Clinical Trial News

Imfinzi plus Imjudo combo significantly improved five-year overall survival rates in unresectable hepatocellular carcinoma patients compared to sorafenib, with 19.6% surviving vs. 9.4%.

The CheckMate -067 trial showed 10-year survival improvements with Opdivo (nivolumab) plus Yervoy (ipilimumab) or Opdivo monotherapy vs. Yervoy monotherapy in advanced melanoma, with median OS of 71.9 months, 36.9 months, and 19.9 months, respectively. The combination therapy demonstrated a 58.3% objective response rate after 10 years, with no new safety signals.

A three-drug regimen of atezolizumab, venetoclax, and obinutuzumab showed a 67.9% response rate in treating DLBCL variant of Richter transformation, with 28.6% complete responses. The regimen demonstrated durable remissions and prolonged survival, potentially becoming a first-line treatment option.

FDA approves Eli Lilly's injectable eczema drug Ebglyss for adults and children 12+, targeting IL-13 protein. Available in weeks, it offers a monthly dosing option compared to competitors like Dupixent.

The CABINET phase III trial showed cabozantinib significantly improved median progression-free survival (PFS) in previously treated neuroendocrine tumors (NETs), with 13.8 months for pNET and 8.4 months for epNET compared to 4.4 and 3.9 months for placebo, respectively. The results, presented at ESMO 2024 and published in NEJM, support cabozantinib as a potential new standard of care for advanced NET patients.

The AMBASSADOR trial, presented at ESMO 2024, evaluated adjuvant pembrolizumab in high-risk muscle-invasive urothelial carcinoma, showing maintained DFS improvement with a hazard ratio of 0.7. The trial supports pembrolizumab's potential role in adjuvant therapy, though survival data is not yet conclusive. No trend for improved outcomes in PD-L1 high population was observed, but a trend favoring bladder primary over upper tract was noted.

Taletrectinib (AB-106) showed high and durable overall response rates with favorable tolerability in ROS1-positive NSCLC patients, with 88.8% confirmed overall response rate (cORR) in ROS1 TKI-naive patients and 55.8% in pretreated patients, according to an integrated analysis from TRUST-I and TRUST-II studies presented at the 2024 ESMO Congress.

The FDA has lifted the partial clinical hold on studies evaluating the WEE1 inhibitor azenosertib in advanced solid tumors. The hold was initially placed on the phase 1 ZN-c3-001 trial, phase 2 DENALI trial for platinum-resistant ovarian cancer, and phase 2 TETON trial for uterine serous carcinoma due to 2 deaths from presumed sepsis in the DENALI trial. After reviewing Zentalis Pharmaceuticals' complete response package, the FDA allowed the studies to resume without changes to the clinical development plan.

The FDA granted RMAT designation to P-BCMA-ALLO1, an investigational TSCM-based allogeneic CAR T-cell therapy for relapsed/refractory multiple myeloma, currently in phase 1/1b clinical development. Early results show promising efficacy and safety with no GVHD, low rates of cytokine release syndrome and neurotoxicity. New findings will be presented at the 21st International Myeloma Society Annual Meeting.

Epitomee Medical's FDA-cleared ingestible capsule supports weight management in adults with BMI 25-40 kg/m², offering a drug-free alternative to existing treatments.