ASCO 2017: I-SPY 2 Trial: Combination of Pembrolizumab Plus Standard Neoadjuvant Therapy in High-Risk Breast Cancer

Excerpt:

“At the 2017 ASCO Annual Meeting, results were presented from the phase II I-SPY 2 trial investigating pembrolizumab (Keytruda) in combination with standard therapy (paclitaxel followed by doxorubicin and cyclophosphamide) as a neoadjuvant treatment for patients with locally advanced triple-negative breast cancer or hormone receptor–positive/HER2-negative breast cancer (Abstract 506).

“Findings showed that the addition of pembrolizumab increased the estimated pathologic complete response rate nearly threefold in patients with triple-negative breast cancer (60% vs 20%) and in patients with hormone receptor–positive/HER2-negative breast cancer (34% vs 13%) compared to standard therapy. Overall, based on Bayesian predictive probability of success in a confirmatory phase III trial, pembrolizumab has graduated from the I-SPY 2 TRIAL for all signatures in which it was tested (triple-negative breast cancer, all HER2-negative, and hormone receptor–positive/HER2-negative).”

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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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Triple-Negative Breast Cancer Patients Who Responded to Immunotherapy Had Long-Term Survival Benefit

Excerpt:

“Among patients with metastatic triple-negative breast cancer (TNBC) who were treated with the anti-PD-L1 cancer immunotherapy atezolizumab (Tecentriq), those who responded to the medicine lived significantly longer (overall survival) compared with those who did not respond, according to data from a phase I clinical trial presented here at the AACR Annual Meeting 2017, April 1-5.

” ‘Triple-negative is an aggressive subtype of breast cancer often affecting younger women and, unfortunately, the current options for metastatic disease remain limited,’ said 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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Expert Discusses Promise of Immunotherapy in TNBC

Excerpt:

“The combination of immunotherapy and chemotherapy is showing promising response rates in certain patients with triple-negative breast cancer (TNBC), said ESO Umberto Veronesi Memorial Award Winner Giuseppe Curigliano, MD, PhD, who addressed genetic determinants of breast cancer immunogenicity in his award lecture at the 15th St. Gallen International Breast Cancer Conference.

“Curigliano emphasized the importance of patient selection in optimizing immunotherapy in breast cancer. In a study done by Curigliano, in collaboration with the Sidra Medical Center in Qatar, a subgroup of patients with TNBC who would derive benefit from checkpoint inhibitors were identified. This group, he stated, should be selected based on individual assessment of tumor-infiltrating lymphocytes.”

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Nab-Paclitaxel Paired With Anti-PD-L1 Immunotherapies in TNBC Studies

Excerpt:

“Combination regimens that pair nab-paclitaxel (Abraxane) with PD-L1 checkpoint blockade immunotherapy agents are emerging as a robust area of investigation in triple-negative breast cancer (TNBC), bolstered by clinical trial results that establish the chemotherapeutic agent as an effective partner for other therapies.

“Although nab-paclitaxel has been combined in some studies with other chemotherapies, the focus is shifting to regimens that include immunotherapies as the efficacy of that approach continues to grow. Nab-paclitaxel, an albumin-bound form of paclitaxel, is indicated for patients with metastatic breast cancer after prior chemotherapy.”

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The Next Few Years Will Bring Stunning Progress for TNBC, Expert Says

Excerpt:

“The treatment landscape for triple-negative breast cancer (TNBC) is transforming, experts say, with the potential additions of immunotherapy and PARP inhibitors. These agents are being explored both as monotherapy and in combination regimens with standard chemotherapy options.

“At the 2016 San Antonio Breast Cancer Symposium, treatment with pembrolizumab (Keytruda) continued to show a consistent durable benefit with an additional year of follow-up for heavily pretreated patients with recurrent PD-L1–positive TNBC, according to findings from the phase Ib KEYNOTE-012 trial.”

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Trial Explores Eliminating Breast Cancer Surgery in Exceptional Responders to Neoadjuvant Therapy

Excerpt:

“A prospective study is investigating whether breast cancer surgery can be eliminated in patients who respond well to neoadjuvant systemic therapy.

“The phase II single-center trial, conducted out of The University of Texas MD Anderson Cancer Center (NCT02945579), aims to determine how often breast cancer recurs in patients who previously received chemotherapy and follow-up radiation therapy, but not surgery, and have no evidence of disease. Forty patients with early-stage, triple-negative or HER2-positive breast cancer care underwent image-guided biopsy after completing chemotherapy and before beginning radiation therapy to see if surgery is necessary.”

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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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G1 Therapeutics Initiates Three Drug Development Programs in Breast Cancer

Excerpt:

G1 Therapeutics, Inc., a clinical-stage oncology company, announced today the expansion of its pipeline of novel cancer therapies with the initiation of three development programs in breast cancer. G1 is enrolling a Phase 2 study of its intravenous CDK4/6 inhibitor trilaciclib for the treatment of triple-negative breast cancer (TNBC), and a Phase 1b/2a study of its oral CDK4/6 inhibitor G1T38 for the treatment of estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer. In addition, G1 is advancing G1T48, its oral selective estrogen receptor degrader (SERD) with the goal of commencing a Phase 1 trial in the fourth quarter of 2017.”

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