相关临床试验
6
1 进行中
药物批准
2
批准总数
监管机构
1
监管机构数
成立时间
2017
进行中（未招募）
1
16.7%
已完成
3
50.0%
终止
1
16.7%
撤回
1
16.7%
- New post hoc analysis of the Phase 2 eNRGy trial demonstrates zenocutuzumab-zbco achieved a 35% overall response rate in treatment-naïve NRG1+ NSCLC patients compared to 31% in previously treated patients. - Treatment-naïve patients experienced significantly longer median duration of response at 17.1 months versus 7.4 months in previously treated patients, with all treatment-related adverse events being grade 1 or 2. - The clinical benefit rate reached 65% in treatment-naïve patients compared to 58% in previously treated patients, supporting early intervention with targeted therapy for this rare molecular subset. - Results were presented at the IASLC-ASCO North America Conference on Lung Cancer, reinforcing zenocutuzumab's potential as a first-line treatment option for NRG1-positive NSCLC patients.
- Zenocutuzumab demonstrated a 37% objective response rate in 19 patients with NRG1-positive cholangiocarcinoma in the phase II eNRGy trial, with a median duration of response of 7.4 months. - The bispecific antibody targeting HER2 and HER3 achieved a median progression-free survival of 9.2 months in this rare cancer subtype that affects fewer than 1% of cholangiocarcinoma patients. - All 16 evaluable patients showed declines in CA 19-9 cancer biomarker levels, with 69% experiencing more than 50% reduction, supporting the drug's anticancer activity. - The FDA granted zenocutuzumab Breakthrough Therapy designation for NRG1-positive cholangiocarcinoma based on these results, expanding beyond its current approvals for lung and pancreatic cancers.
- Debiopharm has licensed SunRock Biopharma's SRB21, a bispecific antibody targeting both HER2 and HER3 receptors, to develop the ADC Debio 2512 using their proprietary MultiLINK™ Linker Technology. - The dual-targeting approach aims to overcome resistance mechanisms that limit current HER2-directed therapies by simultaneously targeting HER2 and HER3 receptors in aggressive cancer types. - HER2-driven cancers are characterized by faster growth, earlier relapse, and higher treatment resistance, with many patients ultimately developing resistance and metastasis despite recent therapeutic advances. - The bispecific ADC strategy represents a potential breakthrough for patients with resistant cancer types by enabling more potent cytotoxic payload delivery while sparing healthy tissues.
- The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Partner Therapeutics' IMREPLYS (sargramostim) for treating patients exposed to myelosuppressive radiation doses. - IMREPLYS represents the same formulation as LEUKINE, which received FDA approval in 2018 for Hematopoietic Syndrome of Acute Radiation Syndrome in the United States. - European Commission approval is expected within 67 days, enabling sales and government stockpiling across all EU member states plus Norway, Iceland, and Liechtenstein. - The approval addresses critical preparedness needs amid current geopolitical threats involving tactical nuclear weapons and radiation exposure risks.
• Belfast-based Diaceutics has signed a multi-year contract worth up to £11.5 million with Partner Therapeutics to commercialize the oncology precision medicine BIZENGRI (zenocutuzumab). • The agreement leverages Diaceutics' DXRX platform and PMx commercialization solutions to identify patients based on genomic profiles and accelerate optimal treatment delivery. • The contract includes £4.5 million in recurring service revenues through September 2026, with potential extension to 2028 that would add another £7 million in revenue.
• Merus N.V. has received FDA approval for Bizengri, its first commercial product, targeting NRG1 gene fusions in various cancers. • Bizengri offers a new treatment option for patients with aggressive cancers who have progressed despite prior systemic therapies. • Merus has partnered with Partner Therapeutics, Inc. for the commercialization of zenocutuzumab (Zeno) in the U.S. for NRG1 fusion-positive cancers.
• Novocure's electrical field-emitting device, combined with chemotherapy, significantly extended survival in locally advanced pancreatic cancer patients by two months in a Phase 3 trial. • The FDA is set to decide on Cytokinetics' aficamten for obstructive hypertrophic cardiomyopathy by September 26, 2025, following positive Phase 3 trial results. • Merus has granted Partner Therapeutics U.S. rights to zenocutuzumab, an experimental cancer drug currently under FDA review for NRG1 fusion-positive tumors, with a decision expected by February 4, 2025. • The FDA is investigating blood cancer cases linked to Bluebird bio's gene therapy Skysona, advising caution and consideration of alternative treatments like stem cell transplants.
- The FDA has granted accelerated approval to Bizengri (zenocutuzumab-zbco) for advanced pancreatic adenocarcinoma and non-small cell lung cancer with NRG1 gene fusions. - Bizengri is the first systemic therapy approved by the FDA specifically targeting NRG1 gene fusions in these cancers after prior systemic therapy. - Clinical trial data showed overall response rates of 40% in pancreatic cancer and 33% in NSCLC, with manageable side effects, supporting the approval. - This approval highlights the importance of biomarker testing to identify NRG1 fusions, enabling personalized treatment for these difficult-to-treat cancers.
• The FDA has granted accelerated approval to Bizengri (zenocutuzumab-zbco) for advanced unresectable or metastatic NRG1+ pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC). • Bizengri is the first and only FDA-approved therapy specifically targeting NRG1 gene fusions in these cancers, offering a new treatment option for patients with disease progression after prior systemic therapy. • Approval was based on overall response rate (ORR) and duration of response (DOR) data from the eNRGy trial, with continued approval contingent on confirmatory trial results. • Bizengri carries a Boxed Warning for Embryo-Fetal Toxicity and warnings for infusion-related reactions, interstitial lung disease/pneumonitis, hypersensitivity/anaphylactic reactions and left ventricular dysfunction.
