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Weekly Top News – Breast Cancer – June 3, 2019

June 3, 2019

letrozole / generics
A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer (clinicaltrials.gov) – May 29, 2019 – P3; N=426; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

 

Keytruda (pembrolizumab) / Merck (MSD)
Imprime PGG + Keytruda: “Imprime PGG in combination with pembrolizumab shows promising clinical benefit in previously-treated, metastatic TNBC patients”; Triple negative breast cancer (Biothera) – Jun 2, 2019 – ASCO 2019: “Clinical response is evident as early as 6 weeks on treatment”  

 

 

Ibrance (palbociclib) / Pfizer
Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer (clinicaltrials.gov) – May 31, 2019 – P3; N=200; Not yet recruiting; Sponsor: Kyoto Breast Cancer Research Network

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Data from P3 KEYNOTE-355 trial (NCT02819518) for 1L TNBC in Q4 2019 (Barclays) – Jun 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 67382590; Page no: 33; REPORT TITLE: “European Pharmaceuticals: IO: Bringing its power to bear in the realm of curative intent”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 05/24/2019

 

Hervelous (trastuzumab biosimilar) / Alvogen, Prestige BioPharma Pte Ltd, Hanwha Chem
European Medicines Agency accepts Marketing Authorisation Application for Prestige BioPharma’s trastuzumab biosimilar HD201 for review (PharmiWeb) – May 28, 2019 – “Prestige BioPharma (herein, Prestige) announced that European Medicines Agency (EMA) has validated and accepted for review the Marketing Authorization Application (MAA) for its trastuzumab biosimilar HD201 (Tuznue®). HD201…is indicated for the treatment of adult patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma….positive top-line results from the Phase I / Phase III global clinical trial of HD201 confirm that HD201 is exceptionally biosimilar to Herceptin in terms of clinical response and PK, in addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials.”

 

Kisqali (ribociclib) / Novartis
Novartis Kisqali significantly extends life in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial (GlobeNewswire) – Jun 1, 2019 – P3, N=672; MONALEESA-7 (NCT02278120); Sponsor: Novartis Pharmaceuticals; “The Phase 3 MONALEESA-7 trial evaluated Kisqali plus endocrine therapy…as initial treatment compared to endocrine therapy alone in pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer…The significant extension in survival met the early efficacy stopping criteria at a pre-specified interim analysis following 192 deaths (median OS, not reached vs. 40.9 [95% CI: 37.8-NE] months; HR=0.712 [0.535-0.948]; p=0.00973). Overall survival rates in the intent-to-treat population (n=672) at 42 months were 70.2% for Kisqali combination therapy compared to 46.0% for endocrine therapy alone. At the time of data cut-off, 35% of women taking Kisqali combination therapy were continuing the treatment. No new safety signals were observed.”

 

Halaven (eribulin mesylate) / Eisai
New study investigating Halaven (eribulin) in metastatic breast cancer (Pharmafield) – May 31, 2019 – “Eisai Europe Ltd and MedSIR have announced a new study investigating Halaven ® (eribulin) treatment efficacy in metastatic breast cancer (MBC)…The REVERT study will investigate the clinical activity of Halaven® (eribulin) in MBC and will investigate the efficacy of a combined endocrine-chemotherapy therapeutic approach in the condition….The first data readout from the REVERT study investigating Halaven ® (eribulin) treatment efficacy in metastatic breast cancer is estimated to be in late 2021.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology presents interim results of phase II CONTROL trial of neratinib in extended adjuvant treatment of HER2-positive early stage breast cancer at the ASCO 2019 Annual Meeting (Businesswire) – Jun 2, 2019 – P2, N=137; CONTROL (NCT02400476); Sponsor: Puma Biotechnology; “The results of the trial showed that the incidence of grade 3 diarrhea for the 137 patients who received the loperamide prophylaxis was 30.7% and that for the 137 patients in this cohort, 20.4% discontinued neratinib due to diarrhea. The median cumulative duration of grade 3 diarrhea was 3 days. For the 64 patients who received the combination of loperamide plus budesonide, the results of the trial showed that the incidence of grade 3 diarrhea was 28.1% and that for the 64 patients in this cohort, 10.9% discontinued neratinib due to diarrhea. The median cumulative duration of grade 3 diarrhea was 2.5 days.”

 

Kisqali (ribociclib) / Novartis
BioItaLEE: Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole(clinicaltrials.gov) – May 28, 2019 – P3; N=287; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Recruiting –> Active, not recruiting; Trial completion date: Oct 2021 –> Nov 2022; Trial primary completion date: Oct 2021 –> Dec 2020

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