PADCEV plus KEYTRUDA is the first and only regimen to improve survival when used before and after standard of care (surgical cystectomy) in cisplatin-ineligible patients with muscle-invasive bladder cancer

PADCEV联合KEYTRUDA是首个且唯一在顺铂不耐受的肌层浸润性膀胱癌患者中，在标准治疗（手术切除）前后使用能提高生存率的方案。

Results will be discussed with global health authorities for potential regulatory filings

结果将与全球卫生当局讨论，以进行潜在的监管文件提交。

NEW YORK AND TOKYO, August 12, 2025

纽约和东京，2025年8月12日

– Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive topline results from the Phase 3 EV-303 clinical trial (also known as KEYNOTE-905). The EV-303 study is evaluating PADCEV

辉瑞公司（纽约证券交易所代码：PFE）和安斯泰来制药公司（东京证券交易所代码：4503，总裁兼首席执行官：冈村直树，“安斯泰来”）今天宣布了3期EV-303临床试验（也称为KEYNOTE-905）的积极顶线结果。EV-303研究正在评估PADCEV。

TM

商标

(enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA

（恩福单抗维多汀），一种针对Nectin-4的抗体药物偶联物，与KEYTRUDA联合使用

TM

商标

(pembrolizumab), a PD-1 inhibitor, as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy.

(pembrolizumab)，一种PD-1抑制剂，作为新辅助和辅助治疗（手术前后）与单独手术（当前的标准治疗）对比，用于不符合顺铂化疗条件或拒绝顺铂化疗的肌层浸润性膀胱癌（MIBC）患者。

At the first interim efficacy analysis, the trial demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS), the study’s primary endpoint, and overall survival (OS), a key secondary endpoint, with neoadjuvant and adjuvant PADCEV plus KEYTRUDA versus surgery alone.

在首次中期疗效分析中，与单独手术相比，新辅助和辅助 PADCEV 加 KEYTRUDA 在无事件生存期（EFS，研究的主要终点）和总生存期（OS，一个关键的次要终点）方面显示出具有临床意义且统计学显著的改善。

An additional secondary endpoint of pathologic complete response (pCR) rate was also met..

病理完全缓解 (pCR) 率的另一个次要终点也已达成。

Christof Vulsteke, M.D., Ph.D., Head of Integrated Cancer Center Ghent (IKG, Belgium) and Clinical Trial Unit Oncology Ghent and EV-303 principal investigator

克里斯托夫·沃尔斯特克医学博士、哲学博士，根特综合癌症中心（IKG，比利时）主任，根特肿瘤临床试验部门负责人，EV-303项目首席研究员

“Patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy have not seen a significant treatment advance beyond surgery and face high rates of disease recurrence and a poor prognosis, even after having their bladder removed. These EV-303 study results mark the first time a systemic treatment approach, used before and after surgery, significantly extended survival over standard-of-care surgery in this population, demonstrating the potential of this combination to address a critical unmet patient need.”.

“不符合顺铂化疗条件的肌层浸润性膀胱癌患者，除了手术外尚未看到显著的治疗进展，即使在膀胱切除后仍面临高复发率和不良预后。这项EV-303研究结果标志着首次有一种系统性治疗方法在术前和术后使用时，相较于标准护理手术显著延长了该人群的生存期，展示了这种组合满足关键未满足患者需求的潜力。”

The trial is continuing to evaluate the secondary EFS, OS and pCR rate endpoints for neoadjuvant and adjuvant KEYTRUDA versus surgery alone as they continue to mature. The safety profiles for PADCEV plus KEYTRUDA and KEYTRUDA monotherapy were consistent with the known profiles of each treatment regimen..

试验继续评估新辅助和辅助KEYTRUDA与单独手术相比的次要EFS、OS和pCR率终点，因为这些数据仍在不断成熟。PADCEV加KEYTRUDA和KEYTRUDA单药治疗的安全性特征与每种治疗方案的已知特征一致。

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas

Moitreyee Chatterjee-Kishore，博士，工商管理硕士，安斯泰来肿瘤开发部门负责人

“These results from EV-303 represent a breakthrough for cisplatin-ineligible patients with muscle-invasive bladder cancer, demonstrating the potential of PADCEV in combination with KEYTRUDA when used before and after surgery as a new standard of care. We look forward to presenting further details on these data at an upcoming medical congress.”.

“EV-303的结果代表了对于无法使用顺铂的肌层浸润性膀胱癌患者的突破，证明了PADCEV联合KEYTRUDA在手术前后使用的潜力，成为一种新的治疗标准。我们期待在即将召开的医学大会上展示这些数据的更多细节。”

Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally.

膀胱癌是全球第九大常见癌症，每年全球有超过614,000名患者被诊断出患有此病。

i

我

MIBC represents approximately 30% of all bladder cancer cases.

MIBC占所有膀胱癌病例的约30%。

ii

二

The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong survival.

肌层浸润性膀胱癌（MIBC）患者的标准治疗是基于顺铂的新辅助化疗，随后进行手术，这已被证明可以延长生存期。

ii

二

However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone.

然而，高达一半的 MIBC 患者没有资格接受顺铂治疗，面临有限的治疗选择，通常仅接受手术治疗。

iii

iii

Johanna Bendell, M.D., Oncology Chief Development Officer, Pfizer

约翰娜·本德尔，医学博士，辉瑞肿瘤学首席开发官

“PADCEV plus KEYTRUDA has already changed the treatment paradigm for patients with locally advanced or metastatic urothelial cancer as standard of care. These latest results underscore the practice-changing potential of this combination in earlier stages of bladder cancer, where it has the potential to improve outcomes for even more patients.

“PADCEV联合KEYTRUDA已经改变了局部晚期或转移性尿路上皮癌患者的治疗模式，成为标准治疗方法。这些最新结果突显了这种组合在膀胱癌更早期阶段的实践变革潜力，有望为更多患者改善治疗效果。”

Thank you to the patients and investigators who participated in this trial.”.

感谢参与本次试验的患者和研究人员。

Results will be submitted for presentation at an upcoming medical congress and will be discussed with global health authorities for potential regulatory filings. Neoadjuvant and adjuvant PADCEV plus KEYTRUDA is also being evaluated in cisplatin-eligible patients with MIBC in the EV-304 Phase 3 clinical trial (also known as KEYNOTE-B15)..

结果将在即将召开的医学大会上提交展示，并与全球卫生当局讨论潜在的监管申报。在EV-304三期临床试验（也称为KEYNOTE-B15）中，也正在评估新辅助和辅助PADCEV联合KEYTRUDA在适合顺铂治疗的MIBC患者中的效果。

+++

+++

About the EV-303 Trial

关于EV-303试验

The EV-303 trial is an ongoing, open-label, randomized, three-arm, controlled, Phase 3 study evaluating neoadjuvant and adjuvant PADCEV in combination with KEYTRUDA or neoadjuvant and adjuvant KEYTRUDA versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy.

EV-303试验是一项正在进行的、开放标签、随机、三臂、对照的III期研究，评估新辅助和辅助PADCEV联合KEYTRUDA或新辅助和辅助KEYTRUDA对比单独手术治疗不适合或拒绝顺铂化疗的MIBC患者的效果。

Patients were randomized to receive either neoadjuvant and adjuvant KEYTRUDA (arm A), surgery alone (arm B) or neoadjuvant and adjuvant PADCEV in combination with KEYTRUDA (arm C)..

患者被随机分配接受新辅助和辅助KEYTRUDA（A组）、单独手术（B组）或新辅助和辅助PADCEV联合KEYTRUDA（C组）。

iv

四

The primary endpoint of this trial is EFS between arm C versus arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy or death due to any cause.

本试验的主要终点是C组与B组之间的EFS，定义为从随机化到以下任一事件首次发生的时间：疾病进展导致无法进行根治性膀胱切除术（RC）或残余病灶患者未能接受RC手术、手术时留下明显的残余病灶、通过影像学和/或活检评估的局部或远处复发，或任何原因导致的死亡。

Key secondary endpoints include OS and pCR rate between arm C and arm B, as well as EFS, OS and pCR rate between arm A and arm B..

关键的次要终点包括C组与B组之间的OS和pCR率，以及A组与B组之间的EFS、OS和pCR率。

iv

四

For more information on the global EV-303 trial, go to

有关全球 EV-303 试验的更多信息，请访问

clinicaltrials.gov

临床试验.gov

.

。

About PADCEV

关于PADCEV

TM

商标

(enfortumab vedotin)

(enfortumab vedotin)

PADCEV

帕德维

TM

商标

(enfortumab vedotin) 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) 是一种首创的抗体药物偶联物 (ADC)，靶向 Nectin-4，这是一种位于细胞表面并在膀胱癌中高度表达的蛋白质。

v

v

Nonclinical data suggest the anticancer activity of PADCEV 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，PADCEV 的抗癌活性是由于它与表达 Nectin-4 的细胞结合，随后将抗肿瘤剂单甲基澳瑞他汀 E（MMAE）内化并释放到细胞中，从而导致细胞停止繁殖（细胞周期停滞）以及程序性细胞死亡（凋亡）。

vi

vi

PADCEV plus KEYTRUDA is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, the European Union, Japan and a number of other countries around the world. PADCEV 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..

PADCEV联合KEYTRUDA已被批准用于治疗局部晚期或转移性尿路上皮癌（la/mUC）的成年患者，不论其是否符合顺铂用药条件，该批准适用于美国、欧盟、日本及世界其他多个国家。PADCEV还被批准作为单药治疗先前接受过PD-1/PD-L1抑制剂和含铂化疗的la/mUC成年患者，或不符合含顺铂化疗条件且先前接受过一种或多种治疗方案的患者。

vi

vi

PADCEV

帕德维

®

®

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

（enfortumab vedotin-ejfv）美国适应症和重要安全信息

BOXED WARNING: SERIOUS SKIN REACTIONS

黑框警告：严重皮肤反应

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 可能导致严重甚至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)，这些反应主要发生在治疗的第一个周期，但也可能在后期出现。

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，并考虑转诊至专科护理，以应对疑似SJS或TEN或严重皮肤反应。

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

对于确诊为SJS或TEN的患者，或出现4级或复发性3级皮肤反应的患者，应永久停用PADCEV。

Indication

指征

PADCEV

恩诺单抗

®

®

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

与 pembrolizumab 联合使用，适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，作为一种单药治疗，适用于局部晚期或转移性尿路上皮癌（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

既往接受过程序性死亡受体-1（PD-1）或程序性死亡配体-1（PD-L1）抑制剂以及含铂化疗，或者

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

不符合接受含顺铂化疗的条件，并且之前接受过一种或多种先前的治疗方案。

PADCEV Important Safety Information

PADCEV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.

接受PADCEV治疗的患者出现了包括致命的SJS或TEN在内的严重皮肤不良反应。SJS和TEN主要发生在第一个治疗周期，但也可能在之后发生。在临床试验中，564名接受PADCEV与pembrolizumab联合治疗的患者中，70%（所有等级）出现了皮肤反应。

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，包括严重事件在内的皮肤反应发生率相较于PADCEV单药治疗更高。联合治疗中出现的大多数皮肤反应包括斑丘疹、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%).

3-4级皮肤反应发生在17%的患者中（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、红斑性皮疹、斑疹和丘疹。其中一名患者（0.2%）发生了致命的大疱性皮炎反应。

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..

严重皮肤反应的中位发生时间为1.7个月（范围：0.1至17.2个月）。皮肤反应导致6%的患者停止使用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，720名接受PADCEV单药治疗的患者中有58%（所有等级）出现皮肤反应。23%的患者出现斑丘疹，34%的患者出现瘙痒。14%的患者出现3-4级皮肤反应，包括斑丘疹、红斑性皮疹、皮疹或药物爆发、对称性药物相关的摩擦部位和屈侧皮疹（SDRIFE）、大疱性皮炎、剥脱性皮炎以及掌跖红斑感觉异常。

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）。在因皮肤反应导致剂量中断后重新开始使用PADCEV的患者（n=75）中，重新使用相同剂量的患者中有24%，重新使用减量剂量的患者中有24%经历了再次发生的严重皮肤反应。

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

皮肤反应导致3.1%的患者停止使用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。根据临床需要，考虑使用局部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，考虑暂停PADCEV直至反应降至1级或更低。若怀疑SJS、TEN或出现3级皮肤反应，应暂停PADCEV并转诊进行专业治疗。

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

对于确诊为SJS或TEN的患者，或出现4级或复发性3级皮肤反应的患者，应永久停止使用PADCEV。

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%).

包括致命事件在内，接受PADCEV治疗的患者中，无论是否预先存在糖尿病，均有发生。基线血红蛋白A1C ≥8% 的患者被排除在临床试验之外。在PADCEV单药临床试验中，720名接受PADCEV治疗的患者中有17%出现了任何级别的高血糖；7%的患者出现了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).

高血糖和糖尿病酮症酸中毒的致命事件各发生一例（0.1%）。3-4级高血糖的发生率在身体质量指数较高和基线A1C较高的患者中持续增加。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%的患者停止使用PADCEV。5%的患者需要开始胰岛素治疗以应对高血糖。在那些开始胰岛素治疗的患者中，66%（23/35）在最后一次评估时已停止使用胰岛素。

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..

密切监测糖尿病或高血糖患者，或有风险的患者的血糖水平。如果血糖升高（> 250 mg/dL），请暂停使用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%).

接受PADCEV治疗的患者中出现了严重、危及生命或致命的肺炎/间质性肺病（ILD）。当PADCEV与派姆单抗联合使用时，在接受联合治疗的564名患者中，有10%发生了任何级别的肺炎/ILD，4%出现了3-4级肺炎/ILD。两名患者（0.4%）发生了致命的肺炎/ILD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)..

当PADCEV与pembrolizumab联合使用时，包括严重事件在内的肺炎/间质性肺病的发生率比单独使用PADCEV时更高。任何级别肺炎/间质性肺病的中位发病时间为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 单药治疗的临床试验中，720 名接受 PADCEV 治疗的患者中有 3% 出现任意级别的肺炎/间质性肺病 (ILD)，0.8% 出现 3-4 级。任意级别肺炎/间质性肺病的中位发病时间为 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.

监测患者是否有肺炎/间质性肺病（ILD）的体征和症状，例如低氧血症、咳嗽、呼吸困难或影像学检查显示间质浸润。通过适当的检查评估并排除导致这些症状的感染性、肿瘤性及其他原因。对于出现2级肺炎/间质性肺病的患者，应暂停使用PADCEV，并考虑减少剂量。

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

所有出现3级或4级肺炎/间质性肺病的患者应永久停用PADCEV。

Peripheral neuropathy (PN)

周围神经病变 (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与派姆单抗联合使用时，在接受联合治疗的564名患者中有67%发生了任何级别的PN（周围神经病变），36%发生了2级神经病变，7%发生了3级神经病变。与PADCEV单独使用相比，PADCEV与派姆单抗联合使用时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)..

出现2级或以上PN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，720名接受PADCEV单药治疗的患者中有53%发生周围神经病变（PN），其中38%为感觉神经病变，8%为肌肉无力，7%为运动神经病变。30%的患者出现2级反应，5%的患者出现3-4级反应。无论患者是否预先存在PN，在接受PADCEV治疗的患者中均观察到PN的发生。

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的中位发病时间为4.9个月（范围：0.1至20个月）。神经病变导致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，当PN发生时，考虑暂停或减少PADCEV的剂量。对于出现3级或以上PN的患者，应永久停用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384名接受PADCEV单药治疗的患者中，40%的患者报告了相关事件，这些临床试验中安排了眼科检查。其中大多数事件涉及角膜，包括与干眼相关的情况，如角膜炎、视力模糊、泪液增多、结膜炎、边缘干细胞缺乏和角膜病变。

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%的患者出现干眼症状，10%的患者出现视力模糊。发生症状性眼部疾病的时间中位数为1.7个月（范围：0至30.6个月）。监测患者的眼部疾病情况。考虑使用人工泪液预防干眼，并在出现眼部症状或症状未缓解时进行眼科评估。

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征，考虑使用眼科局部类固醇治疗。对于有症状的眼部疾病，考虑中断或减少PADCEV的剂量。

Infusion site extravasation

输注部位外渗

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.

在使用PADCEV后观察到因外渗引起的皮肤和软组织反应。在临床试验中，720名接受PADCEV单药治疗的患者中，有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.

红斑、肿胀、温度升高和疼痛在渗漏后2-7天内加重，并在峰值后的1-4周内消退。两名患者（0.3%）出现伴有继发性蜂窝织炎、水疱或脱皮的渗漏反应。在开始使用PADCEV之前确保足够的静脉通路，并在给药期间监测可能的渗漏情况。

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在给孕妇使用时可能对胎儿造成伤害。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治疗期间及最后一剂后2个月内使用有效避孕措施。建议有具生殖潜力女性伴侣的男性患者在PADCEV治疗期间及最后一剂后4个月内使用有效避孕措施。

ADVERSE REACTIONS

不良反应

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

最常见的不良反应，包括实验室异常（≥20％）（PADCEV与pembrolizumab联合使用）

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..

天门冬氨酸氨基转移酶（AST）升高、肌酐升高、皮疹、葡萄糖升高、PN、脂肪酶升高、淋巴细胞减少、丙氨酸氨基转移酶（ALT）升高、血红蛋白减少、疲劳、钠减少、磷减少、白蛋白减少、瘙痒、腹泻、脱发、体重减轻、食欲减退、尿酸升高、中性粒细胞减少、钾减少、干眼症、恶心、便秘、钾升高、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、肌酐升高、皮疹、疲劳、PN（周围神经病变）、白蛋白降低、血红蛋白降低、脱发、食欲减退、中性粒细胞减少、钠降低、ALT升高、磷酸盐减少、腹泻、恶心、瘙痒、尿酸升高、干眼症、味觉异常、便秘、脂肪酶升高、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名既往未治疗的la/mUC患者（PADCEV联合派姆单抗）

Serious adverse reactions

严重的不良反应

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%).

在接受 PADCEV 联合 pembrolizumab 治疗的患者中，50% 出现了这种情况。最常见的严重不良反应（≥2%）为皮疹（6%）、急性肾损伤（5%）、肺炎/间质性肺病（4.5%）、尿路感染（3.6%）、腹泻（3.2%）、肺炎（2.3%）、发热（2%）和高血糖（2%）。

.

。

Fatal adverse reactions

致命的不良反应

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%).

在使用PADCEV联合派姆单抗治疗的患者中，有3.9%的患者出现了相关症状，其中包括急性呼吸衰竭（0.7%）、肺炎（0.5%）以及肺炎/间质性肺病（0.2%）。

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

导致停用 PADCEV 的不良反应发生在 35% 的患者中。

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

导致停药的最常见不良反应（≥2%）

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的不良反应包括周围神经病变（15%）、皮疹（4.1%）和肺炎/间质性肺病（2.3%）。导致PADCEV剂量中断的不良反应发生在73%的患者中。

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的不良反应包括周围神经病变（22%）、皮疹（16%）、COVID‑19（10%）、腹泻（5%）、肺炎/间质性肺病（4.8%）、疲劳（3.9%）、高血糖（3.6%）、ALT升高（3%）和瘙痒（2.5%）。导致PADCEV剂量减少的不良反应发生在42%的患者中。

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

导致剂量减少的最常见的不良反应（≥2%）

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

PADCEV的不良反应为皮疹（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名既往未接受治疗的la/mUC患者，这些患者不符合含顺铂化疗的条件（PADCEV联合帕博利珠单抗）。

Serious adverse reactions

严重的不良反应

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%).

在使用PADCEV联合派姆单抗治疗的患者中，发生了50%的不良事件；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/间质性肺病（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%）。

.

。

Fatal adverse reactions

致命的不良反应

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%).

在接受PADCEV联合pembrolizumab治疗的患者中，有5%发生了以下不良反应，包括败血症（1.6%）、大疱性皮炎（0.8%）、重症肌无力（0.8%）以及肺炎/间质性肺病（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%；最常见的（≥2%）是PN（20%）和皮疹（6%）。

Adverse reactions leading to dose

导致剂量的不良反应

interruption 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%).

在69%的患者中发生了PADCEV的中断；最常见的（≥2%）是周围神经病变（18%）、皮疹（12%）、脂肪酶升高（6%）、肺炎/间质性肺病（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%）。

.

。

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的不良反应发生在45%的患者中；最常见的（≥2%）是周围神经病变（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名既往接受过PD-1/L1抑制剂和铂类化疗的患者（PADCEV单药治疗）

Serious adverse reactions

严重的不良反应

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

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

Fatal adverse reactions

致命的不良反应

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/间质性肺病和盆腔脓肿（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；最常见的（≥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%).

发生在61%的患者中；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).

出现在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名先前接受过PD-1/L1抑制剂治疗且不符合顺铂化疗条件的患者（PADCEV单药治疗）

Serious adverse reactions

严重的不良反应

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

接受PADCEV治疗的患者中有39%发生；最常见的（≥3%）是肺炎、败血症和腹泻（各占5%）。

Fatal adverse

致命的不利因素

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

8%的患者出现了反应，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/间质性肺病（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；最常见的（≥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-糖蛋白和强效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..

同时使用双重P-gp和强效CYP3A4抑制剂可能会增加未结合的单甲基澳瑞他汀E的暴露量，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和强效CYP3A4抑制剂同时给药时，应密切监测患者的毒性迹象。

SPECIFIC POPULATIONS

特定人群

Lactation

泌乳

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

建议哺乳期妇女在使用PADCEV治疗期间及最后一剂后3周内不要进行母乳喂养。

Hepatic impairment

肝功能不全

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

避免在中度或重度肝功能不全的患者中使用PADCEV。

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

有关更多信息，请参阅美国完整的处方信息，包括 PADCEV 的黑框警告。

here

这里

.

。

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.

安斯泰来是一家全球生命科学公司，致力于将创新科学转化为对患者的 VALUE。我们在肿瘤学、眼科、泌尿科、免疫学和女性健康等疾病领域提供变革性的治疗方法。通过我们的研发项目，我们正在为那些医疗需求未得到满足的疾病开拓新的医疗解决方案。

Learn more at .

了解更多，请访问。

www.astellas.com

www.astellas.com

.

。

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.

在辉瑞肿瘤学，我们正处于癌症治疗新时代的前沿。我们行业领先的资产组合和广泛的管线包括三种核心作用机制，从小分子、抗体药物偶联物（ADCs）到双特异性抗体，以及其他免疫肿瘤学生物制品，多角度攻击癌症。

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..

我们专注于在一些全球最常见的癌症中提供变革性的治疗方法，包括乳腺癌、泌尿生殖系统癌症、血液肿瘤学和胸部癌症（包括肺癌）。在科学的推动下，我们致力于加速突破，以帮助癌症患者过上更好、更长寿的生活。

About the Pfizer, Astellas and Merck Collaboration

关于辉瑞、安斯泰来和默克的合作

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

Seagen和Astellas此前与默克达成了一项临床合作协议，以评估Seagen和Astellas的PADCEV联合使用的疗效。

TM

商标

(enfortumab vedotin) and Merck’s KEYTRUDA

（enfortumab vedotin）和默克公司的KEYTRUDA

TM

商标

(pembrolizumab) in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. 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)..

在不符合或拒绝接受顺铂化疗的肌层浸润性膀胱癌（MIBC）患者中使用（pembrolizumab）。辉瑞公司于2023年12月14日成功完成了对Seagen的收购。KEYTRUDA是默克夏普与多姆公司（Merck Sharp & Dohme Corp.，美国新泽西州拉威市默克公司（Merck & Co., Inc.）的子公司，在美国和加拿大以外地区称为MSD）的注册商标。

Astellas Cautionary Notes

安斯泰来警示注记

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，关于当前计划、估算、策略和信念的陈述以及其他非历史事实的陈述是关于安斯泰来未来业绩的前瞻性陈述。这些陈述基于管理层当前的假设和信念，并结合了其目前可获得的信息，涉及已知和未知的风险与不确定性。

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.

可能导致实际结果与前瞻性陈述中讨论的结果存在重大差异的因素包括但不限于：(i) 与医药市场相关的总体经济状况、法律法规的变化，(ii) 汇率波动，(iii) 新产品上市的延迟，(iv) 安斯泰来无法有效营销现有和新产品，(v) 安斯泰来无法在竞争激烈的市场中继续有效研发客户认可的产品，以及 (vi) 第三方侵犯安斯泰来的知识产权。

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..

本新闻稿中包含的关于药品（包括正在开发中的产品）的信息并非旨在构成广告或医疗建议。

Pfizer Disclosure Notice

辉瑞披露声明

The information contained in this release is as of August 12, 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.

本新闻稿中的信息截至2025年8月12日。辉瑞不承担因新信息、未来事件或发展而更新本新闻稿中包含的前瞻性声明的义务。

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

本发布包含有关辉瑞肿瘤学和PADCEV的前瞻性信息

TM

商标

(enfortumab vedotin) in combination with pembrolizumab in cisplatin-ineligible patients with muscle-invasive bladder cancer, including their potential benefits, and plans to submit results from the Phase 3 EV-303 clinical trial for presentation at an upcoming medical congress and to share the Phase 3 EV-303 clinical trial results with the appropriate regulatory authorities to explore potential regulatory filings that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

将(enfortumab vedotin)与pembrolizumab联合用于无法接受顺铂治疗的肌层浸润性膀胱癌患者，包括其潜在益处，并计划提交第3阶段EV-303临床试验的结果在即将召开的医学大会上展示，同时将第3阶段EV-303临床试验结果分享给相关监管机构，以探索潜在的监管申报，其中涉及可能导致实际结果与这些声明中明示或暗示的结果有重大差异的重大风险和不确定性。

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; risks associated with interim 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 with regulatory authorities in particular jurisdictions for any potential indication for PADCEV with pembrolizumab or as a single agent; whether and when any 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.

风险和不确定性包括但不限于：关于PADCEV商业成功的不确定性；研发过程中固有的不确定性，包括能否达到预期的临床终点、临床试验的启动和/或完成日期、监管提交日期、监管批准日期和/或上市日期，以及可能出现不利的新临床数据和对现有临床数据的进一步分析；与中期数据相关的风险；临床试验数据可能受到监管机构不同解释和评估的风险；监管机构是否会对我们的临床研究设计和结果感到满意；是否以及何时可以向特定司法管辖区的监管机构提交任何关于PADCEV联合帕博利珠单抗或作为单药治疗的潜在适应症的申请；是否以及何时针对PADCEV联合帕博利珠单抗或作为单药的任何待审或已提交的申请能够获得监管机构的批准，这将取决于众多因素，包括确定产品的收益是否大于其已知风险，以及进行相关决定。

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, 2024, 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.

辉瑞公司截至2024年12月31日的财政年度的10-K表格年报及其后续的10-Q表格报告中，特别是在标题为“风险因素”和“前瞻性信息及可能影响未来结果的因素”的章节中，以及其后续的8-K表格报告中，均可以找到对风险和不确定性的进一步描述，所有这些文件均已提交给美国证券交易委员会。

Securities and Exchange Commission and available at .

证券交易委员会，可于以下网址获取。

www.sec.gov

www.sec.gov

and

和

www.pfizer.com

www.pfizer.com

.

。

+++

+++

i

我

World Bladder Cancer Patient Coalition. GLOBOCAN 2022: Bladder cancer 9th most common worldwide. Accessed June 23, 2025. Available at:

世界膀胱癌患者联盟。GLOBOCAN 2022：膀胱癌全球第九常见癌症。引用日期：2025年6月23日。可用链接：

https://worldbladdercancer.org/news_events/globocan-2022-bladder-cancer-is-the-9th-most-commonly-diagnosed-worldwide/

https://worldbladdercancer.org/news_events/globocan-2022-bladder-cancer-is-the-9th-most-commonly-diagnosed-worldwide/

ii

二

Bladder Cancer Awareness Network. What is Muscle Invasive Bladder Cancer? Accessed June 23, 2025. Available at:

膀胱癌意识网络。什么是肌层浸润性膀胱癌？访问日期：2025年6月23日。可用资源：

https://bcan.org/what-is-muscle-invasive-bladder-cancer/#:~:text=When%20tumors%20grow%20into%20or,Virginia%20Health%20System%20explain%20MIBC

https://bcan.org/what-is-muscle-invasive-bladder-cancer/#:~:text=当肿瘤生长进入或侵犯膀胱的肌肉层时，弗吉尼亚健康系统解释了MIBC。

.

。

iii

iii

Esteban-Villarrubia J, Torres-Jiménez J, Bueno-Bravo C, García-Mondaray R, Subiela JD, Gajate P. Current and Future Landscape of Perioperative Treatment for Muscle-Invasive Bladder Cancer. Cancers (Basel). 2023 Jan 17;15(3):566. doi: 10.3390/cancers15030566. PMID: 36765525; PMCID: PMC9913718.

埃斯特班-维拉鲁比亚 J，托雷斯-希门尼斯 J，布埃诺-布拉沃 C，加西亚-蒙达拉伊 R，苏比拉 JD，加哈特 P。肌层浸润性膀胱癌围手术期治疗的现状与未来前景。《癌症》（巴塞尔）。2023年1月17日；15(3):566。doi: 10.3390/cancers15030566。PMID: 36765525；PMCID: PMC9913718。

iv

四

National Institute of Health. National Library of Medicine. Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303.

国家卫生研究院。国家医学图书馆。围手术期Pembrolizumab（MK-3475）联合膀胱切除术或围手术期Pembrolizumab联合Enfortumab Vedotin加膀胱切除术对比单独膀胱切除术在不符合顺铂条件或拒绝顺铂的肌层浸润性膀胱癌患者中的研究（MK-3475-905/KEYNOTE-905/EV-303）。

ClinicalTrials.gov identifier: NCT03924895. Published July 24, 2019. Updated June 17, 2025. Accessed June 23, 2025. Available at: .

ClinicalTrials.gov标识符：NCT03924895。发布于2019年7月24日。更新于2025年6月17日。访问于2025年6月23日。可在以下网址获取：。

https://clinicaltrials.gov/study/NCT03924895?term=AREA%5BBasicSearch%5D(myosarcoma)&rank=3

https://clinicaltrials.gov/study/NCT03924895?term=AREA%5BBasicSearch%5D(肌肉瘤)&rank=3

v

v

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. Cancer Res 2016;76(10):3003-13.

Challita-Eid PM, Satpayev D, Yang P, 等。Enfortumab vedotin抗体药物偶联物靶向nectin-4，在多种临床前癌症模型中是一种高效的治疗剂。《癌症研究》2016；76（10）：3003-13。

vi

vi编辑器

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

PADCEV [包装说明书]. 伊利诺伊州北布鲁克：安斯泰来制药美国公司。

Click below for a copy of the full press release

点击下方获取完整新闻稿的副本