The goal of this study is to learn what happens to doravirine (DOR) and islatravir (ISL) in a healthy lactating female's body over time. Researchers want to learn if DOR and ISL are in breast milk.

开始日期2025-09-26

申办/合作机构

Merck Sharp & Dohme LLC

NCT06719570

/ Completed临床1期

An Open-Label Study to Evaluate the Effect of a High-Fat Meal on the Pharmacokinetics of Doravirine/Islatravir (100 mg/0.25 mg) Fixed-dose Combination Tablet and to Compare the Pharmacokinetics of Doravirine/Islatravir to Doravirine and Islatravir Single Entities in Healthy Adult Participants

The purpose of this study is to learn what happens to MK-8591A in a person's body over time. Researchers will compare what happens to MK-8591A in the body when it is given with and without food.

开始日期2024-01-23

申办/合作机构

Merck Sharp & Dohme LLC

NCT05766501

/ Active, not recruiting临床3期

A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

开始日期2023-03-17

申办/合作机构

Merck Sharp & Dohme LLC

100 项与多拉韦林/伊拉曲韦相关的临床结果

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100 项与多拉韦林/伊拉曲韦相关的转化医学

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100 项与多拉韦林/伊拉曲韦相关的专利（医药）

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项与多拉韦林/伊拉曲韦相关的文献（医药）

2026-02-01·LANCET

Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, multicentre, randomised, controlled, double-blind, non-inferiority trial

Article

作者: Su, Feng-Hsiu ; Colson, Amy E ; Ramgopal, Moti N ; Mills, Anthony M ; Johnson, Margaret ; Katner, Harold P ; Crofoot, Gordon ; Lahoulou, Rima ; Diamond, Tracy L ; Barninger, Erika ; Fox, Michelle C ; Bettacchi, Christopher ; Osiyemi, Olayemi O ; Klopfer, Stephanie O ; Eves, Karen ; Xu, Yayun ; Stamm, Luisa M ; Gatanaga, Hiroyuki ; Hinestrosa, Federico

BACKGROUND:

The combination of doravirine and islatravir is under investigation as a fixed-dose, single-tablet regimen for the treatment of HIV-1. We aimed to assess the efficacy and safety of switching to doravirine (100 mg) and islatravir (0·25 mg) from bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV-1.

METHODS:

This phase 3, randomised, controlled, double-blind, non-inferiority trial was conducted at 49 research, community, and hospital-based clinics in six countries: Australia, Chile, Israel, Japan, the UK, and the USA. Adults aged 18 years or older with HIV-1, who were virologically suppressed (with a viral load of HIV-1 RNA <50 copies per mL) for at least 3 consecutive months on bictegravir, emtricitabine, and tenofovir alafenamide and had no history of treatment failure or known resistance to doravirine, were eligible for the study. Participants were randomly assigned, in a 2:1 ratio according to a computer-generated randomisation schedule with a block size of three, to switch to oral doravirine (100 mg) and islatravir (0·25 mg) or to continue bictegravir, emtricitabine, and tenofovir alafenamide, once daily. Participants, investigators, study staff, and sponsor personnel were masked to study treatment; sponsor personnel directly involved in this analysis were unmasked at week 48. The primary endpoint, which was assessed in all randomly assigned participants who received at least one dose of study treatment, was the percentage of participants with a viral load of 50 copies per mL or higher at week 48 according to the US Food and Drug Administration snapshot approach; non-inferiority would be concluded if the upper bound of the multiplicity-adjusted 95% CI for the treatment difference was less than 4%. The trial is registered at ClinicalTrials.gov, NCT05630755, and is ongoing but closed to enrolment.

FINDINGS:

Between Feb 17 and Nov 17, 2023, 585 individuals were screened, of whom 514 were randomly assigned and 513 treated: 342 participants were switched to doravirine (100 mg) and islatravir (0·25 mg) and 171 continued bictegravir, emtricitabine, and tenofovir alafenamide. The median age of the 513 participants was 47 years (IQR 37-58), 403 (79%) were assigned male and 110 (21%) were assigned female at birth, 158 (31%) were Black or African American, and 117 (23%) were Hispanic, Latino, or Latina. At week 48, doravirine and islatravir showed non-inferiority to bictegravir, emtricitabine, and tenofovir alafenamide (viral load ≥50 copies per mL in five [1·5%] of 342 vs one [0·6%] of 171 participants) with a treatment difference of 0·9% (multiplicity-adjusted 95% CI -1·9 to 2·9). The rates of adverse events (74·6% [255 of 342 participants] vs 71·3% [122 of 171 participants]; difference 3·2 [95% CI -4·7 to 11·6]), treatment-related adverse events (10·2% [35] vs 9·4% [16]; 0·9 [-5·1 to 6·0]), serious adverse events (4·4% [15] vs 6·4% [11]; -2·0 [-7·1 to 1·9]), and discontinuations due to adverse events (2·9% [ten] vs 1·8% [three]; 1·2 [-2·3 to 3·9]) were similar in the doravirine and islatravir group and the bictegravir, emtricitabine, and tenofovir alafenamide group, and no deaths were reported.

INTERPRETATION:

The combination of doravirine (100 mg) and islatravir (0·25 mg) has similar efficacy and safety profiles to bictegravir, emtricitabine, and tenofovir alafenamide, and could provide a two-drug, once daily, oral single-tablet option without an integrase strand-transfer inhibitor for adults who are virologically suppressed and want to switch to a different ART regimen.

FUNDING:

Merck Sharp & Dohme, a subsidiary of Merck & Co.

2026-02-01·Lancet HIV

Fixed-dose daily doravirine (100 mg) with islatravir (0·25 mg) versus bictegravir, emtricitabine, and tenofovir alafenamide for initial HIV-1 therapy: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trial

Article

作者: Diamond, Tracy L ; Fox, Michelle C ; Avihingsanon, Anchalee ; Vesnesky, Mary ; Sinclair, Gary ; Paredes, Roger ; Klopfer, Stephanie O ; Gatanaga, Hiroyuki ; Pisculli, Mary L ; Rockstroh, Jürgen K ; Bettacchi, Christopher ; Kassim, Sheetal ; Crabtree Ramírez, Brenda ; Molina, Jean-Michel ; Stamm, Luisa M ; Mugo, Nelly ; Xu, Yayun

BACKGROUND:

Doravirine and islatravir is a two-drug regimen being investigated for the treatment of HIV-1. This study evaluated efficacy and safety of once daily doravirine and islatravir versus bictegravir, emtricitabine, and tenofovir alafenamide in adults with HIV-1 who were treatment-naive.

METHODS:

MK-8591A-053 is a phase 3, randomised, double-blind, active-controlled, non-inferiority study being done at 116 research, community, and hospital-based clinics across 20 countries. Adults aged at least 18 years with HIV-1 RNA of 500 copies per mL or more never previously treated for HIV-1 were randomly assigned (1:1), stratified by screening HIV-1 RNA viral load and CD4-cell count, to received either doravirine (100 mg) and islatravir (0·25 mg) or bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) orally once daily. The primary endpoint was percentage of participants with HIV-1 RNA less than 50 copies per mL at week 48 (FDA snapshot; prespecified non-inferiority margin -10%). Participants who received at least one dose of study intervention were analysed for safety. This trial is ongoing and is registered with ClinicalTrials.govNCT05705349.

FINDINGS:

We screened 756 participants for eligibility between March 8, 2023, and Oct 11, 2024. 269 participants were treated with doravirine-islatravir and 267 with bictegravir-emtricitabine-tenofovir. The last study visit for this analysis occurred on Oct 13, 2025. Median age was 32 years (IQR 26-40), 134 (25%) participants were assigned female at birth, 225 (42%) were White, 92 (17%) had CD4 counts less than 200 cells per μL, 197 (37%) had an HIV-1 RNA greater than 100 000 copies per mL, and 314 (59%) had pre-existing resistance-associated mutations. At week 48, doravirine-islatravir was non-inferior to bictegravir-emtricitabine-tenofovir: 247 (91·8%) of 269 versus 242 (90·6%) of 267 had HIV-1 RNA less than 50 copies per mL (estimated difference 1·2%, 95% CI -3·7 to 6·2). Mean increase in CD4 count was 218 cells per μL in the doravirine-islatravir group and 226 cells per μL in the bictegravir-emtricitabine-tenofovir group (estimated difference -6·8, 95% CI -35·8 to 22·2). Two participants in the doravirine-islatravir group and one in the bictegravir-emtricitabine-tenofovir group with pretreatment HIV-1 RNA greater than 1 million copies per mL and CD4 counts less than 200 cells per μL acquired treatment-emergent mutations. Phenotypic analysis revealed resistance to doravirine in two participants treated with doravirine-islatravir. 38 (14%) of 269 participants in the doravirine-islatravir group and 48 (18%) of 267 in the bictegravir-emtricitabine-tenofovir group had treatment-related adverse events: the most common were increased weight (7, 3%), headache (6, 2%), and dizziness (5, 2%) in the doravirine-islatravir group and increased weight (9, 3%), headache (9, 3%), and decreased estimated glomerular filtration rate (8, 3%) in the bictegravir-emtricitabine-tenofovir group.

INTERPRETATION:

Doravirine (100 mg) and islatravir (0·25 mg) is a two-drug, once daily regimen with efficacy and safety similar to bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) for initial treatment of HIV-1, which could provide an option for treatment without an integrase strand transfer inhibitor.

FUNDING:

Merck Sharp & Dohme, a subsidiary of Merck & Co.

2026-02-01·LANCET

Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on oral antiretroviral therapy: 48-week results of a phase 3, multicentre, randomised, open-label, non-inferiority trial

Article

作者: Grandhi, Anjana ; Jackson, Beth ; Mngqibisa, Rosie ; Kim, Jason ; Bloch, Mark ; Diamond, Tracy L ; Tebas, Pablo ; Braun, Dominique L ; Fuszard, Monica ; Orkin, Chloe ; Fox, Michelle C ; Kumar, Princy ; Eves, Karen ; Walmsley, Sharon ; Klopfer, Stephanie O ; Carr, Andrew ; Stamm, Luisa M ; Velez, Juan Diego ; Yokomaku, Yoshiyuki

BACKGROUND:

Doravirine and islatravir is an investigational, once-daily, single-tablet regimen containing two potent antiretrovirals with complementary mechanisms of action and resistance profiles. We aimed to evaluate the efficacy and safety of switching from stable, oral antiretroviral therapy (ART) to the fixed combination of doravirine (100 mg) and islatravir (0·25 mg) in virologically suppressed adults living with HIV-1.

METHODS:

This phase 3, randomised, active-controlled, open-label, non-inferiority trial was conducted at 53 research, community, and hospital-based clinics in eight countries: Australia, Canada, Colombia, Japan, South Africa, Switzerland, the UK, and the USA. Adults (aged ≥18 years) with a viral load of fewer than 50 copies of HIV-1 RNA per mL on any oral, two-drug or three-drug ART regimen for at least 3 months, with no history of treatment failure, known resistance to doravirine, or active hepatitis B infection, were randomly assigned (2:1) according to a computer-generated randomisation schedule (block size three) to receive oral doravirine (100 mg) and islatravir (0·25 mg) once daily or to continue baseline ART for 48 weeks. Randomisation was stratified by the anchor antiretroviral drug class (integrase strand-transfer inhibitor [INSTI], non-nucleoside reverse transcriptase inhibitor, or protease inhibitor) in the baseline regimen. The primary endpoint (assessed in all treated participants) was the percentage of participants with a viral load of 50 copies per mL or higher at week 48 (analysed according to the US Food and Drug Administration snapshot approach); non-inferiority would be concluded if the upper bound of the multiplicity-adjusted 95% CI for the treatment difference was less than 4%. The safety analysis population included all randomly assigned participants who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov, NCT05631093, and is ongoing but closed to enrolment.

FINDINGS:

Between Feb 20 and Oct 24, 2023, 614 individuals were screened for eligibility, of whom 553 were randomly assigned to receive doravirine and islatravir (n=368) or baseline ART (n=185). 551 participants received at least one dose of allocated medication: 366 in the doravirine and islatravir group and 185 in the baseline ART group. Of these 551 participants, 332 (60%) were assigned male and 219 (40%) were assigned female at birth, and the median age was 51 years (IQR 41-59); 250 (45%) identified as Black or African American and 80 (15%) identified as Hispanic, Latino, or Latina. Doravirine and islatravir showed non-inferiority at week 48, with viral loads of 50 copies per mL or higher in five (1·4%) of 366 participants versus nine (4·9%) of 185 participants on baseline ART (difference -3·6% [multiplicity-adjusted 95% CI -7·8 to -0·8]). Treatment-related adverse events were more common with doravirine and islatravir (44 [12·0%] of 366 participants) than with baseline ART (nine [4·9%] of 185 participants; difference 7·2 [95% CI 2·2 to 11·6]). Rates were similar in the doravirine and islatravir group and the baseline ART group for any adverse event (79·5% [291 of 366 participants] vs 83·8% [155 of 185 participants]; difference -4·3 [-10·7 to 2·8]), serious adverse events (6·3% [23] vs 4·9% [nine]; 1·4 [-3·2 to 5·2]), and discontinuation due to adverse events (0·5% [two] vs 2·2% [four]; -1·6 [-4·9 to 0·2]). One death occurred (in the baseline ART group) and was not considered treatment-related. No participants discontinued treatment as a result of protocol-specified declines in CD4 cell or total lymphocyte counts.

INTERPRETATION:

Doravirine and islatravir is efficacious and well tolerated and would represent the first non-INSTI-based, two-drug regimen for HIV-1 treatment. With increasing concern over the potential development of widespread INSTI resistance, this once-daily, oral, single-tablet regimen could be a potential option for people living with HIV-1 requiring a change to their antiretroviral regimen. The safety and efficacy findings support the ongoing development of islatravir, a drug with long-acting potential.

FUNDING:

Merck Sharp & Dohme, a subsidiary of Merck & Co.

127

项与多拉韦林/伊拉曲韦相关的新闻（医药）

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·新药前沿观察-赛业生物

本周药研大事件：康方古莫奇单抗获批上市；强生10亿美元收购Firefly Bio布局DAC；再鼎维替索妥尤单抗获批，国内首个DLL3/CD3双抗落地

本周药研简讯 2026年6月12日 • 康方生物古莫奇单抗获批上市，国产IL-17A单抗补强银屑病治疗选择 • 强生10亿美元收购Firefly Bio，DAC平台成为肿瘤研发新热点 • 再鼎医药维替索妥尤单抗获批，国内首个DLL3/CD3双抗落地 • ADC Therapeutics CD19-ADC Zynlonta III期确证性研究：达主要终点但死亡信号引发安全性拷问 • 传奇生物LB2501 CD19/CD20双靶点体内CAR-T首批临床数据公布：高剂量组100%缓解，无需化疗预处理 • 诺华del-brax II期达主要终点：面肩肱型肌营养不良症迎来首款潜在疗法 • Tango Therapeutics PRMT5抑制剂联合RAS(ON)抑制剂胰腺癌数据亮眼：新机制组合11/12患者应答 • Biogen salanersen获FDA突破性疗法认定：SMA治疗进入年给药1次反义寡核苷酸时代 • 礼来retatrutide三靶点减重III期阳性：ADA 2026揭晓减重约25%刷新行业标杆 • 默沙东islatravir/lenacapavir HIV口服每周一次复方两项III期成功：首款方案即将申报 NEWS ANALYSIS 药研重磅解读 01 康方生物古莫奇单抗获批上市，国产IL-17A单抗补强银屑病治疗选择 6月11日，国家药监局批准中山康方生物申报的古莫奇单抗注射液上市，商品名为奇佑康，用于治疗适合接受系统治疗或光疗的中度至重度斑块状银屑病成人患者。古莫奇单抗是康方生物自主研发的靶向IL-17A的人源化IgG1单克隆抗体，可通过阻断IL-17A介导的炎症信号通路，干预银屑病相关免疫炎症反应。这一进展标志着国产自免抗体管线进一步进入商业化阶段。银屑病生物制剂赛道已形成TNF-α、IL-17、IL-23等多靶点竞争格局，古莫奇单抗获批将丰富中重度斑块状银屑病患者的治疗选择，也为国产创新抗体从肿瘤领域向自身免疫疾病拓展提供参考。（康方生物） 02 强生10亿美元收购Firefly Bio，DAC平台成为肿瘤研发新热点 6月8日，强生宣布将以10亿美元现金收购Firefly Bio，获得其Firelink降解剂抗体偶联平台。该平台将抗体靶向递送与蛋白降解药物相结合，重点面向KRAS驱动肿瘤等难治实体瘤。与传统ADC相比，DAC思路更强调“抗体精准递送+细胞内致病蛋白降解”的组合创新。这笔交易反映出大药企正在持续押注抗体偶联技术的下一代形态。ADC赛道火热之后，DAC、免疫细胞偶联递送、抗体寡核苷酸偶联等新模式正在成为平台技术竞争焦点。Firefly Bio仍处于较早期阶段，后续成药性仍需验证，但该交易已为DAC赛道热度提供了重要产业信号。（强生） 03 再鼎医药维替索妥尤单抗获批，国内首个DLL3/CD3双抗落地 6月9日，NMPA批准再鼎医药引进的注射用维替索妥尤单抗上市，用于既往接受过至少一线治疗的广泛期小细胞肺癌（SCLC）患者。这是国内首个获批的DLL3/CD3双特异性T细胞衔接器抗体，由强生旗下杨森制药研发，再鼎医药于2024年获得大中华区独家权益。小细胞肺癌约占肺癌总数15%，晚期患者5年生存率不足7%，二线后治疗手段极度匮乏，该药的获批为这一困境带来全新的免疫治疗选择。全球DLL3/CD3双抗市场规模预计2030年突破60亿美元。（再鼎医药） 04 ADC Therapeutics CD19-ADC Zynlonta III期确证性研究：达主要终点但死亡信号引发安全性拷问 6月4日，ADC Therapeutics公布了其CD19靶向ADC药物Zynlonta（loncastuximab tesirine）联合利妥昔单抗治疗复发/难治性弥漫大B细胞淋巴瘤（DLBCL）的LOTIS-5 III期确认性研究结果。在440例患者中，Zynlonta联合方案中位无进展生存期（PFS）为6.1个月 vs 对照4.7个月，达到统计学显著差异。然而，Zynlonta组出现27例死亡（vs 对照组9例），多数发生在75岁以上患者中。公司股价应声暴跌超50%。RBC分析师指出"在其他可用治疗选择存在的背景下，该死亡风险可能难以被临床医生、患者和监管机构接受"。该研究结果揭示ADC技术在血液肿瘤领域面临的疗效-安全性平衡挑战，也为同类CD19-ADC管线的开发提供了重要参考。公司计划8月与FDA沟通，Q4提交监管申请。（ADC Therapeutics） 05 传奇生物LB2501 CD19/CD20双靶点体内CAR-T首批临床数据公布：高剂量组100%缓解，无需化疗预处理 6月3日，传奇生物（Legend Biotech）在EHA 2026年会上以最新突破性口头报告形式公布了其体内CAR-T疗法LB2501的首批I期临床数据。LB2501通过修饰病毒载体在体内直接生成同时靶向CD19和CD20的CAR-T细胞，无需体外细胞制备和淋巴耗竭化疗预处理。在高剂量组（n=6）中，全部患者获得缓解，5例达到完全缓解（CR），所有缓解在首次评估时即观察到。安全性方面，细胞因子释放综合征（CRS）多为1-2级，未见免疫效应细胞相关神经毒性综合征（ICANS）。数据公布后公司股价大涨30%。分析师指出，体内CAR-T若能成功，有望突破传统体外CAR-T的产能瓶颈，潜在销售峰值可达重磅炸弹级别。该数据标志着体内CAR-T技术从概念验证正式迈向临床验证。（传奇生物） 06 诺华del-brax II期达主要终点：面肩肱型肌营养不良症迎来首款潜在疗法 6月11日，诺华公布del-brax治疗面肩肱型肌营养不良症（FSHD）的FORTITUDE I/II期研究C队列结果。该队列在16-70岁患者中评估每6周一次给药vs安慰剂的12个月疗效，研究达到主要终点及关键次要终点，KHDC1L和肌酸激酶（CK）水平显著降低，安全性特征与此前一致。FSHD是一种进行性神经肌肉疾病，临床表现为面部、肩胛和上臂肌肉进行性无力萎缩，当前全球范围内无获批疗法。该阳性数据为正在进行的FORTITUDE-3 III期确证性研究奠定了关键基础，标志着FSHD治疗领域从零到一的突破。（诺华） 07 Tango Therapeutics PRMT5抑制剂联合RAS(ON)抑制剂胰腺癌数据亮眼：新机制组合11/12患者应答 6月8日，Tango Therapeutics公布了PRMT5抑制剂vopimetostat联合Revolution Medicines的RAS(ON)抑制剂daraxonrasib治疗RAS/MTAP缺失型胰腺癌的临床数据。此前Revolution的daraxonrasib单药已在RASOLUTE III期研究中实现生存期翻倍（ASCO 2026全场起立鼓掌），此次联合方案进一步揭示RAS靶向作为胰腺癌治疗支柱的潜力。Tango计划2026年下半年启动联合方案的III期研究。这两项进展共同宣告了胰腺癌"RAS革命"的到来。（Tango Therapeutics） 08 Biogen salanersen获FDA突破性疗法认定：SMA治疗进入年给药1次反义寡核苷酸时代 6月4日，FDA授予Biogen反义寡核苷酸（ASO）疗法salanersen（BIIB115）突破性疗法认定，用于治疗脊髓性肌萎缩症（SMA）。Ib期探索性数据显示，既往基因治疗后应答不佳的SMA患儿在salanersen治疗后运动功能改善，神经退行性生物标志物降低。该疗法仅需每12个月给药一次，相比现有Spinraza（每4个月鞘内注射）和基因治疗一次性给药但不可重复的方案，提供了差异化的治疗选择。目前两项III期研究（STELLAR-1、STELLAR-3）正在进行，第三项（STELLAR-2）即将于本月启动。该进展标志着SMA治疗从"有没有药"进入"选择什么药"的精细化时代。（Biogen） 09 礼来retatrutide三靶点减重III期阳性：ADA 2026揭晓减重约25%刷新行业标杆在6月8日开幕的ADA 2026年会上，礼来公布了retatrutide（GIP/GLP-1/胰高血糖素受体三重激动剂）的关键III期数据，完成治疗的患者平均减重约25%，刷新了药物减重的行业标杆。该"Triple G"药物通过同时激活GIP、GLP-1和胰高血糖素三条代谢通路，实现了超越现有GLP-1单靶点和GIP/GLP-1双靶点药物的减重幅度。礼来凭借retatrutide与已上市的tirzepatide（双靶点），进一步巩固了其在代谢疾病领域的领先地位。此次ADA年会上，辉瑞的berobenatide和罗氏的enicepatide等竞品也公布了数据，但疗效均未超越retatrutide。代谢赛道竞争门槛已被大幅抬高。（礼来） 10 默沙东islatravir/lenacapavir HIV口服每周一次复方两项III期成功：首款方案即将申报 6月9日，吉利德与默沙东联合宣布，islatravir/lenacapavir口服每周一次HIV复方的两项III期研究（ISLEND-1和ISLEND-2）均达到主要终点，在"换药"人群（从现有方案切换）中展示非劣效。该复方整合了默沙东的核苷逆转录酶易位抑制剂islatravir和吉利德的长效衣壳抑制剂lenacapavir，将成为首个口服每周一次HIV治疗方案，有望显著改善患者依从性。每年约20%的HIV患者会更换治疗方案，该市场空间可观。双方已表示将寻求监管批准。此前默沙东的Idvynso已于4月获批，此次成功进一步夯实了两家公司在HIV领域的产品矩阵。（默沙东）关于赛业生物赛业生物自2006年成立，是一家以卓越的模型和服务助力新药研发的创新型CRO企业、国家高新技术企业、国家专精特新小巨人企业。公司依托自主基因编辑技术与先进的疾病模型平台，聚焦肿瘤、代谢性疾病、自身免疫疾病、眼科疾病、神经系统疾病等关键领域，提供涵盖模型构建、体内、外药理药效评估、机制研究等在内的全流程临床前CRO服务。赛业生物持续拓展产品线，在抗体药物发现方向，公司构建了以HUGO-Ab®全人源抗体小鼠为特色的抗体药物研发平台。自主开发的HUGO-Ab®全人源抗体小鼠可高效生成高亲和力的人源化单抗与双抗候选分子；HUGO-GT®全基因组人源化小鼠支持更精准的人源药靶验证与功能研究，进一步推动生物药研发的临床转化效率。赛业生物现有员工超1000人，运营面积逾4万平方米，构建了覆盖全球的服务网络与项目交付体系。未来，公司将持续以“数据+模型”双轮驱动，助力全球药企在新药研发道路上提速前行、突破创新。针对本周资讯中的基因编辑、疾病模型构建、抗体药物发现等热点，以及临床前研发中的核⼼痛点，欢迎扫码或留言咨询。点击「阅读原文」进行咨询！

2026-06-09

·FiercePharma

Merck, Gilead score in effort to develop the first weekly HIV pill

Merck and Gilead have combined their drugs islatravir and lenacapavir to develop what could soon become the first long-acting oral HIV treatment that can be taken weekly. A combination of Merck’s islatravir and Gilead’s lenacapavir has succeeded in two phase 3 trials and is in line to become the first long-acting oral HIV treatment that can be taken weekly.Both trials of the combination regimen—which includes a 2 mg dose of islatravir and a 300 mg dose of lenacapavir—included people with HIV who are virologically suppressed and both achieved their primary efficacy endpoint. In the Islend-1 study, the combo showed its non-inferiority in those who had switched off Gilead’s once-daily pill Biktarvy. In Islend-2, the combo measured up in those who had switched off standard-of-care antiretroviral regimens. No new safety concerns were identified in either study.Gilead and Merck said they plan to submit the data to regulatory authorities around the world and present the findings at a future scientific congress.“Long-acting oral therapies represent a new wave of transformational innovation in HIV drug development, with the potential to reshape the landscape of care,” said Jared Baeten, M.D, Ph.D, Gilead’s SVP, Clinical Development, Virology Therapeutic Area Head, said in a release. “Innovative oral HIV treatment options that allow for less frequent dosing may make a meaningful difference in the lives of people living with the virus, potentially offering more flexibility and discretion.”In a note to clients, analysts from Jefferies said that they viewed the data as a “plus,” but that they expect Biktarvy to remain the standard of care because of its well-established efficacy. While five-year data on Biktarvy has shown that 97% of patients remain suppressed, questions remain about the long-term safety and resistance of ISL/LEN.Gilead’s lenacapavir has been on the market since 2022, when it was approved in the U.S. as Sunlenca for twice-yearly administration for those with drug-resistant HIV. Twelve months ago, the FDA signed off on lenacapavir for pre-exposure prophylaxis (PrEP). It is known commercially in that indication as Yeztugo.Less than two months ago, islatravir was approved for the first time by the FDA in combination with the company’s doravirine. The regimen, known commercially as Idvynso, was endorsed to replace current antiretroviral regimens among adults with HIV who are virologically suppressed and who have no history of virologic treatment failure or treatment substitutions due to doravirine resistance. While islatravir is a newer nucleoside reverse transcriptase translocation inhibitor (NRTTI), doravirine is an older non-nucleoside reverse transcriptase inhibitor (NNRTI). Doravirine has been commercialized since 2018 as part of Merck’s HIV meds Pifeltro and Delstrigo.Gilead dominates the HIV market, recording sales of $14.3 billion last year for Biktarvy. HIV is part of Merck's infectious disease portfolio, which the company projects can generate $15 billion in annual sales by the middle of the next decade, according to a recent presentation.

临床3期上市批准临床结果临床研究

2026-06-09

·BioPharmaDive

Merck, Gilead report mixed outcomes in key lung cancer, HIV studies

Dive Brief:Merck & Co. and partner Gilead Sciences on Monday reported a setback in one late-stage study in lung cancer, but success in two other Phase 3 trials testing an HIV treatment theyre working on.In one announcement, the companies said theyre halting a trial testing Gileads Trodelvy with Mercks Keytruda in frontline, non-small cell lung cancer. Study monitors found a numerical improvement in tumor progression that didnt reach significance, and determined a survival benefit was unlikely.In the other release, the partners revealed an HIV tablet combining Mercks islatravir and Gileads lenacapavir benefited people who switched off of other treatments in two Phase 3 studies. They intend to seek approval of the combination, which could be the first oral, once-weekly treatment for HIV.They didnt specify when an application might be completed, however.Dive Insight:The trio of study results appeared to impact both companies more negatively, given the high-profile nature of the setback in lung cancer.The EVOKE-03 study was another chance for Gilead to validate the hefty $21 billion purchase price it paid for Trodelvys developer Immunomedics. That treatment hasnt been as big a seller as Gilead once envisioned, and has stumbled in multiple other studies. But success in a study in frontline lung cancer, one of the most common tumor types, wouldve helped.The study was also a chance for Merck to extend its dominance in lung cancer, for which Keytruda is a pillar of care. The trial tested Trodelvy, an antibody-drug conjugate aimed at the protein TROP2, alongside Keytruda in the first-line setting. But some analysts were skeptical of the studys chances, given the way it was designed the companies didnt only focus on TROP2-expressing tumors and Trodelvys other struggles.The readout additionally carries implications for another ADC Merck is investing heavily in. Called sacituzumab tirumotecan, or sac-TMT, Merck licensed it from Kelun Biotech and has place it in a sprawling Phase 3 programthat includes 17 studies targeting a range of tumor types. Merck believes the ADC could become a cornerstone drug, and recently spotlighted results from a Phase 3 study in Chinaat the American Society of Clinical Oncology conference.Analysts and investors have been debating whether those findings might carry over to a global study in first-line lung cancer thats now underway. Merck has expressed optimism, citing certain technical differences with sac-TMT. But he EVOKE-03 results could put greater investor scrutiny on sac-TMT data coming from China until the global translation is proven, wrote Leerink Partners Daina Graybosch.Graybosch expected the stocks for both companies to trade lower given outsized investor attention on the more negative of the two announcements. Shares of Gilead dipped 3%, while Mercks stock was only slightly down.Yet the HIV findings could ultimately offset those negatives. Despite a concerted push into oncology, Gileads core business remains its HIV drugs. Its already added to that portfolio with last years approval of a preventive shot called Yeztugo. Another drug for the switch market could boost that business, as some 20% of patients change treatment regimens each year, Graybosch wrote.The positive results also amount to another win for Mercks HIV franchise this year, following the April approval of Idvynso,RBC Capital Markets analyst Trung Huynh wrote in a separate note. '

临床3期ASCO会议上市批准临床结果

100 项与多拉韦林/伊拉曲韦相关的药物交易

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适应症	国家/地区	公司	日期
HIV感染	日本	MSD KK (Tokyo)	2026-03-06

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05705349 (MK-8591A-053, Pubmed \| Lancet HIV) 人工标引	临床3期	HIV感染一线	536	doravirine-islatravir	築壓膚築糧願蓋餘醖鹽(廠艱鹹鬱範構齋繭鏇膚) = 網願餘膚顧窪壓襯鹹簾願獵齋廠遞壓鏇鑰繭夢 (築鑰窪衊積齋餘襯鹽獵 ) 更多	非劣	2026-02-25
				bictegravir-emtricitabine-tenofovir	築壓膚築糧願蓋餘醖鹽(廠艱鹹鬱範構齋繭鏇膚) = 鹽艱積鏇鏇窪膚壓遞廠願獵齋廠遞壓鏇鑰繭夢 (築鑰窪衊積齋餘襯鹽獵 ) 更多
NCT05631093 (MK-8591A-051, Pubmed \| Lancet \| BusinessWire) 人工标引	临床3期	HIV感染	551	doravirine-islatravir	顧範鏇襯網艱醖醖憲鬱(製網積範範製淵憲簾積) = 蓋選廠觸鹹積糧餘積憲觸網構簾夢鏇膚鹹構積 (蓋願鏇鏇齋鏇構壓鹹淵 ) 达到更多	非劣	2026-02-07
				ART	顧範鏇襯網艱醖醖憲鬱(製網積範範製淵憲簾積) = 鏇餘襯繭窪網鹽餘鬱鏇觸網構簾夢鏇膚鹹構積 (蓋願鏇鏇齋鏇構壓鹹淵 ) 达到更多
NCT05630755 (MK-8591A-052, Pubmed \| Lancet \| BusinessWire) 人工标引	临床3期	HIV感染	513	doravirine-islatravir	遞顧獵願襯襯淵蓋獵壓(構膚廠醖廠構糧鹽鬱廠) = 選築醖齋蓋鑰窪顧選憲範夢遞鏇艱窪觸觸網醖 (觸鹽鏇積範齋餘窪衊選 ) 达到更多	非劣	2026-02-01
				Bictegravir/Emtricitabine/Tenofovir Alafenamide	遞顧獵願襯襯淵蓋獵壓(構膚廠醖廠構糧鹽鬱廠) = 構範鑰襯簾夢積鑰蓋憲範夢遞鏇艱窪觸觸網醖 (觸鹽鏇積範齋餘窪衊選 ) 达到更多
NCT05631093 (MK-8591A-051, CTgov)	临床3期	HIV感染	553	DOR+Islatravir (Doravirine/Islatravir (DOR/ISL))	製糧鑰鏇蓋簾鏇淵觸糧 = 糧夢築膚鏇糧鬱膚襯範憲網範壓齋製淵築觸簾 (選獵襯餘觸壓襯窪鹽獵, 醖衊餘衊艱鹹鏇齋憲鹹 ~ 鏇範憲廠夢積窪製襯醖) 更多	-	2025-11-21
				DOR (Baseline ART + DOR/ISL)	製糧鑰鏇蓋簾鏇淵觸糧 = 餘壓顧窪鹽齋糧網鑰網憲網範壓齋製淵築觸簾 (選獵襯餘觸壓襯窪鹽獵, 糧簾築憲遞繭憲齋糧顧 ~ 鹹醖鏇鹹願繭遞鹹遞獵) 更多
NCT05630755 (MK-8591A-052, CTgov)	临床3期	HIV感染	514	Placebo to BIC/FTC/TAF+DOR/ISL (DOR/ISL and Placebo to BIC/FTC/TAF)	鹽鹽鑰齋繭願憲選積遞 = 鬱醖餘繭淵鬱醖鏇網鑰構醖鹽齋鹹膚襯廠觸襯 (廠鬱夢觸鏇廠鹽鏇鬱壓, 範窪壓夢鏇鹹網餘窪顧 ~ 構築簾鹽觸襯襯糧簾鏇) 更多	-	2025-11-18
				Placebo to DOR/ISL+BIC/FTC/TAF (BIC/FTC/TAF and Placebo to DOR/ISL)	鹽鹽鑰齋繭願憲選積遞 = 鹽壓窪築壓繭選鹽夢糧構醖鹽齋鹹膚襯廠觸襯 (廠鬱夢觸鏇廠鹽鏇鬱壓, 製鑰鏇顧鹹艱選選鏇繭 ~ 淵壓遞網糧夢夢衊齋夢) 更多
NCT05630755 (MK-8591A-052, Company_Website)	临床3期	HIV感染	513	placebo+Doravirine+Islatravir-MK8591A	襯積壓窪艱繭襯齋鏇窪(製淵壓構廠鹹淵壓襯鑰) = 糧窪願鹽繭壓範積鏇遞繭衊艱鬱膚構廠夢憲憲 (糧獵淵憲積願顧壓蓋膚 ) 更多	积极	2025-10-15
				placebo+Bictegravir+Tenofovir alafenamide+Emtricitabine	襯積壓窪艱繭襯齋鏇窪(製淵壓構廠鹹淵壓襯鑰) = 醖憲選鹽齋蓋壓鑰夢窪繭衊艱鬱膚構廠夢憲憲 (糧獵淵憲積願顧壓蓋膚 ) 更多
NCT04233879 (Pubmed \| Clin Infect Dis)	临床3期	HIV感染	597	Doravirine/islatravir (100/0.75 mg)	獵鹹願簾選顧遞齋觸淵(鑰構繭襯鏇積顧築觸獵) = AEs leading to discontinuations were higher with doravirine/islatravir (8.7%, 3.7%) due to protocol-specified criteria requiring discontinuation for decreased CD4 and lymphocyte counts 鏇齋壓淵憲壓鹽積襯構 (鑰選壓網鏇淵繭廠蓋簾 ) 更多	-	2025-09-16
				Bictegravir/emtricitabine/tenofovir alafenamide (50/200/25 mg)
NCT04223778 (8591A-017 \| MK-8591A-017, CTgov)	临床3期	HIV感染	672	DOR/ISL (Group 1: Doravirine/Islatravir (DOR/ISL))	製鹹蓋鹹蓋壓淵構簾選 = 淵窪憲願簾獵築顧膚齋網醖蓋糧襯遞積築廠鏇 (觸齋鹹糧糧選鹹鏇選願, 餘夢憲壓襯襯壓廠繭選 ~ 窪窪餘壓壓繭醖鏇蓋衊) 更多	-	2022-09-19
				ART+DOR/ISL (Group 2: Baseline Antiretroviral Therapy (ART))	製鹹蓋鹹蓋壓淵構簾選 = 廠鹹鏇淵網範艱衊觸醖網醖蓋糧襯遞積築廠鏇 (觸齋鹹糧糧選鹹鏇選願, 蓋繭築遞醖壓齋鹽遞鬱 ~ 網壓遞鏇鬱觸憲壓鹹鑰) 更多