Palbociclib Efficacious in Metastatic Breast Cancer

Excerpt:

“Palbociclib can help slow the progression of advanced breast cancer, according to a study published in the Nov. 17 issue of the New England Journal of Medicine.

“Richard Finn, M.D., an assistant professor of medicine at the University of California, Los Angeles, and colleagues tested palbociclib-letrozole as a first-line treatment for estrogen-receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative . They randomly assigned 666 women to receive the or letrozole alone, and followed them for up to three years.

“At that point, the researchers found that 43.7 percent of women in the palbociclib group had either died or seen their cancer progress. That compared with 61.7 percent of women on letrozole alone. Women on the drug combination typically remained progression-free for 24.8 months, versus 14.5 months for women on letrozole. One of the most common side effects—seen in two-thirds of in this study—was neutropenia.”

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Angiochem’s ANG1005 Shows Clinical Benefits and Prolonged Survival for Breast Cancer Patients With Brain Metastases

Excerpt:

“Angiochem, a biotechnology company developing peptide-drug conjugates uniquely capable of crossing the blood-brain barrier, recently presented data from its Phase II trial for its lead compound, ANG1005, at two highly regarded international cancer conferences: The European Society for Medical Oncology (ESMO) 2016 Congress and the European Association of Neuro-Oncology (EANO) 2016 Meeting.

“On Friday Oct 7th, 2016 at the ESMO Congress, Copenhagen, Denmark, Shou-Ching Tang, MD, PhD Leader, Breast Cancer Multidisciplinary Program, Augusta University, Augusta, GA, USA presented a podium presentation titled: ANG1005, a novel peptide-paclitaxel conjugate crosses the BBB and shows activity in patients with recurrent CNS metastasis from breast cancer, results from a phase II clinical study.”

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Study Finds Ribociclib Improves Progression-Free Survival for Women with Metastatic Breast Cancer

Excerpt:

“In a randomized, Phase III trial led by researchers at The University of Texas MD Anderson Cancer Center, ribociclib, in combination with the aromatase inhibitor letrozole, dramatically improved progression-free survival (PFS) of post-menopausal women with hormone receptor-positive metastatic breast cancer, compared to the hormone therapy alone.

“The study found a 44 percent improvement in PFS with ribociclib, a CDK4/6 inhibitor, and letrozole as a front line therapy. Gabriel Hortobagyi, M.D., professor of Breast Medical Oncology, presented the findings at ESMO 2016 Congress, and is the corresponding author of the New England Journal of Medicine paper.”

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Super Patient: Jessica Leip Makes an Impact on Metastatic Breast Cancer Research

Jessica Leip was diagnosed with metastatic breast cancer in 2013. Since then, she has become very active with the Metastatic Breast Cancer Project, an organization that collects samples and data from patients in order to accelerate research. We asked Jessica about her own cancer experiences and her involvement with the MBCProject: Continue reading…


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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New Research Takes Aim at Deadliest Form of Breast Cancer

Excerpt:

“Forget the pink ribbons. Spitting in a tube for science is what unites a growing group of breast cancer patients taking part in a unique project to advance treatment for the deadliest form of the disease.

“For many of the 150,000-plus patients nationwide whose tumors have spread to bones, brains, lungs or other distant organs, the hue heralding breast cancer awareness and survival each October is a little too rosy. They know cancer will likely kill them. And they’ve often felt neglected by mainstream advocacy and medical research.”

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US Breakthrough Status for Novartis' Breast Cancer Drug

Excerpt:

“Novartis’ experimental selective cyclin dependent kinase inhibitor LEE011 (ribociclib) has picked up a Breakthrough Therapy designation in the US for the treatment of certain forms of breast cancer.

“The drug is being developed for use alongside letrozole for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.

“The award indicates the US Food and Drug Administration’s belief that LEE011 could potentially offer an improvement over an available therapy on at least one clinically significant endpoint, and is designed to help speed up its regulatory pathway to ensure quicker access for patients.”

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Palbociclib Addition to Letrozole Improved PFS in ER+/HER2- Breast Cancer

Excerpt:

“Palbociclib (Ibrance), when added to letrozole, increased the median progression-free survival (PFS) rate in patients with ER-positive, HER2-negative advanced or metastatic breast cancer by >10 months, according to results from the phase III PALOMA-2 trial presented at the 2016 ASCO Annual Meeting. 

“The risk of disease progressed was reduced by 42 with the addition of palbociclib, a CDK4/6 inhibitor, when compared with letrozole alone. The combination of palbociclib and letrozole was granted an accelerated approval in February 2015, based on the phase II PALOMA-1 study. These results from PALOMA-2 provide confirmation of the combination’s benefits in the frontline setting.

“ ‘These data represent the longest frontline improvement in median PFS seen to date in women with advanced ER+ breast cancer,’ senior study author Dennis J. Slamon, MD, PhD, chief of the Division of Hematology/Oncology in the UCLA Department of Medicine, said when presenting the findings at ASCO.”

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Lilly Announces Results from MONARCH 1 Trial of Abemaciclib Monotherapy

Excerpt:

“Eli Lilly and Company (LLY) today announced results from the MONARCH 1 Phase 2 study of abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. The data, which were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting by Maura Dickler, M.D., of Memorial Sloan Kettering Cancer Center, showed that single-agent activity was observed in metastatic breast cancer patients, for whom endocrine therapy was no longer a suitable treatment option. The MONARCH 1 results (abstract #510) confirmed objective response (ORR), durability of response (DoR), clinical benefit rate (CBR) and progression-free survival (PFS).

“The single-arm study, designed to evaluate the safety and efficacy of abemaciclib monotherapy, enrolled 132 patients who were given 200 mg of abemaciclib orally every 12 hours until disease progression. Patients enrolled in the study were heavily pretreated, having experienced progressive disease on or after prior endocrine therapy, and had received prior chemotherapy with one or two chemotherapy regimens for metastatic disease. The primary objective of the trial was investigator-assessed ORR, with secondary endpoints of DoR, CBR and PFS.”

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