Weekly Top News – Breast Cancer – June 10, 2019

June 10, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq: “Tecentriq + nab-paclitaxel was well tolerated, with no cumulative toxicities and no new or late-onset safety signals”; Metastatic triple negative breast cancer (Roche) – Jun 4, 2019 – ASCO 2019: “Although not formally testable due to the pre-specified statistical analysis plan, updated median OS improvement from 18 to 25 months was observed in the PD-L1+ population (HR 0.71)”  


Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P3 IMpassion 131 trial (NCT03125902) for 1L TNBC in H1 2020 (Cowen & Co) – Jun 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67405938; Page no: 1; REPORT TITLE: “Roche Holding Ltd.- Estimates raised on higher new product sales forecasts”; AUTHOR: Scala, Stephen, et al; DATE: 05/29/2019


Focus V (anlotinib) / Advenchen, Sino Biopharmaceutical; Keytruda (pembrolizumab) / Merck (MSD)
Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Combined With Pd-1 Antibody (clinicaltrials.gov) – Jun 5, 2019 – P2/3; N=100; Recruiting; Sponsor: Henan Cancer Hospital


Nerlynx (neratinib) / Puma
Puma Biotechnology presents results from phase III NALA trial of neratinib in patients with HER2-positive metastatic breast cancer at the ASCO 2019 Annual Meeting (Businesswire) – Jun 4, 2019 – P3, N=621; NALA (NCT01808573); Sponsor: Puma Biotechnology; “For the primary analysis of centrally confirmed PFS, treatment with neratinib plus capecitabine resulted in a statistically significant improvement in centrally confirmed PFS (hazard ratio=0.76, p=0.0059) compared to treatment with lapatinib plus capecitabine…For the primary analyses of OS, neratinib plus capecitabine resulted in an improvement in OS that trended positively in favor of the neratinib plus capecitabine arm of the study (hazard ratio = 0.88, p=0.21)…Puma plans to submit its New Drug Application to the U.S. Food and Drug Administration based on the Phase III NALA trial results in the second quarter/third quarter of 2019.”


margetuximab (MGAH 22) / MacroGenics
Margetuximab: “Margetuximab plus chemotherapy improved PFS (CBA: HR=0.76, P=0.033; Inv: HR=0.70, P=0.001), ORR, and CBR, compared with trastuzumab plus chemotherapy”; Breast cancer(Macrogenics) – Jun 5, 2019 – ASCO 2019: “Enhanced PFS benefit with margetuximab in exploratory subpopulation of low-affinity CD16A-158F carriers (HR=0.68, P=0.005)”  


Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P3 IMpassion 131 trial (NCT03125902) for 1L TNBC in September 2020 (Barclays) – Jun 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 67382590; Page no: 13; 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


Kadcyla (ado-trastuzumab emtansine) / Roche; tucatinib (ARRY-380) / Seattle Genetics
A Study of Tucatinib vs. Placebo in Combination With Trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer (clinicaltrials.gov) – Jun 5, 2019 – P3; N=460; Not yet recruiting; Sponsor: Seattle Genetics, Inc.


margetuximab (MGAH 22) / MacroGenics
Margetuximab: Regulatory approval in US for 3/4 L HER2 positive metastatic breast cancer in 2020(Macrogenics) – Jun 5, 2019 – ASCO 2019: Regulatory submission in EU in 3/4 L HER2 positive metastatic breast cancer in 2020  


Tecentriq (atezolizumab) / Roche
Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Roche Press Release) – Jun 3, 2019 – P3, N=900; IMpassion130 (NCT02425891); Sponsor: Hoffmann-La Roche; “Data include results from the second overall survival (OS) interim analysis from the phase III IMpassion130 study evaluating Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®[paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the initial (first-line) treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)….At the second interim analysis, statistical significance was not met for overall survival (OS) in the intention-to-treat (ITT) population (median OS=21.0 vs 18.7 months; HR=0.86, 95% CI: 0.72-1.02, p=0.078).”

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