nervous system side effects.

Durvalumab Improves Survival in Limited-Stage Small Cell Lung Cancer Subgroups

  • Durvalumab consolidation therapy shows improved progression-free survival (PFS) and overall survival (OS) in LS-SCLC patients, regardless of prior prophylactic cranial irradiation (PCI).
  • In patients who received carboplatin, durvalumab significantly improved median OS (NR vs 33.4 months) and PFS (27.9 months vs 9.2 months) compared to placebo.
  • Durvalumab's safety profile is manageable, with pneumonitis incidences similar to placebo, supporting its use as a new standard of care for LS-SCLC.
  • The ADRIATIC trial's post-hoc analysis confirms durvalumab's consistent benefit across various subgroups, reinforcing its role in LS-SCLC treatment.

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

NCT03703297Active, Not RecruitingPhase 3
AstraZeneca
Posted 9/27/2018

FDA Approves Resmetirom (REZDIFFRA™) as First Treatment for NASH

  • The FDA granted accelerated approval to resmetirom (REZDIFFRA™) on March 14, 2024, marking it as the first approved therapy for non-alcoholic steatohepatitis (NASH).
  • Resmetirom is an oral, liver-targeting, once-daily THR-β-selective agonist, initially discovered at Roche Nutley, offering a novel approach to NASH treatment.
  • This approval signifies a historic milestone in liver drug discovery, addressing a significant unmet need in the treatment of NASH, now also known as MASH.

Tempus AI Presents AI-Driven Oncology Advancements at ESMO Congress 2024

  • Tempus AI will present four abstracts at the ESMO Congress 2024, showcasing advancements in AI-driven precision medicine for oncology.
  • An oral presentation will highlight Tempus' TIME initiative, which streamlines patient screening and clinical trial matching using AI, improving enrollment.
  • A poster presentation will explore ctDNA monitoring in TKI-treated patients, suggesting its potential for assessing treatment response beyond VAF monitoring.
  • Another poster will demonstrate that comprehensive genomic profiling (CGP) improves access to matched therapies for advanced NSCLC patients in real-world settings.

Novel Drug Candidates Target Diverse Diseases: Malaria, Gastroparesis, and Cancer

  • Novartis unveils NVP-FVP954, a fast-acting IV antimalarial for severe malaria, addressing the urgent need for new treatments due to rising resistance and high infection rates.
  • Altos Therapeutics and Takeda collaborate on TAK-906, a peripherally-restricted D2/D3 receptor antagonist, to treat gastroparesis by targeting the stomach and vomiting center.
  • Revolution Medicines advances RMC-9805, a covalent KRAS(G12D)(ON) molecular glue inhibitor, showing promise in synergizing with PD-1 inhibitors for cancer treatment.

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

NCT05118789RecruitingPhase 1
Nuvalent Inc.
Posted 1/4/2022

FDA Approves Genentech's Ocrevus Zunovo as First Twice-Yearly Subcutaneous MS Treatment

  • The FDA has approved Ocrevus Zunovo, a subcutaneous injection, for relapsing and primary progressive multiple sclerosis.
  • Ocrevus Zunovo is the first and only twice-a-year, 10-minute subcutaneous treatment option for both forms of MS.
  • Approval was based on the Phase III OCARINA II trial, demonstrating similar efficacy and safety to the IV formulation of Ocrevus.
  • The new formulation offers greater flexibility for healthcare providers and patients, especially those with IV access constraints.

A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

NCT05232825CompletedPhase 3
Hoffmann-La Roche
Posted 5/3/2022

Cabozantinib/Nivolumab Shows Consistent Benefits in RCC, Except for Favorable-Risk Group

  • CheckMate 9ER trial data confirms that cabozantinib plus nivolumab significantly improves progression-free survival (PFS) and overall survival (OS) in metastatic clear cell RCC patients.
  • Favorable-risk RCC patients do not experience the same OS benefit from cabozantinib/nivolumab compared to intermediate- and poor-risk groups, mirroring findings from other TKI/IO combinations.
  • Cabozantinib/nivolumab demonstrates manageable toxicity and allows patients to stay on therapy longer, with potential post-discontinuation benefits attributed to immunotherapy's long half-life.
  • The combination of nivolumab and ipilimumab has shown long-term benefits, including treatment-free survival, in intermediate- and poor-risk RCC, according to extended follow-up data from CheckMate 214.

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

NCT03141177Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 7/23/2017

Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)

NCT02853331Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 9/16/2016

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

NCT02811861Active, Not RecruitingPhase 3
Eisai Inc.
Posted 10/13/2016

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

NCT02231749CompletedPhase 3
Bristol-Myers Squibb
Posted 10/16/2014

Patritumab Deruxtecan Shows Promise in HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitor Resistance

  • Patritumab deruxtecan (HER3-DXd) demonstrates a 53.5% response rate in heavily pre-treated HR+/HER2- metastatic breast cancer patients resistant to CDK4/6 inhibitors.
  • The ICARUS-BREAST01 phase II trial reports a median progression-free survival of 9.4 months with patritumab deruxtecan, suggesting improved outcomes compared to conventional third-line chemotherapies.
  • Researchers identified potential factors influencing treatment response, including the distribution of HER3-positive cells within the tumor and drug-induced immune response.
  • Patritumab deruxtecan may represent a new therapeutic option for advanced hormone-dependent breast cancer, warranting further investigation in larger studies.

Tivozanib Monotherapy Shows Superiority Over Tivozanib Plus Nivolumab in Metastatic RCC After ICI Progression

• The phase 3 TiNivo-2 trial revealed that tivozanib monotherapy demonstrated superior progression-free survival (PFS) compared to the combination of tivozanib and nivolumab in metastatic renal cell carcinoma (RCC). • Median PFS was 7.4 months with tivozanib alone versus 5.7 months with the combination, indicating that immune checkpoint inhibitor (ICI) rechallenge may not be beneficial in this setting. • The study suggests that tivozanib monotherapy at 1.34 mg can be considered a second-line treatment option for patients with RCC who have progressed after prior ICI therapy. • The reduced dose of tivozanib in the combination arm (0.89 mg) may have impacted the efficacy, highlighting the importance of optimal dosing in VEGFR TKI therapy.

Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC

NCT03136627CompletedPhase 1
AVEO Pharmaceuticals, Inc.
Posted 3/22/2017

Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

NCT04987203Active, Not RecruitingPhase 3
AVEO Pharmaceuticals, Inc.
Posted 9/9/2021

A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment

NCT04338269CompletedPhase 3
Hoffmann-La Roche
Posted 7/28/2020

FDA Approves Subcutaneous Ocrelizumab (Ocrevus Zunovo) for Multiple Sclerosis

  • The FDA has approved subcutaneous ocrelizumab (Ocrevus Zunovo) for relapsing and primary progressive multiple sclerosis (MS).
  • Ocrevus Zunovo offers a new twice-yearly, 10-minute injection option, providing greater flexibility for patients and healthcare providers.
  • The approval was based on the OCARINA II trial, demonstrating comparable efficacy and safety to intravenous ocrelizumab.
  • Injection site reactions were the most common adverse events, but were generally mild to moderate and did not lead to treatment discontinuation.

A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

NCT05232825CompletedPhase 3
Hoffmann-La Roche
Posted 5/3/2022

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