“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).”
“Improvements in progression-free survival (PFS) with olaparib (Lynparza) over treatment of physician’s choice (TPC) remained consistent regardless of baseline tumor burden for patients with HER2-negative breast cancer with a germline BRCA1/2 mutation (gBRCA1/2m), according to an exploratory analysis from the phase III OlympiAD trial presented at the 2018 Miami Breast Cancer Conference (MBCC).
“Although not powered to show statistical significance between the groups, in those with one metastatic site (n = 71) the median PFS with olaparib was 8.4 months compared with 4.2 months with TPC (HR, 0.62; 95% CI, 0.35-1.13). In patients with ≥2 metastatic sites (n = 231), the median PFS was 6.5 months with olaparib compared with 3.0 months for TPC, which crossed the barrier for statistical significance (HR, 0.59; 95% CI, 0.43-0.82).”
“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.”
“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.”
“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.”
“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.’ ”
“Previously the drug was approved as second-line monotherapy for women failing anti-estrogen therapy, and as second-line combination therapy with palbociclib (Ibrance). It was first approved by the FDA in 2002.”
“At the 2017 ASCO Annual Meeting, results were presented from the phase II I-SPY 2 trial investigating pembrolizumab (Keytruda) in combination with standard therapy (paclitaxel followed by doxorubicin and cyclophosphamide) as a neoadjuvant treatment for patients with locally advanced triple-negative breast cancer or hormone receptor–positive/HER2-negative breast cancer (Abstract 506).
“Findings showed that the addition of pembrolizumab increased the estimated pathologic complete response rate nearly threefold in patients with triple-negative breast cancer (60% vs 20%) and in patients with hormone receptor–positive/HER2-negative breast cancer (34% vs 13%) compared to standard therapy. Overall, based on Bayesian predictive probability of success in a confirmatory phase III trial, pembrolizumab has graduated from the I-SPY 2 TRIAL for all signatures in which it was tested (triple-negative breast cancer, all HER2-negative, and hormone receptor–positive/HER2-negative).”
“The investigational third-generation nonsteroidal oral selective estrogen receptor degrader (SERD) RAD1901 was associated with a 23% objective response rate among 40 heavily pretreated women with estrogen receptor (ER)-positive, HER2-negative breast cancer, according to authors of a phase I dose-escalation and safety cohort study (NCT02338349) presented (abstract 1014) at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2–6 in Chicago.”