Enfortumab vedotin plus pembrolizumab continues to demonstrate superior efficacy versus chemotherapy in a broad population, reinforcing the combination as standard of care in first-line treatment of la/muC

Enfortumab vedotin加pembrolizumab在广泛人群中继续显示出优于化疗的疗效，加强了其作为la/muC一线治疗标准的联合治疗

At nearly 30 months of follow-up in the Phase 3 EV-302 trial, the combination doubled median overall survival and progression-free survival compared to chemotherapy, with no new safety signals identified

在第3阶段EV-302试验的近30个月随访中，与化疗相比，该组合的中位总生存期和无进展生存期翻了一番，没有发现新的安全信号

TOKYO and NEW YORK, February 12, 2025

东京和纽约，2025年2月12日

– Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of PADCEV

–辉瑞公司（纽约证券交易所：PFE）和Astellas制药公司（东京证交所：4503，总裁兼首席执行官：冈村直树，“Astellas”）今天宣布了评估PADCEV疗效和安全性的第三阶段EV-302临床试验（也称为KEYNOTE-A39）的进一步随访结果

®

®

(enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus KEYTRUDA

（enfortumab vedotin ejfv），一种Nectin-4定向抗体-药物偶联物，加上KEYTRUDA

®

®

(pembrolizumab), a PD-1 inhibitor, in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months)..

（pembrolizumab）是一种PD-1抑制剂，用于先前未经治疗的局部晚期或转移性尿路上皮癌（la/mUC）患者。结果显示，在额外的12个月随访（中位随访29.1个月）后，持续的总生存期（OS）和无进展生存期（PFS）获益与主要分析结果一致。。

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These data will be presented during a rapid oral session (Abstract 664) at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2025 in San Francisco, CA, on 14

这些数据将于14日在加利福尼亚州旧金山举行的2025年美国临床肿瘤学会泌尿生殖系统癌症研讨会（ASCO GU）上进行快速口头会议（摘要664）

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February at 4:10pm PT.

2月下午4:10 PT。

Thomas Powles, M.R.C.P., M.D., Professor of Genitourinary Oncology at Queen Mary University of London; Director, Barts Cancer Center, London; EV-302 Primary Investigator

Thomas Powles，M.R.C.P.，M.D.，伦敦玛丽女王大学泌尿生殖系统肿瘤学教授；伦敦巴特斯癌症中心主任；EV-302主要研究者

“These latest findings from the EV-302 trial reaffirm the primary results, which demonstrated survival improvements for patients treated with enfortumab vedotin and pembrolizumab that were previously unprecedented in locally advanced or metastatic urothelial cancer. These data show that the potential survival benefit has become even more robust with extended follow up and further solidify the combination as standard of care.”.

“EV-302试验的这些最新发现重申了主要结果，这些结果表明，接受恩复单抗vedotin和pembrolizumab治疗的患者的生存率有所提高，这在局部晚期或转移性尿路上皮癌中是前所未有的。这些数据表明，随着随访时间的延长，潜在的生存益处变得更加强大，并进一步巩固了联合治疗作为护理标准。”。

Results showed enfortumab vedotin plus pembrolizumab reduced the risk of death by 49% versus chemotherapy (hazard ratio [HR] = 0.51, 95% confidence interval [CI], 0.43-0.61). The median OS was 33.8 months for the combination versus 15.9 months for chemotherapy. The OS benefit was observed in all prespecified subgroups, including cisplatin eligible and ineligible subgroups.

结果显示，与化疗相比，enfortumab vedotin加pembrolizumab可将死亡风险降低49%（风险比[HR]=0.51，95%置信区间[CI]，0.43-0.61）。联合治疗的中位OS为33.8个月，化疗为15.9个月。在所有预先指定的亚组中观察到OS益处，包括顺铂合格和不合格的亚组。

Enfortumab vedotin plus pembrolizumab also reduced the risk of disease progression or death by 52% versus chemotherapy (HR = 0.48, 95% CI, 0.41-0.57). The median PFS was 12.5 months for the combination versus 6.3 months for chemotherapy. The safety profile was consistent with previous findings and no new safety concerns were identified..

Enfortumab vedotin加pembrolizumab与化疗相比，疾病进展或死亡风险降低了52%（HR=0.48，95%CI，0.41-0.57）。联合用药的中位PFS为12.5个月，化疗为6.3个月。安全概况与以前的发现一致，没有发现新的安全问题。。

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Please see Important Safety Information at the end of this press release, including

请参阅本新闻稿末尾的重要安全信息，包括

BOXED WARNING

盒装警告

for enfortumab vedotin.

对于enfortumab vedotin。

In addition to longer follow-up data, an exploratory analysis evaluating treatment outcomes and safety profile in patients with confirmed complete response (cCR) will also be presented. Among patients evaluable for response, confirmed objective response rate (cORR) was 67.5% for enfortumab vedotin plus pembrolizumab compared to 44.2% for chemotherapy.

除了更长的随访数据外，还将提供一项探索性分析，评估确诊完全缓解（cCR）患者的治疗结果和安全性。在可评估疗效的患者中，enfortumab vedotin加pembrolizumab的确诊客观缓解率（cORR）为67.5%，而化疗为44.2%。

Median duration of response (DOR) was 23.3 months (95% CI, 17.8-not estimable [NE]) for the combination and 7.0 months (95% CI, 6.2-9.0) for chemotherapy. A cCR was achieved in 30.4% of patients treated with enfortumab vedotin plus pembrolizumab and 14.5% of patients treated with chemotherapy. Median duration of cCR was not reached for the combination and 15.2 months (95% CI, 10.3-NE) for chemotherapy.

联合用药的中位缓解期（DOR）为23.3个月（95%CI，17.8-不可估计[NE]），化疗为7.0个月（95%CI，6.2-9.0）。30.4%的患者接受了依呋单抗联合派姆单抗治疗，14.5%的患者接受了化疗。联合治疗未达到cCR的中位持续时间，化疗未达到15.2个月（95%CI，10.3-NE）。

In patients with cCR, grade ≥3 treatment-related adverse events occurred in 61.7% of patients in the enfortumab vedotin plus pembrolizumab arm compared to 71.9% in the chemotherapy arm. There were no treatment-related deaths in the cCR subgroup..

。cCR亚组没有治疗相关死亡。。

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Roger Dansey, M.D., Chief Oncology Officer, Pfizer

Roger Dansey，医学博士，辉瑞首席肿瘤官

“Patients with bladder cancer can face a poor prognosis, particularly in the advanced stages, and until recently had few available treatment options. The updated EV-302 results show sustained long-term efficacy in a broad population that includes both cisplatin eligible and ineligible patients and reinforce this combination’s ability to reshape the urothelial cancer treatment landscape.”.

“膀胱癌患者可能面临不良预后，特别是在晚期，直到最近几乎没有可用的治疗选择。最新的EV-302结果显示，在包括顺铂合格和不合格患者在内的广泛人群中，长期疗效持续，并加强了这种组合重塑尿路上皮癌治疗格局的能力。”。

Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas

Ahsan Arozullah，医学博士，医学博士，高级副总裁，肿瘤发展主管，Astellas

“The combination of enfortumab vedotin and pembrolizumab was the first approval to offer an alternative to platinum-containing chemotherapy, which had been the standard of care for first-line locally advanced or metastatic urothelial cancer for decades. We are delighted that the additional follow-up results of the EV-302 trial show a durable benefit.

“enfortumab vedotin和pembrolizumab的组合是首次批准提供含铂化疗的替代方案，铂类化疗几十年来一直是一线局部晚期或转移性尿路上皮癌的标准治疗方法。我们很高兴EV-302试验的额外随访结果显示出持久的益处。

These data represent yet another milestone in our long-standing commitment to helping patients around the world live longer and healthier lives.”.

这些数据代表了我们长期致力于帮助世界各地的患者活得更长、更健康的另一个里程碑。”。

Enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with la/mUC in the United States, the European Union, Japan and a number of other countries around the world. Enfortumab vedotin is also approved as a single agent for the treatment of adult patients with la/mUC who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy..

Enfortumab vedotin plus pembrolizumab在美国，欧盟，日本和世界其他一些国家被批准用于治疗la/mUC成年患者。Enfortumab vedotin也被批准为单一药物，用于治疗先前接受过PD-1/PD-L1抑制剂和含铂化疗或不符合含顺铂化疗资格且先前接受过一种或多种治疗方案的成年la/mUC患者。。

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About EV-302

关于EV-302

The EV-302 trial is an open-label, randomized, controlled Phase 3 study, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated la/mUC. The study enrolled 886 patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.

EV-302试验是一项开放标签，随机，对照的3期研究，评估enfortumab vedotin联合pembrolizumab与先前未治疗的la/mUC患者的含铂化疗。该研究招募了886名先前未经治疗的la/mUC患者，无论PD-L1状态如何，他们都有资格接受含顺铂或卡铂的化疗。

Patients were randomized to receive either enfortumab vedotin in combination with pembrolizumab or platinum-containing chemotherapy. The dual primary endpoints of this trial are OS and PFS per RECIST v1.1 by blinded independent central review (BICR). Select secondary endpoints include ORR per RECIST v1.1 by BICR, DOR per RECIST v1.1 by BICR, and safety..

患者被随机分配接受enfortumab vedotin联合pembrolizumab或含铂化疗。该试验的双重主要终点是通过盲法独立中央审查（BICR）每个RECIST v1.1的OS和PFS。选择次要终点包括BICR的每个RECIST v1.1的ORR，BICR的每个RECIST v1.1的DOR和安全性。。

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The EV-302 trial is part of an extensive clinical program evaluating this combination in multiple stages of urothelial cancer and other solid tumors.

EV-302试验是一项广泛的临床计划的一部分，该计划评估了尿路上皮癌和其他实体瘤的多个阶段的这种组合。

Primary results

主要结果

from the EV-302 study were presented at the European Society for Medical Oncology (ESMO) Congress in October 2023.

EV-302研究的结果于2023年10月在欧洲肿瘤内科学会（ESMO）大会上发表。

About PADCEV

关于跌倒

®

®

(enfortumab vedotin-ejfv)

（enfortumab vedotin-ejfv）

PADCEV

瀑布

®

®

(enfortumab vedotin-ejfv) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.

（enfortumab vedotin ejfv）是针对Nectin-4的一流抗体-药物偶联物（ADC），Nectin-4是一种位于细胞表面并在膀胱癌中高度表达的蛋白质。

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Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis)..

非临床数据表明，enfortumab vedotin的抗癌活性是由于其与表达Nectin-4的细胞结合，然后抗肿瘤剂单甲基auristatin E（MMAE）内化并释放到细胞中，导致细胞不繁殖（细胞周期停滞）和程序性细胞死亡（凋亡）。。

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PADCEV

瀑布

®

®

(enfortumab vedotin-ejfv) U.S. Indication & Important Safety Information

（enfortumab vedotin ejfv）美国指示和重要安全信息

BOXED WARNING: SERIOUS SKIN REACTIONS

盒装警告：严重的皮肤反应

PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later.

PADCEV可引起严重致命的皮肤不良反应，包括史蒂文斯-约翰逊综合征（SJS）和中毒性表皮坏死松解症（TEN），主要发生在第一个治疗周期，但可能会在以后发生。

Closely monitor patients for skin reactions.

密切监测患者的皮肤反应。

Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.

立即停止PADCEV，并考虑转诊接受疑似SJS或TEN或严重皮肤反应的专业护理。

Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.

确诊为SJS或TEN的患者永久停用PADCEV；或4级或复发性3级皮肤反应。

Indication

指示物，指示物，指示物，指示物，指示物，指示物。的，指示物，指示物，指示物。。。的，指示物，指示物，指示物，指示物，指示物，指示物，指示

PADCEV

瀑布

®

®

, in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).

与pembrolizumab联合用于治疗局部晚期或转移性尿路上皮癌（mUC）的成年患者。

PADCEV, as a single agent, is indicated for the treatment of adult patients with locally advanced or mUC who:

PADCEV作为单一药物，适用于治疗局部晚期或mUC的成年患者，这些患者：

have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or

先前曾接受过程序性死亡受体1（PD-1）或程序性死亡配体1（PD-L1）抑制剂和含铂化疗，或

are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

不符合含顺铂化疗的资格，并且之前曾接受过一种或多种治疗方案。

IMPORTANT SAFETY INFORMATION

重要安全信息

Warnings and Precautions

警告和注意事项

Skin reactions

皮肤反应

Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later. Skin reactions occurred in 70% (all grades) of the 564 patients treated with PADCEV in combination with pembrolizumab in clinical trials.

PADCEV治疗的患者发生严重的皮肤不良反应，包括致命的SJS或TEN病例。SJS和TEN主要发生在第一个治疗周期，但可能会在以后发生。在临床试验中，PADCEV联合pembrolizumab治疗的564例患者中有70%（所有级别）发生皮肤反应。

When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate compared to PADCEV as a single agent. The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash.

当PADCEV与pembrolizumab联合使用时，与PADCEV作为单一药物相比，皮肤反应（包括严重事件）的发生率更高。联合治疗发生的大多数皮肤反应包括斑丘疹，黄斑疹和丘疹。

Grade 3-4 skin reactions occurred in 17% of patients (Grade 3: 16%, Grade 4: 1%), including maculo-papular rash, bullous dermatitis, dermatitis, exfoliative dermatitis, pemphigoid, rash, erythematous rash, macular rash, and papular rash. A fatal reaction of bullous dermatitis occurred in one patient (0.2%).

17%的患者发生3-4级皮肤反应（3级：16%，4级：1%），包括斑丘疹，大疱性皮炎，皮炎，剥脱性皮炎，类天疱疮，皮疹，红斑疹，黄斑疹和丘疹。一名患者（0.2%）发生大疱性皮炎的致命反应。

The median time to onset of severe skin reactions was 1.7 months (range: 0.1 to 17.2 months). Skin reactions led to discontinuation of PADCEV in 6% of patients..

严重皮肤反应发作的中位时间为1.7个月（范围：0.1至17.2个月）。皮肤反应导致6%的患者停用PADCEV。。

Skin reactions occurred in 58% (all grades) of the 720 patients treated with PADCEV as a single agent in clinical trials. Twenty-three percent (23%) of patients had maculo-papular rash and 34% had pruritus. Grade 3-4 skin reactions occurred in 14% of patients, including maculo-papular rash, erythematous rash, rash or drug eruption, symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), bullous dermatitis, exfoliative dermatitis, and palmar-plantar erythrodysesthesia.

在临床试验中，使用PADCEV作为单一药物治疗的720例患者中，有58%（所有级别）发生皮肤反应。23%的患者有斑丘疹，34%的患者有瘙痒。14%的患者发生3-4级皮肤反应，包括斑丘疹，红斑疹，皮疹或药疹，对称性药物相关性三叉间和弯曲性皮疹（SDRIFE），大疱性皮炎，剥脱性皮炎和掌底红细胞感觉异常。

The median time to onset of severe skin reactions was 0.6 months (range: 0.1 to 8 months). Among patients experiencing a skin reaction leading to dose interruption who then restarted PADCEV (n=75), 24% of patients restarting at the same dose and 24% of patients restarting at a reduced dose experienced recurrent severe skin reactions.

严重皮肤反应发作的中位时间为0.6个月（范围：0.1至8个月）。在经历导致剂量中断的皮肤反应的患者中，然后重新开始PADCEV（n=75），24%的患者以相同剂量重新开始，24%的患者以减少剂量重新开始，经历了反复的严重皮肤反应。

Skin reactions led to discontinuation of PADCEV in 3.1% of patients..

皮肤反应导致3.1%的患者停用PADCEV。。

Monitor patients closely throughout treatment for skin reactions. Consider topical corticosteroids and antihistamines, as clinically indicated. For persistent or recurrent Grade 2 skin reactions, consider withholding PADCEV until Grade ≤1. Withhold PADCEV and refer for specialized care for suspected SJS, TEN or for Grade 3 skin reactions.

在整个治疗过程中密切监测患者的皮肤反应。根据临床指示，考虑局部使用皮质类固醇和抗组胺药。对于持续性或复发性2级皮肤反应，考虑扣留PADCEV直至≤1级。保留PADCEV，并针对疑似SJS，TEN或3级皮肤反应进行专门护理。

Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions..

确诊为SJS或TEN的患者永久停用PADCEV；或4级或复发性3级皮肤反应。。

Hyperglycemia and diabetic ketoacidosis (DKA),

高血糖和糖尿病酮症酸中毒（DKA），

including fatal events, occurred in patients with and without pre-existing diabetes mellitus, treated with PADCEV. Patients with baseline hemoglobin A1C ≥8% were excluded from clinical trials. In clinical trials of PADCEV as a single agent, 17% of the 720 patients treated with PADCEV developed hyperglycemia of any grade; 7% of patients developed Grade 3-4 hyperglycemia (Grade 3: 6.5%, Grade 4: 0.6%).

包括致命事件，发生在有或没有预先存在的糖尿病患者中，用PADCEV治疗。基线血红蛋白A1C≥8%的患者被排除在临床试验之外。在PADCEV作为单一药物的临床试验中，接受PADCEV治疗的720例患者中有17%发生了任何程度的高血糖症；7%的患者出现3-4级高血糖（3级：6.5%，4级：0.6%）。

Fatal events of hyperglycemia and DKA occurred in one patient each (0.1%). The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. The median time to onset of hyperglycemia was 0.5 months (range: 0 to 20 months).

高血糖和DKA的致命事件各发生一名患者（0.1%）。体重指数较高的患者和基线A1C较高的患者3-4级高血糖的发生率持续增加。高血糖发作的中位时间为0.5个月（范围：0至20个月）。

Hyperglycemia led to discontinuation of PADCEV in 0.7% of patients. Five percent (5%) of patients required initiation of insulin therapy for treatment of hyperglycemia. Of the patients who initiated insulin therapy for treatment of hyperglycemia, 66% (23/35) discontinued insulin at the time of last evaluation.

高血糖导致0.7%的患者停用PADCEV。5%（5%）的患者需要开始胰岛素治疗以治疗高血糖症。在开始胰岛素治疗以治疗高血糖的患者中，66%（23/35）在上次评估时停止了胰岛素治疗。

Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV..

密切监测患有或有糖尿病或高血糖风险的患者的血糖水平。如果血糖升高（>250 mg/dL），则停止使用PADCEV。。

Pneumonitis/Interstitial Lung Disease (ILD)

肺炎/间质性肺病（ILD）

Severe, life-threatening or fatal pneumonitis/ILD occurred in patients treated with PADCEV. When PADCEV was given in combination with pembrolizumab, 10% of the 564 patients treated with combination therapy had pneumonitis/ILD of any grade and 4% had Grade 3-4. A fatal event of pneumonitis/ILD occurred in two patients (0.4%).

。当PADCEV与pembrolizumab联合使用时，联合治疗的564例患者中有10%患有任何级别的肺炎/ILD，4%患有3-4级。两名患者（0.4%）发生肺炎/ILD致命事件。

The incidence of pneumonitis/ILD, including severe events, occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent. The median time to onset of any grade pneumonitis/ILD was 4 months (range: 0.3 to 26 months)..

与PADCEV作为单一药物相比，当PADCEV与pembrolizumab联合使用时，肺炎/ILD（包括严重事件）的发生率更高。任何级别肺炎/ILD的中位发病时间为4个月（范围：0.3至26个月）。。

In clinical trials of PADCEV as a single agent, 3% of the 720 patients treated with PADCEV had pneumonitis/ILD of any grade and 0.8% had Grade 3-4. The median time to onset of any grade pneumonitis/ILD was 2.9 months (range: 0.6 to 6 months).

在PADCEV作为单一药物的临床试验中，接受PADCEV治疗的720例患者中有3%患有任何级别的肺炎/ILD，0.8%患有3-4级。任何级别肺炎/ILD发病的中位时间为2.9个月（范围：0.6至6个月）。

Monitor patients for signs and symptoms indicative of pneumonitis/ILD such as hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Evaluate and exclude infectious, neoplastic and other causes for such signs and symptoms through appropriate investigations. Withhold PADCEV for patients who develop Grade 2 pneumonitis/ILD and consider dose reduction.

在放射学检查中监测患者是否有肺炎/ILD的体征和症状，例如缺氧，咳嗽，呼吸困难或间质浸润。通过适当的调查，评估并排除此类体征和症状的传染性，肿瘤性和其他原因。对于发生2级肺炎/ILD并考虑减少剂量的患者，保留PADCEV。

Permanently discontinue PADCEV in all patients with Grade 3 or 4 pneumonitis/ILD..

所有3级或4级肺炎/ILD患者永久停用PADCEV。。

Peripheral neuropathy (PN)

周围神经病（PN）

When PADCEV was given in combination with pembrolizumab, 67% of the 564 patients treated with combination therapy had PN of any grade, 36% had Grade 2 neuropathy, and 7% had Grade 3 neuropathy. The incidence of PN occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent.

当PADCEV与pembrolizumab联合使用时，联合治疗的564例患者中有67%患有任何级别的PN，36%患有2级神经病，7%患有3级神经病。与PADCEV作为单一药物相比，当PADCEV与pembrolizumab联合使用时，PN的发生率更高。

The median time to onset of Grade ≥2 PN was 6 months (range: 0.3 to 25 months)..

≥2级PN发病的中位时间为6个月（范围：0.3至25个月）。。

PN occurred in 53% of the 720 patients treated with PADCEV as a single agent in clinical trials including 38% with sensory neuropathy, 8% with muscular weakness and 7% with motor neuropathy. Thirty percent of patients experienced Grade 2 reactions and 5% experienced Grade 3-4 reactions. PN occurred in patients treated with PADCEV with or without preexisting PN.

在临床试验中，使用PADCEV作为单一药物治疗的720例患者中，有53%发生PN，其中38%患有感觉神经病，8%患有肌肉无力，7%患有运动神经病。30%的患者经历了2级反应，5%的患者经历了3-4级反应。在有或没有先前存在的PN的情况下，用PADCEV治疗的患者发生PN。

The median time to onset of Grade ≥2 PN was 4.9 months (range: 0.1 to 20 months). Neuropathy led to treatment discontinuation in 6% of patients..

≥2级PN发病的中位时间为4.9个月（范围：0.1至20个月）。神经病导致6%的患者停止治疗。。

Monitor patients for symptoms of new or worsening PN and consider dose interruption or dose reduction of PADCEV when PN occurs. Permanently discontinue PADCEV in patients who develop Grade ≥3 PN.

监测患者是否出现新的或恶化的PN症状，并在PN发生时考虑剂量中断或PADCEV剂量减少。对于PN≥3级的患者，永久停用PADCEV。

Ocular disorders

眼部疾病

were reported in 40% of the 384 patients treated with PADCEV as a single agent in clinical trials in which ophthalmologic exams were scheduled. The majority of these events involved the cornea and included events associated with dry eye such as keratitis, blurred vision, increased lacrimation, conjunctivitis, limbal stem cell deficiency, and keratopathy.

在计划进行眼科检查的临床试验中，384名接受PADCEV治疗的患者中有40%报告了这种情况。这些事件中的大多数涉及角膜，包括与干眼症相关的事件，例如角膜炎，视力模糊，流泪增加，结膜炎，角膜缘干细胞缺乏症和角膜病变。

Dry eye symptoms occurred in 30% of patients, and blurred vision occurred in 10% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.7 months (range: 0 to 30.6 months). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve.

在使用PADCEV治疗期间，30%的患者出现干眼症，10%的患者出现视力模糊。症状性眼部疾病的中位发病时间为1.7个月（范围：0至30.6个月）。监测患者的眼部疾病。如果眼部症状出现或无法缓解，请考虑人工泪液预防干眼症和眼科评估。

Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders..

如果眼科检查后有指示，考虑使用眼用局部类固醇治疗。考虑中断剂量或减少PADCEV剂量治疗症状性眼部疾病。。

Infusion site extravasation

输液部位外渗

Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 720 patients treated with PADCEV as a single agent in clinical trials, 1% of patients experienced skin and soft tissue reactions, including 0.3% who experienced Grade 3-4 reactions. Reactions may be delayed.

在施用PADCEV后观察到继发于外渗的皮肤和软组织反应。在临床试验中使用PADCEV作为单一药物治疗的720例患者中，1%的患者出现皮肤和软组织反应，其中0.3%的患者出现3-4级反应。反应可能会延迟。

Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. Two patients (0.3%) developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration.

外渗后2-7天，红斑，肿胀，体温升高和疼痛恶化，并在高峰后1-4周内消退。两名患者（0.3%）出现继发性蜂窝织炎，大疱或脱落的外渗反应。在开始PADCEV之前确保足够的静脉通路，并在给药期间监测可能的外渗。

If extravasation occurs, stop the infusion and monitor for adverse reactions..

如果发生外渗，停止输液并监测不良反应。。

Embryo-fetal toxicity

胚胎-胎儿毒性

PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose..

PADCEV给孕妇服用时会对胎儿造成伤害。告知患者对胎儿的潜在风险。建议有生殖潜力的女性患者在PADCEV治疗期间和最后一剂后2个月内使用有效的避孕方法。建议有生殖潜力的女性伴侣的男性患者在使用PADCEV治疗期间和最后一次服用后4个月内使用有效的避孕措施。。

ADVERSE REACTIONS

不良反应

Most common adverse reactions, including laboratory abnormalities(≥20%) (PADCEV in combination with pembrolizumab)

Increased aspartate aminotransferase (AST), increased creatinine, rash, increased glucose, PN, increased lipase, decreased lymphocytes, increased alanine aminotransferase (ALT), decreased hemoglobin, fatigue, decreased sodium, decreased phosphate, decreased albumin, pruritus, diarrhea, alopecia, decreased weight, decreased appetite, increased urate, decreased neutrophils, decreased potassium, dry eye, nausea, constipation, increased potassium, dysgeusia, urinary tract infection and decreased platelets..

天冬氨酸氨基转移酶（AST）升高，肌酐升高，皮疹，葡萄糖升高，PN升高，脂肪酶升高，淋巴细胞减少，丙氨酸氨基转移酶（ALT）升高，血红蛋白降低，疲劳，钠降低，磷酸盐降低，白蛋白降低，瘙痒，腹泻，脱发，体重减轻，食欲下降，尿酸升高，中性粒细胞减少，钾减少，干眼，恶心，便秘，钾增加，味觉障碍，尿路感染和血小板减少。。

Most common adverse reactions, including laboratory abnormalities (≥20%) (PADCEV monotherapy)

最常见的不良反应，包括实验室异常（≥20%）（PADCEV单药治疗）

Increased glucose, increased AST, decreased lymphocytes, increased creatinine, rash, fatigue, PN, decreased albumin, decreased hemoglobin, alopecia, decreased appetite, decreased neutrophils, decreased sodium, increased ALT, decreased phosphate, diarrhea, nausea, pruritus, increased urate, dry eye, dysgeusia, constipation, increased lipase, decreased weight, decreased platelets, abdominal pain, dry skin..

血糖升高，AST升高，淋巴细胞减少，肌酐增加，皮疹，疲劳，PN，白蛋白减少，血红蛋白减少，脱发，食欲下降，中性粒细胞减少，钠减少，ALT升高，磷酸盐减少，腹泻，恶心，瘙痒，尿酸盐增加，干眼症，味觉障碍，便秘，脂肪酶增加，体重减轻，血小板减少，腹痛，皮肤干燥。。

EV-302 Study: 440 patients with previously untreated la/mUC (PADCEV in combination with pembrolizumab)

EV-302研究：440名先前未经治疗的la/mUC患者（PADCEV联合pembrolizumab）

Serious adverse reactions

严重不良反应

occurred in 50% of patients treated with PADCEV in combination with pembrolizumab. The most common serious adverse reactions (≥2%) were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%).

PADCEV联合pembrolizumab治疗的患者中有50%发生了这种情况。最常见的严重不良反应（≥2%）是皮疹（6%），急性肾损伤（5%），肺炎/ILD（4.5%），尿路感染（3.6%），腹泻（3.2%），肺炎（2.3%），发热（2%）和高血糖（2%）。

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Fatal adverse reactions

致命不良反应

occurred in 3.9% of patients treated with PADCEV in combination with pembrolizumab including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%).

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Adverse reactions leading to discontinuation of PADCEV occurred in 35% of patients.

35%的患者发生了导致停用PADCEV的不良反应。

The most common adverse reactions (≥2%) leading to discontinuation

最常见的不良反应（≥2%）导致停药

of PADCEV were PN (15%), rash (4.1%) and pneumonitis/ILD (2.3%). Adverse reactions leading to dose interruption of PADCEV occurred in 73% of patients.

PADCEV的发生率为PN（15%），皮疹（4.1%）和肺炎/ILD（2.3%）。73%的患者发生了导致PADCEV剂量中断的不良反应。

The most common adverse reactions (≥2%) leading to dose interruption

导致剂量中断的最常见不良反应（≥2%）

of PADCEV were PN (22%), rash (16%), COVID-19 (10%), diarrhea (5%), pneumonitis/ILD (4.8%), fatigue (3.9%), hyperglycemia (3.6%), increased ALT (3%) and pruritus (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 42% of patients.

PADCEV的发生率为PN（22%），皮疹（16%），新型冠状病毒肺炎（10%），腹泻（5%），肺炎/ILD（4.8%），疲劳（3.9%），高血糖（3.6%），ALT升高（3%）和瘙痒（2.5%）。42%的患者发生了导致PADCEV剂量减少的不良反应。

The most common adverse reactions (≥2%) leading to dose reduction

最常见的不良反应（≥2%）导致剂量减少

of PADCEV were rash (16%), PN (13%) and fatigue (2.7%).

PADCEV的发生率为皮疹（16%），PN（13%）和疲劳（2.7%）。

EV-103 Study: 121 patients with previously untreated la/mUC who were not eligible for cisplatin-containing chemotherapy (PADCEV in combination with pembrolizumab)

EV-103研究：121名先前未经治疗的la/mUC患者不符合含顺铂化疗的条件（PADCEV联合pembrolizumab）

Serious adverse reactions

严重不良反应

occurred in 50% of patients treated with PADCEV in combination with pembrolizumab; the most common (≥2%) were acute kidney injury (7%), urinary tract infection (7%), urosepsis (5%), sepsis (3.3%), pneumonia (3.3%), hematuria (3.3%), pneumonitis/ILD (3.3%), urinary retention (2.5%), diarrhea (2.5%), myasthenia gravis (2.5%), myositis (2.5%), anemia (2.5%), and hypotension (2.5%).

发生在50%的PADCEV联合pembrolizumab治疗的患者中；最常见的（≥2%）是急性肾损伤（7%），尿路感染（7%），尿脓毒症（5%），败血症（3.3%），肺炎（3.3%），血尿（3.3%），肺炎/ILD（3.3%），尿潴留（2.5%），腹泻（2.5%），重症肌无力（2.5%），肌炎（2.5%），贫血（2.5%）和低血压（2.5%）。

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Fatal adverse reactions

致命不良反应

occurred in 5% of patients treated with PADCEV in combination with pembrolizumab, including sepsis (1.6%), bullous dermatitis (0.8%), myasthenia gravis (0.8%), and pneumonitis/ILD (0.8%).

PADCEV联合pembrolizumab治疗的患者中有5%发生，包括败血症（1.6%），大疱性皮炎（0.8%），重症肌无力（0.8%）和肺炎/ILD（0.8%）。

Adverse reactions leading to discontinuation

导致停药的不良反应

of PADCEV occurred in 36% of patients; the most common (≥2%)were PN (20%) and rash (6%).

PADCEV的发生率为36%；最常见（≥2%）是PN（20%）和皮疹（6%）。

Adverse reactions leading to dose interruption

导致剂量中断的不良反应

of PADCEV occurred in 69% of patients; the most common (≥2%)were PN (18%), rash (12%), increased lipase (6%), pneumonitis/ILD (6%), diarrhea (4.1%), acute kidney injury (3.3%), increased ALT (3.3%), fatigue (3.3%), neutropenia (3.3%), urinary tract infection (3.3%), increased amylase (2.5%), anemia (2.5%), COVID-19 (2.5%), hyperglycemia (2.5%), and hypotension (2.5%).

PADCEV的发生率为69%；最常见的（≥2%）是PN（18%），皮疹（12%），脂肪酶升高（6%），肺炎/ILD（6%），腹泻（4.1%），急性肾损伤（3.3%），ALT升高（3.3%），疲劳（3.3%），中性粒细胞减少（3.3%），尿路感染（3.3%），淀粉酶升高（2.5%），贫血（2.5%），COVID-19（2.5%），高血糖（2.5%）和低血压（2.5%）。

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Adverse reactions leading to dose reduction

导致剂量减少的不良反应

of PADCEV occurred in 45% of patients; the most common (≥2%) were PN (17%), rash (12%), fatigue (5%), neutropenia (5%), and diarrhea (4.1%).

PADCEV的发生率为45%；最常见的（≥2%）是PN（17%），皮疹（12%），疲劳（5%），中性粒细胞减少（5%）和腹泻（4.1%）。

EV-301 Study: 296 patients previously treated with a PD-1/L1 inhibitor and platinum-based chemotherapy (PADCEV monotherapy)

EV-301研究：296名先前接受PD-1/L1抑制剂和铂类化疗（PADCEV单一疗法）治疗的患者

Serious adverse reactions

严重不良反应

occurred in 47% of patients treated with PADCEV; the most common (≥2%) were urinary tract infection, acute kidney injury (7% each), and pneumonia (5%).

发生在47%接受PADCEV治疗的患者中；最常见的（≥2%）是尿路感染，急性肾损伤（各7%）和肺炎（5%）。

Fatal adverse reactions

致命不良反应

occurred in 3% of patients, including multiorgan dysfunction (1%), hepatic dysfunction, septic shock, hyperglycemia, pneumonitis/ILD, and pelvic abscess (0.3% each).

发生在3%的患者中，包括多器官功能障碍（1%），肝功能障碍，感染性休克，高血糖，肺炎/ILD和盆腔脓肿（各0.3%）。

Adverse reactions leading to discontinuation

导致停药的不良反应

occurred in 17% of patients; the most common (≥2%) were PN (5%) and rash (4%).

发生在17%的患者中；最常见（≥2%）是PN（5%）和皮疹（4%）。

Adverse reactions leading to dose interruption

导致剂量中断的不良反应

occurred in 61% of patients; the most common (≥4%) were PN (23%), rash (11%), and fatigue (9%).

；最常见的（≥4%）是PN（23%），皮疹（11%）和疲劳（9%）。

Adverse reactions leading to dose reduction

导致剂量减少的不良反应

occurred in 34% of patients; the most common (≥2%) were PN (10%), rash (8%), decreased appetite, and fatigue (3% each).

发生在34%的患者中；最常见的（≥2%）是PN（10%），皮疹（8%），食欲下降和疲劳（各3%）。

EV-201, Cohort 2 Study: 89 patients previously treated with a PD-1/L1 inhibitor and not eligible for cisplatin-based chemotherapy (PADCEV monotherapy)

EV-201，队列2研究：89名先前接受PD-1/L1抑制剂治疗但不符合顺铂化疗（PADCEV单药治疗）条件的患者

Serious adverse reactions

严重不良反应

occurred in 39% of patients treated with PADCEV; the most common (≥3%) were pneumonia, sepsis, and diarrhea (5% each).

发生在39%接受PADCEV治疗的患者中；最常见（≥3%）是肺炎，败血症和腹泻（各5%）。

Fatal adverse reactions

致命不良反应

occurred in 8% of patients, including acute kidney injury (2.2%), metabolic acidosis, sepsis, multiorgan dysfunction, pneumonia, and pneumonitis/ILD (1.1% each).

发生率为8%，包括急性肾损伤（2.2%），代谢性酸中毒，败血症，多器官功能障碍，肺炎和肺炎/ILD（各1.1%）。

Adverse reactions leading to discontinuation

导致停药的不良反应

occurred in 20% of patients; the most common (≥2%) was PN (7%).

发生在20%的患者中；最常见（≥2%）是PN（7%）。

Adverse reactions leading to dose interruption

导致剂量中断的不良反应

occurred in 60% of patients; the most common (≥3%) were PN (19%), rash (9%), fatigue (8%), diarrhea (5%), increased AST, and hyperglycemia (3% each).

发生在60%的患者中；最常见的（≥3%）是PN（19%），皮疹（9%），疲劳（8%），腹泻（5%），AST升高和高血糖（各3%）。

Adverse reactions leading to dose reduction

导致剂量减少的不良反应

occurred in 49% of patients; the most common (≥3%) were PN (19%), rash (11%), and fatigue (7%).

发生在49%的患者中；最常见的（≥3%）是PN（19%），皮疹（11%）和疲劳（7%）。

DRUG INTERACTIONS

药物相互作用

Effects of other drugs on PADCEV

其他药物对PADCEV的影响

(Dual P-gp and Strong CYP3A4 Inhibitors)

（双重P-gp和强CYP3A4抑制剂）

Concomitant use with dual P-gp and strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with dual P-gp and strong CYP3A4 inhibitors..

与双重P-gp和强CYP3A4抑制剂同时使用可能会增加未结合的单甲基auristatin E暴露，这可能会增加PADCEV毒性的发生率或严重程度。当PADCEV与双重P-gp和强CYP3A4抑制剂同时服用时，密切监测患者的毒性迹象。。

SPECIFIC POPULATIONS

特定人群

Lactation Advise

哺乳期建议

lactating women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose.

哺乳期妇女在PADCEV治疗期间和最后一次给药后3周内不进行母乳喂养。

Hepatic impairment

Avoid the use of PADCEV in patients with moderate or severe hepatic impairment.

避免在中度或重度肝功能损害患者中使用PADCEV。

For more information, please see the U.S. full Prescribing Information including BOXED WARNING for PADCEV

here

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About Pfizer Oncology

关于辉瑞肿瘤学

At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics.

。我们业界领先的产品组合和广泛的渠道包括从多个角度攻击癌症的三个核心作用机制，包括小分子，抗体-药物偶联物（ADC）和双特异性抗体，包括其他免疫肿瘤学生物制剂。

We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives..

我们专注于为世界上一些最常见的癌症提供变革性治疗，包括乳腺癌，泌尿生殖系统癌症，血液肿瘤和包括肺癌在内的胸癌。在科学的推动下，我们致力于加速突破，帮助癌症患者过上更好、更长的生活。。

About Astellas

关于安斯泰来

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.

Astellas是一家全球生命科学公司，致力于将创新科学转化为患者的价值。我们在包括肿瘤学、眼科、泌尿学、免疫学和女性健康在内的疾病领域提供变革性疗法。通过我们的研发计划，我们正在为医疗需求未得到满足的疾病开创新的医疗保健解决方案。

Learn more at .

更多信息，请访问。

www.astellas.com

www.astellas.com

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About the Pfizer, Astellas and Merck Collaboration

关于辉瑞、阿斯特拉斯和默克的合作

Seagen and Astellas entered a clinical collaboration agreement with Merck to evaluate the combination of Seagen’s and Astellas’ PADCEV

Seagen和Astellas与默克公司签订了临床合作协议，以评估Seagen和Astellas的PADCEV的组合

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(enfortumab vedotin-ejfv) and Merck’s KEYTRUDA

（enfortumab vedotin-ejfv）和默克的KEYTRUDA

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(pembrolizumab) in patients with previously untreated metastatic urothelial cancer. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada)..

（pembrolizumab）治疗先前未经治疗的转移性尿路上皮癌患者。辉瑞公司于2023年12月14日成功完成了对Seagen的收购。KEYTRUDA是默克公司（Merck&Co.，Inc.，Rahway，NJ，USA）（在美国和加拿大以外称为MSD）的子公司默克夏普公司（Merck Sharp&Dohme Corp.）的注册商标。。

Pfizer Disclosure Notice

辉瑞披露通知

The information contained in this release is as of February 10, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

本版本中包含的信息截至2025年2月10日。辉瑞没有义务因新信息或未来事件或发展而更新本版本中包含的前瞻性声明。

This release contains forward-looking information about Pfizer Oncology and PADCEV

本版本包含有关辉瑞肿瘤学和PADCEV的前瞻性信息

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(enfortumab vedotin-ejfv) in combination with pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

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Risk and uncertainties include, among other things, uncertainties regarding the commercial success of PADCEV; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed in particular jurisdictions for any potential indication for PADCEV with pembrolizumab or as a single agent; whether and when any such applications that may be pending or filed for PADCEV with pembrolizumab or as a single agent may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether PADCEV with pembrolizumab or as a single agent will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial pot.

风险和不确定性包括PADCEV商业成功的不确定性；研究和开发中固有的不确定性，包括满足预期临床终点的能力，我们临床试验的开始和/或完成日期，监管提交日期，监管批准日期和/或发布日期，以及不利的新临床数据的可能性和现有临床数据的进一步分析；临床试验数据受到监管机构不同解释和评估的风险；；是否以及何时可以在特定司法管辖区向pembrolizumab或作为单一代理人提交任何PADCEV潜在适应症的申请；监管机构是否以及何时可以批准任何此类申请，这些申请可能正在等待或提交给pembrolizumab或作为单一代理人的PADCEV，这将取决于无数因素，包括确定产品的益处是否超过其已知风险，以及确定产品的功效，如果批准，PADCEV与pembrolizumab或作为单一代理人是否会取得商业成功；监管机构的决定影响标签、制造过程、安全和/或其他可能影响可用性或商业pot的事项。

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S.

有关风险和不确定性的进一步说明，请参阅辉瑞公司截至2023年12月31日的10-K表年度报告，以及随后的10-Q表报告，包括标题为“风险因素”和“前瞻性信息和可能影响未来结果的因素”的部分，以及随后的8-K表报告，所有这些报告均已提交给美国。

Securities and Exchange Commission and available at .

证券交易委员会，网址为。

www.sec.gov

www.sec.gov

and

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www.pfizer.com

www.pfizer.com

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Astellas Cautionary Notes

Astellas注意事项

In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties.

在本新闻稿中，有关当前计划、估计、战略和信念的声明以及其他非历史事实的声明都是关于阿斯特拉斯未来表现的前瞻性声明。这些声明基于管理层目前的假设和信念，并根据目前可获得的信息，涉及已知和未知的风险和不确定性。

A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties..

许多因素可能导致实际结果与前瞻性声明中讨论的结果存在重大差异。这些因素包括但不限于：（i）与药品市场有关的一般经济条件和法律法规的变化，（ii）货币汇率波动，（iii）新产品发布的延迟，（iv）Astellas无法有效营销现有产品和新产品，（v）Astellas无法继续在竞争激烈的市场上有效研究和开发客户接受的产品，以及（vi）第三方侵犯Astellas的知识产权。。

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

本新闻稿中包含的有关药品（包括目前正在开发的产品）的信息无意构成广告或医疗建议。

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References

参考文献

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Powels T, et al. EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).

Powels T等人，EV-302：enfortumab vedotin联合pembrolizumab（EV+P）与化疗（化疗）在先前未治疗的局部晚期或转移性尿路上皮癌（la/mUC）中的3期全球研究的最新分析。

J Clin Oncol

J Clin肿瘤

43, 2025 (suppl 5; abstr 664)

2025年第43号（补编5；第664条）

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Powels T, Valderrama BP, Gupta S, et al. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer.

Powels T，Valderrama BP，Gupta S等。Enfortumab Vedotin和Pembrolizumab治疗未经治疗的晚期尿路上皮癌。

N Engl J Med

恩格尔 J Med

2024;390:875-888.

2024;390:875-888.

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PADCEV [package insert]. Northbrook, IL: Astellas Pharma US, Inc.

PADCEV[包装插页]。伊利诺伊州诺斯布鲁克：阿斯特拉斯制药美国公司。

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National Cancer Institute. Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302). ClinicalTrials.gov identifier: NCT04223856. Published January 6, 2020. Updated September 27, 2024. Accessed January 6, 2025.

国家癌症研究所。Enfortumab Vedotin和Pembrolizumab与未经治疗的局部晚期或转移性尿路上皮癌（EV-302）单独化疗相比。ClinicalTrials.gov标识符：NCT04223856。2020年1月6日出版。2024年9月27日更新。2025年1月6日访问。

https://clinicaltrials.gov/study/NCT04223856?tab=results#results-overview

https://clinicaltrials.gov/study/NCT04223856?tab=results#results-概述

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Challita-Eid PM, Satpayev D, Yang P, et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models.

Challita-Eid PM，Satpayev D，Yang P等。靶向nectin-4的Enfortumab vedotin抗体-药物偶联物是多种临床前癌症模型中的高效治疗剂。

Cancer Res

癌症研究

2016;76(10):3003-13.

2016;76(10):3003-13.

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