Monotherapy in Endocrine Therapy-Naïve Patients

TRIAL SETUP

FALCON

FALCON: the first phase 3, head-to-head trial of FASLODEX 500 mg vs anastrozole 1 mg1*

FALCON Trial design

FASLODEX 500 mg was studied vs anastrozole 1 mg in FALCON, a phase 3, randomized, double-blind, double-dummy, multicenter study in postmenopausal women (N=462) who had not previously been treated with endocrine therapy.1,2 All patients had locally advanced breast cancer or mBC.1 All patients tested ER+ and/or PgR+, and most (except 1 patient) tested HER2-negative.1

Patients were randomized 1:1 to FASLODEX or anastrozole, and stratified by disease setting (locally advanced or metastatic), use of prior chemotherapy for advanced disease, and presence or absence of measurable disease.1,2

The major efficacy outcome measure of the FALCON Trial was investigator-assessed progression-free survival (PFS), evaluated according to RECIST v.1.1.2

Approximately 99% of patients in FALCON had not been previously treated with endocrine therapy.1,2 Studying estrogen receptor targeting with FASLODEX vs aromatase inhibition with anastrozole in an endocrine therapy-naïve patient population allowed for:

  • Direct comparison between the 2 drugs, which have different mechanisms of action1
  • Study without the confounding effects of previous adjuvant endocrine therapy exposure1

*The efficacy and safety of FASLODEX 250 mg vs anastrozole 1 mg were previously studied in the FIRST Trial, a trial composed of a different patient population than in the FALCON Trial.1,3
Patients in the FASLODEX arm received intramuscular injections of FASLODEX into the buttocks on Days 1, 15, 29, and every 28 (± 3) days thereafter, and placebo anastrozole as a daily oral tablet. Patients in the anastrozole arm received anastrozole as a daily oral tablet, and placebo FASLODEX injections on Days 1, 15, 29, and every 28 (± 3) days thereafter.2

FASLODEX trial design key inclusion and exclusion criteria
FASLODEX trial design key inclusion and exclusion criteria

ER+=estrogen receptor-positive; HER2=human epidermal growth factor receptor 2; mBC=metastatic breast cancer; PgR+=progesterone receptor-positive; RECIST=Response Evaluation Criteria in Solid Tumors; WHO=World Health Organization.
Except for 1 line of cytotoxic chemotherapy.1

Indication for FASLODEX

Monotherapy
FASLODEX is an estrogen receptor antagonist indicated for the:
  • Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy

X

NCCN

The ONLY therapy for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer to receive NCCN Category 1 recommendation as:

  • Combination therapy with palbociclib* and abemaciclib4†
  • Monotherapy4

NCCN=National Comprehensive Cancer Network ® (NCCN ®).

*For postmenopausal women or for premenopausal women receiving ovarian suppression with an LHRH agonist, with hormone receptor-positive and HER2-negative metastatic breast cancer that has progressed after endocrine therapy. 4

Indicated after progression on prior endocrine therapy. 4

NCCNNCCN

 

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Denise F, age 62*

Patients like Denise may be appropriate for FASLODEX1,2

  • Site of metastases: ribs
  • Diagnosis: de novo stage IV ER+ mBC

*Individual results may vary. This representation was not designed to reflect efficacy for an individual patient subgroup.

When your patient is a postmenopausal woman with HR-positive, HER2-negative advanced breast cancer not previously treated with endocrine therapy… 

Treatment considerations

Suspected disease during routine exam

  • 3 months ago, Denise went in for her annual physical
  • The exam revealed potential breast abnormalities, so her gynecologist recommended further testing, including a mammogram

Testing confirms the presence of malignant cells

  • Denise’s mammogram revealed signs of breast cancer
  • A subsequent biopsy confirmed the presence of malignant cells in the left breast 

Further testing confirms metastatic disease

  • Additional scans revealed abnormalities in her ribs; subsequent biopsies confirmed the presence of malignant cells consistent with the primary tumor
  • Denise’s doctor diagnosed de novo stage IV ER+, HER2-negative mBC
  • Tumor profile: 80% ER positivity and 65% PgR positivity

Denise is ready for her initial endocrine therapy

  • Because Denise has ER+ disease, her doctor is interested in a potential treatment approach that addresses the estrogen receptor-dependent nature of her disease
  • Denise has not been treated with prior endocrine therapy

ER+=estrogen receptor-positive; HER2=human epidermal growth factor receptor 2; HR=hormone receptor; mBC=metastatic breast cancer; PgR=progesterone receptor. 

EFFICACY

As initial monotherapy for advanced breast cancer, endocrine therapy-naïve patients

FASLODEX had proven superior PFS vs the aromatase inhibitor anastrozole in a head-to-head trial1

A patient’s first therapy in HR-positive, HER2-negative advanced breast cancer is an important choice. Postmenopausal patients who received FASLODEX as an initial monotherapy in the FALCON Trial experienced a 20% reduction in relative risk of progression, compared with patients who received anastrozole first.1,2

FASLODEX had superior PFS vs anastrozole in the FALCON trial
FASLODEX had superior PFS vs anastrozole in the FALCON trial
  • Median PFS of 16.6 months in patients receiving FASLODEX vs 13.8 months in patients receiving anastrozole1,2
  • Investigator-assessed PFS, the major efficacy outcome measure of the FALCON Trial, was evaluated according to RECIST v.1.11
  • Patients with measurable disease in both groups experienced the following objective response rate: 46.1% (95% CI: 38.9%-53.4%) in patients receiving FASLODEX (n=193) and 44.9% (95% CI: 37.8%-52.1%) in patients receiving anastrozole (n=196)2
  • Median duration of response was 20.0 months (95% CI: 15.90-27.63) in patients receiving FASLODEX and 13.2 months (95% CI: 10.64-16.72) in patients receiving anastrozole1,2

HR=hormone receptor.

PFS results in patients with visceral metastases and patients with non-visceral metastases1

PFS in patients with visceral metastases1

PFS in patients with visceral metastases
PFS in patients with visceral metastases

In patients with visceral metastases, the FASLODEX PFS was a median 13.8 vs 15.9 months in patients receiving anastrozole.1

PFS in patients with non-visceral metastases1

PFS in patients with nonvisceral metastases
PFS in patients with nonvisceral metastases

In patients with nonvisceral metastases, the FASLODEX PFS was a median 22.3 vs 13.8 months in patients receiving anastrozole.1

Visceral metastases and non-visceral metastases Kaplan-Meier charts adapted from Robertson JFR, et al. Lancet. 2016;388: 2997-3005.1

In patients with visceral metastases, the FASLODEX PFS was a median 13.8 vs 15.9 months in patients receiving anastrozole.1

In patients with non-visceral metastases, the FASLODEX PFS was a median 22.3 vs 13.8 months in patients receiving anastrozole.1

  

  • The analysis of the subgroup populations in the FALCON Trial was preplanned.1 However, the test for heterogeneity was not statistically significant across all the subgroups1

FASLODEX performed consistently in most prespecified patient subgroups1

FASLODEX performed consistently in most patient subgroups
FASLODEX performed consistently in most patient subgroups
  • This representation was not designed to assess efficacy in individual subgroups

FASLODEX was studied in an endocrine therapy-naïve patient population1

Patients with visceral metastases and patients with non-visceral metastases were represented in the FALCON Trial1,2

FASLODEX FALCON trial represents both nonvisceral metastases and visceral metastases.
FASLODEX FALCON trial represents both nonvisceral metastases and visceral metastases.

§Includes patients with site of baseline disease as any of the following: adrenal, bladder, central nervous system, esophagus, liver, lung, peritoneum, pleura, renal, small bowel, stomach, pancreas, thyroid, colon, rectum, ovary, biliary tract, ascites, pericardial effusion, spleen, or pleural effusion.1

The majority of patients (84%) had measurable disease2

Approximately 57% of patients were under 65 years of age1

Age range of patients in the FASLODEX FALCON trial.
Age range of patients in the FASLODEX FALCON trial.

The majority of patients (87%) had metastatic disease at baseline2Prior treatment in the FALCON Trial, with timing ranging from the neoadjuvant to metastatic setting1

Prior treatment in the FALCON Trial, with timing ranging from neoadjuvant to metastatic setting.
Prior treatment in the FALCON Trial, with timing ranging from neoadjuvant to metastatic setting.

ABC=advanced breast cancer.

||Represents a protocol deviation in the FALCON Trial. Three patients were found to have received prior hormonal therapy after randomization occurred.1

A treatment discovered.

An experience shared.

When treating patients with ABC, it is important to help your patients understand the treatment journey ahead of them. Connect with your patients today by sharing the story of Kelli, an inspiring woman on FASLODEX treatment.

Kelli is a real FASLODEX patient and has been compensated for her appearance in this video.

Approximately 96% of patients had a WHO performance status of 0 or 11

Patients who had a WHO performance status of 0 to 1 in the FALCON trial.
Patients who had a WHO performance status of 0 to 1 in the FALCON trial.

For WHO performance status, 0 represents normal activity, 1 represents restricted activity, and 2 represents being in bed 50% of the time or less.1

Metastatic sites in the FALCON Trial1,2#

FASLODEX FALCON trial metastatic sites
FASLODEX FALCON trial metastatic sites

#Patients in the FALCON Trial were permitted to have more than 1 site of metastasis.2

**The National Cancer Institute defines musculoskeletal as “having to do with muscles, bones, tendons, ligaments, joints, and cartilage.”4

A treatment discovered.

An experience shared.

When treating patients with ABC, it is important to help your patients understand the treatment journey ahead of them. Connect with your patients today by sharing the story of Kelli, an inspiring woman on FASLODEX treatment.

Kelli is a real FASLODEX patient and has been compensated for her appearance in this video.

SAFETY

Safety profile in FALCON2

FASLODEX adverse reactions
FASLODEX adverse reactions
Laboratory Parameters in the FALCON trial of FASLODEX vs anastrozole
Laboratory Parameters in the FALCON trial of FASLODEX vs anastrozole

CTC=Common Terminology Criteria.

  • Serious adverse reactions were reported by 30 of 228 (13%) patients receiving FASLODEX, and by 31 of 232 (13%) patients receiving anastrozole1
  • Permanent discontinuation associated with an adverse reaction occurred in 4 of 228 (1.8%) patients receiving FASLODEX, and in 3 of 232 (1.3%) patients receiving anastrozole.2 Adverse reactions leading to discontinuation for those patients receiving FASLODEX included drug hypersensitivity (0.9%), injection site hypersensitivity (0.4%), and elevated liver enzymes (0.4%)2
  • In the FASLODEX arm, 98.2% of patients stayed on treatment without discontinuing due to adverse reactions2
  • The most common adverse reactions (≥10%) of any grade reported in patients in the FASLODEX arm were arthralgia, hot flash, fatigue, and nausea2

References: 1. Robertson JFR, Bondarenko IM, Trishkina E, et al. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial. Lancet. 2016;388:2997-3005. 2. FASLODEX® (fulvestrant) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.1.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed April 23, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. NCI Dictionary of Cancer Terms: musculoskeletal. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=44938. Accessed August 8, 2017.