Priming Immune System Before Nivolumab Improves Response in Metastatic TNBC

Excerpt:

“In patients with metastatic triple negative breast cancer (TNBC), turning a nonimmunogenic (“cold”) tumor into an immunogenic (“hot”) tumor appears to be feasible, thereby improving sensitivity to immune therapy with nivolumab (Opdivo).

“In a phase II study of 50 patients with metastatic TNBC who received palliative chemotherapy, priming the immune system with low-dose chemotherapy for 2 weeks or radiation therapy before starting nivolumab resulted in a best objective response rate (ORR) of 24%, announced Marleen Kok, MD, at the 2017 ESMO Congress in Madrid.”

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AKT Inhibitor Ipatasertib in Metastatic Triple-Negative Breast Cancer

Excerpt:

“The randomized phase II LOTUS trial has shown improved progression-free survival with the addition of the AKT inhibitor ipatasertib to paclitaxel in the first-line treatment of metastatic triple-negative breast cancer. These results were reported by Kim et al in The Lancet Oncology. The PI3K/AKT signaling pathway is frequently activated in triple-negative breast cancer.

“In the double-blind trial, 124 patients with unresectable locally advanced or metastatic disease from 44 sites in South Korea, the United States, France, Spain, Taiwan, Singapore, Italy, and Belgium were randomized between September 2014 and February 2016 to receive paclitaxel at 80 mg/m² on days 1, 8, and 15 with either ipatasertib at 400 mg (n = 62) or placebo (n = 62) once daily on days 1 to 21 every 28 days until disease progression or unacceptable toxicity. Stratification factors included tumor PTEN status as determined by immunohistochemistry; deficient expression of PTEN is associated with greater AKT pathway activation. The co-primary endpoints were progression-free survival in the intention-to-treat population and progression-free survival in the PTEN-low population.”

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Sacituzumab Govitecan Demonstrates Durable Responses in Metastatic TNBC

Excerpt:

“Sacituzumab govitecan (IMMU-132) was well tolerated and demonstrated early and durable responses in heavily pretreated patients with metastatic triple-negative breast cancer (mTNBC), according to the results of a recent phase I/II study published in the Journal of Clinical Oncology.

“Sacituzumab govitecan is an antibody–drug conjugate that targets Trop-2, which is expressed in more than 90% of TNBCs, by selectively delivering SN-38, the active metabolite of irinotecan. It was granted a breakthrough therapy designation by the FDA in February 2016 for the treatment of patients with mTNBC, following at least 2 treatments for metastatic disease.”

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Atezolizumab Demonstrates Long-Term Responses in Subset of TNBC

Excerpt:

“According to the results of a phase I study of single agent anti-PD-L1 atezolizumab (Tecentriq) in metastatic triple-negative breast cancer (mTNBC), ten percent of patients showed impressive long-term survival, although researchers said that aside from some biomarker evidence, it’s yet unclear why the drug was more effective in this subset of patients.

“Results of the study were presented this week at the AACR Annual Meeting 2017 by lead author Peter Schmid, MD, PhD, director of the St. Bartholomew’s Breast Centre at St. Bartholomew’s Hospital and Barts Cancer Institute in London.”

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Novel Antibody-Drug Conjugate Targets Triple-Negative Breast Cancer

Excerpt:

“The antibody-drug conjugate sacituzumab govitecan (IMMU-132) produced high objective response rates, many of them quite durable, in a multicenter study of heavily pretreated patients with metastatic triple-negative breast cancer, presented at the 2016 San Antonio Breast Cancer Symposium.

“Trop-2 is a calcium signal transducer that drives tumor growth and has shown promise as a novel therapeutic target in triple-negative breast cancer, since the majority of these tumors express Trop-2. Sacituzumab govitecan targets Trop-2 and selectively delivers high doses of SN-38, the active metabolite of irinotecan that is 1,000 times more active than the parent compound. In addition to drug delivery, sacituzumab govitecan potentially also activates antibody-dependent cell-mediated cytotoxicity.”

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Interim Results from Phase 1b/2 Study Evaluating the Combination of Merck’s KEYTRUDA® (pembrolizumab) and Eisai’s HALAVEN® (eribulin mesylate) Injection in Metastatic Triple-Negative Breast Cancer

Excerpt:

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced new interim data investigating Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in combination with Eisai’s microtubule dynamics inhibitor, HALAVEN® (eribulin) in patients with metastatic triple-negative breast cancer (TNBC). Findings presented during the 2016 San Antonio Breast Cancer Symposium (SABCS) were based on interim data from 39 evaluable patients and showed an overall response rate (ORR) of 33.3% (n=13/39; 95% CI, 19.5-48.1), with one complete response and 12 partial responses (Abstract #: P5-15-02). ORR was similar between PD-L1-positive and -negative cohorts [PD-L1 positive=29.4% (n=5/17; 95% CI, 11.1-51.1); PD-L1 negative=33.3% (n=6/18; 95% CI, 14.1-54.6)]. HALAVEN and KEYTRUDA are not approved for use in combination.”

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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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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.”