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Efficacy and Safety

 

ELUCIDATE (Trial 007): Enabling Lung Cancer Identification Using Folate Receptor Targeting

Study Design

A Phase 3, randomized, single dose, open-label trial that investigated the safety and efficacy of CYTALUX® for intraoperative imaging of folate receptor positive lung lesions.

Primary Endpoint: Clinical Significant Events

Localization of
pulmonary lesion

Detection of one or more
synchronous malignant lesions

Identification of a close
resection margin

Efficacy

19%
In 19% of patients, the primary lung lesion was localized, but not detected with conventional methods.
8%
In 8% of patients, surgeons found one or more occult malignant lesions that were not previously identified.

In 38% of patients, a close resection margin (≤10mm) was identified.*

Surgeons reported changing the scope
of their procedure in 29% of patients,
due to use of CYTALUX.†

* Sarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Mar 3:S0022-5223(23)00185-X. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 02. PMID: 37019717.
† Based on a prespecified exploratory endpoint for the proportion of subjects for whom the surgical plan was changed based on fluorescence imaging both prior to initiation of the surgical procedure and upon re-imaging of the surgical field after surgical procedure prior to closing. (N=100, 95% CI [20.4, 38.9])

LESION SIZE
Size of lesions identified by CYTALUX and not by standard white light in Phase 3 Trial*MEDIANMINIMUM
Primary Lesions13 mm5 mm
Synchronous lesions12 mm2 mm
*as measured by local pathology
LESION depth
Depth of lesions detected by CYTALUX in Phase 3 Trial*MEDIANMAXIMUM
Detected by CYTALUX only10.1 mm27.9 mm
Detected by CYTALUX and white light2.3 mm37.7 mm
*as measured by preoperative CT/PET imaging. The depth of primary lung lesions detected by CYTALUX ranged from 0 to 38 mm from the lung surface (mean depth 6 mm).

Drug-Related Adverse Events

ELUCIDATE Phase 3 Trial

DRUG-RELATED
ADVERSE EVENTS		MILD/MODERATE
n (%)		SEVERE
n (%)
Subjects with at least one drug-related TEAE✝36 (32.1%)3 (2.7%)
Total number of drug-related TEAEs✝555
NO

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

MOST COMMON (>2%) DRUG-
RELATED ADVERSE EVENTS		MILD/MODERATE
n (%)		SEVERE
n (%)
Nausea10 (8.9%)0
Vomiting4 (3.6%)0
Intermittent hypertension3 (2.7%)1 (0.9%)
0%

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

NO

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

0%

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

✝TEAE = Treatment Emergent Adverse Event
N=112 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.

Speak with a representative
about CYTALUX and how to bring this technology to your OR.

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INDICATION

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.

Important Safety Information and Indication for Cytalux® Important Safety Information for 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.