AstraZeneca plc
Swedish–British multinational pharmaceutical and biotechnology company headquartered in Cambridge, England; develops medications across oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation areas; formed in 1999 through the merger of Swedish Astra AB and British Zeneca Group.
相关临床试验
3925
414 进行中
药物批准
40
批准总数
监管机构
1
监管机构数
成立时间
1999
Unknown
9
0.2%
已完成
2748
70.0%
Enrolling By Invitation
1
0.0%
尚未招募
38
1.0%
No Longer Available
4
0.1%
终止
224
5.7%
招募中
249
6.3%
暂停
8
0.2%
Approved For Marketing
6
0.1%
撤回
59
1.5%
进行中（未招募）
375
9.6%
- 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.
- Cellectis' board approved a strategic transformation on September 11, 2026, ending internal development of CAR-T candidates lasme-cel and eti-cel and refocusing on in vivo gene editing. - The company will advance two preclinical programs, .HEAL-101 targeting APOC3 for severe hypertriglyceridemia and .HEAL-201 targeting PCSK9 for severe hypercholesterolemia, both LNP-delivered. - Cellectis attributed the CAR-T exit to improved frontline regimens, bispecific antibody competition and slower enrollment, and will seek partners for the discontinued assets. - The operational realignment is designed to extend the cash runway into H2 2028, with preliminary Phase 1 data from .HEAL-101 expected in H2 2027 and .HEAL-201 in H1 2028.
- Updated ADAURA Phase III data show 79% of adjuvant osimertinib-treated patients with Stage IB-IIIA EGFR-mutated NSCLC alive at eight years versus 64% on placebo. - In the primary Stage II-IIIA population, eight-year overall survival was 74% with osimertinib versus 58% with placebo, a 16-percentage-point difference. - Osimertinib reduced the risk of death by 48% in the overall population (HR 0.52; 95% CI 0.39-0.71) and 47% in the primary population (HR 0.53; 95% CI 0.38-0.75). - Investigators emphasize EGFR testing at diagnosis and completing the three-year adjuvant course, with early discontinuation linked to more than twice the recurrence or death risk.
- AstraZeneca's Phase III SERENA-4 trial of camizestrant (Etcamah) plus palbociclib failed to meet its primary progression-free survival endpoint in ER-positive, HER2-negative advanced breast cancer. - A numerical PFS improvement was observed versus anastrozole plus palbociclib, but the difference did not reach statistical significance, with detailed results pending future presentation. - The safety profile of the combination was consistent with the known profiles of each medicine, and no new safety concerns were identified. - The result contrasts with positive SERENA-6 data that supported the FDA's September 4 accelerated approval of Etcamah in ESR1-mutated disease, and AstraZeneca continues CAMBRIA-1 and CAMBRIA-2 trials in early breast cancer.
- AstraZeneca completed an exclusive licensing agreement with Dizal Pharmaceutical for ZEGFROVY, gaining worldwide development and commercialization rights to the lung cancer drug. - The deal includes $600 million upfront plus up to $900 million in milestone payments, with tiered royalties on global sales for Dizal. - ZEGFROVY, an oral irreversible EGFR inhibitor approved in the U.S. and China for second-line EGFR exon 20 insertion NSCLC, is under FDA review for first-line use.
- Amgen's phase III DeLLphi-305 trial met its primary overall survival endpoint for tarlatamab plus durvalumab versus durvalumab alone as first-line maintenance in extensive-stage small-cell lung cancer. - The 563-patient randomized study enrolled patients whose disease had not progressed after induction with durvalumab, platinum chemotherapy and etoposide, with PFS and ORR also significantly improved. - No numerical survival data, hazard ratios or safety tables were disclosed, and the full dataset is slated for presentation at an upcoming medical meeting and regulatory submission. - Tarlatamab, a DLL3-directed bispecific T-cell engager already approved in second-line ES-SCLC, could move earlier into the maintenance setting if the benefit is confirmed.
- Updated ADAURA Phase III results show adjuvant Tagrisso (osimertinib) reduced the risk of death by 48% versus placebo at eight years in resected EGFR-mutated NSCLC. - In the Stage II-IIIA primary population, 74% of Tagrisso-treated patients were alive at eight years versus 58% on placebo, with a hazard ratio of 0.53. - AstraZeneca described the findings as the longest survival data ever reported in a global Phase III trial in this early-stage lung cancer setting. - Separate real-world data showed early discontinuation of the three-year Tagrisso course more than doubled the risk of recurrence or death.
- Merck is building its next growth phase around a phase III pipeline that has nearly tripled since 2021 and a target of 20 new drug launches by 2030. - The company projects more than $70 billion in non-risk-adjusted commercial opportunity from its current pipeline by the mid-2030s, more than double Keytruda's $35 billion peak consensus estimate. - Merck and Moderna reported the first positive phase 3 result for a personalized mRNA cancer vaccine, though detailed efficacy and overall survival data remain pending. - Management expects the Keytruda loss-of-exclusivity period to resemble a shallow dip or hill with a quick return to growth rather than a revenue cliff.
- The Phase III DeLLphi-305 trial met its primary endpoint, showing tarlatamab plus durvalumab significantly improved overall survival versus durvalumab alone in extensive-stage SCLC. - The combination also improved progression-free survival and objective response rate as first-line maintenance in patients whose disease had not progressed after induction therapy. - Amgen and AstraZeneca reported the survival benefit at a planned interim analysis, with full data to be presented at an upcoming medical meeting. - Oncologists called the results potentially practice-changing for a disease where roughly 40% of patients never reach second-line treatment.
- The FDA granted accelerated approval to camizestrant (Etcamah) with a CDK4/6 inhibitor for HR-positive, HER2-negative advanced breast cancer with emerging ESR1 mutations. - Approval followed the Oncologic Drugs Advisory Committee's 6-3 vote against the application in April, with the agency reviewing supplemental AstraZeneca analyses before deciding. - In the SERENA-6 trial of 315 patients, median progression-free survival was 16 months with camizestrant versus 9.2 months on continued standard therapy, hazard ratio 0.44. - The label carries a boxed warning for QTc-related arrhythmia, and eligibility depends on blood-based ctDNA testing with the newly approved Guardant360 CDx assay.
