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.


Lapatinib/Trastuzumab/AI Triplet Nearly Doubles PFS in HER2+/HR+ Metastatic Breast Cancer

Excerpt:

“The triplet combination of HER2-targeted therapy and an aromatase inhibitor (AI) improved progression-free survival (PFS) by more than 5 months compared with the combination of trastuzumab (Herceptin) and an AI in patients with HER2+/HR+ breast cancer.

“In phase III results from the ALTERNATIVE trial presented at the 2017 ASCO Annual Meeting, the median PFS was 11 months (95% CI, 8.3-13.8) for postmenopausal women with HER2+/HR+ metastatic breast cancer assigned to lapatinib (Tykerb) plus trastuzumab plus an AI compared with 5.7 months (95% CI, 5.5-8.4) for patients assigned to trastuzumab plus an AI. Lead study author William J. Gradishar MD, interim chief of hematology and oncology at Northwestern University’s Feinberg School of Medicine, said that represented a 38% reduction in the risk of progression (HR, 0.62; 95% CI, 0.45-0.88; P = .0064).”

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.


Pembrolizumab Shows Durable Antitumor Activity in TNBC

Excerpt:

“In patients with heavily pretreated metastatic triple-negative breast cancer (TNBC), pembrolizumab (Keytruda) showed durable antitumor activity, according to findings from cohort A of the phase II KEYNOTE-086 trial presented at the 2017 ASCO Annual Meeting.

“The overall response rate (ORR) was 4.7% (95% CI, 2.3-9.2) with single-agent pembrolizumab, including a complete response (CR) rate of 0.6% and a partial response (PR) rate of 4.1%. The stable disease (SD) rate was 20.6%. The median duration of response was 6.3 months (range, 1.2+ to 10.3+).”

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 Active in HR+/HER2- Breast Cancer Patients With Brain Mets

Excerpt:

“Preliminary evidence suggests that abemaciclib penetrated brain metastases and had antitumor activity in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer.

“Results were presented in a poster at the 2017 ASCO Annual Meeting for 23 patients from a stage 1 efficacy analysis from a phase II study.

” ‘What we found were 2 patients who experienced partial responses within the CNS, suggesting there is activity of the agent in the brain and in patients who have HR-positive disease,’ explained lead author Sara M. Tolaney, MD, MPH.”

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 Orphan Drug Designation to Tucatinib for Brain Metastases

Excerpt:

“The FDA granted orphan drug designation to tucatinib for the treatment of patients with breast cancer whose disease metastasized to the brain, according to the drug’s manufacturer.

“Tucatinib (ONT-380, Cascadian Therapeutics) is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER-2 without significant inhibition of EGFR, which has been associated with significant toxicities.”

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.


Dual HER2 Blockade Superior to Single Blockade for HER2+/HR+ Breast Cancer

Excerpt:

“Dual blockade of HER2 with lapatinib plus trastuzumab and an aromatase inhibitor (AI) was superior to single blockade with trastuzumab plus an AI in postmenopausal women with HER2-positive, hormone receptor (HR)-positive metastatic breast cancer, according to the results of the phase III ALTERNATIVE study (abstract 1004) presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2–6 in Chicago.

” ‘Dual HER2 blockade with this triplet of lapatinib/trastuzumab and an AI can offer an effective and well-tolerated chemotherapy-sparing option for patients who are not intended or appropriate for chemotherapy,’ said researcher William J. Gradishar, MD, of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University in Chicago, who presented the results.”

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.


Final TH3RESA, EMILIA Results Confirm Role of Trastuzumab Emtansine in HER2+ Breast Cancer

Excerpt:

“Final results from two large phase III trials confirm that the drug-antibody conjugate trastuzumab emtansine improves overall survival (OS) over other treatment options in patients with previously treated HER2-positive metastatic breast cancer. The results of the EMILIA and TH3RESA trials confirm the agent’s role in this setting.

“Trastuzumab emtansine, which links the antibody trastuzumab with the cytotoxic microtubule inhibitor DM1, was approved based on earlier results of the EMILIA study. The new analysis of that trial offers approximately twice the length of follow-up, at a median of 24.1 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.