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Trishula Therapeutics' TTX-030 Shows Promise in Metastatic Pancreatic Cancer Phase 1 Trial

  • A Phase 1 trial of TTX-030 in first-line metastatic pancreatic cancer showed a median overall survival of 19.1 months in the efficacy-evaluable population.
  • Patients with high HLA-DQ expression (HLA-DQhigh) showed an even greater median overall survival of 21.9 months, suggesting a predictive biomarker.
  • The combination of TTX-030 with gemcitabine/nab-paclitaxel, with or without budigalimab, was well-tolerated, with adverse events consistent with chemotherapy.
  • A Phase 2 trial (ELTIVATE) is underway to further evaluate TTX-030 in metastatic pancreatic adenocarcinoma, focusing on progression-free survival in HLA-DQhigh patients.

Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients

NCT06119217Active, Not RecruitingPhase 2
Trishula Therapeutics, Inc.
Posted 3/25/2024

Pembrolizumab Plus Chemotherapy Improves Overall Survival in Early-Stage TNBC

  • Neoadjuvant pembrolizumab combined with chemotherapy, followed by adjuvant pembrolizumab, significantly improves overall survival in early-stage triple-negative breast cancer (TNBC).
  • The KEYNOTE-522 trial demonstrated a 34% reduction in the risk of death with the pembrolizumab regimen compared to placebo in TNBC patients.
  • At a median follow-up of 75.1 months, the 5-year overall survival rate was 86.6% in the pembrolizumab arm versus 81.7% in the placebo arm.
  • Patients achieving pathological complete response (pCR) showed an overall survival benefit, irrespective of the treatment arm, highlighting the importance of early response.

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

NCT03036488Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 3/7/2017

Pfizer's Ponsegromab Shows Promise in Phase 2 Trial for Cancer Cachexia

  • Pfizer's ponsegromab demonstrated positive results in a Phase 2 trial for treating cancer cachexia, a wasting condition affecting millions worldwide.
  • The study showed that patients receiving ponsegromab experienced improvements in body weight, muscle mass, quality of life, and physical function.
  • Ponsegromab is slated to advance into late-stage trials next year, addressing a critical unmet need as there are currently no FDA-approved treatments for cachexia.
  • Cancer cachexia affects approximately 9 million people globally, highlighting the significance of this potential new therapeutic option.

Pfizer's Ponsegromab Shows Promise in Cancer Cachexia with Significant Weight Gain

  • Pfizer's ponsegromab met the primary endpoint in a Phase II trial, demonstrating clinically meaningful weight gain in cancer cachexia patients.
  • The 400mg dose group achieved a mean weight increase of 5.6% after 12 weeks, surpassing the 5% threshold for clinical significance.
  • Ponsegromab targets Growth/Differentiation Factor 15 (GDF-15), a key driver of cachexia, with plans for pivotal studies starting in 2025.
  • The ongoing Phase II trial included patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer.

Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

NCT05546476CompletedPhase 2
Pfizer
Posted 11/21/2022

A Study of Ponsegromab in People With Heart Failure

NCT05492500TerminatedPhase 2
Pfizer
Posted 9/26/2022

Apple Watch Receives FDA Clearance for Sleep Apnea Detection

  • The FDA has approved sleep apnea detection for Apple Watch Series 9, Series 10, and Watch Ultra 2, accessible via the upcoming watchOS 11 update.
  • The feature requires 10 nights of sleep tracking over 30 days, utilizing the accelerometer to identify potential sleep disturbances.
  • Apple emphasizes that the feature is not a diagnostic tool but an over-the-counter risk assessment, prompting users to seek professional diagnosis.
  • This approval follows similar clearances for sleep apnea detection in devices from Withings and Samsung's Galaxy Watch line.

J&J's Rybrevant Shows Promise in Colorectal Cancer, Phase 3 Trials Planned

  • Rybrevant plus chemotherapy achieved a 49% objective response rate in RAS/BRAF wild-type metastatic colorectal cancer patients who had not received anti-EGFR therapy.
  • The regimen demonstrated a median duration of response of 7.4 months and a median progression-free survival of 7.5 months in the studied patient population.
  • Johnson & Johnson is planning phase 3 trials to compare Rybrevant with the current standard treatment, Erbitux, in first- and second-line settings for mCRC.
  • Rybrevant's activity in colorectal cancer, beyond its approved use in NSCLC, marks a potentially significant advancement for patients with EGFR inhibitor-naïve mCRC.

Apple Watch Receives FDA Clearance for Sleep Apnea Detection Feature

  • The FDA has approved Apple's sleep apnea detection feature for Apple Watch Series 9, Series 10, and Ultra 2, integrated into watchOS 11.
  • The feature identifies potential signs of moderate to severe sleep apnea in individuals aged 18 and older, without prior diagnosis.
  • While not a diagnostic tool, the Apple Watch feature functions similarly to over-the-counter sleep apnea risk assessment devices, prompting users to seek medical evaluation.
  • This approval follows Apple's recent FDA clearance for AirPods Pro 2 as a hearing aid, underscoring the company's growing focus on health-related functionalities.

Pfizer's Ponsegromab Shows Promise in Cancer Cachexia Phase II Trial

  • Pfizer's ponsegromab met the primary endpoint in a Phase II trial, demonstrating clinically meaningful weight gain in cancer patients with cachexia.
  • The 400mg dose group achieved a mean weight increase of 5.6% after 12 weeks, considered clinically significant by experts.
  • Pfizer plans to discuss late-stage development with regulators, aiming to initiate registration-enabling studies in 2025.
  • Ponsegromab, a GDF-15-targeting monoclonal antibody, is also being investigated for heart failure patients with elevated GDF-15 levels.

Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

NCT05546476CompletedPhase 2
Pfizer
Posted 11/21/2022

A Study of Ponsegromab in People With Heart Failure

NCT05492500TerminatedPhase 2
Pfizer
Posted 9/26/2022

Cabozantinib Shows Significant PFS Improvement in Advanced Neuroendocrine Tumors

  • Cabozantinib significantly improved progression-free survival (PFS) in patients with advanced pancreatic neuroendocrine tumors (pNET) and extra-pancreatic NET (epNET) compared to placebo.
  • In the pNET cohort, median PFS was 13.8 months for cabozantinib versus 4.4 months for placebo (HR 0.23, p<0.0001), while in the epNET cohort, median PFS was 8.4 months versus 3.9 months (HR 0.38, p<0.0001).
  • The objective response rate (ORR) was higher with cabozantinib in both cohorts, with 19% in pNET and 5% in epNET, suggesting potential clinical benefit across various subgroups.
  • Exelixis' sNDA for cabozantinib in advanced NET has been accepted by the FDA, with a target action date of April 3, 2025, potentially establishing it as a new standard of care.

Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

NCT03375320Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 10/26/2018

BioVie's Bezisterim Receives Final Approval for Phase 2 Long COVID Trial

  • BioVie Inc. has secured the final scientific approval from the U.S. Army for its Phase 2 trial evaluating bezisterim in treating neurological symptoms associated with long COVID.
  • The Phase 2 trial, expected to commence by early 2025, is a randomized, placebo-controlled study involving approximately 200 patients.
  • Bezisterim, an oral anti-inflammatory and insulin-sensitizing agent, targets chronic inflammation and blood-brain barrier dysfunction, key features of long COVID.
  • The trial is supported by a $12.6 million grant from the Department of Defense, adding to an initial $499,200 for the planning phase.

NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa

NCT05083260CompletedPhase 1
BioVie Inc.
Posted 1/4/2022

Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia

NCT05227820CompletedPhase 2
Neurological Associates of West Los Angeles
Posted 1/19/2022

A Phase 3 Study of NE3107 in Probable Alzheimer's Disease

NCT04669028CompletedPhase 3
BioVie Inc.
Posted 8/5/2021

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