Novel Agents Emerging in Pipeline for HER2+ Breast Cancer

Excerpt:

“There have been significant advances for the treatment of HER2-positive breast cancer over the last decade, says Denise A. Yardley, MD.

“ ‘When we look at the HER2-positive patient, at this point, we have really come a long way with the initial approval of trastuzumab (Herceptin), followed by the addition of pertuzumab (Perjeta), based on the CLEOPATRA data,’ explains Yardley, senior investigator, Breast Cancer Research Program, principal investigator, Sarah Cannon Research Institute. ‘The EMILIA trial has now added T-DM1 (ado-trastuzumab emtansine; Kadcyla), a novel antibody-drug conjugate targeted against HER2.’

“While these FDA approvals have made a large impact for patients with HER2-positive breast cancer, there is still more work to be done. ‘We are really trying to extend the number of novel agents to add to the HER2-population arena,’ Yardley notes.”

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Puma Biotechnology Submits Marketing Authorization Application for PB272 (Neratinib) as Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer in Europe

Excerpt:

“Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that it has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for neratinib. The potential indication is for the extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with trastuzumab (Herceptin®)-based adjuvant therapy. The submission is based upon the ExteNET Phase III study, which reached its primary endpoint whereby neratinib demonstrated a statistically significant reduction of risk of invasive disease recurrence or death versus placebo.”

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Neoadjuvant HER2+ Breast Cancer Options Need Refinement, Expert Says

Excerpt:

“While recent findings from the I-SPY 2 trial have shown potential with the combination of ado-trastuzumab emtansine (T-DM1; Kadcyla) and pertuzumab (Perjeta) for patients with HER2-positive breast cancer, the neoadjuvant space still has a lot of work ahead, according to Lisa A. Carey, MD.

“Results presented at the 2016 AACR Annual Meeting1 showed that, out of the 249 patients enrolled on the I-SPY 2 study, 54% of those who received T-DM1/pertuzumab experienced a pathological complete response (pCR) rate compared with 22% of those who received the combination of paclitaxel (Abraxane) plus trastuzumab (Herceptin).

“This suggests that T-DM1 could increase overall survival (OS) in this patient population, but Carey adds more research with the regimen needs to be conducted.”

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Neratinib Plus Paclitaxel vs. Trastuzumab Plus Paclitaxel in Breast Cancer

Excerpt:

“While neratinib plus paclitaxel was not superior to trastuzumab plus paclitaxel as first-line treatment for ERBB2-positive metastatic breast cancer in terms of progression-free survival, the combination was associated with delayed onset and reduced frequency of central nervous system metastases, a finding that requires a larger study to confirm, according to an article published online by JAMA Oncology.

“Metastatic ERBB2-positive breast cancer has a characteristic spread with most patients developing liver metastases and about half having poor prognosis with central nervous system involvement.

“Ahmad Awada, M.D., of the Jules Bordet Institute, Brussels, and coauthors conducted a randomized clinical trial to examine progression-free survival in women with recurrent or metastatic ERBB2-positive breast cancer. They also examined secondary outcomes that included time to symptomatic or progressive central nervous system lesions and safety.”

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EBCC-10 NEWS: Combination of Lapatinib and Trastuzumab Shrinks HER2 Positive Breast Cancer Significantly in 11 Days After Diagnosis

“Amsterdam, The Netherlands: Approximately a quarter of women with HER2 positive breast cancer, who were treated with a combination of the targeted drugs lapatinib and trastuzumab before surgery and chemotherapy, saw their tumours shrink significantly or even disappear, according to results from a clinical trial.

“Professor Nigel Bundred told the 10th European Breast Cancer Conference (EBCC-10) today (Thursday): ‘This has ground-breaking potential because it allows us to identify a group of patients who, within 11 days, have had their tumours disappear with anti-HER2 therapy alone and who potentially may not require subsequent chemotherapy. This offers the opportunity to tailor treatment for each individual woman.’

“Prof Bundred, who is Professor of Surgical Oncology at The University of Manchester and the University Hospital of South Manchester NHS Foundation Trust (UK), was presenting results from the UK EPHOS-B multi-centre, clinical trial, in which 257 women with newly-diagnosed, operable, HER2 positive disease were recruited between November 2010 and September 2015.”


Single Dose of Trastuzumab Kick Starts Immune Response in Certain Breast Cancers

“A tumor’s immune response to a single dose of the HER2 inhibitor trastuzumab predicted which patients with HER2-positive breast cancer would respond to the drug on a more long-term basis, according to the results of a study published recently in Clinical Cancer Research.

“In addition, Vinay Varadan, PhD, assistant professor at Case Western Reserve University School of Medicine and member of the Case Comprehensive Cancer Center, and his colleagues found that women with the HER2-enriched subtype of HER2-positive breast cancer—a subtype that is estrogen and progesterone receptor negative—had the highest rate of immune response to treatment with trastuzumab, with significant increases in immune response after a single dose of the drug.

“ ‘Our study showed, for the first time, that the immune-cell–activating properties of trastuzumab are likely related to the subtypes of breast cancer,’ Varadan said. ‘Knowing this can inform future trials studying the usefulness of adding immunotherapy drugs to trastuzumab.’ “


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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Drugs Prevent Heart Damage during Breast Cancer Treatment, Study Shows

“Heart medication taken in combination with chemotherapy reduces the risk of serious cardiovascular damage in patients with early-stage breast cancer, according to results from a new landmark clinical trial.

“Existing research has shown some cancer therapies such as Herceptin greatly improve survival rates for , but come with a fivefold risk of heart failure—a devastating condition as life-threatening as the cancer itself.

“A new five-year study, led by researchers at the University of Alberta and Alberta Health Services and funded by the Canadian Institutes for Health Research (CIHR) and Alberta Cancer Foundation, shows that two kinds of heart medications, beta blockers and ACE inhibitors, effectively prevent a drop in heart function from cancer treatment.”


T-DM1 Improved Overall Survival for Heavily Pretreated Patients With HER2-positive Breast Cancer

“Among patients with HER2-positive, metastatic breast cancer that had progressed despite treatment with two or more forms of HER2-targeted therapy (trastuzumab [Herceptin] and lapatinib [Tykerb]), median overall survival was increased for those treated with trastuzumab emtansine (T-DM1 [Kadcyla]) compared with those who received treatment of physician’s choice, according to results from the phase III TH3RESA clinical trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8–12.

“The HER2-targeted antibody-drug conjugate T-DM1 was approved by the U.S. Food and Drug Administration in February 2013 for treating patients with HER2-positive, metastatic breast cancer that had progressed after treatment with trastuzumab and a taxane.”