MedPath

Clinical Trial News

Real-World Data Confirms Low-Severity Safety Profile for Lisocabtagene Maraleucel Across Blood Cancer Settings

  • Real-world data from 877 patients and clinical trial data from 702 patients demonstrate that most cytokine release syndrome and neurological events with lisocabtagene maraleucel occur within 15 days of infusion and are not severe.
  • Among patients experiencing late-onset adverse events after day 15, the vast majority were grade 1/2 events that resolved without requiring intensive care unit-level management.
  • The findings support optimized monitoring strategies that could improve patient access to CAR-T therapy while maintaining safety standards across multiple blood cancer indications.

Sintilimab/Chidamide Combination Shows Promising Results in Early-Stage Natural Killer T-Cell Lymphoma

  • The phase 2 SCENT-2 trial demonstrated that sintilimab plus chidamide followed by P-GemOx achieved a 95.7% objective response rate with 93.6% complete response in 47 patients with treatment-naïve early-stage ENKTL.
  • At 17 months median follow-up, the combination showed excellent survival outcomes with 1-year progression-free survival of 95.7% and overall survival of 95.3%.
  • The treatment regimen demonstrated manageable toxicity profile, with most adverse effects attributed to the P-GemOx chemotherapy component rather than the immunotherapy combination.
  • Results suggest this novel chemotherapy-reduced approach may serve as an effective induction regimen for treatment-naïve patients with early-stage extranodal natural killer T-cell lymphoma.

Anti-Inflammatory Diet Reduces Death Risk by 87% in Stage III Colon Cancer Patients

  • Patients with stage III colon cancer consuming the most pro-inflammatory diets had an 87% higher risk of death compared to those with the least inflammatory diets in a phase 3 clinical trial analysis.
  • The study analyzed 1,625 patients from the CALGB/SWOG 80702 trial using empirical dietary inflammatory pattern (EDIP) scores to assess dietary inflammation levels.
  • Combining anti-inflammatory diets with higher physical activity levels provided the greatest survival benefit, reducing death risk by 63% compared to patients with pro-inflammatory diets and low activity.
  • The protective effect of anti-inflammatory diets remained consistent regardless of whether patients received the anti-inflammatory drug celecoxib during treatment.

Real-World Data Shows Yescarta CAR-T Therapy Safe and Effective in Outpatient Setting

  • Kite presented real-world data from 238 patients showing comparable safety and effectiveness outcomes for Yescarta CAR-T therapy administered in outpatient versus inpatient settings for relapsed/refractory large B-cell lymphoma.
  • The analysis found no significant differences in rates of cytokine release syndrome, neurologic events, or immune effector cell-associated neurotoxicity syndrome grade ≥3 between treatment settings.
  • Nearly 25% of outpatient-assigned patients avoided hospital admission within 30 days, and 50% avoided admission within 3 days, demonstrating potential cost-effective advantages.
  • The study supports expanding access to this potentially curative one-time treatment while reducing healthcare system burden and improving patient convenience.

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

  • 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.

Dual-Target CAR T Cell Therapy Achieves Tumor Shrinkage in 62% of Recurrent Glioblastoma Patients

  • A novel dual-target CAR T cell therapy targeting EGFR and IL13Rα2 proteins achieved tumor shrinkage in 62% of patients with recurrent glioblastoma, the most aggressive form of brain cancer.
  • The experimental treatment delivered directly into cerebrospinal fluid showed encouraging survival signals, with 43% of patients surviving beyond 12 months compared to typical 6-10 month survival rates.
  • Penn researchers established the therapy's safety profile and maximum tolerated dose, paving the way for upcoming clinical trials in newly diagnosed glioblastoma patients.

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

  • 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.

Casdatifan Plus Cabozantinib Combination Shows 46% Response Rate in Kidney Cancer Trial

  • Arcus Biosciences reported a 46% confirmed overall response rate for the casdatifan plus cabozantinib combination in patients with clear cell renal cell carcinoma who had progressed on prior immunotherapy.
  • The Phase 1/1b ARC-20 study demonstrated a manageable safety profile with no meaningful overlapping toxicity between the HIF-2α inhibitor casdatifan and tyrosine kinase inhibitor cabozantinib.
  • These promising results support the initiation of PEAK-1, a Phase 3 study comparing the combination to cabozantinib monotherapy in immunotherapy-experienced patients.
  • The data were presented at the 2025 ASCO Annual Meeting and exceeded historic benchmarks for either agent alone in the second-line setting.

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

  • 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.

Structured Exercise Program Reduces Colon Cancer Recurrence by 28% in Landmark International Trial

  • A landmark Phase 3 trial involving 889 colon cancer patients across six countries found that structured exercise programs reduced cancer recurrence and death risk by 28% and 37% respectively.
  • Patients who worked with personal trainers for three years after completing surgery and chemotherapy showed significantly better outcomes than those receiving only lifestyle advice booklets.
  • The exercise intervention demonstrated benefits comparable to or exceeding many approved cancer drugs, but without the associated toxicity and side effects.
  • Results suggest oncologists should consider recommending structured exercise programs as standard care for colon cancer patients following treatment completion.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.