Tagged News
Novel IL-2 Derivative Shows Complete Remission in Advanced Skin Cancer Patient After One Year
• 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.
FDA Advisory Committee Votes 6-2 in Favor of Daratumumab for High-Risk Smoldering Multiple Myeloma
• The FDA's Oncologic Drug Advisory Committee (ODAC) voted 6-2 that daratumumab (Darzalex Faspro) demonstrates a favorable benefit-risk profile for patients with high-risk smoldering multiple myeloma, potentially offering the first approved therapy for this precursor condition.
• The phase 3 AQUILA trial showed daratumumab significantly delayed progression to active multiple myeloma with a 51% reduction in risk of progression or death compared to active monitoring, with 5-year PFS rates of 63.1% versus 40.8%.
• Committee members expressed concerns about risk classification accuracy and potential overtreatment, but ultimately determined the benefits outweighed risks for this malignant condition that has an 80% five-year progression risk to symptomatic multiple myeloma.
Related Clinical Trials:
Janssen Research & Development, LLC
Posted 11/7/2017
FDA Advisory Committee Rejects New Indications for Genentech's Columvi and Pfizer's Talzenna Combination
• The FDA's Oncologic Drugs Advisory Committee voted 8-1 against approving Genentech's Columvi for a new indication, citing concerns about the pivotal trial's applicability to US patients.
• In a separate decision, the same committee unanimously rejected (8-0) Pfizer's application for Talzenna in combination with Xtandi for first-line treatment in adults with prostate cancer.
• These negative recommendations highlight the FDA's increasing scrutiny of oncology drug applications and may signal stricter requirements for clinical trial design and population representation.
Poolbeg Pharma Secures £4.1 Million Fundraising to Advance Clinical Programs in Oncology and Obesity
• Poolbeg Pharma has announced a £4.1 million conditional fundraising to advance its POLB 001 Phase 2a trial for cancer immunotherapy-induced Cytokine Release Syndrome and oral GLP-1 proof of concept trial for obesity.
• The fundraising comprises a £2.655 million placing, £1.345 million in direct subscriptions, and up to £100,000 from a retail offer, with shares issued at 2.5 pence each, representing a 12% discount to the previous closing price.
• The proceeds will extend Poolbeg's cash runway into 2027, supporting multiple near-term clinical data catalysts including first patient dosing for POLB 001 in H2 2025 and topline data expected in H2 2026.
CCM Biosciences to Present Breakthrough 4th-Generation EGFR Inhibitors for NSCLC at ASCO 2025
• 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.
FDA Advisory Committee Rejects Genentech's Columvi Expansion for Transplant-Ineligible DLBCL Patients
• The FDA's Oncologic Drugs Advisory Committee voted 8-1 against expanding Genentech's bispecific antibody Columvi for transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.
• Committee members expressed concerns about the applicability of the Phase III STARGLO study data to the U.S. population, as half of the participants were Asian patients with only 25 enrolled from North America.
• Columvi, which targets CD20 and CD3 proteins, was initially approved in June 2023 for DLBCL patients who had undergone at least two prior lines of systemic therapy.
Glofitamab-GemOx Shows Survival Benefit in Phase 3 STARGLO Trial for R/R DLBCL, But FDA Advisory Committee Questions US Applicability
• The phase 3 STARGLO trial demonstrated that glofitamab combined with gemcitabine and oxaliplatin nearly doubled median overall survival to 25.5 months compared with 12.9 months for rituximab-GemOx in transplant-ineligible R/R DLBCL patients.
• Despite showing a 41% reduction in death risk and 63% reduction in disease progression, the FDA's Oncologic Drugs Advisory Committee voted 8-to-1 against the applicability of the trial data to US patients, citing regional outcome differences.
• Glofitamab, a CD20xCD3 bispecific antibody, is currently approved in over 30 countries and has accelerated approval in the US, with an FDA decision on full approval expected by July 20, 2025.
Related Clinical Trials:
Hoffmann-La Roche
Posted 2/23/2021
Hoffmann-La Roche
Posted 2/21/2017
Tempus and Verastem Partner to Develop Companion Diagnostic for First FDA-Approved KRAS-Mutant LGSOC Treatment
• 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.
Aging Impairs CAR-T Cell Therapy Effectiveness Through Metabolic Decline, Swiss Study Reveals
• New research from Swiss institutions demonstrates that age-related immune decline significantly reduces the effectiveness of CAR-T cell cancer therapy by impairing mitochondrial function and metabolism.
• Scientists identified decreased levels of nicotinamide adenine dinucleotide (NAD) as the key factor behind reduced antitumor activity in CAR-T cells from older individuals.
• Researchers successfully rejuvenated aged CAR-T cells by restoring NAD levels in preclinical models, suggesting potential strategies to improve immunotherapy outcomes in older cancer patients.
Finnish Researchers Develop Gene Signature Test to Predict Cancer Immunotherapy Response
• University of Turku scientists have identified a five-gene signature that predicts which cancer patients will respond to bexmarilimab immunotherapy, potentially improving treatment outcomes through personalized selection.
• The study revealed bexmarilimab works best in "immunologically silent" tumor environments by activating macrophages against cancer cells, while also triggering B cell responses in adjacent healthy tissue.
• This Finnish-developed immunotherapy has shown promising results across multiple solid tumor types, with researchers now working toward clinical validation of the gene signature for patient profiling.