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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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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Comparing Combination Treatments in HER2-Positive Early Breast Cancer

Excerpt:

“In patients with HER2-positive early breast cancer, data from a phase III trial has shown a significantly higher pathological complete response (pCR) rate with neoadjuvant docetaxel plus carboplatin plus trastuzumab plus pertuzumab (TCH+P) versus trastuzumab emtansine plus pertuzumab (T-DM1+P).

“According to the results of the KRISTINE trial, the TCH+P regimen was also associated with a higher rate of breast conserving surgery. However, researchers reported that T-DM1+P had a notably better safety profile and that health-related quality of life and physical functioning were maintained longer.

“ ‘Neoadjuvant TCH+P achieved a superior pCR rate compared with T-DM1+P and was associated with a higher breast-conserving-surgery rate,’ said Sara A. Hurvitz, MD, General Internal Medicine, Hematology & Oncology, UCLA Medical Center in Santa Monica, CA. ‘However, neoadjuvant T-DM1+P had a more favorable safety profile, with lower incidence of grade 3 or greater adverse events, serious adverse events, and adverse events leading to treatment discontinuation.’ ”

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Neoadjuvant T-DM1/Pertuzumab Combo Boosts pCR in HER2+ Breast Cancer

Excerpt:

“Neoadjuvant ado-trastuzumab emtansine (T-DM1; Kadcyla) in combination with pertuzumab (Perjeta) improved pathologic complete response (pCR) compared with standard of care in patients with advanced HER2-positive breast cancer, according to recently reported data from the adaptively randomized I-SPY 2 trial.

“Of the 249 patients with HER2-positive disease included in the I-SPY 2 trial, 54% of those who received T-DM1/pertuzumab experienced a pCR compared with 22% of those who received the combination of paclitaxel (Abraxane) plus trastuzumab (Herceptin).

“These findings suggest that T-DM1 may ultimately increase survival in these patients, says lead study author Angela M. DeMichele, MD, professor of Medicine and Epidemiology at the University of Pennsylvania.”

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​​A Presurgery Combination Therapy May Improve Outcomes for Women With HER2-positive Breast Cancer

Excerpt:

“Results from the I-SPY 2 TRIAL show that a neoadjuvant (presurgery) therapy combination of the antibody-drug conjugate trastuzumab emtansine (T-DM1; Kadcyla) and pertuzumab (Perjeta) was more beneficial than paclitaxel plus trastuzumab for women with HER2-positive invasive breast cancer, according to research presented here at the AACR Annual Meeting 2016, April 16-20.

“In this portion of the I-SPY2 TRIAL, the investigators tested if T-DM1 plus pertuzumab could bring a substantially greater proportion of patients to the primary endpoint of pathological complete response [pCR] compared with paclitaxel plus trastuzumab. They also examined whether this combination could meet that goal without the need for patients to receive paclitaxel. pCR is an outcome in which, following neoadjuvant therapy, no residual invasive cancer is detected in the breast tissue and lymph nodes removed during surgery.”

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TDM-1 With Docetaxel/Pertuzumab Offers Benefit in Advanced HER2-Positive Breast Cancer

Excerpt:

“Combining trastuzumab emtansine with docetaxel both with and without pertuzumab yielded promising efficacy in a phase Ib/IIa study of patients with HER2-positive locally advanced (LABC) or metastatic breast cancer (MBC). Many patients, however, required dose reductions due to toxicity.

“Trastuzumab emtansine (T-DM1) is a drug-antibody conjugate, and has been shown to offer significant survival benefits in phase III trials of HER2-positive metastatic breast cancer. ‘In preclinical studies, T-DM1 exhibited enhanced antitumor activity when combined with docetaxel or pertuzumab,’ wrote study authors led by Miguel Martin, MD, PhD, of Hospital General Universitario Gregorio Marañón in Madrid.”

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Pertuzumab Not Cost Effective in Metastatic HER2-Positive Breast Cancer

“Though the addition of pertuzumab to docetaxel and trastuzumab as first-line therapy for HER2-positive breast cancer has been shown to yield a substantial survival benefit, a new analysis shows that there is very little chance that pertuzumab would be cost effective in the United States.

“The CLEOPATRA trial showed that pertuzumab along with docetaxel and trastuzumab (THP) resulted in a median survival in HER2-positive metastatic breast cancer patients of 56.5 months, compared with only 40.8 months for the latter two drugs alone (TH). ‘These exceptional results come at a price,’ wrote researchers led by Ben Y. Durkee, MD, PhD, of Stanford University in California. ‘Our work shows that an insurer could expect to pay $4,649 per week for the THP regimen at Medicare rates. Private contractors and smaller entities would pay more.’

“The researchers used a decision-analytic Markov model to evaluate the regimen’s cost effectiveness, based on the study population from CLEOPATRA and the assumed number of patients for whom the THP regimen would be recommended in the metastatic setting. Results were published online ahead of print in the Journal of Clinical Oncology.”


Roche's Perjeta Regimen Approved in Europe for Use Before Surgery in Early Stage Aggressive Breast Cancer

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved the use of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy for the neoadjuvant treatment (use before surgery) of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the EC based on pCR data.

“Every year in Europe nearly 100,000 people are diagnosed with HER2-positive breast cancer, an aggressive type of the disease that is more likely to progress than HER2-negative cancer.1,2 Treating people with breast cancer early, before the cancer has spread, may improve the chance of preventing the disease from returning. Neoadjuvant treatment is given before surgery and is aimed at reducing tumour size so it is easier to surgically remove. pCR is achieved when there is no tumour tissue detectable at the time of surgery in the affected breast or in the affected breast and local lymph nodes. It is a common measure of neoadjuvant treatment effect in breast cancer and it can be assessed more quickly than traditional endpoints in eBC.

“ ‘Today’s approval is a significant milestone in the neoadjuvant treatment of HER2-positive early breast cancer, bringing Perjeta to patients years earlier than typical adjuvant treatment,’ said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. ‘We are committed to making the Perjeta regimen available to appropriate patients in the EU as early as possible.’ “


More Lessons from CLEOPATRA Trial: Benefits of Adding Perjeta

“Clinical trials generate massive amounts of data, which can be difficult to summarize in a 10-minute presentation at a medical conference.

“However, every study and every presentation related to the study have ‘money slides,’ the critical information for clinicians, researchers, and patients. Homing in on money slides can help reduce the time, effort, and confusion related to sorting out the results and meaning of clinical studies.

“At the 2014 meeting of the European Society of Medical Oncology, investigators reported practice-changing results from a randomized clinical trial in advanced breast cancer. In the accompanying video, Joseph Sparano, MD, of Albert Einstein College of Medicine and Montefiore Medical Center in New York City, uses the concept of money slides to offer a concise yet complete assessment of the CLEOPATRA trial results and implications.”