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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.

Revolution Medicines Advances First-in-Class KRAS(G12D) Molecular Glue Inhibitor RMC-9805 with Novel Cyclophilin A Mechanism

OncologyTargeted Therapy
  • Revolution Medicines has developed RMC-9805, a first-in-class covalent KRAS(G12D)(ON) molecular glue inhibitor that targets the previously "undruggable" KRAS(G12D) mutant using a cyclophilin A-recruiting tricomplex mechanism.
  • The compound employs a finely tuned aziridine covalent handle to engage a poorly nucleophilic mutant Asp residue, representing a breakthrough in targeting this challenging oncogenic mutation.
  • Preclinical data presented at AACR 2024 demonstrated that RMC-9805 synergizes with PD-1 inhibitors, and the compound is making progress in clinical development.
  • The discovery leveraged structural and modeling insights to overcome the technical challenges of inhibiting KRAS(G12D), which has been considered one of the most difficult cancer targets to drug.

A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

NCT05888831Active, Not RecruitingPhase 1
Bristol-Myers Squibb
Posted 6/6/2023

Novartis Receives CDSCO Approval for Phase IIIb Trial of Asciminib in Chronic Myeloid Leukemia

OncologyTargeted Therapy
  • Novartis Healthcare has secured approval from India's CDSCO expert committee to conduct a Phase IIIb roll-over study of asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia.
  • Asciminib (ABL001) functions as a novel allosteric inhibitor targeting the BCR-ABL1 kinase's myristoyl pocket, distinguishing it from traditional ATP-competitive tyrosine kinase inhibitors used in CML treatment.
  • The multi-center, open-label study will assess long-term safety in patients who have completed previous Novartis-sponsored asciminib trials and are deemed to benefit from continued treatment.

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

NCT04971226Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 10/6/2021

A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL

NCT02081378CompletedPhase 1
Novartis Pharmaceuticals
Posted 4/24/2014

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs

NCT03106779CompletedPhase 3
Novartis Pharmaceuticals
Posted 10/26/2017

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

NCT05456191Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 11/21/2022

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