AZEDRA was studied in the largest prospective
trial of patients with advanced pheochromocytoma
and paraganglioma

AZEDRA was studied in a Phase II, prospective, multicenter, open-label,
single-arm trial

68
patients received at least one
therapeutic dose of AZEDRA
50
patients received two
therapeutic doses of AZEDRA

Most patients were heavily pretreated and had received multiple types and lines of therapy

Metastatic Sites

Number of Prior
Treatment Modalities

Types of Prior
Treatment Modalities‡

Most Phase II trial AZEDRA® patients had disease in multiple locations.
Number of Prior Treatment Modalities.

†Prior treatment modalities include surgery, radiation therapy, I-131 MIBG, and non-MIBG therapies.

Multiple types and lines of therapy.

‡Among patients treated with at least one dose of AZEDRA (N=68).

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Learn about the proven efficacy of AZEDRA with actual patient cases from the pivotal Phase II trial

Patient background and medical history

Relevant medical history
  • Date of diagnosis: July 2006
  • Antihypertensive medication: Doxazosin 1 mg qd
  • Prior surgeries: Right adrenalectomy in July 2006
  • Prior systemic therapies: None

Tumor Profile

  • Tumor type: Pheochromocytoma
  • Secretory profile: Norepinephrine, epinephrine
  • Metastatic locations: Lung, small bowel
  • MIBG avidity: Confirmed through patient workup and dosimetric scan
Baseline labs
Test Normal Range Patient Value
Creatinine Clearance 90–140 mL/min NR
Bilirubin 5.13–17.1 µmol/L 6.84 µmol/L
Hemoglobin 120–160 g/L 115 g/L
Leukocytes 4–11 x109/L 6.3 x109/L
Neytrophils 2–8.25 x109/L 3.92 x109/L
Platelets 150–450 x109/L 311 x109/L
A posterior scan following a dose of AZEDRA®.

Posterior I-131 MIBG

Scan following a therapeutic dose of AZEDRA
(435 mCi). Numerous metastatic lesions in the lung and small bowel are best appreciated on this posterior scan and are indicated by arrows.

Results following treatment with AZEDRA

AZEDRA therapeutic dosing

First dose administered in March 2010, second dose 3 months later in June 2010

Primary endpoint: antihypertensive medication reduction
  • Responder: Yes, 100% (discontinuation)
  • Duration of response: 22.36 months
Secondary endpoint: tumor marker response
Plasma Testing Normal Range Patient Value Percentage Change
Chromogranin A 27.4 µmol/L 7 µg/L - 74%
Metanephrine 1,292.85 pmol/L 1,034.28 pmol/L - 20%
Normetanephrine 10,073.70 pmol/L 5,935.02 pmol/L - 41%
24-hour Urine Testing
Metanephrine 2,377 nmol/day 1,906.32 nmol/day - 20%
Normetanephrine 8,905.26 nmol/day 6,715.80 nmol/day - 25%

Patient name and photo are for illustrative purposes but clinical details are derived from an individual treated in the Phase II trial of AZEDRA. Individual results may vary in clinical use of AZEDRA in patient with pheochromocytoma and paraganglioma (PPGL).

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Patient background and medical history

Relevant medical history
  • Date of diagnosis: July 2009
  • Antihypertensive medication: Metoprolol (100 mg), Metyrosine (500 mg)
  • Prior surgeries: September 2009
  • Prior systemic therapies: None

Tumor Profile

  • Tumor type: Paraganglioma
  • Secretory profile: Norepinephrine
  • Metastatic locations: Lung, pancreas, para-aortic nodes
Baseline labs
Test Normal Range Patient Value
Creatinine Clearance 90–140 mL/min 131 mL/min
Bilirubin 5.13–17.1 µmol/L 13.68 µmol/L
Hemoglobin 120–160 g/L 131 g/L
Leukocytes 4–11 x109/L 14 x109/L
Neytrophils 2–8.25 x109/L 10.4 x109/L
Platelets 150–450 x109/L 241 x109/L
Anterior and posterior scans following a dose of AZEDRA®.

Anterior (left) and
Posterior (right) I-131 MIBG

Scan following the first therapeutic dose of AZEDRA (487 mCi) showed increased activity in the left lower lobe lung nodule (long arrow) and slightly increased activity in both adrenal glands (short arrows) which may be physiologic. The abdominal masses noted on the CT are not appreciated on this exam.

Results following treatment with AZEDRA

AZEDRA therapeutic dosing

First dose administered in March 2010, second dose 3 months later in June 2010

Primary endpoint: antihypertensive medication reduction
  • Responder: No
  • Duration of response: 2.54 months
Secondary endpoint: tumor marker response
Plasma Testing Baseline Value Value at 12 months Percentage Change
Chromogranin A 8.2 µmol/L 5.0 µg/L - 39%
Metanephrine 167.3 pmol/L 126.8 pmol/L - 24%
Normetanephrine 2,577.1 pmol/L 1,682.6 pmol/L - 34%
24-hour Urine Testing
Metanephrine 6,280.4 nmol/day 4,997.0 nmol/day - 20%
Normetanephrine 5,421.4 nmol/day 4,722.9 nmol/day - 13%

Patient name and photo are for illustrative purposes but clinical details are derived from an individual treated in the Phase II trial of AZEDRA. Individual results may vary in clinical use of AZEDRA in patient with pheochromocytoma and paraganglioma (PPGL).

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