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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Enobosarm Meets Pre-Specified Primary Efficacy Endpoint in Ongoing Phase 2 Clinical Trial in ER+/AR+ Breast Cancer

Excerpt:

“GTx, Inc. (Nasdaq: GTXI) today announced that enobosarm achieved the pre-specified primary efficacy endpoint in the 9 mg dose cohort from patients in both stage 1 and the ongoing stage 2 of its Phase 2 clinical trial in women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. The primary efficacy endpoint requires at least nine patients (out of a total of 44 evaluable patients) to achieve clinical benefit, defined as either a complete response, partial response or stable disease, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks of treatment. In this ongoing trial, the efficacy endpoint was achieved in the first 22 confirmed evaluable patients, and the trial will continue enrolling and treating eligible patients with enobosarm until 44 evaluable patients have completed the trial. Enobosarm has been well tolerated among patients treated to date in the 9 mg dose cohort with the majority of adverse events being either grade 1 or 2.”

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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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Does Efficacy Require Toxicity, or Is It Time to Reconsider Presurgical Endocrine Therapy for Estrogen-Receptor-Positive Breast Cancer?

Excerpt:

“Neoadjuvant endocrine therapy – designed to reduce the size of breast tumors before surgical removal – appears to be as effective as neoadjuvant chemotherapy for patients with localized, estrogen-receptor (ER)-positive breast cancer with considerably fewer side effects. The study conducted by a Massachusetts General Hospital (MGH) Cancer Center research team appears in the current print issue of JAMA Oncology and was published online earlier this year.”

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Tamoxifen Linked to Reduced Contralateral Breast Cancer Risk

Excerpt:

“Use of tamoxifen and aromatase inhibitors during and after breast cancer treatment were found to reduce the risk of contralateral breast cancer in a community healthcare setting, according to a study published in JAMA Oncology.

“The authors of the real-world retrospective study found that among estrogen receptor (ER)-positive breast cancer patients who survived at least 5 years, tamoxifen use for 4 years or more prevented an estimated three contralateral breast cancer cases for every 100 women by year 10. This absolute risk reduction is consistent with prior results from tamoxifen clinical trials, according to study authors led by Gretchen L. Gierach, PhD, MPH, of the division of cancer epidemiology and genetics at the National Cancer Institute.”

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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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Results of Two Practice-Changing Breast Cancer Trials Upheld

Excerpt:

“Results of two pivotal breast cancer trials reported at the 2016 ASCO Annual Meeting confirmed the practice-changing findings that resulted from earlier findings.

“The phase III PALOMA-2 trial confirmed results from the smaller, open-label phase II PALOMA-1 trial that led to the U.S. Food and Drug Administration (FDA) approval of the cyclin-dependent kinase 4/6 inhibitor palbociclib (Ibrance). The drug was approved in combination with letrozole for the first-line treatment of metastatic disease.

“ ‘These data represent the longest front-line improvement in median progression-free survival seen to date in women with advanced estrogen receptor (ER)-positive breast cancer,’ said Dennis Slamon, MD, Director of Clinical/Translational Research and Professor of Medicine at the University of California, Los Angeles, and Director of the Revlon/UCLA Women’s Cancer Research Program.”

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New Research on Triple Negative Breast Cancer Emerges at ASCO 2016


The American Society of Clinical Oncology (ASCO) meeting of 2016 is behind us, but oncologists, patients, and journalists are still analyzing the most interesting presentations made there. Below, we describe some of the more prominent results in triple negative breast cancer (TNBC), both promising and disappointing.

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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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