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


“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


“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


“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.”

Beta Blockers May Lead to New Novel Triple Negative Breast Cancer Treatments

“New research published in the March 2016 issue of The FASEB Journal, shows that a commonly prescribed class of high blood pressure drugs may have the potential to slow the growth of triple negative breast cancer tumors. These drugs, called ‘beta blockers’ work by counteracting the pro-growth effect caused by adrenaline by affecting the the beta2-adrenoceptor.

” ‘Previous studies have linked increased stress with accelerated onset of metastasis in some forms of breast cancer,’ said Michelle L. Halls, Ph.D., a researcher involved in the work from the Drug Discovery Biology Theme at Monash Institute of Pharmaceutical Sciences at Monash University in Parkville, Victoria, Australia. ‘By understanding how stress accelerates invasion in aggressive breast tumor cells, this work will inform future studies into whether beta-blockers could be a useful adjuvant therapy in the treatment of some aggressive breast cancers.’ “

FDA Assigns Sacituzumab Govitecan Breakthrough Designation for TNBC

“The FDA has granted sacituzumab govitecan (IMMU-132) breakthrough therapy designation for the treatment of patients with triple-negative breast cancer (TNBC) following at least 2 treatments for metastatic disease, according to Immunomedics, the manufacturer of the investigational antibody-drug conjugate.

“The designation, which will expedite the development and review of sacituzumab govitecan in TNBC, is based on a phase II trial in which the therapy induced a response rate of 31% in heavily pretreated patients with metastatic TNBC.

“ ‘We believe breakthrough therapy designation for IMMU-132 further validates this potential therapeutic for patients with TNBC, and we are delighted to receive this important recognition,’ Cynthia L. Sullivan, president and chief executive officer, of Immunomedics, said in a statement. ‘We continue to assess partnering opportunities while completing the scale-up manufacturing and regulatory activities for an international, randomized, controlled, registration trial in TNBC, based on the special protocol assessment agreement that was already granted by the FDA,’ she added.”

Putting Immune Checkpoint Blockade to the Test in Breast Cancer

About 10 months ago, we asked: Is There a Future for Immunotherapy in Breast Cancer? Now, we can answer this question with a qualified “yes.” The data show why:

Triple-negative breast cancer (TNBC)

TNBC has long been considered to be more amenable to immune system-based treatments than other types of breast cancer because it is more immunogenic; that is, relatively high levels of immune cells accumulate within or adjacent to TNBC tumors. These immune cells could be triggered to attack tumors if properly activated. TNBC tumors are also likely to have a higher mutational burden (number of genetic mutations). This is one of the predictors of sensitivity to a type of treatment called immune checkpoint blockade.  Drugs known as checkpoint inhibitors block the proteins PD-1 or PD-L1. In cancer, PD-L1 proteins on tumor cells bind to PD-1 proteins on immune T cells and inhibit their tumor-killing activity. Immune checkpoint drugs disable this interaction and enable activation of T cells. These drugs are actively being explored in TNBC in clinical trials.

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Atezolizumab/Nab-Paclitaxel Combo Shows High Response Rates in TNBC

“Upfront treatment with the PD-L1 inhibitor atezolizumab (MPDL3280A) plus nab-paclitaxel (Abraxane) showed a confirmed objective response rate (ORR) of 66.7% in patients with metastatic triple-negative breast cancer (TNBC), according to data presented at the 2015 San Antonio Breast Cancer Symposium.

“In the phase Ib study, atezolizumab plus nab-paclitaxel was explored across several lines of treatment regardless of PD-L1 status for patients with metastatic TNBC. In the second-line setting, the confirmed ORR was 25% and in the third-line and beyond the ORR was 28.6%. Across the full trial, the ORR was 41.7%.

“ ‘For the efficacy, we saw a very high response rate, which is extremely exciting and encouraging,’ said lead investigator Sylvia Adams, MD, associate professor of Medicine, NYU Perlmutter Cancer Center. ‘The combination was well-tolerated without additive toxicity. We saw only toxicity that was predictable for the single agents alone.’ “