Patients With Breast Cancer Harboring AR Biomarker Likely to Respond to Enzalutamide


“In patients with hormone receptor (HR)-positive advanced breast cancer and no prior endocrine therapy who were positive for a gene signature-based biomarker indicating androgen receptor (AR)-signaling, the addition of enzalutamide (Xtandi) to exemestane was found to significantly improve progression-free survival (PFS) from 4 months to 16.5 months.

“Moreover, the phase II trial showed no effect of enzalutamide on PFS in the overall cohort of patients nor in the biomarker-positive population who received prior endocrine therapy, said Denise Yardley, MD, at the 2017 San Antonio Breast Cancer Symposium.”

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Entinostat Anchors New Combo in HR+ Breast Cancer Study


“A dual approach to overcoming resistance to endocrine therapy in patients with advanced hormone receptor (HR)–positive breast cancer is under investigation in a phase III trial that adds the novel drug entinostat to standard exemestane therapy after disease progression.

“The combination has generated excitement in the oncology drug development field after demonstrating an 8-month overall survival (OS) benefit over exemestane alone in the phase II ENCORE 301 study. Those positive results prompted the FDA to grant a breakthrough therapy designation to entinostat in this setting.”

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Merrimack Presents Expanded Analysis from Seribantumab (MM-121) Phase 2 Breast Cancer Study at the AACR Precision Medicine Series


“Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) today presented an expanded analysis of its Phase 2 study of seribantumab (MM-121) in combination with exemestane in HER2-negative, hormone receptor positive metastatic breast cancer.  Top line results from this study were announced in 2014. The final analysis, as well as a poster on Merrimack’s investigational companion diagnostic for seribantumab, were presented this week at the AACR Precision Medicine Series: Targeting the Vulnerabilities of Cancer, in Miami, Florida.

” ‘This data package underscores the most significant finding from all of our seribantumab Phase 2 studies – the identification of a heregulin-positive cancer cell phenotype that infiltrates approximately 30-50% of tumors and that may directly impact response to current standard-of-care therapies.  This hypothesis is supported by a strong consistent data set that spans three solid tumor types where we saw improved progression free survival when seribantumab was added to each of the standard-of-care regimens,’ saidAkos Czibere, MD, Ph.D., Senior Medical Director and Team Lead for the seribantumab program. ‘We are currently pursuing a registration study for seribantumab in patients with non-small cell lung cancer whose disease has progressed following immunotherapy.’ ”

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Aromasin Plus OFS May Reduce Risk of Recurrent Breast Ca (CME/CE)


“Premenopausal women with hormone receptor-positive, HER2-negative breast cancer may benefit from exemestane (Aromasin) plus ovarian function suppression (OFS) versus tamoxifen with or without OFS, analysis of recurrence-risk data from the TEXT and SOFT trials has indicated.

“Those with a high recurrence risk may experience a 10% to 15% improvement in the 5-year breast cancer-free interval (BCFI) with aromatase inhibitor (AI) exemestane plus OFS, while those at intermediate risk may experience an improvement of at least 5% with the same regimen, according to Meredith M. Regan, ScD, of Dana-Farber Cancer Institute in Boston, MA, and colleagues.

“Patients at lowest risk of recurrence had minimal benefit with exemestane plus OFS, the study showed, which is online in the Journal of Clinical Oncology.”

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For Certain Women, Ovarian Suppression Reduces Risk of Breast Cancer Recurrence When Given with Exemestane after Adjuvant Chemo

The gist: A new treatment approach might improve outcomes for certain premenopausal women with breast cancer. In the new approach a drug, surgery, or radiation is used to make the patient’s ovaries stop producing estrogen. In a clinical trial, some premenopausal women with breast cancer were treated with so-called “ovarian suppression” along with the drug exemestane. Others were treated with ovarian suppression along with the drug tamoxifen, and others took only tamoxifen. Ovarian suppression did not improve outcomes for all women in the trial, but it did improve outcomes for  premenopausal women with early-stage, hormone receptor-positive breast cancer who had already received chemotherapy after surgery. These women did better with ovarian suppression plus exemestane than they did with ovarian suppression with tamoxifen or tamoxifen alone.

“In the phase III SOFT trial reported in The New England Journal of Medicine, Francis et al found that the addition of ovarian suppression to tamoxifen did not improve disease-free survival among all women with premenopausal breast cancer but appeared to have a beneficial effect in those who had received adjuvant chemotherapy and remained premenopausal. Treatment with exemestane plus ovarian suppression vs tamoxifen alone was associated with significantly better outcomes in this higher-risk group.

“In the study, 3,066 premenopausal women with breast cancer were randomly assigned between December 2003 and January 2011 to receive 5 years of tamoxifen (n = 1,021), tamoxifen plus ovarian suppression (n = 1,024), or exemestane plus ovarian suppression (n = 1,021). Randomization was stratified by receipt or nonreceipt of adjuvant chemotherapy. Ovarian suppression was achieved by triptorelin treatment, bilateral oophorectomy, or bilateral ovarian irradiation. Patients had a median age of 43 years, 46.7% of the patients had not received prior chemotherapy, 53.3% had received prior chemotherapy and remained premenopausal, and 34.9% of patients had node-positive disease.

“The primary analysis tested the hypothesis that tamoxifen plus ovarian suppression would improve disease-free survival vs tamoxifen alone. The study was originally designed to compare disease-free survival between the three treatment groups with three pairwise comparisons. However, enrolled patients were older and had lower-risk characteristics than anticipated and the rate of disease-free survival was higher than expected. A protocol amendment to the statistical analysis plan was adopted in 2011 that designated the test of superiority of tamoxifen/ovarian suppression over tamoxifen alone as the primary analysis and the comparison of exemestane/ovarian suppression vs tamoxifen alone as a secondary analysis…

“The investigators concluded: ‘Adding ovarian suppression to tamoxifen did not provide a significant benefit in the overall study population. However, for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal, the addition of ovarian suppression improved disease outcomes. Further improvement was seen with the use of exemestane plus ovarian suppression.’ “

Everolimus–Exemestane Combination Failed to Significantly Extend OS in Advanced Breast Cancer

The gist: A clinical trial with volunteer patients tested a treatment for postmenopausal women with HR-positive, HER-2–negative advanced breast cancer. The treatment combines the drugs everolimus and exemestane. The clinical trial compared it to exemestane alone. The combination did NOT appear to give longer overall survival rates than exemestane alone.

“The addition of everolimus to exemestane extended OS in postmenopausal women with HR-positive, HER-2–negative advanced breast cancer, but the difference was not statistically significant, according to results of the BOLERO-2 study.

“BOLERO-2 is a randomized phase 3, double blind, international trial.

“Prior results showed the addition of 10 mg daily everolimus (Afinitor, Novartis) — an inhibitor of mammalian target of rapamycin (mTOR) — to 25 mg daily exemestane significantly extended PFS compared with exemestane alone (7.8 months vs. 3.2 months; P<.001).

“In the current study, Martine Piccart, MD, PhD, professor of oncology at the Université Libre de Bruxelles in Belgium and director of medicine at Institut Jules Bordet, and colleagues presented OS outcomes as part of a prospectively planned secondary-endpoint analysis.

“Results showed patients assigned the combination demonstrated longer median OS (31 months vs. 26.6 months; HR=0.89; 95% CI, 0.73-1.1), but the difference was not statistically significant.

“ ‘Ongoing translational research should further refine the benefit of mTOR inhibition and related pathways in this treatment setting,’ Piccart and colleagues wrote.”

Everolimus Plus Exemestane Extended PFS in Invasive Lobular Carcinoma

The gist: This article discusses the results of a clinical trial—a research study with volunteer patients. The trial tested a new treatment for patients with advanced, HR-positive, HER-2-negative invasive lobular carcinoma. The new treatment combines the drugs everolimus and exemestane. The researchers found that it significantly prolonged the amount of time patients lived without their cancer worsening.

“The addition of everolimus to exemestane significantly prolonged PFS in a subset of patients with HR-positive, HER-2–negative advanced breast cancer who had invasive lobular carcinoma at baseline, according to a subanalysis of the BOLERO-2 trial presented at the Breast Cancer Symposium.

“Gabriel N. Hortobagyi, MD, FACP, professor of medicine in the department of breast medical oncology at The University of Texas MD Anderson Cancer Center, and colleagues evaluated data from 104 patients with invasive lobular carcinoma. The cohort included patients with predominantly peritoneal, gastrointestinal and ovarian metastases.

“Patients received exemestane (Aromasin, Pfizer) with everolimus (Afinitor, Novartis; n=64) or placebo (n=40).

“The median age of the patients was 63 years, and 47.1% had measurable disease. Thirty-six percent of patients had visceral metastases of the lung, liver, pleural and peritoneum; 10% had lung metastases; and 23% had liver metastases.”

Breast Cancer Drug Aromasin May Be Option for Some Premenopausal Women


“The drug exemestane worked slightly better than the drug tamoxifen at preventing a recurrence of breast cancer in certain premenopausal women, according to a new study.

“Almost 93 percent of women on exemestane (Aromasin) remained free of breast cancer after five years, compared to about 89 percent of the women on tamoxifen. That’s according to the study of nearly 4,700 women with breast cancer who all had their ovarian function suppressed.

“However, the researchers found no differences in overall survival between the two drugs.

“And both drugs came with significant side effects. For Aromasin, those side effects included osteoporosis, vaginal dryness and decreased sex drive, among others. For tamoxifen, side effects included blood clots, hot flashes and urinary incontinence, according to the study.”