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).”

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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+).”

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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.”

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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.”

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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.”

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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.”

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Longer Survival Seen with Breast Cancer Mets

Excerpt:

“An increasing number of women in the U.S. survive with metastatic breast cancer (MBC) as both median and 5-year survival rates improved, especially among younger women, according to a back-calculation method study.

“As of Jan. 1, 2017, 154,794 women were estimated to be living with MBC in the country, 75% of whom had initial diagnoses of stage I to III breast cancer and later progressed to MBC, reported Angela Mariotto, PhD, of the NCI in Bethesda, Md., and colleagues.

“The data showed a twofold increase in 5-year survival for women, ages 15 to 49, with MBC at diagnosis (de novo MBC), from 18% in 1992-1994 to 36% in 2005-2012, they wrote in Cancer Epidemiology, Biomarkers & Prevention.”

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FDA Approves Co-Packaging of Ribociclib With Letrozole for Metastatic Breast Cancer

Excerpt:

“The FDA has approved co-packaging of the oral medications ribociclib (Kisqali) and letrozole (Femara) for the treatment of postmenopausal women with HR-positive, HER2-negative advanced breast cancer.

“With the new Kisqali Femara Co-Pack, patients can obtain a full 28-day cycle of the 2 medicines in 1 package with 1 prescription and 1 copay, and the cost will be the same as that for Kisqali alone, according to Novartis, which manufactures both medications.”

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FDA Grants Fast Track Designation to Reolysin for Metastatic Breast Cancer

Excerpt:

“The FDA granted fast track designation to pelareorep for the treatment of metastatic breast cancer, according to the drug’s manufacturer.

“Pelareorep (Reolysin, Oncolytics Biotech) is an immuno-oncology viral-agent designed to induce selective tumor lysis, and promote an inflamed tumor phenotype through innate and adaptive immune responses, according to a company-issued press release.

“An open-label, randomized phase 2 study evaluated the addition of IV pelareorep to paclitaxel for patients with advanced or metastatic breast cancer.”

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