IND Application for Ph 3 Study of Neoadjuvant KN026 +Albumin-bound Docetaxel in Breast Cancer Approved

“Alphamab Oncology and CSPC Pharmaceutical Group jointly announced that an application for a phase III clinical study (Study ID: KN026-004) of the anti-HER2 bispecific antibody KN026 combined with albumin-bound Docetaxel HB1801 has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer.”

Share:

More News

PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission

“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the

The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from

“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is