相关临床试验
613
267 进行中
药物批准
18
批准总数
监管机构
1
监管机构数
成立时间
2010
进行中（未招募）
255
41.6%
Available
1
0.2%
已完成
231
37.7%
No Longer Available
2
0.3%
尚未招募
12
2.0%
招募中
78
12.7%
终止
29
4.7%
Unknown
1
0.2%
撤回
4
0.7%
- Japan's MHLW approved trastuzumab deruxtecan plus pertuzumab for HER2-positive unresectable or recurrent breast cancer and datopotamab deruxtecan for triple-negative disease on September 16, 2026. - DESTINY-Breast09 showed the T-DXd combination cut the risk of progression or death by 44% versus THP, with median PFS of 40.7 versus 26.9 months. - TROPION-Breast02 demonstrated a 5.0-month median overall survival gain with datopotamab deruxtecan over chemotherapy in patients who were not candidates for PD-1/PD-L1 inhibitors. - Both DXd antibody-drug conjugates carry an interstitial lung disease warning in Japan, requiring baseline chest CT and ongoing pulmonary monitoring during treatment.
- The EMA's CHMP has recommended EU approval of Enhertu as monotherapy for adults with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant therapy. - The opinion rests on DESTINY-Breast05, in which Enhertu cut the risk of invasive disease recurrence or death by 53% versus T-DM1 (HR 0.47; 95% CI 0.34-0.66; p<0.0001). - At three years, 92.4% of patients on Enhertu were alive and free of invasive disease versus 83.7% on T-DM1, with no new safety concerns reported. - Enhertu is already approved for this adjuvant indication in the US, Brazil, Canada and India; the European Commission will now review the CHMP recommendation.
- NICE has recommended Enhertu for routine NHS use in England for adults with HER2-low advanced or metastatic breast cancer after prior treatment progression. - The decision follows a UK-US pharmaceutical pricing deal that raised NICE's cost-effectiveness threshold and a new quality-of-life assessment method. - Clinical trials showed Enhertu extended median overall survival to 23.4 months versus 16.8 months with standard chemotherapy, a 6.6-month gain. - About 1,000 patients a year in England are expected to be eligible, with Scotland already providing access since 2023 and 26 other European countries covering it.
- NICE has reversed its 2024 rejection of Enhertu, allowing doctors in England to prescribe the drug for HER2-low metastatic breast cancer from Thursday. - Enhertu offers patients almost seven extra months of life on average, with some living up to three years longer, affecting about 1,000 women annually. - The reversal follows a UK-US trade deal raising medicine spending by 25% and NICE's QALY threshold increase from £30,000 to £35,000. - Charities welcomed access but noted thousands missed out during the two-year delay, with Breast Cancer Now calling for systemic reform.
- Enhertu achieved a median progression-free survival of 14.3 months as first-line therapy in HER2-mutant advanced NSCLC, a six-month improvement over pembrolizumab plus chemotherapy. - The Phase 3 DESTINY-Lung04 trial randomized 454 patients 1:1 and showed Enhertu reduced the risk of disease progression or death by 37%. - Objective response rate was 70% with Enhertu versus 44.5% with standard of care, with median duration of response of 13.4 versus 9.7 months. - Interim overall survival data were 46.9% mature with no formal hypothesis testing, and imbalanced subsequent therapy patterns may limit interpretation of the OS result.
- GSK and Hansoh reported that the B7-H3-targeted antibody-drug conjugate risvutatug rezetecan reduced the risk of death by 54% versus topotecan in relapsed small cell lung cancer. - In the phase III ARTEMIS-008 trial, median overall survival reached 18.5 months with Ris-Rez versus 10.3 months with topotecan after a median 12.2 months of follow-up. - Secondary endpoints favored Ris-Rez, with median progression-free survival of 7.2 versus 3.0 months and objective response rates of 58.3% versus 12.6%. - Grade 3 or higher treatment-related adverse events occurred in 60.9% of Ris-Rez patients versus 78.2% with topotecan, with hematologic toxicities predominating.
- PM360 has named Alex Gorsky, former Chairman and CEO of Johnson & Johnson, as its 2026 Lifetime Achievement Award honoree, recognizing his leadership across the company's Pharmaceutical, Medical Device, and Consumer businesses. - Lina Polimeni, Senior Vice President and Chief Marketing Officer—Consumer at Eli Lilly and Company, has been selected as PM360's inaugural Chief Marketing Officer of the Year. - The honorees, along with 31 Brand Champions and over 100 finalists across nine categories, will be celebrated at the 18th Annual Trailblazer Awards Gala on September 29 at Gotham Hall in New York City. - The Trailblazer Awards, established in 2009, recognize innovation and measurable impact in life sciences marketing, with winners selected by the PM360 Editorial Advisory Board.
- Nucleai and Gilead Sciences are collaborating to apply AI-powered Tissue Intelligence to Gilead's global antibody-drug conjugate (ADC) clinical development programs across multiple oncology indications. - The collaboration has analyzed large datasets of H&E and IHC whole-slide images from several Gilead clinical studies, generating candidate spatial biomarkers for future scientific presentations and publications. - Nucleai's platform integrates computational pathology, spatial biology, and clinical outcomes data to map protein expression patterns, tumor heterogeneity, and the tumor microenvironment. - The partnership reflects growing industry recognition that AI-powered tissue analytics can strengthen biomarker development and precision medicine across oncology portfolios.
- The global esophageal cancer market across seven major markets was valued at USD 1.3 billion in 2025 and is projected to grow at a 6% CAGR through 2036, according to a DelveInsight report. - Approximately 79,000 incident cases of esophageal cancer were reported across the 7MM in 2025, with the United States accounting for the largest treatment market share. - Emerging therapies including antibody-drug conjugates such as Telisotuzumab adizutecan, bispecific antibodies like Zanidatamab, and next-generation immunotherapies are expected to reshape the treatment landscape. - Recent FDA approvals of durvalumab, pembrolizumab, and tislelizumab in perioperative and frontline settings have expanded immunotherapy options for esophageal cancer patients.
- Charles "Chuck" Leitgeb, Deputy Director of State Government Relations at Bayer US, was elected Chair of the HINJ Board of Trustees, effective July 1, 2026. - Adam Brand of Otsuka America Pharmaceutical was elected Vice Chair, with Christopher Guiton (Johnson & Johnson) as Treasurer and Derek Naten (Keenova Therapeutics) as Secretary. - Adam Taliaferro of Johnson & Johnson was reappointed Chair of the HINJ Steering Committee, with George Coutros of Sanofi US reappointed as Vice Chair. - The board includes senior government affairs leaders from major pharmaceutical companies including Novo Nordisk, Merck, BD, Novartis, and Daiichi Sankyo.
