Alpelisib Active in PIK3CA-Altered Solid Tumors

Excerpt:

“Alpelisib (BYL719) induced a disease control rate (DCR) of 58.2% in patients with advanced solid tumors, according to results from a phase Ia study published in the Journal of Clinical Oncology.

“Treatment with the oral PIK3CA selective inhibitor led to a stable disease rate of 52.2%. Thirteen (9.7%) patients maintained stable disease for more than 24 weeks.

“Investigators reported ‘encouraging signs of antitumor activity’ in patients with PIK3CA-mutant, ER-positive/HER2-negative breast cancer, and other PIK3CA-altered advanced solid tumors.”

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Updated Data from Phase 3 Trial of Ibrance® (Palbociclib) plus Letrozole in ER+, HER2- Metastatic Breast Cancer Confirm Improvement in Progression-Free Survival

Excerpt:

“Pfizer Inc. (NYSE:PFE) today announced updated progression-free survival (PFS) results from the Phase 3 PALOMA-2 trial reinforcing the clinical benefit of IBRANCE® (palbociclib) combined with letrozole. The data, which will be presented at the 2017 San Antonio Breast Cancer Symposium (SABCS) on December 8 [abstract #P5-21-03], demonstrate that the combination of IBRANCE plus letrozole reduced the risk of disease progression by 44 percent and improved median PFS by more than one year compared to letrozole plus placebo (27.6 months [95% CI: 22.4, 30.3] vs 14.5 months [95% CI: 12.3, 17.1]) when used as the initial treatment for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer (HR=0.56 [95% CI: 0.46, 0.69]). This updated, post-hoc analysis included a median follow-up of more than three years, which is the longest to date of any Phase 3 study of a CDK 4/6 inhibitor.”

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FDA Grants Fast Track Designation to Elacestrant for Breast Cancer Subtype

Excerpt:

“The FDA granted fast track designation to elacestrant for the treatment of ER-positive, HER-2-negative advanced or metastatic breast cancer, according to the drug’s manufacturer.

“Elacestrant (RAD1901, Radius Health) an investigational oral selective ER downregulator/degrader is under investigation as a nonsteroidal treatment for hormone-driven or hormone-resistant breast cancer.”

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ESMO 2017 Press Release: LORELEI: Taselisib Boosts Breast Tumor Shrinkage

Excerpt:

“Adding taselisib to letrozole before surgery significantly improved outcomes for patients with early breast cancer that was both estrogen receptor positive and HER2-negative (ER+/HER2-) according to results of the LORELEI trial, presented at the ESMO 2017 Congress in Madrid.

” ‘We were able to detect a reduction in tumor size after only 16 weeks of treatment, compared to patients who received letrozole plus placebo,’ said study investigator Dr. Cristina Saura, from Vall d’Hebron University Hospital in Barcelona, Spain. ‘Any decrease in tumor measurements is something positive for patients because this means the drug has had activity against their tumor in a short period of time.’ ”

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