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Weekly Top News – Breast Cancer – July 29, 2019

July 30, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq: Regulatory approval in combination with nab-paclitaxel in EU and Japan for 1L TNBC in 2019 (Roche) – Jul 26, 2019 – H1 2019 Results: Regulatory approval in combination with nab-paclitaxel in US and EU for 1L non sq NSCLC in 2019  
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Faslodex (fulvestrant) / AstraZeneca; Ibrance (palbociclib) / Pfizer
A Multicentre, International Neoadjuvant (NA), Randomized, Double-blind Phase III Trial comparing FULVESTRANT to a combination of FULVESTRANT and PALBOCICLIB in patients with operable Luminal Breast Cancer (SAFIA Trial) (ID 4733) (ESMO 2019) – Jul 26, 2019 – Abstract #198P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Kisqali (ribociclib) / Novartis
Ribociclib (RIB) + letrozole (LET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC) and central nervous system (CNS) metastases: Subgroup analysis from the phase 3b CompLEEment-1 trial (ID 4024) (ESMO 2019) – Jul 26, 2019 – Abstract #333P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Kisqali (ribociclib) / Novartis
Interim Results From CompLEEment-1 (A Phase 3b Study of Ribociclib and Letrozole as First-Line Therapy for Advanced Breast Cancer in an Expanded Population): Spanish cohort results (ID 1370) (ESMO 2019) – Jul 26, 2019 – Abstract #336P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Tecentriq (atezolizumab) / Roche
ALEXANDRA/IMpassion030: A phase 3 study of standard adjuvant chemotherapy with or without atezolizumab in early stage triple negative breast cancer. (ID 4334) (ESMO 2019) – Jul 26, 2019 – Abstract #289TiP; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Kisqali (ribociclib) / Novartis
First Canadian Interim Analysis from the Phase IIIb CompLEEment-1 Ribociclib + Letrozole HR+ HER2- Advanced Breast Cancer Trial (ID 1109) (ESMO 2019) – Jul 26, 2019 – Abstract #337P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Keytruda (pembrolizumab) / Merck (MSD)
Merck’s Keytruda (pembrolizumab) in combination with chemotherapy met primary endpoint of pathological complete response (pCR) in pivotal phase 3 KEYNOTE-522 trial in patients with triple-negative breast cancer (TNBC) (Merck (MSD) Press Release) – Jul 29, 2019 – P3, N=1,174; KEYNOTE-522 (NCT03036488); Sponsor: Merck; “Merck…announced that the Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of the dual-primary endpoints of pathological complete response (pCR) following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone, regardless of PD-L1 status.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Faslodex (fulvestrant) / AstraZeneca;Imfinzi (durvalumab) / AstraZeneca, Celgene
H1 2019 Results (AstraZeneca Press Release) – Jul 25, 2019 – “Tagrisso sales of $1,414m, representing growth of 86% in the half (92% at CER) that was driven by 2018 regulatory approvals in the 1st-line EGFR7 -mutated (EGFRm) NSCLC8 setting…Imfinzi sales of $633m, representing growth of 244% (248% at CER)…Lynparza sales of $520m, representing growth of 93% (100% at CER), driven by expanded use in the treatment of ovarian and breast cancer in the US and Europe…The performance from more-mature Oncology medicines in the half included Faslodex growth of 4% (8% at CER) to $521m and an 8% decline in Iressa sales (3% at CER) to $252m…Pipeline: anticipated major news flow – H2 2019 – Tagrisso – NSCLC (1st line, EGFRm): regulatory decision (CN)…”

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