MedPath

Clinical Trial News

Sun Pharma's Sonidegib Shows Promise Across Multiple Cancer Indications Beyond Basal Cell Carcinoma

  • Sonidegib phosphate (Odomzo), currently approved for locally advanced basal cell carcinoma, is being investigated for multiple additional cancer indications including gastroesophageal junction adenocarcinoma and medulloblastoma.
  • The oral anticancer agent, developed by Sun Pharma Advanced Research (SPARC), has demonstrated potential in treating various solid tumors and hematologic malignancies, expanding its therapeutic scope.
  • The drug's development program spans across multiple challenging cancers, including glioblastoma, breast cancer, and chronic myelocytic leukemia, highlighting its potential as a versatile oncology treatment.

Minovia's MNV-201 Cell Therapy Shows Promise for Rare Pearson Syndrome Treatment

  • Minovia Therapeutics advances MNV-201, a novel mitochondrial cell therapy utilizing CD34+ cells enriched with placental mitochondria, for treating Pearson syndrome and myelodysplastic syndrome.
  • The innovative treatment, based on Mitochondrial Augmentation Therapy (MAT) platform, represents a potential breakthrough for patients with inherited mitochondrial diseases.
  • Israeli-based Minovia Therapeutics continues clinical development of the intravenous therapy, expanding treatment options for rare mitochondrial disorders including Leigh syndrome.

Cebranopadol Shows Promise in Phase 3 Trial for Acute Pain Management

  • Tris Pharma's cebranopadol significantly reduced pain intensity in patients following abdominoplasty in the ALLEVIATE-1 Phase 3 trial.
  • The investigational dual-NMR agonist demonstrated a favorable safety profile, comparable to placebo, with nausea being the most common adverse event.
  • Cebranopadol targets both nociceptin/orphanin FQ peptide (NOP) and μ-opioid peptide (MOP) receptors, offering a novel approach to pain relief.
  • Tris Pharma plans to submit a New Drug Application (NDA) for cebranopadol later this year, with further studies in chronic pain indications planned.

A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty

NCT06545097Active, Not RecruitingPhase 3
Tris Pharma, Inc.
Posted 9/3/2024

A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT05743075CompletedPhase 3
Nuance Pharma (shanghai) Co., Ltd
Posted 3/10/2023

A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy

NCT06423703RecruitingPhase 3
Tris Pharma, Inc.
Posted 7/18/2024

Emicizumab Shows Promise for Acquired Hemophilia A Treatment in Development Pipeline

• Chugai Pharmaceutical's Emicizumab (Hemlibra) is advancing in development for acquired hemophilia A, offering a potential new treatment option through its unique bispecific antibody mechanism.
• The drug, already approved for congenital hemophilia A, is administered subcutaneously and works by targeting both Factor IXa and Factor X to prevent bleeding episodes.
• As a subsidiary of Roche, Chugai is leveraging its biotechnology expertise to expand Hemlibra's therapeutic applications, including development for mild to moderate acquired hemophilia A and von Willebrand Disease.

RYBREVANT Plus Chemotherapy Shows Positive Survival Trend in EGFR-Mutated Lung Cancer

  • Updated results from the Phase 3 MARIPOSA-2 study show RYBREVANT plus chemotherapy demonstrates a favorable trend toward improved overall survival.
  • At 18 months, 50% of patients treated with the combination were alive, compared to 40% receiving chemotherapy alone.
  • The combination significantly improved treatment discontinuation rates and prolonged time to subsequent therapy.
  • The safety profile of RYBREVANT plus chemotherapy was consistent with established profiles of individual treatments.

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer

NCT06385080RecruitingPhase 1
Janssen Research & Development, LLC
Posted 4/22/2024

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 Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

NCT05908734Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/18/2023

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

A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

NCT06532032Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 7/23/2024

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

NCT04538664Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/13/2020

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

NCT05379595RecruitingPhase 1
Janssen Research & Development, LLC
Posted 7/29/2022

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

NCT04077463Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 9/4/2019

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

NCT02609776Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/24/2016

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

NCT05498428RecruitingPhase 2
Janssen Research & Development, LLC
Posted 11/11/2022

A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies

NCT04606381Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 11/10/2020

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

NCT05488314Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/13/2022

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 5/18/2023

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

NCT05388669Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 8/5/2022

AbbVie's Pivekimab Sunirine and Deciphera's Vimseltinib: Valuation and Clinical Overview

  • Pivekimab sunirine, developed by AbbVie, is projected to generate $21 million in US revenue by 2038, targeting CD123-positive hematologic malignancies.
  • Vimseltinib, by Deciphera Pharmaceuticals, is expected to reach $173 million in US revenue by 2034, focusing on advanced malignancies and tenosynovial giant cell tumor.
  • Risk-adjusted net present value (rNPV) models, incorporating phase transition success rates and approval likelihood, offer conservative valuations for both drugs.
  • Both drugs leverage kinase inhibitor technology, with Pivekimab sunirine using an antibody-drug conjugate and Vimseltinib targeting the FMS kinase (CSF1R).

Advancements in NSCLC Treatment: Novel Immunotherapy Combinations and Perioperative Strategies Show Promise

• A phase 2 study (RELATIVITY-104) reveals that adding relatlimab to nivolumab and chemotherapy improves outcomes in advanced NSCLC with PD-L1 ≥ 1% and non-squamous histology. • Perioperative nivolumab demonstrates a 40% reduction in disease recurrence or death compared to neoadjuvant nivolumab plus chemotherapy in resectable NSCLC, according to patient-level data analysis. • A phase 2 trial suggests aggressive local consolidative therapy (LCT) combined with systemic chemotherapy may extend survival in stage IV NSCLC with oligometastases.

A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

NCT04623775Active, Not RecruitingPhase 2
Bristol-Myers Squibb
Posted 2/17/2021

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

NCT04025879Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 11/5/2019

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

NCT02998528CompletedPhase 3
Bristol-Myers Squibb
Posted 3/4/2017

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%

NCT06561386RecruitingPhase 3
Bristol-Myers Squibb
Posted 10/7/2024

Perioperative Nivolumab Reduces Recurrence and Death in Resectable NSCLC

  • A new analysis of the CheckMate 77T and 816 trials reveals that perioperative nivolumab (before and after surgery) reduces the risk of disease recurrence or death by 40% in patients with resectable non-small cell lung cancer (NSCLC).
  • The benefit of perioperative nivolumab was observed regardless of the patient's baseline cancer stage, suggesting broad applicability across different stages of resectable NSCLC.
  • Patients with less than 1% tumor expression of PD-L1 experienced greater reductions in disease recurrence and death with perioperative nivolumab compared to those with higher PD-L1 expression.
  • The study suggests that incorporating postoperative immunotherapy with nivolumab may offer a significant advantage over neoadjuvant nivolumab alone in treating resectable NSCLC.

IL-21 Enhanced NK Cells Show Promise in Glioblastoma; Pembrolizumab Trials Halted

• IL-21-modified natural killer (NK) cells demonstrated superior safety and long-term tumor control compared to IL-15 NK cells in targeting glioblastoma (GBM). • Merck's phase 3 trials of pembrolizumab combined with stereotactic body radiotherapy (SBRT) were halted due to lack of improvement in event-free or overall survival. • NXP800 received FDA orphan drug designation for ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers, showing antitumor effects. • A phase 3 trial has begun evaluating BAY 2927088, a HER2-mutant-selective TKI, versus standard of care for advanced NSCLC with activating HER2 mutations.

Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

NCT03924869TerminatedPhase 3
Merck Sharp & Dohme LLC
Posted 6/25/2019

Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

NCT03833167Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 4/1/2019

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04634552RecruitingPhase 2
Janssen Research & Development, LLC
Posted 2/1/2021

A Study to Learn More About How Well Sevabertinib (BAY 2927088) Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

NCT06452277RecruitingPhase 3
Bayer
Posted 8/28/2024

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017

Datopotamab Deruxtecan Shows Promise in Advanced Non-Small Cell Lung Cancer

• Datopotamab deruxtecan shows a clinically meaningful trend in improving overall survival for advanced nonsquamous non-small cell lung cancer patients who have received prior therapy. • In nonsquamous NSCLC patients, datopotamab deruxtecan improved overall survival by 2.3 months compared to docetaxel, regardless of actionable genomic alterations. • NeoCOAST-2 trial results show datopotamab deruxtecan plus IMFINZI and chemotherapy demonstrating promising response rates in early-stage resectable NSCLC patients. • AstraZeneca and Roche Tissue Diagnostics are collaborating to co-develop a TROP2-QCS biomarker companion diagnostic to identify patients most likely to benefit from datopotamab deruxtecan.

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

NCT05061550RecruitingPhase 2
AstraZeneca
Posted 4/14/2022

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

NCT04656652Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/21/2020

Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)

NCT04484142Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/30/2021

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

NCT05104866Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/18/2021

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.