Pooled clinical trial analyses evaluating outcomes of HER2-low vs HER2-0 expression in patients with metastatic breast cancer following chemotherapy.

The therapeutic importance of subsetting patients with HER2-negative breast cancer according to their tumors' cellular HER2 expression (e.g., HER2-low vs.

Outcomes of patients aged ≥26 years with relapsed or refractory B-cell acute lymphoblastic leukemia in ZUMA-3 and historical trials.

Brexucabtagene autoleucel (brexu-cel) is an autologous anti-CD19 CAR T-cell therapy approved in the USA and European Union (EU) for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL; aged ≥26 years in EU). Here, outcomes for patients with R/R B-ALL aged ≥26 years in ZUMA-3 treated with brexu-cel were compared with historical standard-of-care (SOC) therapy. After median follow-up of 26.

Historic Clinical Trial External Control Arm Provides Actionable GEN-1 Efficacy Estimate Before a Randomized Trial.

Purpose: To inform continued development of the novel immune agent GEN-1, we compared ovarian cancer patients' end points from a neoadjuvant single-arm phase IB study with those of similar historic clinical trial (HCT) patients who received standard neoadjuvant chemotherapy.

Methods: Applying OVATION-1 trial (ClinicalTrials.gov identifier: NCT02480374) inclusion and exclusion criteria to Medidata HCT data, we identified historical trial patients for comparison.

Intercalation and reactions of CO under single layer graphene/Ni(111): the role of vacancies.

We use synchrotron radiation-induced core level photoemission spectroscopy to investigate the influence of vacancies, produced by ion bombardment, on monolayer graphene/Ni(111) exposed to CO at pressures ranging from ultra-high vacuum (10 mbar) up to near ambient (5.6 mbar) conditions. CO intercalates at a rate which is comparable to the one observed in absence of defects and reacts the Boudouard reaction producing additional carbon atoms and CO.

Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies.

Introduction: Real-world data (RWD) can contextualize findings from single-arm trials when randomized comparative trials are unethical or unfeasible. Findings from single-arm trials alone are difficult to interpret and a comparison, when feasible and meaningful, to patient-level information from RWD facilitates the evaluation. As such, there have been several recent regulatory applications including RWD or other external data to support the product's efficacy and safety.