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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.

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 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

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

A Study of TAVO412 in Patients with Cancer (TAVO412)

NCT06761651RecruitingPhase 1
Tavotek Biotherapeutics
Posted 12/20/2023

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

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

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

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

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 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

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

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

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.

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