Three-Drug Breast Cancer Regimen Slows Progression

Excerpt:

“Adding a drug to a standard regimen for hormone receptor (HR)-positive and HER2-positive breast cancer improved progression-free survival, a researcher said here.

“In a Phase II randomized trial, investigators compared an aromatase inhibitor (AI) combined with pertuzumab (Perjeta) and trastuzumab (Herceptin) versus an AI just with trastuzumab in women with locally advanced or metastatic breast cancer, Grazia Arpino, MD, PhD, of the University of Naples Federico II in Italy, reported at a general session at the San Antonio Breast Cancer Symposium.

“The three-drug combination led to a median of 18.89 months without progression, compared with 15.8 months for the two drugs.”

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Gradalis®, Inc. Announces Dosing of First Patient in Pilot Study Combining Vigil® Engineered Autologous Tumor Cell Immunotherapy and Durvalumab in Advanced Breast Cancer

Excerpt:

“Gradalis®, Inc., a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in a pilot study combining Vigil® Engineered Autologous Tumor Cells (EATCs) with durvalumab in advanced breast cancer. This is an open-label, investigator-sponsored study supported partly by a grant from Gradalis, to evaluate the safety, tolerability, and efficacy of the combination of Vigil engineered autologous tumor cell immunotherapy and durvalumab (an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1)) in patients with no PD-L1 expression and locally advanced or metastatic triple negative breast cancer (TNBC), that have progressed following two prior lines of therapy.”

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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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Video: Dr. Joanne Blum on the Function of Talazoparib in Locally Advanced and/or Metastatic Breast Cancer

“Joanne Blum, MD, PhD, breast medical oncologist, director, Hereditary Cancer Risk Program, Baylor Charles A. Sammons Cancer Center, discusses the function of the oral PARP inhibitor talazoparib (BMN 673) in BRCA mutation subjects with locally advanced and/or metastatic breast cancer. Blum says the BRCA mutation works in combination with talazoparib in order to better cut off the appropriate pathways for the tumors.

“Blum said during the phase I trial that looked at talazoparib, patients experienced grade 1 neutropenia, cytopenia and fatigue. Blum added that the toxicities were very mild.”

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Phase III BELLE-2 Trial Meets Primary Endpoint of Progression-free Survival

“Among women with locally advanced or metastatic hormone receptor-positive breast cancer that was resistant to hormone therapy, those who had mutated PIK3CA detected in their blood benefited from a combination of the investigational PI3K inhibitor buparlisib and fulvestrant, according to data from the phase III BELLE-2 trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8–12.

“ ‘BELLE-2 is a randomized, phase III clinical trial designed to assess the efficacy of the investigational PI3K inhibitor buparlisib in combination with fulvestrant in breast cancer patients whose tumors no longer respond to aromatase inhibitors,’ said José Baselga, MD, PhD, physician-in-chief and chief medical officer at Memorial Sloan Kettering Cancer Center in New York.”


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.’ “


Many Mastectomy Patients with Locally Advanced Breast Cancer Do Not Get Postop Radiation

“Breast cancer patients who undergo a mastectomy should receive subsequent radiation treatment if their cancer has spread to four or more nearby lymph nodes, however, according to a new study, only 65 percent of these women are getting the recommended postmastectomy radiation therapy (PMRT). The researchers looked at nearly 57,000 cases of breast cancer, and their study has been published as an ‘article in press’ on the Journal of the American College of Surgeons website in advance of print publication this spring.

“Several studies1 have found that PMRT reduces the risk of breast cancer recurrence and improves survival in patients whose cancer is “locally advanced” with a pathologic stage of N2 or N3 using the American Joint Committee on Cancer (AJCC) staging system.2 The AJCC defines N2 cancer primarily as having spread to between four and nine axillary, or underarm, lymph nodes but no other organs, and N3 disease involves 10 or more axillary lymph nodes.2

” ‘My colleagues and I were quite startled by the finding that a third of patients with N2/N3 disease did not receive PMRT, which is the standard of care,’ said lead author Quyen D. Chu, MD, MBA, FACS, professor of surgery at Louisiana State University (LSU) Health Sciences Center, Shreveport.”


Kadcyla/Perjeta Combo Does Not Improve Outcomes for Patients with Advanced, Untreated, HER2-Positive Breast Cancer

The gist: Combining the breast cancer drugs Kadcyla and Perjeta does not seem to improve outcomes for advanced, HER2-positive patients, compared to Kadcyla alone or Herceptin plus chemotherapy. That was the conclusion of a recent clinical trial that tested the combo in people who had not yet been treated for their advanced cancer. Herceptin plus chemotherapy is a cheaper option than Kadcyla plus Perjeta.

“Patients who got a combination of Kadcyla and Perjeta lived without their disease worsening for a similar amount of time as those who got Kadcyla alone, or those receiving the older medicine Herceptin plus chemotherapy, the Basel, Switzerland-based company said in a statement today. The study, dubbed Marianne, looked at 1,095 patients with a genetic mutation known as HER2 whose cancer has spread and who haven’t already tried other treatments.

“A successful combination of Kadcyla and Perjeta may have helped Roche replace sales of Herceptin that the company would lose should that medicine face competition from cheaper copies in coming years. Herceptin was Roche’s third-biggest drug in the first nine months of this year, with revenue of 4.7 billion Swiss francs ($4.8 billion).”


Continued Event-Free Survival Benefit of Neoadjuvant/Adjuvant Trastuzumab in HER2-Positive Locally Advanced Breast Cancer

The gist: A recent clinical trial found that the drug trastuzumab (Herceptin) improves survival and lowers the risk of recurrence for women with HER2-positive, locally advanced breast cancer. Patients in the trial received Herceptin as part of both neoadjuvant (before surgery) and adjuvant (after surgery) treatment. The researchers followed the patients for five years after treatment.

“As reported by Gianni et al in The Lancet Oncology, long-term follow-up of women with HER2-positive locally advanced breast cancer receiving neoadjuvant chemotherapy alone vs with neoadjuvant and adjuvant trastuzumab (Herceptin) in the phase III NOAH trial has shown continued event-free survival benefit of trastuzumab treatment and a strong association of event-free survival with pathologic complete response rate in trastuzumab recipients.

“In this open-label trial, 235 women with HER2-positive locally advanced or inflammatory breast cancer were randomly assigned to receive neoadjuvant chemotherapy alone (n = 118) or with 1 year of trastuzumab given concurrently with neoadjuvant chemotherapy and continued after surgery. (A parallel group with HER2-negative disease received neoadjuvant chemotherapy alone; outcomes in this group are not reported here.)”