Continuous Low-Dose Ribociclib Active in Advanced Breast Cancer Causes Less Neutropenia

Excerpt:

“Continuous low-dose ribociclib shows preliminary activity, and has an acceptable safety profile as an alternative to intermittent ribociclib dosing when combined with fulvestrant in the treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer.

“A phase Ib study, presented at the 2016 San Antonio Breast Cancer Symposium, demonstrated a confirmed partial response (PR) of 13.3% in the continuous ribociclib arm, compared with 23.1% in the intermittent ribociclib arm, but a lower rate of high-grade neutropenia in patients receiving continuous dosing of ribociclib.”

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GTx Reports Results from Ongoing Enobosarm Phase 2 Clinical Trial in ER+/AR+ Breast Cancer

Excerpt:

“GTx, Inc. (GTXI) announced today positive initial data from its ongoing open-label enobosarm Phase 2 clinical trial in women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. The pre-specified threshold for success of the trial was met early in the 9 mg cohort with 9 patients achieving a clinical benefit response at 24 weeks among the first 22 evaluable patients in that cohort, as reported by the Company on November 28, 2016. Clinical Benefit Response (CBR) is defined as a complete response (CR), partial response (PR) or stable disease (SD), as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks of treatment.”

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Targeting Estrogen Receptor Improves Progression-Free Survival in Advanced Breast Cancer

Excerpt:

“Fulvestrant significantly increases progression-free survival in women with hormone-receptor-positive advanced breast cancer, particularly those with less aggressive lower-volume disease, researchers reported at the ESMO 2016 Congress in Copenhagen.

“Fulvestrant is a selective estrogen receptor degrader that targets the function of the hormone receptor so, unlike aromatase inhibitors such as anastrozole, it does not interfere with estrogen levels themselves.”

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Encouraging Results For Ribociclib In Advanced Breast Cancer

Excerpt:

“At the European Society for Medical Oncology (ESMO) Congress this week, investigators presented data for a new and potentially important drug, ribociclib (Novartis). This oral medication is clearly active in hormone receptor-positive (ER+ or PR+) breast cancer. The findings of the MONALEESA trial were published in the NEJM.

“The main result is that for the most common form of advanced breast cancer, adding ribociclib to letrozole significantly improved progression-free survival (PFS), as compared to adding a placebo. After a year and a half (18 months) in this randomized, controlled clinical trial, PFS among women receiving ribociclib was 63.0%, vs. 42.2% in the placebo arm. That’s a big difference, when you consider that 99% of the patients on the study have stage 4, metastatic breast cancer.”

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Gradalis®, Inc. Announces Dosing of First Patient in Pilot Study Combining Vigil® Engineered Autologous Tumor Cell Immunotherapy and Durvalumab in Advanced Breast Cancer

Excerpt:

“Gradalis®, Inc., a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in a pilot study combining Vigil® Engineered Autologous Tumor Cells (EATCs) with durvalumab in advanced breast cancer. This is an open-label, investigator-sponsored study supported partly by a grant from Gradalis, to evaluate the safety, tolerability, and efficacy of the combination of Vigil engineered autologous tumor cell immunotherapy and durvalumab (an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1)) in patients with no PD-L1 expression and locally advanced or metastatic triple negative breast cancer (TNBC), that have progressed following two prior lines of therapy.”

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Innovative Trials Produce Promising Breast Cancer Drugs

Excerpt:

“An innovative set of clinical trials have identified two drugs that could provide a fighting chance for women with advanced breast cancer.

“The drugs, neratinib and veliparib, both appear effective in helping women diagnosed with stage 2 or 3 , researchers report.

“These are the first two drugs to come out of the I-SPY clinical , a research effort intended to streamline  testing by better guiding treatments to those who would most benefit from them, said one of the study authors, Dr. Laura Esserman. She is director of breast cancer care at the University of California, San Francisco’s Comprehensive Cancer Center.”

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Mutation Status May Guide Endocrine Therapy for Advanced Breast Cancer

Excerpt:

“Plasma analysis of ESR1 mutations may aid in the identification of appropriate endocrine therapy for patients with advanced breast cancer who progress after treatment with aromatase inhibitors, according to study results published in Journal of Clinical Oncology.

“ ‘Although diverse mechanisms of resistance to endocrine therapy have been described, recent evidence identified mutations in the ER gene (ESR1),’ Nicholas C. Turner, MA, MRCP, PhD, consultant medical oncologist at The Royal Marsden NHS Foundation Trust and team leader at the Breakthrough Breast Cancer Research Centre at Institute for Cancer Research, London, and colleagues wrote. ‘ESR1 mutations occur rarely in primary breast cancer, but have a high prevalence in advanced breast cancers previously treated with aromatase inhibitors, implying evolution through selective treatment pressure.’ ”

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One-Two Punch of Palbociclib, Paclitaxel Shows Promise against Advanced Breast Cancer

“Combining the new breast cancer drug palbociclib with paclitaxel (Taxol) shrank tumors in nearly half of patient with estrogen-receptor (ER) positive breast cancer, according to new research from the Perelman School of Medicine at the University of Pennsylvania. The results will be presented Saturday at the 2015 San Antonio Breast Cancer Symposium. A second study provides new clues to how breast cancer develops resistance to the palbociclib, a common occurrence among many patients who take the drug.

” ‘Results of the first study found that palbociclib and paclitaxel can be safely combined on an alternating dosing schedule,’ said Angela DeMichele, MD, MSCE, the Alan and Jill Miller Associate Professor in Breast Cancer Excellence in Penn’s Abramson Cancer Center, and senior author on the study. ‘The high response rate we saw suggests this combination may hold benefits for patients over paclitaxel alone. Based on these results, a larger clinical trial to determine the benefits is warranted.’ “


FDA Grants Priority Review to Ibrance for New Indication in Advanced Breast Cancer

“The FDA granted priority review to a supplemental new drug application for the breast cancer medication palbociclib.

“Palbociclib (Ibrance, Pfizer) — an oral agent that inhibits cyclin-dependent kinases (CDK) 4 and 6 — already is approved for use in combination with letrozole for treatment of postmenopausal women with ER-positive, HER-2–negative advanced breast cancer as initial endocrine-based therapy for metastatic disease.

“The supplemental application requests that the approval be expanded to allow for use of palbociclib in combination with fulvestrant in women with hormone receptor-positive, HER-2–negative metastatic breast cancer that progressed after endocrine therapy. The application requests approval in this setting regardless of patients’ menopausal status or receipt of prior treatment for metastatic disease.”