Talazoparib Granted Priority Review by FDA for BRCA+ Metastatic Breast Cancer

Excerpt:

“A new drug application (NDA) for the PARP inhibitor talazoparib has been granted a priority review by the FDA for the treatment of patients with germline BRCA mutation–positive, HER2-negative locally advanced or metastatic breast cancer, according to Pfizer, the manufacturer of the agent.

“In results from the phase III EMBRACA trial, on which the application is based, talazoparib reduced risk of disease progression or death by 46% compared with chemotherapy in patients with BRCA-positive advanced breast cancer. At a median follow-up of 11.2 months, the Median progression-free survival (PFS) at the median follow-up of 11.2 months was 8.6 months (95% CI, 7.2-9.3) with talazoparib versus 5.6 months (95% CI, 4.2-6.7) with physician’s choice of therapy (HR, 0.54; 95% CI, 0.41-0.71; P <.0001). The objective response rate (ORR) was 62.6% (95% CI, 55.8-69.0) compared with 27.2% (95% CI, 19.3-36.3), respectively (odds ratio, 4.99; 95% CI, 2.9-8.8; 2-sided P value <.0001).”

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Ribociclib Active Across Premenopausal Breast Cancer Subgroups

Excerpt:

“The progression-free survival (PFS) benefit for ribociclib (Kisqali) in pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer was sustained across patient subgroups, according to findings from the phase III MONALEESA-7 trial presented at the 2018 Miami Breast Cancer Conference.

“MONALEESA-7 randomized patients to either the CDK4/6 inhibitor ribociclib in combination with tamoxifen or a nonsteroidal aromatase inhibitor (NSAI; letrozole or anastrozole) plus goserelin (n = 335), or to endocrine treatment plus goserelin (n = 337). Across the overall study population, the median PFS was 23.8 months for the ribociclib arm compared with 13.0 months for the control arm (HR, 0.553; 95% CI, 0.441-0.694; P <.0001).”

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Lilly Breast Cancer Treatment Lands Another Approval

Excerpt:

“The U.S. Food and Drug Administration has given another approval for a breast cancer treatment developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The announcement marks the third FDA approval for Verzenio in five months.

“The most recent ruling approves Verzenio, also known as abemaciclib, for use in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of postmenopausal women with advanced or metastatic breast cancer. Lilly says the approval follows the results of a successful Phase 3 clinical trial.”

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FDA Approves First Treatment for Breast Cancer with a Certain Inherited Genetic Mutation

Excerpt:

“The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation. Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx.”

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US Awards Novartis’ Kisqali ‘Breakthrough’ Status

Excerpt:

“Novartis’ CDK4/6 inhibitor Kisqali has picked up Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer.

“The US Food and Drug Administration has awarded the designation for of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.”

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Talazoparib Superior to Chemotherapy in BRCA-Associated Metastatic Breast Cancer

Excerpt:

“Approximately 5% of patients with sporadic breast cancer harbor mutations in BRCA1 or BRCA2; genes that are involved in the DNA repair process. Several phase I/II clinical studies have shown activity of single agent poly(ADP-ribose) polymerase (PARP) inhibitors in patients with metastatic breast cancer (MBC) and BRCA1/2 mutations. Recently in the randomized phase III OlympiAD trial, the PARP inhibitor olaparib improved progression-free survival (PFS) by 2.8 months over standard chemotherapy in patients with human epidermal growth factor 2 (HER2)–negative MBC and germline BRCA mutations.”

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Abemaciclib/Pembrolizumab Combo Shows Early Promise for HR+/HER2- Breast Cancer

Excerpt:

“The combination of abemaciclib (Verzenio) and pembrolizumab (Keytruda) showed preliminary signs of activity without additive toxicity for patients with pretreated HR-positive, HER2-negative metastatic breast cancer, according to early results from a pilot trial presented in a poster at the 2017 San Antonio Breast Cancer Symposium (SABCS).

“At a 16-week analysis, the objective response rate (ORR) with the combination was 14.3%, which was less than the response rate seen with single-agent abemaciclib in the MONARCH-1 trial (19.7%). However, the trial investigators noted that the median time to response for abemaciclib has historically been 3.7 months, suggesting the efficacy is likely to improve with longer follow-up. At 16 weeks, the ORR in the MONARCH-1 trial was 6.8%.”

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Antibody-Drug Conjugate Improves Responses In Metastatic Triple-Negative Breast Cancer

Excerpt:

“Treatment with IMMU-132 (sacituzumab govitecan) elicited an objective response rate (ORR) of 34 percent in patients with heavily pretreated metastatic triple-negative breast cancer, according to updated findings from a phase 2 study presented at the 2017 San Antonio Breast Cancer Symposium (SABCS).

“In the 110-patient single-arm trial, the ORR was accompanied by stable disease (SD) for 6 months or more in 11 percent of patients, for an overall disease control rate of 45 percent. The median progression-free survival (PFS) with IMMU-132 was 5.5 months and the median overall survival (OS) was 12.7 months.”

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In Young Women With Metastatic Breast Cancer, Kisqali Delays Tumor Growth And Relieves Symptoms

Excerpt:

“At this year’s San Antonio Breast Cancer Symposium, several reports on new treatments for advanced breast cancer caught my attention. In an impressive analysis presented by Dr. Debu Tripathy, ribociclib (Kisqali, Novartis) extended progression-free survival (PFS) and improved the quality of life in young women with metastatic hormone receptor (HR) positive, HER2 negative tumors.

“Ribociclib meets ‘a clear and unmet need for premenopausal patients with HR positive, HER2 negative advanced breast cancer,’ Tripathy said at the press meeting in San Antonio. Novartis sponsored the MONALEESA-7 trial in which 672 eligible women with metastatic disease were randomized to receive hormone-blocking agents with either ribociclib or a placebo. The study registered women between age 25 and 58; the median age was around 44 years; the groups were divided evenly. The international study includes metastatic breast cancer patients in North and South America, Europe, Asia and Australia.”

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