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

In a subgroup analysis of patients with confirmed FR+ ovarian cancer who underwent interval debulking surgery,

additional lesions were found in 40% of interval debulking patients**

Patient-level false positive rate with respect to the detection of ovarian cancer lesions confirmed by central pathology was 20%; 95% CI [0.137, 0.280]

* 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 EVENTSMild/Moderate
n (% n/N)
SEVERE
n (% n/N)
Subjects with at least one drug related TEAE43 (28.7%)2 (1.3%)
Total number of drug- related adverse events632
ZERO

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)
Nausea27 (18.0%)0
Vomiting8 (5.3%)0
Abdominal Pain7 (4.6%)0
0%

of all drug-related adverse events were mild-to-moderate.

ZERO

drug-related serious adverse events were observed in any patient dosed with CYTALUX.

0%

of all drug-related adverse events were mild-to-moderate.

N=150 study subjects infused with CYTALUX

Misinterpretation of Camera Images

Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer. Fluorescence may be seen in non-cancerous tissue including areas of the bowel, kidneys, lymph nodes and inflamed tissue.