MedPath

Tagged News

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.

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

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

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

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 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 TAVO412 in Patients with Cancer (TAVO412)

NCT06761651RecruitingPhase 1
Tavotek Biotherapeutics
Posted 12/20/2023

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

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.

Novel Drug Combination Shows Promise for B-Cell Acute Lymphoblastic Leukemia with Reduced Toxicity

OncologyTargeted Therapy
  • Cambridge researchers have developed a promising combination therapy using venetoclax and inobrodib that effectively targets B-cell acute lymphoblastic leukemia (B-ALL), potentially reducing the need for toxic chemotherapy.
  • The drug combination works by exploiting cancer cell metabolism, triggering ferroptotic cell death even in cells resistant to venetoclax alone, offering new hope for both pediatric and adult patients.
  • Unlike current treatments that require over two years of chemotherapy or risky procedures like bone marrow transplants, this oral therapy could provide a less toxic alternative while maintaining effectiveness.

FDA Questions Pfizer's Approach to Expand Talzenna's Indication in Prostate Cancer

OncologyPrecision MedicineTargeted Therapy
  • The FDA has raised concerns about Pfizer's strategy to expand Talzenna's indication to all castration-resistant prostate cancer patients, questioning the reliance on an "incompletely defined" subgroup without HRR gene mutations.
  • Pfizer is seeking to broaden Talzenna's current first-line indication from only HRR-mutated castration-resistant prostate cancer to an all-comers population, representing a significant potential market expansion.
  • The regulatory scrutiny highlights ongoing challenges in precision medicine approaches and biomarker-based treatment strategies in oncology drug development.

FDA Advisory Committee Rejects Pfizer's Talzenna Expansion for Broader Prostate Cancer Population

OncologyPrecision MedicineTargeted Therapy
  • Pfizer's application to expand Talzenna's indication to all castration-resistant prostate cancer (CRPC) patients was rejected by FDA's advisory committee due to insufficient data in biomarker-negative patients.
  • The company sought to broaden Talzenna's current approval beyond patients with HRR gene mutations, but FDA questioned the reliance on an "incompletely defined" subgroup analysis.
  • FDA oncology chief Richard Pazdur emphasized that chance effects could not be ruled out due to the lack of a formal efficacy analysis in patients without HRR mutations.

Taiwan to Expand National Health Insurance Coverage for Cancer Immunotherapies and Targeted Drugs

Targeted TherapyOncology
• Taiwan's National Health Insurance Administration will expand coverage to include three types of cancer immunotherapies for lung, colorectal, and breast cancers, benefiting up to 3,400 patients starting June 2025.
• The expansion will also cover two PARP inhibitors (olaparib and niraparib) for treating five cancer types, including ovarian, fallopian tube, peritoneal, breast, and prostate cancers, helping approximately 775 additional patients.
• Patients could save between NT$1.71 million to NT$2.47 million annually in medical expenses, with the government allocating NT$3.295 billion from a dedicated cancer fund for immunotherapies.

CytomX Doses First Patient in Combination Trial of CX-801 with Keytruda for Metastatic Melanoma

OncologyTargeted Therapy
  • CytomX Therapeutics has dosed the first patient in a Phase 1 trial combining its masked interferon alpha-2b (CX-801) with Merck's Keytruda in patients with metastatic melanoma.
  • The novel combination aims to address the high unmet need in PD-1 refractory melanoma by localizing interferon's potent immune-stimulating effects to tumors while minimizing systemic toxicities.
  • Initial Phase 1a translational and biomarker data from this study are expected in the second half of 2025, potentially advancing a new approach in combination immuno-oncology therapy.

First In Human Study of CX-801 in Advanced Solid Tumors

NCT06462794RecruitingPhase 1
CytomX Therapeutics
Posted 8/30/2024

New Mainland Chinese Cancer Drug Shows Promising Results in Phase 1 Trial

OncologyTargeted Therapy
  • A multinational study led by Chinese University of Hong Kong researchers found that D3S-001, a mainland-developed cancer drug, effectively treats tumors driven by KRAS-G12C gene mutations.
  • The phase 1 trial demonstrated remarkable efficacy with over 70% of the 42 participating patients experiencing significant tumor shrinkage or complete disappearance after treatment.
  • Researchers noted that D3S-001 inhibits the KRAS-G12C mutation more quickly and potentially for longer durations than existing first-generation inhibitors, showing promise for non-small-cell lung, colorectal, and pancreatic cancers.

Onco-Dermatology Emerges as Critical Component of Multidisciplinary Cancer Care

Targeted TherapyOncology
  • Onco-dermatology has become essential for managing skin, hair, and nail toxicities from modern cancer therapies, with different treatment modalities causing distinct dermatologic adverse effects.
  • Multidisciplinary collaboration between oncologists, dermatologists, and pharmacists enables proactive management strategies that keep patients on life-saving cancer treatments while maintaining quality of life.
  • Recent advances include preemptive treatment protocols for EGFR inhibitor-induced rashes and scalp cooling technology for chemotherapy-induced hair loss, particularly benefiting breast cancer patients.
  • Evidence-based preventive strategies and early intervention protocols are being developed through ongoing clinical trials to optimize patient outcomes and treatment adherence.

Eisai's Remitoro Clears Post-Marketing Surveillance Requirements for T-Cell Lymphoma Treatment in Japan

OncologyRare DiseaseTargeted Therapy
  • Japan's Ministry of Health has lifted the all-case surveillance requirement for Eisai's anticancer agent Remitoro after reviewing safety data from 111 patients and efficacy data from 85 patients with T-cell lymphoma.
  • Remitoro, a fusion protein combining IL-2 and diphtheria toxin, demonstrated an overall response rate of 16.5% across both peripheral and cutaneous T-cell lymphoma patients in the post-marketing study.
  • Common adverse reactions included elevated liver enzymes (22.5%), capillary leak syndrome (21.6%), and decreased platelet count (15.3%), confirming the safety profile in real-world clinical settings.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.