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Weekly Top News – Breast Cancer – May 13, 2019

May 13, 2019

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
Pivotal phase II DESTINY-Breast01 trial met primary endpoint, supporting global regulatory submission plan to start in H2 2019 (AstraZeneca Press Release) – May 7, 2019 – P2, N=230; DESTINY-Breast01 (NCT03248492); Sponsor: Daiichi Sankyo, Inc; “The HER2-targeting antibody drug conjugate (ADC) and potential new medicine was evaluated in patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine….The safety and tolerability profile of trastuzumab deruxtecan was also consistent with previous experience. These results are expected to support planned global regulatory submissions, including a Biologics License Application with the US Food and Drug Administration (FDA) anticipated in the second half of 2019.”

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: Interim OS analysis from P3 E2112 trial (NCT02115282) in combination with exemestane for advanced HR+ breast cancer in Q4 2019 (Syndax) – May 7, 2019 – Q1 2019 Results: Final OS analysis in Q2 2020
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entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: NDA submission for advanced HR+, HER2- breast cancer in 2020 (Syndax) – May 7, 2019 – Q1 2019 Results
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Avastin (bevacizumab) / Roche; Tecentriq (atezolizumab) / Roche; Kadcyla (ado-trastuzumab emtansine) / Roche; Venclexta (venetoclax) / Roche, AbbVie; Perjeta (pertuzumab) / Roche; entrectinib (RXDX-101) / Roche
Roche to present new data highlighting comprehensive approach to cancer care at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Roche Press Release) – May 10, 2019 – “Roche….announced that new data from clinical trials of 17 approved and investigational medicines across 27 cancer types, including hard-to-treat and rare tumours, will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, United States, from 31 May– 4 June, 2019. A total of 155 abstracts that include a Roche medicine will be presented at this year’s meeting.”

 

Herceptin Hylecta (trastuzumab/hyaluronidase-oysk) / Roche, Halozyme Therapeutics; pegvorhyaluronidase alfa (PEGPH20) / Halozyme Therapeutics
Halozyme reports first quarter 2019 results (PRNewswire) – May 7, 2019 – “‘We enjoyed a strong start to 2019 as our first quarter included a new ENHANZE® collaboration with argenx, positive phase III data from Janssen’s COLUMBA study evaluating a subcutaneous formulation of DARZALEX®, and FDA approval of Herceptin Hylecta™’….On ENHANZE® we anticipate regulatory submissions by ENHANZE® partner Janssen for the subcutaneous formulation of DARZALEX®, a new phase 3 trial initiation by one of our ENHANZE® partners and multiple Phase 1 trial initiations. On PEGPH20, we project the announcement of topline results from our HALO-301 pivotal phase 3 trial in pancreas cancer in the second half of the year.'”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology reports first quarter 2019 financial results (Businesswire) – May 9, 2019 – “…’During 2019, we anticipate the following key milestones for Puma: (i) filing a new drug application for neratinib based on the results of the Phase III trial in third-line metastatic breast cancer in the summer of 2019; (ii) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the summer of 2019; and (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in other countries in the second half of 2019.”

 

Tecentriq (atezolizumab) / Roche; Herceptin (trastuzumab) / Roche; Perjeta (pertuzumab) / Roche
Genentech to present new data highlighting comprehensive approach to cancer care at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) – May 10, 2019 – P3, N=900; IMpassion130 (NCT02425891); P3, N=808; CLEOPATRA (CLEOPATRA); Sponsor: Hoffmann-La Roche; “Key presentations in breast cancers: Key data to be presented at ASCO include…second interim analysis of overall survival (OS) results, updated safety data and patient-reported outcomes (PROs) from the Phase III IMpassion130 study of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane…) for the treatment of PD-L1-positive, metastatic triple-negative breast cancer (TNBC)…Additional data include an eight-year, end-of-study analysis from the Phase III CLEOPATRA study of Perjeta® (pertuzumab) plus Herceptin® (trastuzumab) and chemotherapy for first-line treatment of HER2-positive metastatic breast cancer.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology reports first quarter 2019 financial results (Businesswire) – May 9, 2019 – P3, N=621; NALA (NCT01808573); P2, N=392; SUMMIT (NCT01953926); P2, N=650; CONTROL (NCT02400476); Sponsor: Puma Biotechnology; “…’During 2019, we anticipate the following key milestones for Puma: (i) presenting data from the Phase III trial of neratinib in third-line metastatic breast cancer patients in the second quarter of 2019; (ii) reporting additional data from the Phase II CONTROL trial in the second quarter of 2019; and (iii) reporting Phase II data from the SUMMIT basket trial in patients with HER2 mutations in the second half of 2019′.”

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals reports fourth quarter 2018 financial results and provides clinical and business update (Syndax Press Release) – May 6, 2019 – P3, N=600; NCT02115282; “The Company continues to anticipate the next interim OS analysis for E2112, its NCI-sponsored, ECOG-ACRIN led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer, in the second quarter of 2019. Additional interim analyses will be conducted by ECOG-ACRIN approximately every six months until either an OS benefit is observed, or the final target number of events occur. Any positive OS assessment would enable the Company to file for full regulatory approval.”

 

HLX02 (trastuzumab biosimilar) / Fosun Pharma
Henlius biosimilar HLX02 gets NDA acceptance from NMPA (Biospectrumasia) – May 8, 2019 – “Shanghai Henlius Biotech, Inc., subsidiary of Shanghai Fosun Pharmaceutical Group Co. has recently received a New Drug Application (NDA) acceptance from the National Medical Products Administration (NMPA) for its biosimilar HLX02, a trastuzumab for injection.”

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