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Clinical Trial News

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.

Tafasitamab Regimen Demonstrates Improved PFS in Advanced Follicular Lymphoma

  • The addition of tafasitamab-cxix to lenalidomide and rituximab has shown improved outcomes for patients with relapsed or refractory follicular lymphoma.
  • The phase 3 inMIND trial, which included 654 adults, met its primary endpoint of PFS by investigator assessment among patients with follicular lymphoma.
  • Key secondary endpoints, including PFS in the overall study population and PET complete response, were also met in the trial.
  • Incyte plans to submit a supplemental biologics license application by year-end for follicular lymphoma patients who failed prior anti-CD20 or chemoimmunotherapy.

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

NCT04680052Active, Not RecruitingPhase 3
Incyte Corporation
Posted 4/15/2021

Pfizer-BioNTech COVID-Flu Combo Vaccine Faces Setback Due to Influenza B Response

  • Phase 3 trial of Pfizer-BioNTech's combined COVID-19 and influenza mRNA vaccine reveals suboptimal antibody response for influenza B component, necessitating formula adjustments.
  • The 8,000-subject study aimed to demonstrate non-inferiority to existing Comirnaty COVID-19 vaccine and standard flu vaccines, following promising phase 1/2 results.
  • Setback potentially opens opportunity for Moderna, whose competing COVID-flu combination vaccine showed superior immune responses in Phase 3 trials, targeting potential approval by 2025-2026.

A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

NCT06097273CompletedPhase 3
ModernaTX, Inc.
Posted 10/19/2023

Vimgreen Completes Enrollment in Phase 2 Trial of VG081821AC for Parkinson's Disease

  • Vimgreen Pharmaceuticals has completed enrollment of 150 participants in a Phase 2 trial of VG081821AC for early-to-mid stage Parkinson's disease.
  • The trial is a 12-week, multicenter, randomized, double-blind, placebo-controlled study evaluating VG081821AC as a monotherapy.
  • VG081821AC, a novel adenosine A2A receptor antagonist and inverse agonist, aims to improve motor symptoms and potentially modify disease progression.
  • The primary endpoint is the change from baseline in MDS-UPDRS Part III score, with trial completion expected in November.

CARVYKTI® Demonstrates Significant Benefit in High-Risk Multiple Myeloma After One Line of Therapy

  • Cilta-cel shows promise for functional high-risk myeloma, significantly improving outcomes compared to standard care.
  • Patients treated with cilta-cel had a 73% reduced risk of disease progression or death, with 77% in remission after one year.
  • The overall response rate to cilta-cel was significantly higher, with 67% achieving a complete response or better, versus 38% with standard care.
  • Safety profiles for cilta-cel in patients with one prior line of therapy were comparable to those in later lines of therapy.

A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

NCT04181827Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 6/12/2020

FDA Approves Imfinzi for Resectable Non-Small Cell Lung Cancer

  • The FDA has approved Imfinzi (durvalumab) in combination with chemotherapy for adult patients with resectable early-stage NSCLC.
  • The approval was based on the AEGEAN trial, which showed a 32% reduction in the risk of recurrence, progression, or death versus chemotherapy alone.
  • Treatment with Imfinzi plus neoadjuvant chemotherapy resulted in a pathologic complete response rate of 17.2% compared to 4.3% with chemotherapy alone.
  • Imfinzi is now an important new treatment option for patients with resectable NSCLC, addressing the high rates of recurrence after surgery and chemotherapy.

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