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T-DXd Combinations Show Promise in HER2+ Gastric and GEJ Cancers

  • Trastuzumab deruxtecan (T-DXd) combined with fluoropyrimidine showed notable antitumor activity in HER2-positive gastric and gastroesophageal junction (GEJ) cancers.
  • The combination of T-DXd and fluoropyrimidine yielded the highest overall response rate (ORR) of 78% and a median progression-free survival (PFS) of 20 months.
  • Adding pembrolizumab to T-DXd and fluoropyrimidine introduced greater toxicities, including a higher incidence of drug-related interstitial lung disease.
  • A reduced-dose triplet of T-DXd, fluoropyrimidine, and pembrolizumab showed manageable safety, warranting further investigation in HER2-positive tumors.

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

NCT04379596RecruitingPhase 2
AstraZeneca
Posted 6/3/2020

Enfortumab Vedotin Plus Pembrolizumab Shows Durable Response in Advanced Urothelial Carcinoma

  • Five-year follow-up data from EV-103 study shows enfortumab vedotin plus pembrolizumab yields durable responses in cisplatin-ineligible, advanced urothelial carcinoma patients.
  • The combination therapy achieved a 73.3% overall response rate, with 41.5% of patients alive at five years, surpassing historical benchmarks.
  • The median overall survival reached 26 months, supporting the use of enfortumab vedotin plus pembrolizumab as a first-line standard of care.
  • Treatment-related adverse events, such as skin reactions and peripheral neuropathy, were manageable, with most resolving or improving after discontinuation.

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

NCT03288545Active, Not RecruitingPhase 1
Astellas Pharma Global Development, Inc.
Posted 10/11/2017

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

NCT04223856Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 3/30/2020

iTeos' TIGIT Inhibitor Shows Promise in Lung Cancer, Reviving Interest in the Target

  • iTeos Therapeutics' belrestotug, combined with GSK's Jemperli, demonstrated encouraging tumor shrinkage in lung cancer patients, with overall response rates significantly higher than Jemperli alone.
  • The Phase 2 trial results have sparked renewed interest in TIGIT as a therapeutic target, despite previous setbacks with other TIGIT inhibitors from companies like Roche and Merck.
  • Safety concerns exist, as the combination therapy was associated with a higher incidence of serious side effects and treatment-related deaths compared to Jemperli monotherapy.
  • iTeos and GSK have initiated a Phase 3 trial to further evaluate the efficacy and safety of belrestotug plus Jemperli against the current standard of care, Keytruda.

A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)

NCT06472076RecruitingPhase 3
GlaxoSmithKline
Posted 6/10/2024

Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)

NCT04738487Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 4/7/2021

Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006)

NCT05298423Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/3/2022

Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

NCT05226598Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 3/24/2022

Rybrevant Demonstrates Promising Activity in Metastatic Colorectal Cancer

  • Rybrevant (amivantamab) plus chemotherapy achieved a 49% objective response rate (ORR) in RAS/BRAF wild-type metastatic colorectal cancer patients in the Phase II OrigAMI-1 study.
  • The combination therapy showed potential to render some patients eligible for curative surgery, suggesting a significant clinical benefit.
  • Johnson & Johnson plans to initiate two Phase III trials to further evaluate Rybrevant in colorectal cancer, expanding its potential therapeutic applications.
  • These findings support the strategy of targeting multiple oncogenic pathways with a single bispecific antibody, offering a novel approach to cancer treatment.

Aortic Valve Replacement Enhances Myocardial Perfusion and Exercise Capacity

  • Aortic valve replacement (AVR) improves myocardial perfusion and exercise capacity in patients with aortic stenosis.
  • The study used cardiovascular magnetic resonance to assess myocardial blood flow and cardiopulmonary exercise testing for exercise capacity.
  • AVR leads to reverse remodeling of the left ventricle and improved coronary microcirculation, enhancing overall cardiac function.
  • Findings support AVR as an effective intervention for improving cardiac physiology and exercise tolerance in aortic stenosis patients.

Pembrolizumab Plus Chemoradiotherapy Significantly Improves Overall Survival in Advanced Cervical Cancer

  • Phase 3 trial data presented at ESMO Congress show pembrolizumab plus chemoradiotherapy significantly improved overall survival (OS) in women with high-risk locally advanced cervical cancer.
  • The 36-month OS rate was 82.6% with pembrolizumab versus 74.8% with placebo, demonstrating a significant survival benefit (HR = 0.67; 95% CI, 0.5-0.9).
  • The FDA previously approved pembrolizumab plus chemoradiotherapy based on progression-free survival (PFS) data, and these OS results further support its use as a new standard of care.
  • While the pembrolizumab regimen had a manageable safety profile, a higher percentage of women experienced grade 3 or higher treatment-related adverse events (69.1% vs. 61.3%).

FDA Rejects MDMA-Assisted Therapy for PTSD, Sparking Controversy

  • The FDA has declined to approve MDMA-assisted therapy for PTSD, a decision that has sparked disappointment among researchers and advocates.
  • A Phase III study showed that 71% of participants receiving MDMA-assisted therapy no longer met the criteria for PTSD.
  • Lykos Therapeutics, the company overseeing the research, is pursuing all available regulatory pathways to address the FDA's concerns.
  • Experts argue that the decision is a setback for PTSD treatment, especially given the limitations and side effects of existing SSRI medications.

BL-B01D1 Demonstrates Promising Efficacy and Safety in Urothelial Carcinoma

  • BL-B01D1, an EGFR x HER3 bispecific antibody-drug conjugate, shows encouraging preliminary efficacy in previously treated urothelial carcinoma patients.
  • The Phase 2 trial highlights a favorable safety profile at a 2.2 mg/kg dose administered every three weeks.
  • Patients with one prior line of chemotherapy showed a 75% objective response rate, indicating potential in the second-line setting.
  • Clinical activity was observed across various levels of EGFR and HER3 expression, supporting its versatile therapeutic potential.

Incyte's Retifanlimab Shows Promise in Advanced Anal Cancer

• Phase 3 trial data reveals that retifanlimab combined with chemotherapy significantly reduces the risk of disease progression or death in patients with recurrent or metastatic squamous cell carcinoma of the anal canal. • Patients receiving the retifanlimab combination therapy experienced a median progression-free survival of 9.3 months, compared to 7.4 months in those treated with chemotherapy alone. • The combination therapy also showed potential for higher overall survival rates, although further long-term data is needed to confirm this advantage, suggesting a new treatment option for this cancer.

Keytruda Plus Lenvima with TACE Improves Progression-Free Survival in Liver Cancer

  • Phase 3 LEAP-012 trial shows Keytruda plus Lenvima with TACE significantly improved progression-free survival (PFS) in unresectable, non-metastatic hepatocellular carcinoma (HCC).
  • The combination therapy reduced the risk of disease progression or death by 34% compared to TACE alone, marking a clinically meaningful improvement.
  • Median PFS increased to 14.6 months with the Keytruda plus Lenvima regimen, compared to 10.0 months with TACE alone, demonstrating a substantial benefit.
  • While overall survival (OS) data are not yet mature, an encouraging trend toward improvement was observed with the combination therapy.

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

NCT04246177Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/22/2020

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