Sacituzumab Govitecan Elicits Durable Responses for Pretreated TNBC

Excerpt:

“Treatment with sacituzumab govitecan (IMMU-132) was well-tolerated and induced durable responses, some lasting longer than 1 year, for heavily pretreated patients with metastatic triple-negative breast cancer (TNBC), according to findings from an ongoing phase I/II study presented at the 2016 San Antonio Breast Cancer Symposium (SABCS).

“In the single-arm trial, the confirmed objective response rate (ORR) was 30% with sacituzumab govitecan, and the duration of response was 8.9 months (95% CI, 6.1-11.3). The median progression-free survival was 6.0 months (95% CI, 5.0-7.3) and the median overall survival was 16.6 months (95% CI, 11.1-20.6).”

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tnAcity Data Presented at SABCS Evaluates the Investigational Use of ABRAXANE® as First-Line Treatment of Metastatic Triple Negative Breast Cancer

Excerpt:

“Celgene Corporation (CELG) today announced that the results of its randomized phase II tnAcity trial of ABRAXANE® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) will be presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) December 6-10, 2016. The trial found that an investigational weekly combination regimen of ABRAXANE + carboplatin had significantly longer progression-free survival (PFS) (7.4 months) compared to weekly regimens of either ABRAXANE + gemcitabine (5.4 months) or of carboplatin + gemcitabine (6.0 months) as first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC).”

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Anticipated METRIC Results Could Lead to First Targeted Agent Approved in TNBC

Excerpt:

“Findings from a highly anticipated, randomized, phase II trial could possibly pave the path for the FDA approval of the first targeted therapy for patients with triple-negative breast cancer (TNBC), explains Linda T. Vahdat, MD.

“The METRIC study is exploring the efficacy and safety of glembatumumab vedotin (CDX-011) versus standard capecitabine in this subset of patients, particularly in those with high levels of glycoprotein NMB (gpNMB) expression (NCT01997333).

“The antibody-drug conjugate is a novel approach designed to target a very difficult-to-treat patient population, whose sole approved treatment option is standard chemotherapy, Vahdat stresses.”

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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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I-SPY 2: Veliparib–Carboplatin Improves Complete Response Rate in Triple-Negative Breast Cancer

Excerpt:

“The addition of veliparib–carboplatin to standard chemotherapy appeared likely to improve rate of pathologic complete response among women with triple-negative breast cancer, according to results of I-SPY 2 published inThe New England Journal of Medicine.

“Researchers calculated an 88% predictive probability that the veliparib (ABT-888, AbbVie) and carboplatin combination would remain effective when added to standard chemotherapy in phase 3 confirmatory trials.”

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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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Despite ASCO Mishap, Data Still Intriguing for Sacituzumab Govitecan in TNBC

Excerpt:

“Sacituzumab govitecan (IMMU-132) had an objective response rate (ORR) of 33% in pretreated patients with triple-negative breast cancer (TNBC), according to updated findings from a phase II study reported by Immunomedics, the manufacturer of the antibody-drug conjugate.

“The results were originally scheduled to be presented at the 2016 ASCO Annual Meeting; however, the study was excluded from the conference when ASCO became aware that its meeting embargo had been violated when the chairman of Immunomedics reported the results at a conference in April. The ASCO exclusion did not question the quality of the research findings, according to a statement from Immunomedics.”

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Pembrolizumab Promising in Metastatic Triple-Negative Breast Cancer

Excerpt:

“Results from a phase Ib trial suggest that the programmed death 1 (PD-1) inhibitor pembrolizumab has activity and an acceptable toxicity profile as single-agent therapy in heavily pretreated, advanced triple-negative breast cancer (TNBC).

“ ‘TNBC tumors are frequently of high histological grade, present at an advanced stage, are typically more aggressive and difficult to treat than hormone receptor–positive tumors, and are associated with a higher risk of early relapse,’ wrote study authors led by Rita Nanda, MD, of the University of Chicago. ‘Given the suboptimal outcomes with chemotherapy, new targeted therapies for TNBC are urgently needed.’ ”

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Study Refines the Risk for Breast Cancer Recurrence

“The risk for local recurrence of breast cancer decreases as event-free survival lengthens, according to an analysis of a large database from the Netherlands.

“The study, which also demonstrated that recurrence risk varies substantially by subtype, should help physicians counsel women with breast cancer.

” ‘The risk of local recurrence as a first event within 5 years after diagnosis was low overall, at 3%. It differed by subtype, with ER-positive, PR-positive, HER2-negative breast cancer with the lowest risk and triple-negative with the highest risk,’ said Martine Moossdorff, MD, who is currently a doctoral candidate at Maastricht University Medical Center, in the Netherlands.”