Carl Lokko
- Organon (NYSE:OGN) and partner Shanghai Henlius Biotech said that a phase 3 trial of their biosimilar to Roche's (OTCQX:RHHBY) Perjuta (pertuzumab) met its primary endpoint.
- That endpoint was the total pathological complete response (tpCR). Secondary endpoints still under evaluation include tpCR rate assessed by investigators; breast pathologic complete response rate; objective response rate; event-free survival; disease-free survival; safety; pharmacokinetics; and immunogenicity.
- Organon has global commercialization rights for the biosimilar, HLX11, except for China, where Shanghai Henlius has rights.
- Perjuta is approved for the treatment of HER2-positive breast cancer.
