MedPath

Clinical Trial News

Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial for Idiopathic Pulmonary Fibrosis

• Nerandomilast met the primary endpoint in the FIBRONEER-IPF trial, demonstrating a statistically significant absolute change from baseline in Forced Vital Capacity (FVC) at week 52 compared to placebo. • The FIBRONEER-IPF trial, involving over 1177 patients across more than 30 countries, stands as the largest IPF trial conducted to date. • Boehringer Ingelheim plans to submit a new drug application to the FDA and other health authorities based on these positive results, seeking approval for nerandomilast in treating IPF. • Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, has received Breakthrough Therapy Designation from the FDA for IPF, highlighting its potential to address unmet needs.

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

NCT05321069CompletedPhase 3
Boehringer Ingelheim
Posted 10/6/2022

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

NCT05321082CompletedPhase 3
Boehringer Ingelheim
Posted 11/16/2022

Epitomee Medical's Weight Loss Pill Receives FDA Approval, Stock Surges

  • Epitomee Medical's weight loss pill has secured FDA approval, marking a significant milestone for the company in a competitive market.
  • Following the FDA's decision, Epitomee's stock experienced a substantial surge of 200% within two days, reflecting investor optimism.
  • The company now faces the challenge of establishing its product in a crowded weight loss market, requiring strategic market positioning.
  • This approval provides a new option for individuals seeking medical interventions for weight management, addressing a significant health need.

Antennova's ATN-037 Shows Promise in Checkpoint Inhibitor-Resistant Cancers

  • Antennova presented Phase I/Ib data for ATN-037, a CD73 inhibitor, at ESMO 2024, demonstrating its potential to overcome resistance to checkpoint inhibitors.
  • In NSCLC and melanoma patients resistant to CPIs, ATN-037 combined with pembrolizumab showed an overall response rate of 21.1% and a disease control rate of 89.5%.
  • The Phase I dose escalation study suggests ATN-037 can reverse resistance to anti-PD-1 therapies, warranting further investigation in Phase II trials.
  • Antennova has initiated the dose optimization and expansion phase of the Phase II STAMINA trial in Australia and plans to expand to China in late October 2024.

Ivonescimab Shows Promise in Combination Therapies for CRC, TNBC, and HNSCC

  • Ivonescimab, a bispecific antibody, demonstrates encouraging anti-tumor activity and a manageable safety profile in Phase II trials for metastatic colorectal cancer (CRC).
  • In advanced triple-negative breast cancer (TNBC), ivonescimab combined with chemotherapy achieved a 72.4% overall response rate and 100% disease control rate in first-line treatment.
  • Ivonescimab, with or without ligufalimab, shows clinical benefit in recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), with overall response rates of 30% and 60%, respectively.
  • Summit Therapeutics plans to expand clinical development of ivonescimab in solid tumors beyond non-small cell lung cancer, based on positive Phase II data.

A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

NCT05382442RecruitingPhase 2
Akeso
Posted 6/27/2022

A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors

NCT05229497Unknown StatusPhase 1
Akeso
Posted 5/4/2022

A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer

NCT05227664RecruitingPhase 2
Akeso
Posted 3/23/2022

Regeneron's Fianlimab and Libtayo Combo Shows Sustained Melanoma Response

• Regeneron's combination therapy of fianlimab and Libtayo demonstrates continued benefit in advanced melanoma patients after two years, according to Phase I trial data. • The combination achieved a 25% complete response rate and a 57% objective response rate across three cohorts of advanced melanoma patients. • The median progression-free survival was 24 months, with the median duration of response not yet reached, indicating a durable treatment effect. • A Phase III trial comparing the combination to Keytruda is underway, with results anticipated in 2025, potentially expanding treatment options.

Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

NCT03005782CompletedPhase 1
Regeneron Pharmaceuticals
Posted 11/7/2016

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

NCT05352672RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 7/14/2022

A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)

NCT06246916RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 9/9/2024

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

NCT05608291Active, Not RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 1/16/2023

A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma

2022-502825-17-00RecruitingPhase 2/3
Regeneron Pharmaceuticals Inc.
Posted 9/18/2024

Zynyz Plus Chemotherapy Shows Promise in Advanced Anal Cancer

  • Incyte's Zynyz (retifanlimab) combined with chemotherapy significantly improved progression-free survival in previously untreated patients with advanced anal cancer.
  • The Phase III POD1UM-303 trial is the first and largest study evaluating a first-line checkpoint inhibitor for advanced anal cancer, addressing a high unmet medical need.
  • Zynyz plus platinum-based chemotherapy may represent a new standard of care for patients with advanced squamous cell anal cancer, according to study presenter Sheela Rao.
  • Incyte plans to seek FDA approval for Zynyz in anal cancer based on these findings, potentially offering a new treatment option.

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

NCT04472429Active, Not RecruitingPhase 3
Incyte Corporation
Posted 1/12/2021

Epitomee Medical Receives FDA Approval for Weight Management Pill

  • Epitomee Medical's weight management pill has received FDA approval for sale in the US, causing a significant surge in the company's share price.
  • The pill works by expanding in the stomach to create a feeling of fullness, targeting individuals with mild to moderate obesity.
  • Clinical trial data showed that 27% of patients lost at least 10% of their body weight using Epitomee's pill.
  • Epitomee plans to partner with distributors in the US and Europe, with a product launch anticipated in the third quarter of 2025.

Durvalumab Plus Chemotherapy Improves Outcomes in Muscle-Invasive Bladder Cancer

  • The NIAGARA phase 3 trial demonstrated that perioperative durvalumab combined with neoadjuvant chemotherapy significantly improved event-free survival in cisplatin-eligible MIBC patients.
  • Overall survival was also significantly improved with the addition of durvalumab, showing a 25% reduction in the risk of death compared to chemotherapy alone.
  • The combination of durvalumab and chemotherapy did not result in a significant increase in grade 3 or 4 adverse events compared to chemotherapy alone, suggesting a manageable safety profile.
  • These findings support perioperative durvalumab with neoadjuvant chemotherapy as a potential new standard of care for cisplatin-eligible muscle-invasive bladder cancer.

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

NCT03732677Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/16/2018

FDA Approves First Over-the-Counter Hearing Aid Software for Apple AirPods

  • The FDA has approved the first over-the-counter (OTC) hearing aid software, designed for use with widely available consumer audio products like Apple's AirPods.
  • This authorization aims to increase the accessibility and affordability of hearing support for adults experiencing perceived mild to moderate hearing loss.
  • Apple's AirPods Pro will feature Hearing Test and Hearing Aid capabilities, potentially benefiting over a billion people affected by hearing loss worldwide.
  • The FDA also issued warning letters to two Chinese nonclinical testing laboratories, citing concerns over data quality, integrity, and animal care violations.

In Vivo CAR T-Cell Therapies Advance to Clinical Trials, Promising Faster, Cheaper Cancer Treatment

  • In vivo CAR T-cell generation uses off-the-shelf reprogramming cassettes, potentially reducing manufacturing time and costs compared to ex vivo CAR Ts.
  • Clinical trials are underway to assess the safety and efficacy of in vivo CAR T-cell therapies in treating blood cancers and autoimmune diseases.
  • Lentiviral vectors and lipid nanoparticles (LNPs) are being explored as delivery vehicles for CAR payloads, each with unique advantages and challenges.
  • Researchers are expanding the application of in vivo CAR T-cell therapies beyond T cells to target myeloid cells for solid tumor treatment.

CAR-pNK Cell Immunotherapy for Relapsed/Refractory CD33+ AML

NCT02944162Unknown StatusPhase 1
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Posted 10/1/2016

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

NCT02892123CompletedPhase 1
Jazz Pharmaceuticals
Posted 9/30/2016

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

NCT04484012RecruitingPhase 2
City of Hope Medical Center
Posted 12/31/2020

A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

NCT03744676CompletedPhase 2
Juno Therapeutics, a Subsidiary of Celgene
Posted 11/29/2018

Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma

NCT04257578Active, Not RecruitingPhase 1
University of Washington
Posted 12/2/2020

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

NCT03483103CompletedPhase 2
Juno Therapeutics, a Subsidiary of Celgene
Posted 7/27/2018

MedPath

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

© 2025 MedPath, Inc. All rights reserved.