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.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


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.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


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%.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


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.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


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.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


New SERM Shows Promise in Advanced Breast Cancer

Excerpt:

“In women with estrogen receptor-positive, hormone-refractory metastatic breast cancer, oral Z-endoxifen hydrochloride, the potent metabolite of tamoxifen, provided substantial drug exposure regardless of CYP2D6 genotype, acceptable toxicity, and promising antitumor activity, researchers reported.

“Results from a phase I study in 38 patients with metastatic breast cancer demonstrated a clinical benefit rate (stable disease ≥ 6 months) of 26.3%. including a partial response by RECIST criteria in three patients who experienced progression during prior tamoxifen therapy, according to Matthew P. Goetz, MD, of the Mayo Clinic in Rochester, Minnesota, and colleagues.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


FDA Grants Priority Review to Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer

Excerpt:

“The FDA has granted a priority review to a new drug application (NDA) for abemaciclib (Verzenio) for use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.

“The NDA was based on data from the phase III MONARCH 3 trial in which the addition of abemaciclib to anastrozole or letrozole reduced the risk of progression or death by 46% compared with the nonsteroidal aromatase inhibitor (NSAI) alone for previously untreated patients with HER2-negative, HR-positive advanced breast cancer.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


FDA Approves Verzenio for Hormone Receptor-Positive, HER-2-Negative Breast Cancer

Excerpt:

“The FDA approved abemaciclib for the treatment of women with hormone receptor-positive HER-2-negative advanced or metastatic breast cancer who progressed following endocrine therapy.

The agency approved abemaciclib (Verzenio, Eli Lilly) — an investigational cyclin-dependent kinase 4/6 inhibitor —in combination with fulvestrant (Faslodex, AstraZeneca) following progression on endocrine therapy, and as a monotherapy for patients with metastatic disease previously treated with endocrine therapy and chemotherapy.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


FDA Grants Breakthrough Therapy Designation to DS-8201 for HER-2-Positive Breast Cancer

Excerpt:

“The FDA granted breakthrough therapy designation to DS-8201 for the treatment of HER-2-positive locally advanced or metastatic breast cancer that progressed after treatment with other HER-2-targeting agents.

“The agency based the designation on preliminary evidence from a phase 1 study designed to evaluate the safety, tolerability and efficacy of DS-8201 (Daiichi Sankyo), an investigational HER-2-targeting antibody-drug conjugate.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.