Efficacy and Safety
Phase 3 (006 Study): CYTALUX® FOR FR+ OVARIAN CANCER
Study Design
A Phase 3, Randomized, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of CYTALUX for Intraoperative Imaging of Folate Receptor Positive Ovarian Cancer
N=150 patients infused with CYTALUX; N=134 patients analyzed for primary and secondary endpoints
Efficacy
* Women highly suspicious for or with confirmed ovarian cancer who underwent both normal and fluorescent light evaluation (Intent-to-Image set); N=134, 95% CI [19.6, 35.2]
** Phase 3 (006 Study): CYTALUX FOR FR+ OVARIAN CANCER; N=58, 95% CI [27.0, 53.4]. This subgroup analysis utilized a smaller analysis set than the primary endpoint and was not adjusted to control for error, so the results are not conclusive and should be interpreted cautiously.
Drug-Related Adverse Events
Phase 3 (006 Study): CYTALUX FOR FR+ OVARIAN CANCER
DRUG-RELATED ADVERSE EVENTS | Mild/Moderate n (% n/N) | SEVERE n (% n/N) |
---|---|---|
Subjects with at least one drug related TEAE | 43 (28.7%) | 2 (1.3%) |
Total number of drug- related adverse events | 63 | 2 |
drug-related serious adverse events were observed in any patient dosed with CYTALUX.
MOST COMMON DRUG-RELATED ADVERSE EVENTS | MILD/MODERATE n (% n/N) | SEVERE n (% n/N) |
---|---|---|
Nausea | 27 (18.0%) | 0 |
Vomiting | 8 (5.3%) | 0 |
Abdominal Pain | 7 (4.6%) | 0 |
of all drug-related adverse events were mild-to-moderate.
drug-related serious adverse events were observed in any patient dosed with CYTALUX.
of all drug-related adverse events were mild-to-moderate.
N=150 study subjects infused with CYTALUX