相关临床试验
122
84 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2010
进行中（未招募）
84
68.8%
Approved For Marketing
1
0.8%
已完成
23
18.9%
招募中
6
4.9%
终止
5
4.1%
撤回
1
0.8%
暂无批准数据
- Alteogen signed an exclusive option and license agreement with Novartis for its hyaluronidase ALT-B4, with maximum payments reaching $3.223 billion if all options and milestones are achieved. - Novartis secured multiple options to develop and commercialize subcutaneous formulations of biopharmaceuticals using ALT-B4, choosing it over Halozyme's Enhanze platform. - ALT-B4's patent protection extends into the early 2040s, while Halozyme's core composition-of-matter patents expire between 2027 and 2029, reinforcing Alteogen's long-term exclusivity position.
- Pfizer's Talzenna combined with Xtandi demonstrated statistically significant and clinically meaningful improvement in radiologic progression-free survival in patients with HRR-mutated hormone-sensitive prostate cancer. - The Talapro-3 trial results markedly exceeded the pre-specified target hazard ratio of 0.63, with early analysis showing a strong trend toward overall survival benefit. - Success could expand Talzenna's market beyond its current castration-resistant prostate cancer indication, though Johnson & Johnson's Akeega already secured FDA approval for hormone-sensitive disease in December 2024. - Pfizer plans to submit the results to global regulators for potential expanded approval, representing a significant advancement for patients with HRR gene mutations earlier in their disease course.
- GSK and AnaptysBio are engaged in dueling lawsuits over their 11-year collaboration agreement covering the cancer immunotherapy Jemperli, with GSK seeking to terminate the deal and halve royalty payments. - The dispute centers on GSK's alleged testing of experimental drugs with competitor PD-1 inhibitors like Keytruda rather than with Jemperli, which AnaptysBio claims violates exclusivity obligations. - Jemperli recorded $785 million in sales through the first nine months of 2025 and is on track to become a $1 billion blockbuster, triggering a $75 million milestone payment to AnaptysBio. - The outcome could significantly impact AnaptysBio's revenue stream, potentially reducing annual royalties from $390 million to $195 million once Jemperli reaches peak sales of $2.7 billion.
- GSK's subsidiary Tesaro has filed litigation in Delaware Chancery Court against AnaptysBio, alleging material breach of their 2014 license agreement for the cancer drug Jemperli (dostarlimab). - The lawsuit stems from AnaptysBio's attempt to revoke Tesaro's license, with Tesaro claiming this breach entitles it to secure a perpetual license and reduce royalties and milestone payments by 50%. - Jemperli is currently approved in over 35 countries for endometrial cancer and is undergoing trials for additional cancers including rectal, colon, and head and neck cancers. - The legal dispute follows AnaptysBio's counter-claims that Tesaro failed to meet certain contractual obligations under the original licensing agreement.
- Zymeworks Inc. has appointed Dr. Adam Schayowitz as Acting Chief Development Officer to advance the company's broad portfolio of nominated product candidates and strengthen strategic partnerships. - Dr. Schayowitz brings nearly 20 years of oncology drug development experience, having led dozens of global development programs from initiation through approval and commercialization at companies including Pfizer, Tesaro, and Algeta. - The appointment comes at a pivotal moment for Zymeworks as the company advances therapeutic candidates including recent IND clearance for ZW251 and expanded global approvals of zanidatamab for HER2-positive biliary tract cancer. - Zymeworks is rapidly advancing a robust pipeline leveraging expertise in antibody drug conjugates and multispecific antibody therapeutics, with ZW191 Phase 1 study actively recruiting and ZW251 expected to enter clinical trials in 2025.
- GSK's anti-TIM-3 monoclonal antibody cobolimab failed to improve overall survival in the Phase III COSTAR trial for advanced non-small cell lung cancer patients previously treated with immunotherapy. - The study tested both triple therapy (cobolimab plus Jemperli and docetaxel) and double combination (Jemperli plus docetaxel) against docetaxel alone, with neither meeting the primary efficacy endpoint. - This setback adds to a growing list of failed TIM-3 checkpoint inhibitor programs from major pharmaceutical companies including Novartis, Roche, and Bristol Myers Squibb. - Despite the failure, cobolimab remains in Phase II studies for liver cancer, cervical cancer, and melanoma, though GSK has not confirmed its development plans.
- PARP inhibitors have demonstrated efficacy in platinum-sensitive epithelial ovarian cancer, particularly in high-grade serous disease, and in breast cancer with BRCA1/2 mutations. - Olaparib maintenance therapy significantly improved progression-free survival in relapsed high-grade serous ovarian cancer, especially in patients with BRCA1/2 mutations. - Clinical trials are underway to evaluate PARP inhibitors like veliparib, rucaparib, and niraparib in various solid tumors, aiming to identify predictive biomarkers for patient selection. - Research suggests PARP inhibitors' mechanism involves multiple aspects of PARP1 biology, including BER inhibition, PARP1 trapping, defective BRCA1 recruitment, and NHEJ activation.
- Niraparib maintenance therapy significantly improves progression-free survival (PFS) in patients with recurrent, platinum-sensitive ovarian cancer, regardless of BRCA mutation status. - The NOVA trial, a phase 3 study, demonstrated a statistically significant and clinically meaningful benefit with niraparib compared to placebo in prolonging time to disease progression. - Niraparib showed efficacy in both patients with and without germline BRCA mutations, highlighting its potential as a broad maintenance therapy option. - The safety profile of niraparib was manageable, supporting its use as a maintenance strategy to extend remission in recurrent ovarian cancer.
