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Clinical Trial News

Sanofi's KT-474 Shows Promise as First-in-Class MyD88 Inhibitor for Inflammatory Diseases

  • KT-474, a novel small molecule, selectively inhibits MyD88, a key signaling protein in inflammatory pathways, offering a potential new approach to treating immune-mediated diseases.
  • Preclinical data suggest KT-474's unique mechanism of action could provide therapeutic benefits in conditions where MyD88 signaling is dysregulated.
  • Sanofi is advancing KT-474, also known as SAR444656, as a potential first-in-class therapy, highlighting its innovative approach to targeting the MyD88 pathway.
  • The development of KT-474 represents a significant advancement in the pursuit of selective inhibitors for challenging targets within the innate immune system.

FDA Advisory Committee to Review Lexicon's Sotagliflozin for Type 1 Diabetes and CKD

  • The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will review Lexicon's Zynquista (sotagliflozin) on October 31, 2024.
  • Lexicon is seeking approval for sotagliflozin as an adjunct to insulin for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).
  • The FDA's decision on sotagliflozin is anticipated by December 20, 2024, the PDUFA goal date, which remains unchanged.
  • Lexicon aims to present comprehensive evidence supporting sotagliflozin's benefit/risk profile for this patient population.

FDA Approves Lazertinib Plus Amivantamab for First-Line EGFR-Mutated NSCLC

  • The FDA has approved lazertinib (LECLAZA) in combination with amivantamab (RYBREVANT) as a first-line treatment for NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
  • The approval was based on the Phase 3 MARIPOSA study, which demonstrated a 30% reduction in the risk of disease progression or death compared to osimertinib.
  • The combination therapy showed a median progression-free survival of 23.7 months versus 16.6 months with osimertinib, and a longer duration of response (25.8 months vs. 16.8 months).
  • This marks the first FDA approval of a Korea-born anticancer drug and represents a significant milestone for Yuhan Corporation's R&D investments.

FDA Approves Rybrevant Plus Lazcluze for EGFR-Mutated Advanced NSCLC

• The FDA has approved Rybrevant plus Lazcluze as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. • This combination marks the first chemotherapy-free regimen demonstrating superiority over osimertinib in patients with EGFR exon 19 deletions or exon 21 L858R substitution mutations. • Clinical trial data from the MARIPOSA study showed a 30% reduction in disease progression or death risk compared to osimertinib, with a median PFS of 23.7 months versus 16.6 months. • The Rybrevant plus Lazcluze regimen offers a novel, multitargeted approach, directly targeting common EGFR mutations and engaging the immune system for improved patient outcomes.

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

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

NCT05388669Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 8/5/2022

A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies

NCT04606381Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 11/10/2020

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 5/18/2023

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

NCT02609776Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/24/2016

A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

NCT05908734Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/18/2023

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

NCT05488314Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/13/2022

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT04988295Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/17/2021

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

NCT04538664Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/13/2020

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

NCT04077463Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 9/4/2019

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

NCT05498428RecruitingPhase 2
Janssen Research & Development, LLC
Posted 11/11/2022

FTC Orange Book Patent Challenge Initiative Shows Mixed Results as Most Listings Remain in Force

  • The Federal Trade Commission has challenged over 400 pharmaceutical patent listings in the FDA's Orange Book since September 2023, claiming many are improperly listed to delay generic competition.
  • Only three companies—GlaxoSmithKline, Glaxo Group, and Kaléo—have voluntarily delisted patents, while the vast majority of challenged listings remain in force.
  • The challenged patents relate to drugs generating billions in revenue, including GSK's Trelegy Ellipta ($1.756 billion) and other respiratory medications.
  • The FTC has not yet brought formal enforcement actions, raising questions about the agency's authority in patent listing disputes traditionally handled by FDA mechanisms.

Tirzepatide Shows Promise in Reducing Diabetes Risk and Outperforming Insulin

  • Tirzepatide significantly reduces the risk of developing type 2 diabetes by 94% in adults with pre-diabetes and obesity or overweight, offering a potential breakthrough in diabetes prevention.
  • The drug demonstrates sustained weight loss, with participants experiencing an average decrease of 22.9% in body weight on the 15 mg dose over a three-year period.
  • A meta-analysis reveals that tirzepatide outperforms conventional insulin in managing type 2 diabetes, showing superior efficacy in reducing blood sugar, weight, and cardiovascular risks.
  • Tirzepatide presents a promising alternative to insulin, with potential for improved clinical outcomes and a generally comparable or lower risk of side effects.

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

NCT04184622CompletedPhase 3
Eli Lilly and Company
Posted 12/4/2019

FDA Issues Complete Response Letter for Regeneron's Linvoseltamab in Relapsed/Refractory Multiple Myeloma

  • The FDA issued a Complete Response Letter (CRL) for Regeneron's linvoseltamab Biologics License Application (BLA) in relapsed/refractory multiple myeloma.
  • The CRL cites issues from a pre-approval inspection at a third-party fill/finish manufacturer unrelated to linvoseltamab.
  • Regeneron is collaborating with the manufacturer and the FDA to resolve the issues and expedite the availability of linvoseltamab.
  • The EMA's regulatory review of linvoseltamab for the same indication remains ongoing.

Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

NCT03761108RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 1/23/2019

GSK's GSK5764227 Receives FDA Breakthrough Therapy Designation for Extensive-Stage Small Cell Lung Cancer

  • The FDA granted Breakthrough Therapy Designation to GSK5764227 for extensive-stage small cell lung cancer (ES-SCLC) post-platinum chemotherapy.
  • The designation is based on Phase 1 ARTEMIS-001 trial data, showing promising efficacy and manageable toxicity in pretreated solid tumors.
  • GSK5764227, a B7-H3-targeted antibody-drug conjugate, showed a 63.6% objective response rate in SCLC patients in the ARTEMIS-001 trial.
  • GSK plans to initiate global Phase 1/2 studies in the second half of 2024 to support a registrational pathway for GSK5764227.

ARTEMIS-001: Phase 1 Study of the HS-20093 in Patients With Advanced Solid Tumors

NCT05276609RecruitingPhase 1
Shanghai Hansoh Biomedical Co., Ltd
Posted 11/28/2021

Liquidia's Yutrepia Receives Tentative FDA Approval for Pulmonary Hypertension

  • Liquidia's Yutrepia (treprostinil) inhalation powder receives tentative FDA approval for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • The approval is tentative due to United Therapeutics' existing regulatory exclusivity for a competing treprostinil product, Tyvaso DPI, until May 23, 2025.
  • Clinical backing comes from the Phase III INSPIRE trial, demonstrating Yutrepia's safety and tolerability in both treprostinil-naïve patients and those transitioning from other inhaled treprostinil treatments.
  • Liquidia plans to challenge the FDA's decision to grant regulatory exclusivity to United Therapeutics, aiming for the full approval of Yutrepia as soon as possible.

FDA Grants Fast Track Designation to Arthrosi's AR882 for Tophaceous Gout

  • The FDA has granted Fast Track designation to Arthrosi Therapeutics' AR882 for treating clinically visible tophi in gout patients, expediting its development and review.
  • AR882, a next-generation URAT1 inhibitor, aims to address the unmet need for effective gout treatments, particularly in patients with visible tophi.
  • Arthrosi Therapeutics is currently advancing AR882 through a pivotal Phase 3 clinical program, demonstrating its commitment to addressing this critical medical need.

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