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 malignant 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 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

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)
Nausea	27 (18.0%)	0
Vomiting	8 (5.3%)	0
Abdominal Pain	7 (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 and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung. Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, lungs, and inflamed tissue.

Product Information

WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during administration of CYTALUX.

INDICATION AND USAGE
CYTALUX® is an FDA approved optical imaging agent indicated as an adjunct for intraoperative identification of:

Malignant lesions in adult patients with ovarian cancer.
Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during administration of CYTALUX. Reactions typically occurred within 15 minutes of the start of infusion. CYTALUX infusion interruption or discontinuation due to adverse reactions occurred in 11% of all patients. Treatment with antihistamines and/or anti-nausea medication may be used. If an adverse reaction occurs during administration, the infusion can be interrupted and resumed after treatment of the reaction.

Risk of Misinterpretation
Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung. Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, lungs, and inflamed tissue.

Embryo-Fetal Toxicity
Based on its mechanism of action, CYTALUX may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating CYTALUX treatment.

Risk of Pafolacianine Aggregation and Infusion Reactions
Use of the incorrect diluent to prepare the CYTALUX infusion solution can cause the aggregation of pafolacianine; aggregation may induce infusion reactions such as nausea, vomiting, abdominal pain or rash. Use only 5% Dextrose Injection to prepare the CYTALUX infusion solution. Do not use other diluents.

DRUG INTERACTIONS
Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to folate receptors and could reduce the detection of lesions with CYTALUX. Avoid administration of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX

ADVERSE REACTIONS
The safety of CYTALUX was evaluated in four open label clinical studies, two studies (N = 44 and N = 150) in patients with ovarian cancer and two studies (N = 100 and N = 112) in patients with known or suspected cancer in the lung. A total of 406 patients received 0.025 mg/kg of CYTALUX via intravenous administration.

Adverse reactions that occurred in > 1% of patients were: nausea (13%), vomiting (5%), abdominal pain (2%), flushing (2%), other infusion-related reactions (2%), hypersensitivity (2%), elevation in blood pressure (1%), dyspepsia (1%), and chest discomfort (1%). Adverse reactions occurred during the administration of CYTALUX in 17% of patients.

See full Prescribing Information to learn more.