The purpose of this study is to learn about the effects of a new study medicine called PF-08046032, when taken alone and when taken with another medicine called sasanlimab, for the treatment of advanced cancers. The effects are studied in adult participants with certain types of lymphomas or solid tumors that are advanced or metastatic (spread to other parts of the body).
The study has three parts:
* Part A will test PF-08046032 alone at increasing dose levels in participants with certain lymphomas (cancer that begins in cells of the immune system) and in participants with certain solid tumors whose disease has worsened on or after standard treatments.
* Part B will test PF-08046032 (at selected doses) and sasanlimab in participants with certain solid tumors, including those whose disease has worsened on or after standard treatments as well as participants before receiving standard treatments.
* Part C will further test the combination of PF-08046032 and sasanlimab in participants with specific types of solid tumors based on the results from Part A and Part B of the study.
All participants will receive the study drug PF-08046032. Only participants in Part B and Part C of the study will also receive sasanlimab. PF-08046032 will be given as an intravenous (IV) infusion, which means it will be injected directly into a vein. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin.

开始日期2025-04-25

申办/合作机构

Pfizer Inc.

NCT06218069

/ Not yet recruiting临床2/3期IIT

Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor (IMPRINT)

This study investigates whether a single subcutaneous administration of anti-PD-1 antibody can induce CD8+ T-cell tumor-infiltration that can be non-invasively monitored with [89Zr]crefmirlimab berdoxam PET imaging as an imaging biomarker.

开始日期2025-02-01

申办/合作机构

Radboud University Medical Center

[+3]

CTIS2024-511358-36-00

/ Recruiting临床2期IIT

Selective Bladder-Sparing Trial with Sasanlimab as Maintenance Treatment Based On Clinical Response To Neoadjuvant Treatment In Molecularly Categorized Muscle Invasive Bladder Cancer Patients - ?HM-87884561

开始日期2024-12-20

申办/合作机构-

100 项与萨善利单抗相关的临床结果

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100 项与萨善利单抗相关的转化医学

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100 项与萨善利单抗相关的专利（医药）

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项与萨善利单抗相关的文献（医药）

2024-05-01·Future oncology (London, England)

CREST: phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer

Article

作者: Shore, Neal D ; Hu, Hailong ; Kretkowski, Michal ; Saltzstein, Daniel ; Pierce, Kristen J ; Redorta, Joan Palou ; Galsky, Matthew D ; Ku, Ja Hyeon ; Randall, Alison E ; Vermette, Jennifer J ; Steinberg, Gary D ; Tarazi, Jamal C ; Powles, Thomas B ; Penkov, Konstantin ; Bedke, Jens

Bacillus Calmette-Guérin (BCG) is the standard of care for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). BCG in combination with programmed cell death-1 (PD-1) inhibitors may yield greater anti-tumor activity compared with either agent alone. CREST is a phase III study evaluating the efficacy and safety of the subcutaneous PD-1 inhibitor sasanlimab in combination with BCG for patients with BCG-naive high-risk NMIBC. Eligible participants are randomized to receive sasanlimab plus BCG (induction ± maintenance) or BCG alone for up to 25 cycles within 12 weeks of TURBT. The primary outcome is event-free survival. Secondary outcomes include additional efficacy end points and safety. The target sample size is around 1000 participants.

2024-01-01·Therapeutic Advances in Medical Oncology

Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies

Article

作者: Saenko, Daria Viktorovna ; Pavlov, Dmitri ; Hirohashi, Tomoko ; Bondarenko, Igor ; Cho, Byoung Chul ; Kowalski, Karey ; Ursol, Grygorii Mykolaiovych ; Davis, Craig ; Boyko, Vasyl ; Fadeeva, Natalya Vladimirovna ; Kislov, Nikolay Viktorovich ; Hotko, Yevhen Stepanovych ; Guo, Jun ; Kulyaba, Yaroslav ; Shen, Chia-I ; Ahn, Hee Kyung ; Gong, Yi ; Michelon, Elisabete ; Yamamoto, Noboru ; Penkov, Konstantin

Background::

Sasanlimab (PF-06801591), a humanized immunoglobulin G4 monoclonal antibody, binds to programmed cell death protein-1 (PD-1), preventing ligand (PD-L1) interaction.

Objectives::

To evaluate pharmacokinetics (PK), safety, tolerability, and efficacy of two subcutaneous sasanlimab dosing regimens.

Design::

An open-label study consisting of phases Ib and II. Phase Ib: non-randomized, dose escalation, and expansion study in Asian participants with advanced malignancies.

Phase II::

conducted globally in participants with non-small-cell lung cancer with PD-L1 positive or PD-L1 status unknown tumors; participants were randomized 1:2 to receive subcutaneous sasanlimab 300 mg once every 4 weeks (300 mg-Q4W) or 600 mg once every 6 weeks (600 mg-Q6W).

Methods::

Primary endpoint in phase Ib: dose-limiting toxicity (DLT) occurring in first treatment cycle; in phase II: Ctrough and AUC.

Results::

A total of 155 participants (phase Ib, n = 34; phase II, n = 121) received sasanlimab. Phase Ib: no DLT reported. Phase II: ratio of adjusted geometric mean for AUCtau was 231.2 (90% CI, 190.1–281.2) and Ctrough was 111.5 (90% CI, 86.3–144.0) following 600 mg-Q6W (test) versus 300 mg-Q4W (reference). Phase Ib: grade 3 treatment-related adverse events (TRAEs) occurred in 1/4 (25%) and 3/12 (25%) participants treated in 300 mg-Q4W dose escalation and expansion cohorts, respectively. Phase II: grade 3 TRAEs occurred in 3/41 (7.3%) and 3/80 (3.8%) participants treated with 300 mg-Q4W and 600 mg-Q6W, respectively; no grade 4/5 TRAEs. Phase II: confirmed objective response was observed in 11/41 (26.8% (95% CI, 14.2–42.9)) and 12/80 (15.0% (95% CI, 8.0–24.7)) participants treated with 300 mg-Q4W and 600 mg-Q6W, respectively.

Conclusions::

Phase Ib regimens were considered safe with no DLTs reported. In phase II, 600 mg-Q6W regimen criteria were met for AUCtau and Ctrough metrics to support PK-based extrapolation of efficacy of alternative regimen. Regimens were well tolerated, showing anti-tumor activity in participants with advanced solid tumors. Administration of sasanlimab at a dose of 600 mg-Q6W subcutaneously may serve as a convenient alternative to 300 mg-Q4W administration.

Trial registration::

NCT04181788 (ClinicalTrials.gov); 2019-003818-14 (EudraCT).

2023-08-01·ESMO open

A phase Ib/II dose expansion study of subcutaneous sasanlimab in patients with locally advanced or metastatic non-small-cell lung cancer and urothelial carcinoma

Article

作者: Grilley-Olson, J E ; Li, M ; Cho, B C ; Odintsova, S ; Korożan, M E ; Braiteh, F ; Bonato, V ; Osipov, M ; Pikiel, J ; Yang, W ; Ribas, A ; Lugowska, I ; Damore, M A ; Kurochkin, A ; Bowers, M ; Penkov, K ; Jacobs, I A ; Johnson, M L ; Bondarenko, I ; Ahn, H K

BACKGROUND:

Sasanlimab is an antibody to the programmed cell death protein 1 receptor. We report updated data of subcutaneous sasanlimab in non-small-cell lung cancer (NSCLC) and urothelial carcinoma dose expansion cohorts from a first-in-human phase Ib/II study.

PATIENTS AND METHODS:

Patients were ≥18 years of age with NSCLC or urothelial carcinoma, and no prior immunotherapies, who progressed on or were intolerant to systemic therapy, or for whom systemic therapy was refused or unavailable. Patients received subcutaneous sasanlimab at 300 mg every 4 weeks (q4w). Primary objectives were to evaluate safety, tolerability, and clinical efficacy by objective response rate (ORR).

RESULTS:

Sixty-eight and 38 patients with NSCLC and urothelial carcinoma, respectively, received subcutaneous sasanlimab. Overall, sasanlimab was well tolerated; 13.2% of patients experienced grade ≥3 treatment-related adverse events. Confirmed ORR was 16.4% and 18.4% in the NSCLC and urothelial carcinoma cohorts, respectively. ORR was generally higher in patients with high programmed death-ligand 1 (PD-L1) expression (≥25%) and high tumor mutational burden (TMB; >75%). In the NSCLC and urothelial carcinoma cohorts, median progression-free survival (PFS) was 3.7 and 2.9 months, respectively; corresponding median overall survival (OS) was 14.7 and 10.9 months. Overall, longer median PFS and OS correlated with high PD-L1 expression and high TMB. Longer median PFS and OS were also associated with T-cell inflamed gene signature in the urothelial carcinoma cohort.

CONCLUSIONS:

Subcutaneous sasanlimab at 300 mg q4w was well tolerated with promising clinical efficacy observed. Phase II and III clinical trials of sasanlimab are ongoing to validate clinical benefit. Subcutaneous sasanlimab may be a potential treatment option for patients with NSCLC or urothelial carcinoma.

项与萨善利单抗相关的新闻（医药）

2025-04-09

·VIP说

肿瘤免疫治疗策略2.0

# 本篇笔记仅基于公开资料和信息撰写、为个人观点、供学术交流所用、不构成任何建议 #我用了差不多一个月的时间，看了几十家代表公司的产品线、几千篇研报和点评、几万个注册临床试验，想要看清楚肿瘤免疫治疗棋局的现状和未来。这不符合我的本性，我是宁可去无人区探险，也不想投入毫厘铢锱不能差错的极致内卷中。但是，现实就是，现在和未来很长一段时间内，免疫检查点抑制剂都会是肿瘤治疗的基石，即使MNC们早就已经布局于免疫检查点抑制剂之外甚至肿瘤治疗之外，国内大多数药企还有一段国产替代的长路要走。既然不能提前退休，只能强忍着非常严重的内卷PTSD看棋局，这种不适感压制了我的段子手级别语言天赋，所以这篇笔记会写的非常......直白。我个人给免疫治疗策略1.0的定义，就是大家手里都有个PD-(L)1抑制剂产品。全球已经有32个/国内已经有24个PD-(L)1抑制剂产品上市。图片引用来自“IO笔记”。至于免疫治疗策略2.0，就是如何进一步迭代和升级。PD-(L)1抑制剂产品本身的迭代和升级，目前大家的策略非常一致，改良单抗本身没能创造出什么奇迹，就开发双抗/多抗和复方，以及皮下注射、口服小分子、ADC等新剂型。双抗/多抗和复方本质类似于联合给药方案，所以放到后面再说。开发皮下注射剂型看上去是个捷径，不过如果大家的目标是国际市场，可能会有专利侵权风险：阿斯利康7.5亿美元引进Alteogen透明质酸酶技术，后者深陷侵权风险口服小分子PD-(L)1抑制剂，我是没有“小药说药”那么关注，而且似乎已经冷却：靶向PD-1/PD-L1小分子药物的研究进展至于PD-(L)1 ADC，反正已经热闹起来：靶向PD-L1 ADC：辉瑞首次国内申报临床！复宏汉霖、映恩生物“勇攀高峰”此外，国内外很多家药企已经想开了，不搞什么伪创新药，帕博利珠单抗核心专利将于2028年到期，直接开发生物类似药。国内外我已经数出来10个帕博利珠单抗类似药在做注册临床试验了，还有3个纳武利尤单抗生物类似药。更广谱的迭代和升级策略，就是以PD-(L)1抑制剂产品为基石，开发各种联合给药方案。汇总信息还是医药魔方做得最漂亮（反正我下载了PPT）：PD-1/PD-L1抑制剂中美获批及全球注册性临床试验15年动态趋势医药魔方PPT中部分内容截图：类似的汇总信息报告和点评很多，都能让大家一眼看清楚肿瘤免疫治疗棋局已经内卷到什么地步，看完不但没有思路，反而更加焦虑了。所以我们还是采用最简单高效的fast follow的老办法，看看几十家代表公司的肿瘤免疫治疗产品线，看看follow谁家的具体策略最适合自家。1. 默沙东/默克帕博利珠单抗(PD-1单抗)，长期被群殴和围攻的药王，王冠太重。在肿瘤领域，默沙东/默克不断探索和拓展其各种联合给药方案，并且积极布局复方和皮下等新剂型，双抗等新产品，以求夯实其在肿瘤领域的领先地位。复方主要是MK-1308A(PD-1+CTLA-4，Pembrolizumab+Quavonlimab)，MK-7684A(PD-1+TIGHT，Pembrolizumab+Vibostolimab)，MK-4280A(PD-1+LAG-3，Pembrolizumab+favezelimab)，2024年12月宣布终止开发后两个，目前只有MK-1308A还在推进。皮下剂型MK-3475A的III期临床试验刚官宣成功。近年来，默沙东/默克的肿瘤产品线重点已经布局于免疫检查点抑制剂之外，但免疫检查点抑制剂还是肿瘤治疗的基石，肿瘤领域且没有禁忌症，什么新产品都尝试联联看，就像吃什么菜都要配一碗白米饭。看帕博利珠单抗适应症布局是一项极其艰巨的工作，我差不多用了半个月时间，剩下几十个产品用了剩下的半个月时间。太多了。不仅因为默沙东/默克财大气粗，有把握的III期试验开几百个，没把握的I-II期试验和IIT开几千个，更因为帕博利珠单抗是基石中的基石，米饭中的白米饭，其他药企开发联合给药方案也是首选帕博利珠单抗。即使默沙东/默克没有布局，其他药企也会填空，所有瘤种所有适应症，完全没有空缺。最后得去翻默沙东/默克官网的PPT，才能找出他家真正的主线。如果布局图里出现了个别空缺，那也是某些III期临床试验失败导致的，绝不是没人尝试过填空。比如大家都吃过瓜的LEAP系列。但是有三个瘤种，即著名的冷肿瘤们，卵巢癌、胰腺癌、前列腺癌，所有药企都是屡战屡败+屡败屡战。先驱栽坑里那是代价，后来者再盲目跳坑，我可能忍不住嘲笑了，如果不是颠覆性作用机制的新药，建议不要再尝试将免疫治疗用于这几个瘤种。2. BMS纳武利尤单抗(PD-1单抗)，没能问鼎药王，所以在此基础上早早开发出皮下注射剂型，与伊匹木单抗(Ipilimumab, CTLA-4)联合方案，与Relatlimab(LAG-3单抗)联合方案，甚至开发了复方OPDUALAG(Nivolumab+Relatlimab)，均已成功获批多个适应症。也曾在TIGHT、IDO等靶点药物联合方案上栽过跟头，最新产品是复方BMS-986489(PD-1+fucosyl-GM1, Nivolumab+BMS-986012)。近年来，BMS的肿瘤产品线重点也已经布局于免疫检查点抑制剂之外。但免疫检查点抑制剂还是肿瘤治疗的基石，主动或被动开发联合方案也非常多。3. 罗氏阿替利珠单抗(PD-L1单抗)，其实已经算差异化开发了，靶点从PD-1换成了PD-L1。阿替利珠单抗是早早成功开发了皮下注射剂型。之后开发双抗时换回PD-1单抗，包括Tobemstomig(RO7247669, PD-1/LAG-3)，Lomvastomig(PD-1/TIM-3, RO7121661)。罗氏在肿瘤免疫治疗方面不算成功，主要是因为阿替利珠单抗与Tiragolumab(TIGHT单抗)的联合方案投入太大，受伤太深。但是深挖一下新技术平台，还能翻出来PD1-IL2v，PDL1 LNA等产品。值得注意的是，阿替利珠单抗用于三阴性乳腺癌非常波折，各种姿势的III期临床试验失败和撤回适应症，鉴于特瑞普利单抗在同一适应症里取得过成功，咱们不能说三阴性乳腺癌不适合免疫治疗，但PD-1单抗似乎比PD-L1单抗强一些。肾癌、尿路上皮癌、头颈癌、宫颈癌里也有类似情况，建议谨慎选择PD-L1单抗。4. 阿斯利康度伐利尤单抗(PD-L1单抗)，早期策略和BMS类似，开发皮下注射剂型，还有和替西木单抗(Tremelimumab, CTLA-4)的联合给药方案。后来者的好处就是可以避开先驱们栽过的坑，适应症开发都比较顺利。现在已经不做复方了，直接换双抗，Volrustomig(PD-1/CTLA-4)，Sabestomig(PD-1/TIM-3)，Rilvegostomig (PD-1/TIGHT)。发起IO+ADC潮流的应该就是他家，而且他家明显艺高人胆大，最偏爱Rilvegostomig (PD-1/TIGHT)，这是要死磕TIGHT靶点的节奏。5. 辉瑞、吉列德、再生元、GSK、Incyte、BIOCAD可以说，辉瑞几乎错了肿瘤免疫治疗浪潮。Avelumab(PD-L1单抗)开发顺位非常靠后，所以从超级冷门小适应症下手—皮肤默克尔细胞癌，弯道超车获批上市后，目前仅在膀胱癌领域取得成功（联合阿昔替尼用于肾癌一线是基于PFS成功附条件获批，但是OS失败，现在很尴尬；用于非小细胞肺癌、头颈癌和胃癌都是全面失败）。后来一度想悄悄开发PD-1单抗皮下注射剂型Sasanlimab（未获批上市），最终还是抢跑PF-08046054(PD-1 ADC)。后来者后来到辉瑞这个地步，如果还不愿赌服输，就得这么另辟蹊径。但是Sasanlimab有点过，首个适应症居然选择联合BCG用于非肌层浸润性膀胱癌，之前帕博利珠单抗和纳武利尤单抗都挑战失败的适应症，全球均未有免疫检查点抑制剂类产品获批。吉列德也是后来者，但是通过收购Arcus获得了赛帕利单抗(Zimberelimab，PD-1单抗)，果然顺产没有顺手快。在国内，赛帕利单抗用于经典型霍奇金淋巴瘤和晚期宫颈癌已获批上市。但是他家的联合给药方案，目前以Domvanalimab(TIGHT单抗)为主，又是一个死磕TIGHT靶点的。再生元不算后来者，Cemiplimab(PD-1单抗)虽然不算先驱，但是通过小适应症—皮肤鳞状细胞癌和皮肤基底细胞癌，早早弯道超车获批上市。他家毕竟是资深肿瘤免疫疗法biotech，联合给药方案非常多，目前以联合Fianlimab(LAG-3单抗)为主。GSK不算后来者也不算先驱，多塔利单抗(Dostarlimab，PD-1单抗) 通过小适应症—dMMR/MSI-H子宫内膜癌，早早弯道超车获批上市，之后仅专注于子宫内膜癌、结直肠癌和头颈癌，坚定的反内卷思维，深得我心。Incyte真不容易，当初为了卡瑞利珠单抗和恒瑞分分合合，最后终于拥有了自己的Retifanlimab(PD-1单抗)。跟辉瑞类似，因为Retifanlimab开发顺位非常靠后，所以从超级冷门小适应症下手—皮肤默克尔细胞癌，弯道超车获批上市。后来居然又被再鼎引入中国继续开发，反正各种不容易。再看Incyte产品线，始终专注于肿瘤免疫疗法，口服PD-L1，PD-1/LAG-3双抗、PD-1/TGF-βRII双抗均有布局。Prolgolimab(PD-1单抗)由俄罗斯药企BIOCAD开发，获得俄罗斯卫生部批准上市，用于治疗转移性黑色素瘤。在两国总理的共同见证下，由上药集团引进入国内共同开发，上药集团不愧是一流国企，非常正确。值得一提的是，Prolgolimab都这么正确了也没有躺平，继续开发复方BCD-217(Prolgolimab+Nurulimab，PD-1+CTLA-4)，还开发了帕博利珠单抗生物类似药。6. 其他外企艾博维：Budigalimab(PD-1单抗)Budigalimab绝对算后来者，我个人高度怀疑艾博维是为了联合其他自家真爱的新产品才被迫开发了基石。到现在最高开发阶段II期临床试验。强生：Cetrelimab(PD-1单抗)也不知道这个产品是不是和辉瑞的Sasanlimab高度类似，首个适应症居然也选择非肌层浸润性膀胱癌，但联合了自家TAR-200，我个人觉得就是为了陪衬TAR-200。2025年1月15日，强生宣布递交TAR-200的上市申请，用于治疗卡介苗（BCG）不应答的高危非肌肉侵袭性膀胱癌（HR-NMIBC）伴原位癌（CIS）患者。此次递交通过实时肿瘤审评（RTOR）项目，允许FDA在完全申请正式递交之前就开始审评以加快进度。 TAR-200为一种膀胱内局部给药的新型递送系统，采用一种双重小片设计，材质为硅聚合物半透小管，吉西他滨在膀胱持续缓慢释放。BI：Ezabenlimab(PD-1单抗)反正我个人高度怀疑BI是为了联合其他自家真爱的新产品才被迫开发了基石。到现在最高开发阶段II期临床试验。安进：Zeluvalimab(PD-1单抗)在安进最新的产品线信息里已经找不到Zeluvalimab了，但是找到了纳武利尤单抗生物类似药，预期2025年获批上市。放弃死磕开发顺位过于滞后的伪创新药，拥抱生物类似药，拥抱效率和利润，毕竟肿瘤免疫治疗也不是安进公司的主线，顶多用来联合其他自家真爱的新产品。Agenus：Botensilimab(PD-1单抗)Agenus还算比较重视Botensilimab，但主要是为了配合新一代产品—Balstilimab(CTLA-4单抗)，声称可以将冷肿瘤转化为热肿瘤。首个适应症选择联合Balstilimab用于non-MSI-H结直肠癌。坚定的反内卷思维，深得我心。BioNTech：BNT327(PD-L1/VEGF双抗)等收购普米斯生物等biotechs，跳过肿瘤免疫治疗1.0时代，直接飞跃至2.0时代潮头，拥有各种最热门双抗和ADC，又是顺产哪有顺手快的成功案例和典型代表。不过最新的消息是BNT311(PD-L1/4-1BB双抗)退回Genmab，这不是一个好消息，真正成功的双抗也不多。BioNTech的策略虽然有抄袭AZ，但非常清晰明确，值得学习。先分析免疫检查点抑制剂单药或既往的联合给药方案，在全球范围内获批过哪些适应症，还有哪些细分人群中有未被满足的临床需求，既往放弃开发或开发失败适应症的困难在哪里。再分析或补充自家产品线里的产品，是否有新颖的作用机制可能攻克之前的困难。最后设计BNT327的临床开发计划：第一步，联合化疗去攻克确定性高、能快速实现高市场价值的适应症；第二步，联合各种新颖作用机制的新产品，填补之前未被满足的临床需求；第三步，探索更多、更新的联合给药方案和适应症。篇幅原因，写完外企部分已经快5000字了，改天再写国内企业部分。信息量过大，CPU干烧到头晕，所有重点点到即止，如有疏漏错误，请大家多包涵。# 本篇笔记仅基于公开资料和信息撰写、为个人观点、供学术交流所用、不构成任何建议 #

抗体药物偶联物免疫疗法生物类似药

2025-03-14

·EndPoints

Pfizer terminates an early-stage STING agonist trial

Pfizer’s pipeline prioritization has now turned to a STING agonist, with an early-stage study termination of the asset, a spokesperson confirmed to Endpoints News . The company ended a Phase 1 trial of its STING agonist PF-07820435 “due to business strategy and not for safety concern with study drug,” the spokesperson said in a Thursday afternoon email. The asset remained in Pfizer’s pipeline as recently as last month’s quarterly update. The New York drug giant was testing the candidate alone and in combination with its late-stage anti-PD-1 monoclonal antibody called sasanlimab. The study enrolled nine patients with advanced solid tumors, according to an update to the US federal trials database this week. Pfizer originally planned to bring 140 patients into the trial, according to a historical record of the study. PF-07820435 was orally delivered, whereas other STING agonists in development have been delivered via other mechanisms, including antibody-drug conjugates (like at Mersana Therapeutics ) and IV-infused candidates (including at Takeda ). Pfizer has revised its pipeline multiple times in recent quarters as it undergoes billions of dollars in cost cuts, and as its new R&D and medical leadership team settle into place .

临床1期抗体药物偶联物

2025-03-14

·BioSpace

Pfizer’s Pipeline Pruning Ends Early-Stage STING Trial

iStock, tomozina Pfizer was studying PF-07820435, an orally available agonist of the STING protein, for solid tumors. Pfizer has terminated a Phase I trial of its investigational STING therapy in advanced solid tumors, according to an update to the study’s clinicaltrials.gov page on Thursday. The move to discontinue the trial of PF-07820435 was based on “strategic business reasons,” according to the webpage. “The decision was not based on any safety and/or efficacy concerns.” BioSpace has reached out to Pfizer to confirm the discontinuation and will update this space accordingly. The Phase I trial was testing PF-07820435, with or without the PD-1 inhibitor sasanlimab, in nine patients with confirmed diagnoses of solid tumors. The main objective of the study was to establish the safety of PF-07820435 and detect early signals of efficacy, as well as determine the drug’s recommended dose for further studies. The study was initiated in February last year. STING, which stands for “stimulator interferon genes,” is a protein that plays a central role in a patient’s anti-cancer immune response by activating type I interferons and other inflammatory players. An orally available drug, PF-07820435 belongs to a class of drugs called STING agonists, which work by triggering the STING pathway and promoting immune activity against cancer cells. As of this writing, PF-07820435 remains on the pharma’s pipeline page . If Pfizer does eventually decide to completely drop PF-07820435, it will be the latest casualty in the pharma’s push to trim its pipeline and refine its business strategy. In December 2024, Pfizer turned its back on Sangamo Therapeutics and its gene therapy candidate giroctocogene fitelparvovec, which the companies were previously developing for hemophilia A. Phase III data released in July 2024 showed that 84% of patients treated with giroctocogene fitelparvovec maintained factor VIII activity above 5%, and majority achieved factor VIII levels greater than 15% of normal. Pfizer and Sangamo were supposed to Biologics License Application for giroctocogene fitelparvovec this year. The termination of the companies’ partnership will take effect on April 21, after which the pharma will transition the hemophilia A program back to Sangamo. Last month, Pfizer announced it was pulling its hemophilia B gene therapy Beqvez from markets worldwide—a decision the company pinned on “the limited interest patients and their doctors have demonstrated in hemophilia gene therapies.” Pfizer, in September 2024, likewise withdrew Oxbryta, an oral hemoglobin S polymerization inhibitor that won the FDA’s approval in 2019 for sickle cell disease. The drug has since been linked to a higher occurrence of complications and death.

临床1期基因疗法上市批准临床3期临床结果

100 项与萨善利单抗相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	临床3期	美国	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	中国	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	日本	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	澳大利亚	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	比利时	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	加拿大	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	法国	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	德国	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	意大利	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	波兰	Pfizer Inc.	2019-12-30

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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


NCT04165317 (CREST, NEWS) 人工标引	临床3期	非肌层浸润性膀胱肿瘤	-	sasanlimab + standard-of-care Bacillus Calmette-Guérin	獵構選簾淵製窪壓簾鬱(齋鑰蓋窪鏇願壓窪簾製) = CREST met its primary endpoint. 窪壓齋顧憲築顧鑰衊憲 (蓋願壓鏇觸獵醖構繭窪 ) 达到更多	积极	2025-01-10
				standard-of-care Bacillus Calmette-Guérin
NCT04181788 (2019-003818-14, Pubmed \| Ther Adv Med Oncol)	临床2期	肺癌 PD-L1 positive	155	Sasanlimab 300 mg-Q4W	艱廠廠選遞顧膚獵鏇選(壓遞醖遞鑰範鬱獵艱簾) = 夢鬱膚觸廠構餘顧衊醖淵壓壓繭醖鏇鹹鹹獵積 (廠觸餘廠蓋願鏇壓醖淵, 14.2 ~ 42.9)	积极	2024-01-01
				Sasanlimab 600 mg-Q6W	艱廠廠選遞顧膚獵鏇選(壓遞醖遞鑰範鬱獵艱簾) = 鹹鏇艱壓憲艱顧鹽鏇襯淵壓壓繭醖鏇鹹鹹獵積 (廠觸餘廠蓋願鏇壓醖淵, 8.0 ~ 24.7)
NCT04181788 (2019-003818-14, CTgov)	临床2期	非小细胞肺癌	155	PF-06801591 (Phase 1b Escalation 300 mg SC Q4W)	網壓繭鏇夢壓鬱簾鬱鹽 = 餘選窪醖繭淵醖網憲遞鬱蓋願鑰醖壓鏇願襯願 (獵壓糧鏇築艱範鑰艱製, 蓋糧鹽遞遞廠窪鏇鹹築 ~ 觸製簾餘鏇淵窪獵衊餘) 更多	-	2023-05-08
				PF-06801591 (Phase 1b Expansion 300 mg SC Q4W)	網壓繭鏇夢壓鬱簾鬱鹽 = 鬱顧鬱築艱衊窪夢艱選鬱蓋願鑰醖壓鏇願襯願 (獵壓糧鏇築艱範鑰艱製, 構簾憲選觸遞範願餘鹽 ~ 網鹽簾簾艱鹹顧襯獵鏇) 更多
NCT02573259 (ESMO2020)	临床1期	转移性非小细胞肺癌 \| 尿路上皮癌	106	SC PF-06801591 300mg q4w	壓築簾繭窪鹽壓獵遞淵(廠廠鏇選憲繭積淵壓夢) = 衊廠窪構淵蓋繭膚襯襯觸鏇醖夢選鑰鬱顧鬱網 (齋鑰壓糧艱製窪構廠繭 ) 更多	积极	2020-09-17
NCT02573259 (AACR2020)	临床1期	转移性非小细胞肺癌 \| 尿路上皮癌	106	PF-06801591 300 mg	壓顧獵顧窪獵觸齋製壓(網糧簾鏇壓糧餘廠夢膚) = 餘齋膚憲選構壓窪鑰構獵鹽壓壓遞積夢蓋衊製 (鹽蓋艱壓憲選範構網醖 )	积极	2020-08-15
NCT02573259 (ESMO2019)	临床1期	转移性非小细胞肺癌 \| 尿路上皮癌	106	SC PF-06801591 300mg q4w	餘築憲願窪鏇蓋觸鹽膚(艱衊製網簾築選齋遞廠) = 4.7% 蓋遞製淵艱構鬱顧鏇鑰 (積餘範遞鑰築願淵獵遞 ) 更多	积极	2019-09-30
NCT02573259 (Pubmed \| JAMA Oncol) 人工标引	临床1期	实体瘤	40	PF-06801591 (intravenously)	築獵壓構襯獵襯餘製窪(醖襯窪選選築製醖製選) = No dose-limiting toxic effects were observed. 壓遞襯餘構獵衊廠蓋鏇 (齋築鹽蓋鏇醖窪顧鬱蓋 )	积极	2019-07-01
				PF-06801591 (subcutaneously)