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Clinical Trial News

Summit Therapeutics' Ivonescimab Shows Promising Results in Lung Cancer Trial, Co-CEO Becomes Billionaire

  • Summit Therapeutics' shares surged following positive trial data of ivonescimab in non-small cell lung cancer, increasing market capitalization.
  • Ivonescimab demonstrated a 49% reduction in tumor progression risk compared to Merck's Keytruda in the trial presented at the World Conference on Lung Cancer.
  • Co-CEO Maky Zanganeh's stake in Summit Therapeutics has elevated her to billionaire status, recognizing her leadership and the drug's potential.
  • A global Phase 3 trial is planned to seek FDA approval for ivonescimab, with multiple ongoing trials in China for various cancer types.

Summit Therapeutics' Ivonescimab Outperforms Keytruda in Lung Cancer Trial

  • Summit Therapeutics' ivonescimab demonstrated superior progression-free survival compared to Merck's Keytruda in a Phase 3 trial for non-small cell lung cancer (NSCLC).
  • The trial showed ivonescimab reduced the risk of disease progression or death by 49% compared to Keytruda, with a median progression-free survival of 11.14 months versus 5.82 months.
  • Ivonescimab, already approved in China for a specific lung cancer variant, is being investigated for other indications, including colorectal cancer, potentially expanding its market.
  • Despite promising results, Summit Therapeutics' high valuation reflects anticipated success, posing a risk for investors if the drug's development faces setbacks.

Canaritech Launches Operations to Transform Clinical Research in Latin America

  • Canaritech, a new CRO, has launched to offer comprehensive clinical trial services throughout Latin America, aiming to drive medical innovation and enhance healthcare outcomes.
  • The CRO is strategically positioned with offices in Mexico, Peru, Chile, and Colombia, providing expertise in navigating the complex regulatory landscapes of the region.
  • Canaritech offers services including feasibility studies, regulatory consulting, trial management, and decentralized clinical trials, focusing on patient-centric approaches.
  • The company aims to improve trial efficiency and inclusivity by leveraging digital technologies and real-world evidence data collection in Latin American clinical research.

Ovarian Function Suppression Enhances Survival in Select HER2-Positive Breast Cancer

  • Exploratory analysis of the HERA trial reveals that ovarian function suppression (OFS) combined with endocrine therapy significantly improves long-term survival in premenopausal women with HER2-positive, hormone receptor-positive breast cancer.
  • The 10-year disease-free survival rate increased from 59.6% with tamoxifen alone to 70.9% with the addition of OFS, demonstrating a substantial benefit in disease control.
  • Overall survival rates at 10 years also saw a marked improvement, rising from 74.0% to 84.7% with the inclusion of OFS in the treatment regimen.
  • While OFS can be challenging due to toxicity, its use should be considered in selected high-risk patients to improve survival outcomes.

Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer

NCT00045032CompletedPhase 3
Hoffmann-La Roche
Posted 11/1/2001

Apellis Pharmaceuticals' C3G/IC-MPGN Drug Shows Promise Amidst Syfovre Setbacks

  • Apellis Pharmaceuticals faces headwinds with a negative CHMP opinion on Syfovre, impacting its European market prospects.
  • Analyst Yigal Nochomovitz reaffirms a Buy rating for Apellis, citing market overreaction as a buying opportunity.
  • Phase 3 results for Apellis' drug targeting C3G/IC-MPGN indicate potential peak sales of $800-900 million in the U.S.
  • Needham also maintains a Buy rating on Apellis (APLS) with a price target of $85.00, reinforcing positive outlook.

Black Diamond Therapeutics Announces Phase 2 Data for BDTX-1535 in Recurrent EGFRm NSCLC

  • Black Diamond Therapeutics will present initial Phase 2 clinical trial results for BDTX-1535 in recurrent EGFRm NSCLC.
  • The webcast presentation is scheduled for Monday, September 23, 2024, at 8:00 a.m. ET.
  • BDTX-1535 is a brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR mutant NSCLC and GBM.
  • Black Diamond's MasterKey therapies target families of oncogenic mutations, aiming to overcome resistance and minimize toxicities.

RACE Act Drives Pediatric Cancer Drug Testing via PDX Models

• The RACE for Children Act mandates testing of new oncology drugs in children if their molecular targets are relevant to pediatric cancers, impacting drug development. • Patient-derived xenograft (PDX) models, which preserve the heterogeneity of original tumors, are crucial for preclinical testing of drugs for rare pediatric cancers. • The ITCC-P4 consortium, including Charles River Laboratories, supports drug developers with preclinical testing, offering access to over 200 characterized PDX models. • This initiative aims to accelerate the development of effective treatments for pediatric cancers, ultimately increasing treatment options for young patients.

Tapotoclax Shows Limited Efficacy in Myelodysplastic Syndromes After HMA Failure

  • Tapotoclax demonstrated a manageable safety profile in high-risk MDS patients who had previously failed hypomethylating agents (HMAs), according to a phase 1 study.
  • Although no objective responses were observed, some patients experienced reductions in bone marrow blasts and decreased transfusion dependence.
  • The trial was terminated early due to a lack of clinical activity during the dose-exploring phase, despite the drug's tolerability.
  • Researchers suggest that tapotoclax may warrant further investigation in combination with HMAs or other therapies due to its observed anti-leukemic effects.

AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia

NCT05209152TerminatedPhase 1
Amgen
Posted 11/14/2022

EBV-Specific Immune Response Distinct in Multiple Sclerosis Compared to Other Demyelinating Diseases

  • A new study reveals that patients with multiple sclerosis (MS) exhibit a unique immune response to the Epstein-Barr virus (EBV) compared to those with neuromyelitis optica spectrum disorder (NMOSD), MOGAD, and Susac’s Syndrome.
  • The research identifies elevated levels of EBV-specific T-cell receptor sequences in MS patients, suggesting a potential link between EBV and MS pathogenesis.
  • Certain MS therapies, including ocrelizumab, teriflunomide, and dimethyl fumarate, were found to reduce EBV-specific T-cell responses, indicating a possible mechanism of action.
  • The study highlights the potential for targeting the EBV-specific immune response as a therapeutic strategy in MS, warranting further investigation.

CAR T-Cell Therapy Shows Promise in DLBCL Treatment for ASCT-Eligible and Ineligible Patients

  • Axicabtagene ciloleucel (axi-cel) demonstrates statistically significant event-free survival (EFS) and overall survival (OS) benefits in relapsed/refractory DLBCL patients eligible for autologous stem cell transplant (ASCT).
  • Lisocabtagene maraleucel (liso-cel) shows positive EFS and PFS outcomes in the TRANSFORM trial, offering a potential advantage in DLBCL treatment with a distinct costimulation.
  • Both axi-cel and liso-cel exhibit promising complete response rates in ASCT-ineligible DLBCL patients, with manageable safety profiles, as observed in the ALYCANTE and PILOT studies, respectively.

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

NCT03575351CompletedPhase 3
Celgene
Posted 10/23/2018

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

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

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03391466CompletedPhase 3
Kite, A Gilead Company
Posted 1/25/2018

Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation

NCT04531046Active, Not RecruitingPhase 2
The Lymphoma Academic Research Organisation
Posted 3/10/2021

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