Organon and Shanghai Henlius Biotech Provides Update on P-III Trial of HLX11 (Biosimilar, Perjeta)
Shots:
- The P-III study assessing safety & efficacy of HLX11 vs Perjeta (pertuzumab) in addition to trastuzumab & docetaxel (Q3W, 4 cycles) as a neoadjuvant regimen for treating patients, randomized 1:1, with HER2+/HR- locally advanced breast cancer has reached the 1EP
- The 1EP of the trial includes total pathological complete response (tpCR) rate as per IRC while the 2EPs are tpCR rate assessed by investigators, breast pathologic complete response (bpCR) rate, ORR, EFS, DFS, safety, PK & immunogenicity
- Additionally, Henlius granted Organon exclusive global commercialization rights (excl. China) for two biosimilar candidates, incl. HLX11, as per a license and supply agreement signed in 2022
Ref: Organon | Image: Organon
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
