MedPath

Tagged News

Servier to Present Phase 3 Data on IDH-Mutated Cancer Therapies at ASCO 2025

Precision MedicineTargeted TherapyOncology
  • Servier will showcase its precision medicine research for IDH-mutated cancers at the 2025 ASCO Annual Meeting in Chicago, focusing on chondrosarcoma, cholangiocarcinoma, and myelodysplastic syndrome.
  • The company, which allocates over 65% of its R&D budget to oncology, will present updates on several Phase 3 programs aimed at developing new treatment options for patients with IDH-mutated cancers.
  • As a global leader in IDH-mutant targeted therapies, Servier's presentations will reinforce its commitment to advancing precision medicine through mutation identification and understanding cancer progression mechanisms.

Rigel Pharmaceuticals Unveils Promising Final Data from GAVRETO and REZLIDHIA Clinical Trials at ASCO and EHA 2025

OncologyTargeted TherapyPrecision Medicine
  • Final data from the Phase 1/2 ARROW study demonstrates GAVRETO's durable efficacy in RET fusion-positive NSCLC, with a 70.3% overall response rate and median overall survival of 44.3 months.
  • GAVRETO shows promising anti-tumor activity in various RET fusion-positive solid tumors beyond lung cancer, including a 100% response rate in pancreatic cancer patients.
  • REZLIDHIA data supports its potential clinical benefit when used in earlier treatment lines for relapsed/refractory AML patients and as maintenance therapy, with particularly strong outcomes in patients with fewer prior therapies.

FORE Biotherapeutics Secures $38 Million in Series D-2 Financing to Advance Plixorafenib Clinical Trials

Targeted TherapyOncologyPrecision Medicine
  • FORE Biotherapeutics has raised $38 million in Series D-2 financing to advance its global Phase 2 FORTE Master Protocol evaluating plixorafenib across multiple BRAF-mutated cancer indications.
  • The company anticipates interim analyses in 2025 across three monotherapy indications: BRAF V600 primary recurrent CNS tumors, rare BRAF V600 mutated solid tumors, and advanced solid tumors with BRAF fusions.
  • Plixorafenib, designed with a first-in-class mechanism to address limitations of earlier BRAF inhibitors, has previously demonstrated promising efficacy with a 67% overall response rate in BRAF V600 primary recurrent CNS tumors.

Peptide Drug Conjugates Emerge as Next-Generation Cancer Therapeutics with Over 30 Candidates in Clinical Development

Targeted TherapyOncologyDrug Approval
  • Peptide drug conjugates represent a novel targeted therapy approach that combines disease-targeting peptides with small molecule drugs to deliver treatments directly to diseased tissues while minimizing systemic toxicity.
  • The global peptide drug conjugate market has experienced remarkable growth of over 300% absolute growth and 27% CAGR from 2018-2024, with market opportunities exceeding $1.4 billion.
  • Two peptide drug conjugates have received regulatory approval as of May 2025: Novartis's Lutathera for gastroenteropancreatic neuroendocrine tumors and Oncopeptides' Pepaxti for multiple myeloma.
  • More than 30 peptide drug conjugate candidates are currently advancing through various stages of clinical trials, primarily focused on oncology applications but expanding into neurodegenerative and inflammatory disorders.

NeoGenomics Launches c-MET Companion Diagnostic for Advanced Non-Small Cell Lung Cancer Treatment

Targeted TherapyDrug ApprovalOncologyPrecision Medicine
  • NeoGenomics has commercially launched c-MET CDx for NSCLC, a companion diagnostic assay that detects c-Met protein overexpression in advanced non-small cell lung cancer patients with a 48-hour turnaround time.
  • The diagnostic test supports patient selection for newly FDA-approved targeted therapy EMRELIS™ (telisotuzumab vedotin-tllv), offering a precision medicine approach for a biomarker observed in up to 50% of advanced NSCLC patients.
  • This validated companion diagnostic complements NeoGenomics' broader PanTracer™ portfolio, enhancing comprehensive biomarker profiling capabilities for lung cancer treatment decisions.

AstraZeneca Showcases Groundbreaking Cancer Research at ASCO 2025 with Two Plenary Presentations

OncologyTargeted TherapyPrecision MedicineRare Disease
  • AstraZeneca will present over 80 abstracts at ASCO 2025, including two plenary presentations featuring camizestrant for HR-positive breast cancer and IMFINZI for early gastric cancer, marking their seventh consecutive year with plenary data.
  • The SERENA-6 trial is the first positive Phase III study for a next-generation oral SERD in first-line HR-positive breast cancer, pioneering the use of circulating tumor DNA to guide treatment decisions.
  • DESTINY-Breast09 data shows ENHERTU plus pertuzumab is the first treatment in over a decade to demonstrate superiority over standard care in first-line HER2-positive metastatic breast cancer.

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

NCT02564900CompletedPhase 1
Daiichi Sankyo Co., Ltd.
Posted 9/1/2015

Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas

NCT04924608Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/19/2021

Genomic Testing Emerges as Critical Tool in Brain Cancer Treatment, Experts Emphasize

OncologyTargeted TherapyDrug Approval
  • Comprehensive genomic profiling is crucial for brain cancer patients, enabling personalized treatment approaches and identification of actionable mutations like NTRK fusions, according to Dr. Manmeet Ahluwalia.
  • The recent FDA approval of vorasidenib (Voranigo) for IDH-mutant gliomas represents a breakthrough in targeted therapy for brain tumors and provides hope for developing additional brain-penetrating drugs.
  • Clinical trials remain the optimal treatment option for aggressive brain cancers like glioblastoma, with increasing availability in both academic centers and larger community practices.

Novel IL-2 Derivative Shows Complete Remission in Advanced Skin Cancer Patient After One Year

OncologyTargeted Therapy
• A 73-year-old patient with advanced cutaneous squamous cell carcinoma has remained cancer-free for over a year following treatment with WTX-124, a novel conditionally activated IL-2 pro-drug, in a clinical trial at HonorHealth Research Institute.
• The investigational drug is engineered to remain inactive until it reaches the tumor microenvironment, potentially delivering the benefits of IL-2 therapy with significantly reduced toxicity compared to conventional treatments.
• This breakthrough offers new hope for the nearly 40,000 U.S. patients annually who develop advanced cutaneous squamous cell carcinoma, particularly those who have failed standard treatments including checkpoint inhibitor therapy.

CCM Biosciences to Present Breakthrough 4th-Generation EGFR Inhibitors for NSCLC at ASCO 2025

OncologyPrecision MedicineTargeted Therapy
  • CCM Biosciences will present data on novel 4th-generation EGFR inhibitors (CCM-205, CCM-245, and CCM-308) that overcome both mutational and non-mutational resistance to 3rd-generation inhibitors in NSCLC at ASCO 2025.
  • The company's compounds significantly outperform other investigational 4th-generation inhibitors in various drug resistance models and show efficacy as both monotherapies and in combination with existing treatments.
  • CCM Biosciences plans to file an Investigational New Drug (IND) application this year to advance clinical candidates from its EGFR inhibitor program into clinical trials.

Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC

NCT02504489CompletedPhase 3
BeyondSpring Pharmaceuticals Inc.
Posted 12/1/2015

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

NCT01942135CompletedPhase 3
Pfizer
Posted 9/26/2013

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

Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT03909334Active, Not RecruitingPhase 2
Xiuning Le
Posted 7/25/2019

Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection

NCT04762459Enrolling by InvitationPhase 3
Chinese Academy of Medical Sciences
Posted 8/1/2021

Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Tumor Suppressor Gene Mutation

NCT04500717Unknown StatusPhase 3
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Posted 10/1/2020

AK112 in Advanced Non-Small Cell Lung Cancer

NCT05499390Active, Not RecruitingPhase 3
Akeso
Posted 11/9/2022

A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

NCT02912949Active, Not RecruitingPhase 2
Partner Therapeutics, Inc.
Posted 1/1/2015

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

Evaluating High-dose Furmonertinib with Bevacizumab and Pemetrexed for EGFRm NSCLC with Leptomeningeal Metastasis

NCT06643000RecruitingNot Applicable
Henan Cancer Hospital
Posted 12/20/2024

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

NCT04035486Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/2/2019

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

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

Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

NCT05607550Active, Not RecruitingPhase 3
ArriVent BioPharma, Inc.
Posted 6/1/2023

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

Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation

NCT01996098Unknown StatusPhase 3
Sun Yat-sen University
Posted 1/1/2014

A trial to learn how safe Dato-DXd is when given with osimertinib, and how well it works compared to osimertinib alone in people who have advanced or metastatic non-small cell lung cancer (NSCLC) with a mutation in the EGFR gene

2023-509883-89-00RecruitingPhase 3
AstraZeneca AB
Posted 4/29/2024

TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

NCT04129502Active, Not RecruitingPhase 3
Takeda
Posted 1/10/2020

A trial to learn how safe Dato-DXd is and how well it works in people with NSCLC that has advanced after receiving osimertinib

2024-511362-37-00RecruitingPhase 3
AstraZeneca AB
Posted 10/4/2024

Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

NCT02125240Unknown StatusPhase 3
Betta Pharmaceuticals Co., Ltd.
Posted 9/1/2014

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer with EGFR or HER2 Mutation (WU-KONG1)

NCT03974022Active, Not RecruitingPhase 1
Dizal Pharmaceuticals
Posted 7/9/2019

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

Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib

NCT06120140RecruitingPhase 2
Janssen Research & Development, LLC
Posted 2/16/2024

A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

NCT05120349Active, Not RecruitingPhase 3
AstraZeneca
Posted 2/21/2022

Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer

NCT04181060RecruitingPhase 3
National Cancer Institute (NCI)
Posted 12/28/2020

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

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

A Study of TAVO412 in Patients with Cancer (TAVO412)

NCT06761651RecruitingPhase 1
Tavotek Biotherapeutics
Posted 12/20/2023

Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

NCT03944772Active, Not RecruitingPhase 2
AstraZeneca
Posted 6/25/2019

Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations

NCT06041776RecruitingPhase 3
Betta Pharmaceuticals Co., Ltd.
Posted 3/28/2023

A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer

NCT04036682Active, Not RecruitingPhase 1
Cullinan Therapeutics Inc.
Posted 10/31/2019

To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

NCT04853342RecruitingPhase 3
Allist Pharmaceuticals, Inc.
Posted 6/7/2021

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT02296125Active, Not RecruitingPhase 3
AstraZeneca
Posted 12/3/2014

REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

NCT05973773RecruitingPhase 3
Taiho Oncology, Inc.
Posted 6/30/2023

A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)

NCT03521154Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/19/2018

Tempus and Verastem Partner to Develop Companion Diagnostic for First FDA-Approved KRAS-Mutant LGSOC Treatment

Precision MedicineDrug ApprovalOncologyTargeted Therapy
  • Tempus AI and Verastem Oncology have announced a collaboration to develop a companion diagnostic test for the recently FDA-approved combination therapy of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer.
  • The partnership builds on Tempus' confirmatory testing in Verastem's Phase 2 RAMP-201 clinical trial, with their FDA-approved xT CDx assay now being used as an investigational assay in the global Phase 3 RAMP-301 trial.
  • Low-grade serous ovarian cancer (LGSOC) is a rare form affecting younger women, accounting for 6-10% of serous ovarian cancers, with historically poor response to chemotherapy and limited treatment options.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.