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Gilead's Dual-Target CAR-T Therapy Achieves 62% Response Rate in Recurrent Glioblastoma

CAR-TOncology
  • Gilead Sciences' dual-target CAR-T therapy shrank tumors in 62% of patients with recurrent glioblastoma, a rare achievement for this fatal brain cancer.
  • The experimental treatment targets both EGFR and interleukin-13 receptor alpha 2, injected directly into spinal fluid to overcome glioblastoma's multiple tumor cell populations.
  • While responses were encouraging, benefits proved largely temporary with many patients relapsing within two to three months after treatment.
  • Kite is developing a triple-target version to improve persistence and plans to test the therapy in newly diagnosed patients next year.

World-First Clinical Trial Demonstrates Exercise Significantly Improves Colon Cancer Survival

Oncology
  • A groundbreaking 17-year international clinical trial involving 889 colon cancer patients shows that structured exercise programs reduce cancer recurrence risk by 28% and death risk by 37%.
  • The CO.21 Challenge study, published in the New England Journal of Medicine, is the first clinical trial designed specifically to test whether exercise can improve cancer survival outcomes.
  • Researchers emphasize that exercise should now be considered a standard treatment for colon cancer rather than just a quality-of-life intervention, requiring integration into healthcare systems.
  • The study involved patients with Stage 3 or high-risk Stage 2 colon cancer who completed surgery and chemotherapy, with participants following a 3-year structured exercise program of 2.5 hours weekly moderate-intensity activity.

Health Education Materials With/Out a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer

NCT00819208Active, Not RecruitingNot Applicable
Canadian Cancer Trials Group
Posted 6/2/2009

Johnson & Johnson's Pasritamig Shows Promising Anti-Tumor Activity in First-in-Human Prostate Cancer Trial

Oncology
  • Johnson & Johnson announced first-in-human Phase 1 results for pasritamig, a novel bispecific T-cell engager targeting KLK2, showing promising anti-tumor activity in metastatic castration-resistant prostate cancer patients.
  • The study demonstrated a favorable safety profile with 40% of patients experiencing no treatment-related adverse events and no treatment discontinuations due to toxicity.
  • Among 33 patients in the efficacy group, 42.4% achieved ≥50% PSA reduction with a median radiographic progression-free survival of 7.9 months.
  • The drug's convenient once-every-six-weeks outpatient dosing schedule represents a potential advantage for community-based cancer care delivery.

A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

NCT04898634Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 7/13/2021

Atezolizumab Plus Chemotherapy Reduces Recurrence Risk by 50% in Stage III dMMR Colon Cancer

Monoclonal AntibodyOncology
  • The phase 3 ATOMIC trial demonstrated that adding atezolizumab to standard chemotherapy reduced the risk of recurrence or death by 50% in patients with stage III dMMR colon cancer.
  • Three-year disease-free survival improved significantly from 76.6% with chemotherapy alone to 86.4% with the combination treatment across 712 patients.
  • This represents the first successful immunotherapy adjuvant study in colon cancer and establishes a new standard of care for this patient population.
  • The safety profile was manageable, with only a slight increase in nonfebrile neutropenia compared to known profiles of each individual treatment.

Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair (ATOMIC)

2024-517269-18-00Active, Not RecruitingPhase 3
National Cancer Institute, AIO-Studien gGmbH
Posted 10/16/2017

AstraZeneca Advances AZD0022, Novel Oral KRASG12D Inhibitor, in First-in-Human Phase I/IIa Trial

Monoclonal AntibodyTargeted TherapyOncology
  • AstraZeneca is developing AZD0022, a potent oral KRASG12D-selective inhibitor that demonstrates robust pathway inhibition and anti-tumor activity in preclinical models.
  • The drug is currently being investigated in the ALAFOSS-01 study, a first-in-human Phase I/IIa trial for patients with KRASG12D-mutated solid tumors.
  • Preclinical data shows enhanced therapeutic responses when AZD0022 is combined with cetuximab, with sustained tumor regressions observed in colorectal and pancreatic cancer models.
  • The clinical trial includes both monotherapy and combination therapy modules, targeting multiple cancer types including colorectal, lung, and pancreatic cancers.

A trial to learn how safe AZD0022 is, how well it works, and how it moves throughout the body over time in adults with tumors that have a KRAS-G12D mutation, when given alone and with other cancer drugs

2024-516699-14-00RecruitingPhase 1/2
AstraZeneca AB
Posted 10/18/2024

Trinity Life Sciences Partners with Ontada to Enhance Real-World Oncology Data Analytics for Drug Development

OncologyAI
  • Trinity Life Sciences has formed a strategic collaboration with Ontada, a McKesson business, to provide life sciences companies with real-time oncology insights for pre- and post-launch decision making.
  • The partnership combines Trinity's commercial analytics expertise with Ontada's iKnowMed electronic health record system, which contains data from over 2.4 million patient records across 80+ tumor types.
  • The collaboration aims to accelerate commercial decision-making in community oncology through AI-enhanced analytics and deeper patient journey insights.
  • Ontada's real-world data platform serves more than 2,400 oncology community-based providers across the United States through The US Oncology Network and Onmark practices.

NAPOLI 3 Post-Hoc Analysis Identifies Characteristics Associated with Long-Term Survival in Metastatic Pancreatic Cancer

Oncology
  • A post-hoc analysis of the Phase III NAPOLI 3 trial identified characteristics associated with long-term survival in metastatic pancreatic adenocarcinoma patients treated with the NALIRIFOX regimen.
  • Long-term survivors (n=15) achieved a median overall survival of 19.5 months, with younger age at diagnosis and specific tumor locations being key factors.
  • Dose modifications and treatment delays enabled patients to receive higher cumulative doses and stay on treatment longer, contributing to improved outcomes.
  • The findings provide important insights for a cancer where fewer than 20% of patients survive longer than one year.

A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment

NCT04083235CompletedPhase 3
Ipsen
Posted 2/11/2020

Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas

NCT00844649CompletedPhase 3
Celgene
Posted 3/1/2009

Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

NCT00112658CompletedPhase 2
UNICANCER
Posted 11/1/2004

Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer

NCT01494506CompletedPhase 3
Merrimack Pharmaceuticals
Posted 11/1/2011

Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma

NCT01526135CompletedPhase 3
UNICANCER
Posted 4/16/2012

Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer

NCT01804790CompletedPhase 3
UNICANCER
Posted 1/1/2012

Large-Scale Study Reveals Significant Racial Disparities in Early-Onset Colorectal Cancer Diagnosis

Real World EvidenceOncology
  • A comprehensive analysis of 105,000 colorectal cancer patients found that Black, Hispanic, Latino, and American Indian populations are disproportionately represented in early-onset cases diagnosed before age 50.
  • Early-onset patients were significantly more likely to be diagnosed at advanced stages (III and IV), with a 10 percentage point higher likelihood compared to average-onset patients.
  • Current screening guidelines starting at age 45 fail to cover over half of early-onset patients, particularly those under 44, highlighting the need for risk-based screening approaches.
  • The study revealed diagnostic delays of 4-8 months longer for younger patients, emphasizing the urgent need for reduced time from symptom onset to definitive diagnosis.

Dual Immunotherapy Combination Significantly Extends Survival in Advanced Cutaneous Squamous Cell Carcinoma

Monoclonal AntibodyOncology
  • A phase II clinical trial demonstrated that combining avelumab and cetuximab nearly quadrupled median progression-free survival compared to avelumab alone in patients with advanced cutaneous squamous cell carcinoma.
  • The combination therapy achieved a median progression-free survival of 11.1 months versus 3.0 months for avelumab monotherapy, with a hazard ratio of 0.48 and statistical significance.
  • The study enrolled 57 evaluable patients with advanced cSCC, showing that dual immunotherapy targeting both PD-L1 and EGFR pathways creates synergistic anti-tumor effects.
  • Results provide valuable insights for future trials combining standard-of-care immunotherapies with cetuximab to improve outcomes in this aggressive skin cancer.

Avelumab with or Without Cetuximab in Treating Patients with Advanced Skin Squamous Cell Cancer

NCT03944941Active, Not RecruitingPhase 2
Alliance for Clinical Trials in Oncology
Posted 6/17/2019

Dual-Targeted CAR-T Therapy KITE-363 Shows 87% Response Rate in Relapsed B-Cell Lymphoma

CAR-TOncology
  • KITE-363, a dual CD19/CD20-targeted CAR-T therapy, achieved an 87% objective response rate with 78% complete responses in CAR-T naive patients with relapsed/refractory large B-cell lymphoma.
  • The therapy demonstrated superior CAR-T cell expansion compared to existing treatments, with peak levels 3-5 fold higher than axicabtagene ciloleucel.
  • Safety profile showed manageable toxicity with no grade 3 or 4 cytokine release syndrome or neurotoxicity in primary refractory patients at the recommended dose.
  • Primary refractory patients achieved 80% response rates with 67% complete responses, addressing a critical unmet need in this difficult-to-treat population.

Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

NCT04989803RecruitingPhase 1
Kite, A Gilead Company
Posted 10/27/2021

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