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Clinical Trial News

Ivonescimab Monotherapy Shows Significant PFS Improvement in NSCLC

  • Ivonescimab monotherapy reduced the risk of disease progression or death by 49% compared to pembrolizumab in PD-L1 positive advanced NSCLC patients.
  • The HARMONi-2 trial demonstrated a median progression-free survival of 11.14 months with ivonescimab versus 5.82 months with pembrolizumab.
  • Summit Therapeutics plans to initiate the HARMONi-7 Phase III trial in early 2025, focusing on first-line PD-L1 high advanced NSCLC.
  • Phase II data of ivonescimab in perioperative NSCLC showed encouraging major pathological response and pathological complete response rates.

Summit Therapeutics Completes Enrollment in Phase III HARMONi Trial and Receives FDA Fast Track Designation for Ivonescimab

  • Summit Therapeutics has completed enrollment in the Phase III HARMONi trial evaluating ivonescimab plus chemotherapy for EGFR-mutated NSCLC after TKI failure.
  • The FDA granted Fast Track designation to ivonescimab in combination with platinum-based chemotherapy for EGFR-mutated NSCLC post EGFR-TKI therapy.
  • HARMONi is a multi-regional trial conducted in North America, Europe, and China, with topline data expected in mid-2025.
  • Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, has shown promise in clinical trials, including HARMONi-2 where it outperformed pembrolizumab.

Phase 3 Clinical Study of AK112 for NSCLC Patients

NCT05184712Active, Not RecruitingPhase 3
Akeso
Posted 1/25/2022

A Trial of AK112 (PD-1/VEGF Bispecific Antibody) in Patients With NSCLC

NCT04900363Active, Not RecruitingPhase 1
Akeso
Posted 5/21/2021

AK112 in Advanced Non-Small Cell Lung Cancer

NCT05499390Active, Not RecruitingPhase 3
Akeso
Posted 11/9/2022

A Trial of AK112 (PD1/VEGF Bispecific) in Combination With Chemotherapy in Patients With NSCLC

NCT04736823RecruitingPhase 2
Akeso
Posted 2/1/2021

First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

NCT05099172Active, Not RecruitingPhase 1
Bayer
Posted 10/25/2021

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

NCT04035486Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/2/2019

Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations

NCT05364073Active, Not RecruitingPhase 1
ArriVent BioPharma, Inc.
Posted 6/30/2022

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

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

NCT05061550RecruitingPhase 2
AstraZeneca
Posted 4/14/2022

BCAAs and Clinical Outcomes: Leucine's Role in Malnourished Patients

  • A recent study investigates the association between branched-chain amino acids (BCAAs), particularly leucine, and clinical outcomes in patients at nutritional risk.
  • The research highlights a complex, potentially U-shaped relationship between leucine levels and mortality in this patient population.
  • Findings suggest that both low and high levels of leucine may be associated with increased mortality risk, warranting further investigation.
  • The study underscores the importance of personalized nutritional support, considering individual metabolic profiles for improved patient outcomes.

Vaxcyte's VAX-31 Shows Promise in Broad-Spectrum Pneumococcal Disease Prevention

  • Vaxcyte's VAX-31 vaccine demonstrated a favorable safety profile and strong immune response against all 31 serotypes in adults aged 50 and older.
  • The company's XpressCF platform enables the development of broad-spectrum vaccines that overcome the limitations of traditional cell-based approaches.
  • VAX-31 is rapidly advancing to Phase 3 clinical trials, with potential FDA approval expected by late 2026 or 2027, positioning Vaxcyte as a leader in the pneumococcal vaccine market.
  • Vaxcyte's robust financial position, with $2.8 billion in liquid reserves, supports its research and development efforts through FDA approval and commercialization.

Imetelstat Shows Durable Transfusion Independence in Lower-Risk MDS

  • Updated results from the phase 3 IMerge study demonstrate that imetelstat provides sustained red blood cell transfusion independence (RBC-TI) in patients with lower-risk MDS.
  • The majority of patients responding to imetelstat achieved a durable response, with a median duration of RBC-TI of 51.6 weeks, indicating a clear clinical benefit.
  • Treatment with imetelstat did not show a detriment in overall survival compared to placebo, suggesting a favorable risk-benefit profile for the drug.
  • Imetelstat was approved by the FDA on June 6, 2024, for adult patients with low- to intermediate-1–risk MDS and transfusion-dependent anemia.

Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

NCT02598661Active, Not RecruitingPhase 2
Geron Corporation
Posted 1/12/2016

FDA Clears Think Surgical's TMINI Robotic System for Medacta Knee Implants

  • Think Surgical's TMINI robotic system has received FDA 510(k) clearance for use with Medacta's GMK Sphere and SpheriKA knee systems, expanding robotic-assisted TKA options.
  • The collaboration between Think Surgical and Medacta aims to integrate robotic surgery platforms with advanced knee implant systems for personalized solutions.
  • This partnership reflects Medacta's commitment to offering cutting-edge technologies and sustainable innovation in total knee replacement procedures.
  • The integration seeks to enhance surgical precision and improve patient outcomes in robotic-assisted total knee arthroplasty.

Azithromycin Mass Distribution Reduces Childhood Mortality in Sub-Saharan Africa

  • A study in sub-Saharan Africa showed that twice-yearly azithromycin distribution to children aged 1-59 months significantly reduced all-cause mortality.
  • The AVENIR trial challenges WHO's recommendation to limit azithromycin distribution to infants in high-mortality areas, suggesting broader application may be more effective.
  • Researchers emphasize the need to balance mortality reduction with monitoring for antimicrobial resistance (AMR) in wider azithromycin distribution programs.
  • The trial demonstrated a 14% lower mortality rate in children receiving azithromycin compared to placebo, highlighting the potential for widespread implementation.

NHS Approves Trifluridine-Tipiracil and Bevacizumab Combo for BRAF-Mutated Bowel Cancer

  • The NHS has approved a combination of trifluridine-tipiracil hydrochloride and bevacizumab for treating BRAF V600E-mutated bowel cancer after two failed treatments.
  • Clinical trials demonstrated the drug combination extended survival by nearly a year in patients with limited treatment options, and up to seven years in rare cases.
  • The BRAF mutation, present in about 10% of bowel cancer cases, leads to rapid cancer growth and resistance to standard treatments, often affecting younger individuals.
  • Patient groups emphasize the importance of early diagnosis and awareness of bowel cancer symptoms among young people to improve outcomes.

Beyond LDL: Novel Cholesterol Targets and Therapies Show Promise in Reducing Cardiovascular Risk

  • Researchers are exploring treatments for lipoprotein(a), a genetically influenced cholesterol type unaffected by statins, with therapies showing potential in early trials.
  • HDL cholesterol research shifts focus from simply raising levels to improving functionality, exemplified by CSL112, though recent trials showed it did not meet its primary endpoint.
  • Triglyceride-lowering strategies face scrutiny as studies yield conflicting results, suggesting triglycerides may be indicators rather than direct causes of cardiovascular issues.
  • Emerging focus on remnant cholesterol highlights its potential role in atherosclerosis, prompting investigation into novel treatments to clear these particles from the bloodstream.

Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

NCT05581303Active, Not RecruitingPhase 3
Amgen
Posted 12/14/2022

Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD

NCT04023552Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 12/12/2019

Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

NCT03473223CompletedPhase 3
CSL Behring
Posted 3/21/2018

Leqembi Offers Alzheimer's Patients More Time, Faces Logistical Hurdles

  • Leqembi, developed by Biogen and Eisai, is a monoclonal antibody that moderately slows cognitive decline in early-stage Alzheimer's patients, offering them more functional time.
  • The rollout of Leqembi faces challenges, including reimbursement uncertainties, diagnostic test requirements, and limited availability of neurologists and specialized infusion centers.
  • Despite the drug's potential benefits, it carries risks of brain swelling and bleeding, necessitating careful patient monitoring and adherence to strict eligibility criteria.
  • Eisai and Biogen are working on more convenient formulations of Leqembi, such as monthly infusions and subcutaneous injections, to ease the burden on patients and expand access.

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