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Clinical Trial News

Amivantamab Shows Promise in Colorectal Cancer as Phase 3 Trials Launch Following Encouraging Phase 1b/2 Results

Oncology
  • The phase 1b/2 OrigAMI-1 trial demonstrated that amivantamab monotherapy achieved a 22% objective response rate and 3.7-month median progression-free survival in advanced colorectal cancer patients.
  • Combination therapy with amivantamab plus FOLFOX or FOLFIRI showed enhanced efficacy with a 43% objective response rate and 7.4-month median progression-free survival in a smaller patient cohort.
  • Two phase 3 trials, OrigAMI-2 and OrigAMI-3, have been launched to further evaluate amivantamab versus cetuximab in metastatic colorectal cancer patients with RAS and BRAF wild-type status.
  • The bispecific antibody's trifunctional mechanism targeting EGFR and MET receptors, plus immune cell-directed activity, positions it as a potential improvement over current anti-EGFR therapies for the 50% of metastatic colorectal cancer patients eligible for treatment.

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

NCT06750094RecruitingPhase 3
Janssen Research & Development, LLC
Posted 12/12/2024

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 Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

NCT06662786RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/18/2024

Comprehensive Biomarker and Prognostic Framework Emerges for ATTR-CM Disease Monitoring

  • Healthcare professionals now have access to a comprehensive framework for monitoring ATTR-CM progression using multiple biomarkers including NT-proBNP, troponin, and serum free light chains.
  • Disease progression can be detected through a combination of clinical indicators, cardiac imaging findings, and functional assessments including the six-minute walk test.
  • Regular monitoring involves echocardiography, cardiac MRI, and nuclear imaging alongside biomarker evaluations to track amyloid deposition and cardiac deterioration.
  • The integrated approach enables early detection of disease progression and timely therapeutic interventions to optimize patient outcomes.

FDA Grants First-Ever Authorization for AI Platform to Predict Breast Cancer Risk from Mammograms

AIPrecision Medicine
  • Clairity receives FDA De Novo authorization for CLAIRITY BREAST, the first AI platform to predict five-year breast cancer risk using routine screening mammograms alone.
  • The platform analyzes subtle imaging features invisible to the human eye to deliver validated risk scores through existing clinical infrastructures.
  • This breakthrough addresses limitations of traditional risk models that rely on age and family history, despite 85% of breast cancer patients having no family history.
  • The technology promises more equitable healthcare by overcoming biases in traditional models built primarily on European Caucasian women data.

QIAGEN Partners with Foresight Diagnostics and Tracer Biotechnologies to Expand Minimal Residual Disease Testing Portfolio

  • QIAGEN announced strategic partnerships with Foresight Diagnostics and Tracer Biotechnologies to advance minimal residual disease (MRD) testing capabilities across solid tumors and hematological cancers.
  • The collaboration with Foresight will develop a kit-based version of the CLARITY assay for lymphoma, transitioning from central laboratory service to broader clinical access for companion diagnostic applications.
  • Tracer Biotechnologies will work with QIAGEN to create companion diagnostics for MRD testing in solid tumors using the QIAcuity digital PCR platform, offering cost-efficient alternatives to next-generation sequencing.
  • These partnerships strengthen QIAGEN's oncology portfolio by enabling decentralized, non-invasive MRD testing to guide personalized treatment decisions and support pharmaceutical co-development projects.

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT04663347Active, Not RecruitingPhase 1
Genmab
Posted 11/3/2020

Trastuzumab Deruxtecan Combination Reduces Disease Progression Risk by 44% in HER2-Positive Metastatic Breast Cancer

Monoclonal Antibody
  • A new treatment combining trastuzumab deruxtecan (T-DXd) with pertuzumab reduced the risk of disease progression or death by 44% compared to standard care in HER2-positive metastatic breast cancer patients.
  • The combination therapy achieved a median progression-free survival of 40.7 months versus 26.9 months with standard THP treatment, representing the first major advance in over a decade for this cancer type.
  • Complete cancer remission was observed in 15% of patients receiving the new combination compared to 8.5% with standard therapy, with results expected to be submitted to global regulators for approval.
  • The study involved nearly 400 patients and represents a potential new first-line standard treatment for HER2-positive metastatic breast cancer, which comprises 15-20% of all breast cancer cases.

Real-World Study Shows Belantamab Mafodotin Maintains Efficacy in High-Risk Multiple Myeloma Patients Despite Treatment Withdrawal

Real World Evidence
  • A multicenter study of 81 relapsed refractory multiple myeloma patients treated with belantamab mafodotin demonstrated a 40% overall response rate and 15% complete response rate, with median progression-free survival of 5 months.
  • Despite 67% of patients being ineligible for the original DREAMM-2 trial due to high-risk features, efficacy outcomes remained comparable to the pivotal study that led to initial FDA approval.
  • Ocular toxicity affected 69% of patients with grade 3+ events in 43%, leading to treatment discontinuation in 53% of cases, though no permanent blindness occurred.
  • Extramedullary disease emerged as the only significant predictor of both inferior progression-free survival and overall survival on multivariable analysis.

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916

NCT02064387CompletedPhase 1
GlaxoSmithKline
Posted 7/29/2014

Extended Low-Dose Apixaban Reduces VTE Recurrence by 87% in High-Risk Patients

  • The HI-PRO trial demonstrated that low-dose apixaban 2.5 mg twice daily significantly reduced symptomatic venous thromboembolism recurrence by 87% compared to placebo in patients with provoked VTE and enduring risk factors.
  • Only 1.3% of patients receiving apixaban experienced VTE recurrence versus 10.0% in the placebo group, with major bleeding occurring in just 0.3% of apixaban patients.
  • The study supports extended anticoagulation for select high-risk patients, though additional research is needed to identify which subgroups benefit most from prolonged treatment.

ImmuneOncia's CD47 Antibody IMC-002 Shows 30% Response Rate in Advanced Hepatocellular Carcinoma Trial

Monoclonal Antibody
  • ImmuneOncia's next-generation CD47-targeting antibody IMC-002 demonstrated a 30% partial response rate when combined with lenvatinib in advanced hepatocellular carcinoma patients, significantly higher than the typical 10% seen with current second-line therapies.
  • The Phase 1b trial showed a favorable safety profile with 96% of adverse events being Grade 1-2, no neutropenia or thrombocytopenia, and median progression-free survival of 8.3 months.
  • AI-powered digital pathology analysis revealed a 60% objective response rate in patients with high CD47 expression versus no response in low-expression patients (p=0.018), supporting CD47 as a predictive biomarker.
  • Two patients have remained on treatment for over one year, with two of three partial responders being resistant to first-line immunotherapy, suggesting potential for sustained benefit in treatment-resistant cases.

Merck Explores $3+ Billion Acquisition of Swiss Biotech MoonLake Immunotherapeutics

  • Merck has held acquisition talks with Swiss biotech MoonLake Immunotherapeutics for more than $3 billion, according to Financial Times reports citing three people familiar with the matter.
  • The pharmaceutical giant submitted a nonbinding offer earlier this year which was initially rejected, though discussions could potentially be revived as Merck seeks to rebuild its pipeline.
  • The acquisition interest comes as Merck faces the looming patent expiration of its blockbuster cancer drug Keytruda beginning in 2028, creating urgency to diversify its revenue streams.
  • MoonLake's shares surged 19% in extended trading following the acquisition reports, while the biotech's position ahead of late-stage clinical data strengthens its negotiating position.

atai Life Sciences and Beckley Psytech Announce $390 Million Merger to Create Psychedelic Mental Health Leader

  • atai Life Sciences and Beckley Psytech have agreed to merge in an all-share transaction valued at $390 million, creating a market-leading mental health company focused on rapid-acting psychedelic therapies.
  • The combined entity, operating as atai Beckley, will feature a synergistic pipeline of proprietary psychedelic compounds differentiated by convenient administration routes and short clinic times.
  • A key near-term catalyst is the anticipated mid-2025 topline data from Beckley's Phase 2b trial of BPL-003 for treatment-resistant depression, representing the largest controlled trial of mebufotenin.
  • The merger is contingent on achieving pre-agreed success criteria in the ongoing BPL-003 Phase 2b study, with transaction closure expected in the second half of 2025.

BPL-003 Efficacy and Safety in Treatment Resistant Depression

NCT05870540CompletedPhase 2
Beckley Psytech Limited
Posted 9/14/2023

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