Top News from 2017 San Antonio Breast Cancer Symposium (SABCS)

Myriad Genetics Presents Pivotal Validation Study for New riskScore™ Test at the 2017 San Antonio Breast Cancer Symposium

December 06, 2017

Myriad Genetics, Inc., a leader in molecular diagnostics and personalized medicine, has announced results from a ground-breaking validation study to better define the risk of breast cancer in women of European ancestry who test negative for a hereditary cancer mutation with the myRisk® Hereditary Cancer test.  The results are being featured in a Spotlight presentation at the 2017 SABCS.

Kisqali® first and only CDK4/6 inhibitor to show superior efficacy vs. oral endocrine therapy as 1L treatment in randomized Phase III trial in premenopausal women with HR+/HER2- advanced breast cancer

December 6, 2017

Novartis has announced results from the Phase III MONALEESA-7 trial in premenopausal or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer demonstrating Kisqali® (ribociclib) in combination with an aromatase inhibitor or tamoxifen and goserelin as initial endocrine-based therapy significantly prolonged progression-free survival (PFS) compared to endocrine therapy and goserelin alone. These data were presented as a late-breaker oral presentation at the 2017 SABCS.

Immunomedics announces updated results with sacituzumab govitecan (IMMU-132) in patients with relapsed or refractory metastatic triple-negative breast cancer (mTNBC)

December 6, 2017

Immunomedics, Inc. has announced that a blinded, independent review by an adjudication team of radiologists has determined an ORR of 31%, including six complete responses (CRs) and 28 partial responses (PRs), in 110 patients with mTNBC after receiving treatment with sacituzumab govitecan, the Company’s lead investigational antibody-drug conjugate (ADC), in a Phase 2 study. The independent centrally-reviewed (ICR) median DOR was 9.1 months.

Updated Data from Phase 3 Trial of Ibrance® (Palbociclib) Plus Letrozole In Er+, Her2- Metastatic Breast Cancer Confirm Improvement in Progression-Free Survival

December 6, 2017

Pfizer Inc. has 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, 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.

Radius Investigational Drug Elacestrant (RAD1901) Continues to Show Promise in Advanced ER+ / HER2- Breast Cancer at the 2017 San Antonio Breast Cancer Symposium

December 7, 2017

Radius Health, Inc. has provided an update on data from the Phase 1 005 clinical study of elacestrant (RAD1901), an oral selective estrogen receptor degrader (SERD), in patients with estrogen receptor positive (ER+) breast cancer. The data were presented at a Spotlight Presentation during the 2017 SABCS. Elacestrant recently received Fast Track designation from the U.S. Food and Drug Administration.

Seattle Genetics Presents Updated Phase 1 Data for Ladiratuzumab Vedotin (SGN-LIV1A) in Patients with Triple Negative Breast Cancer

December 7, 2017

Seattle Genetics, Inc. has announced updated data from an ongoing phase 1 clinical trial evaluating ladiratuzumab vedotin in patients with metastatic triple negative breast cancer (TNBC) at the 2017 SABCS. Ladiratuzumab vedotin is an investigational antibody-drug conjugate (ADC) designed to deliver a potent and clinically validated cell-killing agent, monomethyl auristatin E (MMAE), to cancer cells which express the protein LIV-1. LIV-1 is expressed on multiple solid tumors including breast, prostate, melanoma, ovarian, uterine, and cervical cancers.

Long-Term Efficacy Data from the Phase III GeparSepto Study in High Risk Early Breast Cancer Patients Treated with ABRAXANE® Vs. Solvent-Based Paclitaxel to Be Reported

December 7, 2017

The German Breast Group (GBG) and Celgene Corporation have announced long-term invasive disease-free survival results from the GeparSepto clinical trial comparing the investigational use of ABRAXANE® (paclitaxel albumin-bound particles for injectable suspension) to paclitaxel in early high-risk breast cancer patients at the 2017 SABCS. The results from the 1,206 patient study found that ABRAXANE demonstrated a significantly higher disease-free survival rate, a secondary efficacy endpoint, in high risk early breast cancer patients when compared to conventional solvent-based paclitaxel.

Updated Analysis of Phase Ib/II Study of Eribulin And Pembrolizumab Combination Regimen in Metastatic Triple-Negative Breast Cancer 

December 08, 2017

Eisai Co., Ltd. has announced that a presentation on the updated analysis of a global Phase Ib/II clinical study (ENHANCE 1 / Study 218) of its in-house discovered and developed anticancer agent eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: Halaven®, “eribulin”) in combination with the anti-PD-1 therapy pembrolizumab (product name: KEYTRUDA®) developed by Merck & Co., Inc., in patients with metastatic triple-negative breast cancer was given at a spotlight session of the 40th SABCS.

Myriad Genetics Presents Results from Two Important EndoPredict® Studies 

December 08, 2017

Myriad Genetics, Inc., a leader in molecular diagnostics and personalized medicine, has announced new results from two studies with EndoPredict® that have featured at the 2017 SABCS.  EndoPredict is a second-generation prognostic gene expression test for patients with breast cancer. The results show that 27.3 percent of those with a low EndoPredict score and 7.7 percent with a high score achieved excellent tumor response (RCB0/I) to neoendocrine therapy.

Talazoparib Significantly Extends Progression-Free Survival in Phase 3 Embraca Trial of Patients with Metastatic Breast Cancer

December 8, 2017

Pfizer Inc. has announced that the Phase 3 EMBRACA trial in patients with germline (inherited) BRCA1/2-positive (gBRCA+) locally advanced and/or metastatic breast cancer (MBC) demonstrated superior progression-free survival (PFS) in patients treated with talazoparib, compared to patients who received physician’s choice standard of care chemotherapy. Median PFS was 8.6 months (95% CI: 7.2, 9.3) for patients treated with talazoparib and 5.6 months (95% CI: 4.2, 6.7) for those treated with chemotherapy [HR: 0.54 (95% CI: 0.41, 0.71), p<0.0001]. This represents a 46% reduction in the risk of disease progression. In addition, the proportion of patients achieving a complete or partial response (objective response rate) in the talazoparib group was more than twice that of the control arm (62.6% for talazoparib vs. 27.2% for chemotherapy [OR: 4.99 (95% CI: 2.9-8.8), p<0.0001]). Talazoparib is an investigational, oral, dual-mechanism poly ADP ribose polymerase (PARP) inhibitor that is taken once daily.

 

Top News from 2017 San Antonio Breast Cancer Symposium (SABCS) last edit: 2017-12-12T20:33:28+00:00 da Luca

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