Zanidatamab

Zymeworks Inc. announces progress in its R&D, including the nomination of ZW209 as its fifth development candidate in solid tumors, 18 months ahead of schedule. The company expands into autoimmune and inflammatory diseases (AIID) and hematology oncology, leveraging its Azymetric™ technology. ZW1528, targeting respiratory inflammation, is highlighted. Zymeworks plans to advance five drug candidates into clinical trials for solid tumors by 2026, with IND applications for ZW209, ZW220, and ZW251 expected by 2025-2026.

ALX Oncology to host a webcast on Dec 17, 2024, discussing Phase 1b/2 trial data of evorpacept with zanidatamab for metastatic breast cancer, presented at SABCS 2024. Event features ALX leadership and Dr. Alberto J. Montero, with live and archived access available.

Zanidatamab-hrii (Ziihera), a HER2-targeting bispecific antibody, is now a category 2A treatment option in NCCN guidelines for biliary tract cancer (BTC). FDA accelerated approval was based on HERIZON-BTC-01 trial results showing a 52% ORR and 14.9 months DOR. The trial enrolled 62 HER2+ BTC patients previously treated with gemcitabine. Updated results at 2024 ASCO showed median OS of 15.5 months, with higher rates in HER2 IHC 3+ patients. Zanidatamab inhibits tumor growth through multiple mechanisms and is the first chemotherapy-free option for BTC. Common AEs included diarrhea, infusion-related reactions, abdominal pain, and fatigue, with manageable safety profile. Ongoing trials aim to validate benefits and explore zanidatamab in other HER2-expressing cancers.

November 2024 saw numerous FDA approvals, designations, and clinical trial advancements in oncology, including revumenib for KMT2A-rearranged acute leukemia, obe-cel for relapsed/refractory B-cell ALL, and fast track designations for ALE.P02 in Claudin-1-positive tumors. Other highlights include orphan drug designations for LBL-024 in neuroendocrine cancer and elraglusib in Ewing sarcoma, and a new drug application for sunvozertinib in EGFR-mutant NSCLC.

Jazz Pharmaceuticals (JAZZ) posted Q3 top-and-bottom-line beats, projecting 2024 earnings above expectations, driven by sales growth from Xywav and Epidiolex. The company received accelerated approval for Ziihera, a treatment for HER2-positive biliary tract cancer, and anticipates phase 3 PFS results on Zanidatamab. JAZZ trades at a discount to peers, making it attractive for value investors.

The FDA approved PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody as a companion diagnostic for zanidatamab-hrii to assess HER2+ status in biliary tract cancer patients, identifying those eligible for zanidatamab treatment. This is the first FDA-approved companion diagnostic for HER2+ BTC, potentially improving clinical outcomes.

The FDA approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to assess HER2-positive status in biliary tract cancer patients, identifying those eligible for zanidatamab-hrii treatment. Zanidatamab received accelerated approval for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The phase 2b HERIZON-BTC-01 trial supported the approval, showing a 52% ORR and 14.9-month median DOR in HER2 IHC 3+ patients. Long-term follow-up data maintained cORR and DCR, with a median OS of 15.5 months. Safety data indicated common TRAEs like diarrhea and infusion-related reactions, with no deaths attributed to zanidatamab.

Jazz Pharmaceuticals' zanidatamab (Ziihera) receives US FDA accelerated approval for HER2-positive biliary tract cancer, marking the first dual HER2-targeted bispecific antibody for this indication. Based on HERIZON-BTC-01 trial data, Ziihera shows a 52% objective response rate and 14.9-month median duration of response, positioning it as an effective treatment option. The approval underscores the growing role of bispecific antibodies in cancer therapy, with sales of such antibodies projected to exceed $40 billion by 2029.