BREAST CANCER

A cohort of cancer centers was selected to serve as models for identifying key strategies for racial and ethnic minority group engagement in clinical trials. On the basis of several qualifying criteria, such as sustained accrual of minorities into clinical cancer research, an established minority population ≥10% in the overall catchment, an established clinical trial infrastructure, and a formal community outreach program, the investigators identified 8 cancer centers for participation.

In a case-based-style discussion, Tanios S. Bekaii-Saab, MD, and Wells Messersmith, MD, reviewed the treatment of patients with colorectal cancer whose tumors express rare gene mutations or molecular signatures, such as <em>NTRK</em> fusions.

ABP 980, a trastuzumab biosimilar, has been approved by the FDA&nbsp; for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.

<em>Targeted Oncology</em>&nbsp;spoke with experts in attendance at the 2019 ASCO Annual Meeting to review what they believed were some of the biggest takeaways from this year&#39;s presentation across the fields of lung cancer, breast cancer, GI cancers, genitourinary cancers, melanoma, and multiple myeloma.

Combining neratinib with capecitabine showed a 24% reduction in the risk of disease progression or death compared with lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer who had previously received 2 lines of HER2-targeted therapy,&nbsp;according to the results of the phase III NALA trial presented at the 2019 ASCO Annual Meeting.

In the placebo-controlled phase II FAKTION trial, a combination of capivasertib and fulvestrant showed a significant increase in progression-free survival compared to the use of fulvestrant alone in patients with endocrine-resistant estrogen receptor-positive advanced breast cancer.

Based on the results from a phase III SOPHIA clinical trial, the HER2-targeted antibody, margetuximab, was superior to trastuzumab in improving progression-free survival in patients with pretreated HER2-positive metastatic breast cancer. In CD16A-158F carriers, the PFS was significantly enhanced.<br /> &nbsp;

Ross Mudgway, BS, explains how a multidisciplinary approach as well as open discussions with the patient can help determine the best course of action for patients with metastatic breast cancer.

Findings from a cohort of the&nbsp;phase II Targeted Agent and Profiling Utilization Registry (TAPUR) basket study revealed that heavily pretreated patients with&nbsp;metastatic breast cancer and high mutational burden benefited from pembrolizumab monotherapy.&nbsp;

According to findings from the phase III MONALEESA-7 trial, peri and premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer treated with ribociclib plus endocrine therapy demonstrated an estimated overall survival rate of 70.2% at 42 months compared with 46% for placebo and endocrine therapy.

According to the latest Annual Report to the Nation on the Status of Cancer, cancer death rates have declined in men, women, and children across all cancer types, and have continued to decline between 1999 and 2016. In a special section of this year&rsquo;s report, however, data show that both cancer incidence and death rates were higher in women aged 20 to 49 compared to male counterparts.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;May 2019, including several new approvals, orphan drug designations, breakthrough therapy designations, fast track designations, and more.

The FDA has granted a fast track designation to the investigational agent lasofoxifene for the treatment of women with estrogen receptor-positive, HER2-negative metastatic breast cancer who have an ESR1 mutation. The agent is currently being investigated in a phase II trial in this setting.

Based on data from the phase III SOLAR-1 trial, alpelisib (Piqray) has been approved by the FDA for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

HER2+ BC: Residual Disease After Neoadjuvant Therapy

Early HER2+ Breast Cancer

Pembrolizumab monotherapy missed the prespecified primary endpoint of superior overall survival compared to chemotherapy in the phase III KEYNOTE-119 trial, in which the PD-1 inhibitor was being investigated as a second- or third-line treatment for patients with metastatic triple-negative breast cancer.

By eating a balanced, low-fat diet and daily portions of vegetables, fruit, and grains, women have a 21% lower risk of dying from breast cancer, according to research to be presented during the upcoming 2019 ASCO Annual Meeting in Chicago.

Findings from ongoing immunotherapy studies are expected to change the treatment paradigm in breast cancer as these agents become available to larger subsets of patients, according to Hope S. Rugo, MD, and Elizabeth A. Mittendorf, MD, PhD, who presented data at the 36th Annual Miami Breast Cancer Conference&reg;&nbsp;hosted by Physicians&rsquo; Education Resource&reg;, LLC.

In topline findings from the phase II DESTINY-BreastO1 study,&nbsp;[fam-] trastuzumab deruxtecan demonstrated encouraging responses in patients with unresectable and/or metastatic HER2-positive breast cancer that has been previously treated with ado-trastuzumab emtansine.

The FDA has granted a fast track designation to a novel CCR5 antagonist, leronlimab (PRO 140), for use in combination with carboplatin to treat patients with CCR5-positive metastatic triple-negative breast cancer.

Ado-trastuzumab emtansine has been approved by the FDA for use as an adjuvant treatment option for patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment with&nbsp;trastuzumab and chemotherapy.