dm+d

Unassigned

New Medicines

Unresectable, locally advanced or metastatic, HER2-positive breast cancer- second-line

Information

New molecular entity
Medac
Byondis

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Pre-registration (Filed)
Jul 22EMA accepts MAA for trastuzumab duocarmazine in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. Byondis is also preparing a submission to the MHRA [8].
Jul 22FDA accept BLA for trastuzumab duocarmazine in patients with HER2-positive unresectable locally advanced or metastatic breast cancer and assign a PDUFA action date of 12/5/23 [7].
May 22Byondis and medac enter into a license, collaboration and supply agreements for trastuzumab duocarmazine. Under terms of the agreement, medac receives an exclusive license to commercialize SYD985 in the EU, UK and other European countries [6].
Jan 18Granted Fast Track designation by US FDA for treatment of HER2-positive metastatic breast cancer that has progressed during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease, or progressed during or after [ado-]trastuzumab emtansine treatment [3].

Category

Antibody-drug conjugate composed of an anti-HER2 antibody, trastuzumab, and a cleavable linker-drug called valine-citrulline-seco-DUocarmycin-hydroxyBenzamide-Azaindole (vc-seco-DUBA). SYD985 incorporates Byondis’ duocarmazine linker-drug technology ByonZine®.
In 2017, there were 46,109 new diagnoses of breast cancer in England, and 10,219 deaths from breast cancer. It is estimated that ~15-20% of women with breast cancer will have HER2-positive tumours [2].
Unresectable, locally advanced or metastatic, HER2-positive breast cancer- second-line
Intravenous

Trial or other data

Jun 21Byondis announce PIII TULIP trial meets primary endpoint of PFS, demonstrating a statistically significant improvement over physician’s choice. Byondis now plan to explore partnerships with pharma companies to commercialise SYD985 [5].
Sep 20Primary completion date of PIII NCT03262935 is now July 21 [4].
Nov 17Recruitment to PIII TULIP study (NCT03262935) in which women aged ≥18 years with unresectable locally advanced or metastatic HER2-positive breast cancer will receive IV trastuzumab duocarmazine every 3 weeks vs. physician’s choice chemotherapy starts. Approximately 436 women will be recruited in several countries including in US, EU and UK. Primary outcome is PFS [1].