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Weekly Top News – Breast Cancer – October 7, 2019

October 7, 2019

Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Safety data consistent with known safety profile of Verzenio”; Metastatic breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
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Verzenio (abemaciclib) / Eli Lilly
Verzenio: Data from P3 monarchE trial (NCT03155997) in HR+/HER2- breast cancer in mid-2021 (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
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Verzenio (abemaciclib) / Eli Lilly
Health-related quality of life in MONARCH 3: Abemaciclib plus an aromatase inhibitor as initial therapy in women with HR-positive (HR +), HER2-negative (HER2) advanced breast cancer (DGHO 2019) – Sep 30, 2019 – Abstract #P1006; Pres time: Oct 14, 2019; 12:00 PM – 12:05 PM; Location: A6; P3; “Abemaciclib plus AI resulted in clinically meaningful and statistically significant changes in diarrhea, and clinically not meaningful differences in other symptom scores. Increased GI-related symptoms were consistent with the manageable, reversible AE profile. No clinically meaningful differences in global health status or functional scores were observed.”

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Abemaciclib + NSAI and Abemaciclib + fulvestrant showed significant PFS benefit in predominantly Chinese HR +/HER –advanced breast cancer patients”; Breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019
P3 data
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Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Verzenio significantly extended life by 9.4 months”; Breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
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Tecentriq (atezolizumab) / Roche
Tecentriq by Roche not approved on NHS for triple negative breast cancer (Pharmafield) – Oct 3, 2019 – “Draft guidance published by NICE does not recommend atezolizumab, Tecentriq by Roche, for treating people with a type of breast cancer that has spread to other parts of the body….Atezolizumab with nab-paclitaxel does not meet NICE’s Cancer Drugs Fund criteria because it does not have a plausible potential to be cost-effective and there is no clear evidence that further trial data would resolve the uncertainties associated with this appraisal.”

 

Ibrance (palbociclib) / Pfizer; Verzenio (abemaciclib) / Eli Lilly; Faslodex (fulvestrant) / AstraZeneca
CDK4/6 inhibitor+fulvestrant combo nears getting benefit (Korea Biomedical Review) – Oct 2, 2019 – “The combination therapy of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor and fulvestrant for advanced or metastatic breast cancer has taken the first step to receive insurance benefits. The Health Insurance Review and Assessment Service (HIRA)’s Cancer Drug Review Committee decided in September to grant reimbursement for Pfizer’s Ibrance (ingredient: palbociclib) plus fulvestrant and Lilly’s Verzenio (abemaciclib) plus fulvestrant, sources said on Monday.”

 

Tecentriq (atezolizumab) / Roche
A small molecule triple-negative breast cancer immunotherapy that targets the Liver-X-Receptor. (CRI-CIMT-EATI-AACR 2019) – Oct 4, 2019 – Abstract #A203; “There is only FDA-approved immunotherapy for TNBC, Atezolizumab for patients with high PD-L1 expression, which unfortunately only marginally improves patient survival (~2 months)…Lastly, through extracellular flux analysis and mitochondrial activity profiling we have determined that LXR activation severely disrupts mitochondrial function in CD8+ T-cells. Our discoveries implicate LXR as a central mediator of TNBC immune evasion and as a promising treatment target for the development of novel small molecule immunotherapies for TNBC.”

 

 

Verzenio (abemaciclib) / Eli Lilly; Faslodex (fulvestrant) / AstraZeneca
Abemaciclib in combination with fulvestrant in patients with HR + / HER2- advanced breast cancer who had demonstrated primary or secondary resistance to previous endocrine therapy (DGHO 2019) – Sep 30, 2019 – Abstract #P1008; Pres time: Oct 14, 2019; 12:10 PM – 12:15 PM; Location: A6; P3; “Abemaciclib+F improved PFS and ORR with a generally tolerable safety profile in pts with HR+/HER2- ABC and primary/secondary ETR. Although pts with primary ETR typically have poor prognosis, the benefit from abemaciclib+F was maintained in this population. Previously presented at ESMO 2018, FPN 329P, Grischke E et al.”

 

Verzenio (abemaciclib) / Eli Lilly
Management of abemaciclib-associated adverse events in patients with HR + / HER2- advanced breast cancer: analysis of MONARCH studies (DGHO 2019) – Sep 30, 2019 – Abstract #P1007; Pres time: Oct 14, 2019; 12:05 PM – 12:10 PM; Location: A6; P2, P3; “Introduction: Abemaciclib is a CDK4/6 inhibitor dosed continuously, with demonstrated efficacy and an acceptable safety profile in patients (pts) with HR+/HER2- advanced breast cancer (ABC) alone (MONARCH 1, NCT02102490) or in combination with fulvestrant (MONARCH 2, NCT02107703) or non-steroidal aromatase inhibitors (MONARCH 3, NCT02246621). Abemaciclib dose adjustments and/or supportive medication were effective in managing AEs in pts with ABC in the MONARCH trials. Understanding the safety profile of abemaciclib can inform AE management and can extend time on treatment. Previously presented at ESMO 2018, FPN 339P, Rugo HS et al.”

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