Weekly Top News – Breast Cancer – July 1, 2019

July 2, 2019

Nerlynx (neratinib) / Puma
Puma Biotechnology submits a Supplemental New Drug Application to U.S. FDA for neratinib to treat HER2-positive metastatic breast cancer (Businesswire) – Jul 1, 2019 – “Puma Biotechnology, Inc….has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease)….The sNDA is supported by the results of the Phase III NALA trial…”


capivasertib (AZD5363) / Otsuka, AstraZeneca
Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (clinicaltrialsregister.eu) – Jun 26, 2019 – P3; N=800; Ongoing; Sponsor: AstraZeneca AB


Tecentriq (atezolizumab) / Roche; Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka
CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer (GlobeNewswire) – Jun 28, 2019 – “Roche…announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®; nab-paclitaxel) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression (≥ 1%) and who have not received prior chemotherapy for metastatic disease.The CHMP recommendation is based on data from the Phase III IMpassion130 study…”


Talzenna (talazoparib) / Pfizer
Talzenna: “The Committee confirmed that all issues previously identified in this application had been addressed [treatment of adult patients with germline breast cancer susceptibility gene (BRCA) mutated human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer].” (EMEA) – Jun 26, 2019 – CHMP Final Minutes for the meeting on 23-26 April 2019: “The Committee adopted a positive opinion recommending the granting of a marketing authorisation by consensus together with the CHMP assessment report and translation timetable.”


[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
DS-8201 regulatory estimate: Submission for approval in HER2+ breast cancer in June-September 2019 (J.P. Morgan) – Jun 28, 2019 – A subscription to Thomson ONE is required to gain full access to report 67534138; Page no: 1; REPORT TITLE: “Daiichi Sankyo (4568): Raise price target and reiterate overweight rating “; AUTHOR: Kumagai, Naomi, et al; DATE: 06/20/2019


epirubicin / generics
MYELOSUPPRESSION AND MONITORING OF ABSOLUTE NEUTROPHIL COUNTS IN EPIRUBICIN/CYCLOPHOSPHAMIDE-TREATED BREAST CANCER PATIENTS: RESULTS FROM A PHASE-2A COLLABORATIVE TRIAL OF THE AGO-B AND CESAR STUDY GROUPS (MASCC-ISOO 2019) – Jun 24, 2019 – Pres time: Jun 23, 2019; 02:16 PM – 02:19 PM; Location: Station 2; “ANC monitoring may be most informative if measured on day 11 or day 12 to assess the first occurrence (incidence) and on days 13 to 15 for the presence of grade 4 neutropenia (prevalence). A reliable and early detection system for grade 4 neutropenia offers an opportunity for the instigation of preventative measures to mitigate the infection risk for patients.”


Zirabev (bevacizumab biosimilar) / Pfizer
Pfizer receives U.S. FDA approval for its oncology biosimilar, Zirabev (bevacizumab-bvzr) (Businesswire)- Jun 28, 2019 – “Pfizer Inc…announced the United States (U.S.) Food and Drug Administration(FDA) has approved ZIRABEV™ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer…The FDA approval was based on review of a comprehensive data package which demonstrated biosimilarity of ZIRABEV to the reference product. This includes results from the REFLECTIONS B7391003 clinical comparative study…”


Talzenna (talazoparib) / Pfizer; ZEN-3694 / Zenith Capital Corp
Zenith Epigenetics announces dosing of first patient in triple negative breast cancer trial with Pfizer(GlobeNewswire) – Jun 27, 2019 – “Zenith Epigenetics Ltd….announced today that it has dosed the first patient in a Phase 1b/2 clinical trial undertaken in collaboration with Pfizer Inc….The trial will evaluate the combination, safety and efficacy of the Company’s ZEN-3694, a novel and differentiated bromodomain and extra-terminal domain inhibitor (‘BETi’), and Pfizer’s talazoparib, a poly ADP ribose polymerase inhibitor (‘PARPi’), in patients with locally advanced or metastatic triple negative breast cancer without germline BRCA1/2 mutations.”


Minerva Biotechnologies announces FDA acceptance of IND application for huMNC2-CAR44 T cells to treat metastatic breast cancer (Businesswire) – Jun 24, 2019 – “Minerva Biotechnologies…announced today that the U.S. FDA…has approved their IND (Investigational New Drug) application to conduct clinical trials with huMNC2-CAR44, an autologous CAR T cell therapy for solid tumors. huMNC2-CAR44 targets MUC1* (muk one star), a cleaved form of MUC1 present on over 75% of solid tumor cancer cells. Unlike the normal full-length MUC1, MUC1* is a potent growth factor receptor that is rendered constitutively active when onco-embryonic growth factor NME7AB binds to and dimerizes its truncated extracellular domain. Minerva intends to commence clinical trials in breast cancer before the end of 2019.”


Arvinas receives authorization to proceed for ARV-471, a PROTAC protein degrader to treat patients with locally advanced or metastatic ER+ / HER2- breast cancer (GlobeNewswire) – Jun 25, 2019 – “Arvinas, Inc….announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug application (IND) for ARV-471, an oral estrogen receptor (ER) PROTAC® protein degrader, designed to selectively target ER for the treatment of patients with locally advanced or metastatic ER positive / HER2 negative breast cancer. Arvinas expects to initiate a Phase 1 clinical trial for ARV-471 in the third quarter of 2019.”

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