Primary endpoint met in Phase 3 TALAPRO-3 study demonstrating a statistically significant and clinically meaningful reduction in risk of disease progression or death in HRR gene-mutated metastatic hormone sensitive prostate cancer

TALAPRO-3 三期研究的主要终点已经达到，研究表明在HRR基因突变的转移性激素敏感性前列腺癌中，疾病进展或死亡的风险显著降低，具有统计学意义和临床意义。

Consistent rPFS efficacy benefit was observed in patients whose tumors harbored BRCA and non-BRCA HRR gene alterations

在肿瘤携带BRCA和非BRCA HRR基因改变的患者中观察到一致的rPFS疗效获益。

Interim analysis showed a strong trend toward improvement in overall survival

中期分析显示总体生存率有显著改善的趋势

These results will be discussed with global health authorities to potentially expand TALZENNA indication in this earlier stage disease

这些结果将与全球卫生当局讨论，以潜在扩大TALZENNA在此早期阶段疾病的适应症。

NEW YORK--(BUSINESS WIRE)--

纽约--（商业资讯）--

Pfizer Inc.

辉瑞公司

(NYSE: PFE) today announced positive topline results from the Phase 3 TALAPRO-3 study of TALZENNA

(NYSE: PFE) 今天宣布了 TALZENNA 的三期 TALAPRO-3 研究的积极顶线结果。

®

®

(talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI

(talazoparib)，一种口服聚ADP核糖聚合酶（PARP）抑制剂，与XTANDI联合使用

®

®

(enzalutamide), an androgen receptor pathway inhibitor (ARPI), in people with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).

恩杂鲁胺（一种雄激素受体通路抑制剂（ARPI）），用于同源重组修复（HRR）基因突变的转移性去势敏感性前列腺癌（mCSPC），也称为转移性激素敏感性前列腺癌（mHSPC）患者。

The study met its primary endpoint, with TALZENNA plus XTANDI demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS), compared to placebo plus XTANDI. The results markedly exceeded the pre-specified target hazard ratio of 0.63, with the majority of patients remaining progression-free at the time of analysis.

该研究达到了其主要终点，与安慰剂加XTANDI相比，TALZENNA加XTANDI在影像学无进展生存期（rPFS）方面显示出具有统计学意义和临床意义的改善。结果显著超过了预先设定的目标风险比0.63，在分析时大多数患者仍然无疾病进展。

Consistent efficacy benefit was also observed in patients whose tumors harbored BRCA and non-BRCA HRR gene alterations..

在肿瘤携带BRCA和非BRCA HRR基因改变的患者中也观察到一致的疗效获益。

“Current treatment approaches leave many patients with HRR gene-mutated metastatic castration-sensitive prostate cancer vulnerable to early disease progression,” said Neeraj Agarwal, M.D., FASCO, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute at the University of Utah, and global lead investigator for TALAPRO-3.

“当前的治疗方案使得许多携带HRR基因突变的转移性去势敏感性前列腺癌患者容易出现疾病早期进展，”犹他大学亨茨曼癌症研究所癌症研究教授、FASCO成员、TALAPRO-3全球首席研究员尼拉杰·阿加瓦尔医学博士表示。

“The TALAPRO-3 results demonstrate that treatment with TALZENNA in combination with XTANDI earlier in the disease course significantly extends the time patients can live without their cancer worsening.”.

“TALAPRO-3 研究结果表明，在疾病进程早期使用 TALZENNA 联合 XTANDI 治疗可显著延长患者癌症无恶化生存时间。”

At the time of the interim analysis, results showed a strong trend toward improved overall survival (OS), a key secondary endpoint. Benefits were also observed in other secondary endpoints, including overall response rate, duration of response, and time to Prostate-Specific Antigen (PSA) progression.

在中期分析时，结果显示总体生存率（OS）有显著改善的趋势，这是一个关键的次要终点。在其他次要终点也观察到了益处，包括总体反应率、反应持续时间以及前列腺特异性抗原（PSA）进展时间。

The safety of TALZENNA plus XTANDI was consistent with the known safety profile of each medicine, and no new safety signals were identified..

TALZENNA联合XTANDI的安全性与每种药物的已知安全性一致，且未发现新的安全信号。

Prostate cancer is the second most common cancer in men worldwide, with an estimated 1.4 million new cases diagnosed globally in 2022

前列腺癌是全球男性中第二常见的癌症，据估计，2022年全球新诊断病例达140万。

1

1

and 330,000 new cases anticipated in the United States in 2026.

预计到 2026 年，美国将新增 330,000 个病例。

2

2

mCSPC, is a form of advanced prostate cancer that has spread beyond the prostate but is still sensitive to androgen inhibition.

mCSPC，是一种已扩散到前列腺以外但仍然对雄激素抑制敏感的晚期前列腺癌。

3

3

Despite recent treatment advances, 50% to 65% of patients with mCSPC progress to metastatic castration-resistant prostate cancer (mCRPC) within two years, with increased risk in HRR gene-mutated patients.

尽管近期治疗有所进展，但50%至65%的mCSPC患者在两年内会发展为转移性去势抵抗性前列腺癌（mCRPC），并且HRR基因突变患者的患病风险更高。

4-6

4-6

“Alterations in DNA damage repair genes, such as HRR genes, are found in approximately 25% of metastatic prostate cancers and associated with a worse prognosis and are less responsive to current standards of care, representing a group with a high unmet need,” said Jeff Legos, Chief Oncology Officer, Pfizer.

“大约25%的转移性前列腺癌中发现了DNA损伤修复基因（如HRR基因）的改变，这些改变与较差的预后相关，并且对当前的标准治疗反应较低，代表了一个具有高度未满足需求的群体，”辉瑞首席肿瘤学官杰夫·莱戈斯表示。

“TALZENNA plus XTANDI is already a standard of care in HRR gene-mutated metastatic castration-resistant prostate cancer, and these unprecedented results demonstrate the potential to deliver benefit earlier in the disease course. These findings underscore Pfizer’s leadership in precision medicine and commitment to bringing more personalized treatment options to people living with prostate cancer.”.

“TALZENNA 加 XTANDI 已经是 HRR 基因突变的转移性去势抵抗性前列腺癌的护理标准，这些前所未有的结果表明了其在疾病更早阶段提供益处的潜力。这些发现凸显了辉瑞在精准医疗领域的领导地位及其为前列腺癌患者带来更个性化治疗选择的承诺。”

TALZENNA plus XTANDI in HRR gene-mutated mCSPC is an investigational treatment regimen. The TALAPRO-3 results will be submitted for presentation at an upcoming medical congress and will be discussed with global health authorities for potential regulatory submissions.

TALZENNA联合XTANDI用于HRR基因突变的mCSPC是一种研究性治疗方案。TALAPRO-3的结果将提交给即将召开的医学大会进行展示，并将与全球卫生当局讨论以进行潜在的监管提交。

TALZENNA plus XTANDI is currently approved in 60 countries, including in the United States for adults with HRR gene-mutated mCRPC and in the European Union for adults with mCRPC in whom chemotherapy is not clinically indicated.

TALZENNA 加 XTANDI 目前已在 60 个国家获得批准，包括在美国用于 HRR 基因突变的 mCRPC 成人患者，以及在欧盟用于未临床指征化疗的 mCRPC 成人患者。

About TALAPRO-3

关于TALAPRO-3

The Phase 3 TALAPRO-3 trial is a multicenter, randomized, double-blind, placebo-controlled study that enrolled 599 patients with mCSPC [with ≤3 months of ADT (chemical or surgical) with or without an approved ARPI in the mCSPC setting] at sites in the U.S., Canada, Europe, South America, and the Asia-Pacific region.

TALAPRO-3 三期试验是一项多中心、随机、双盲、安慰剂对照研究，在美国、加拿大、欧洲、南美和亚太地区的试验点招募了599名患有转移性去势敏感性前列腺癌（mCSPC，接受≤3个月的雄激素剥夺治疗（化学或手术），无论是否联合使用已批准的雄激素受体通路抑制剂（ARPI））的患者。

Patients with histologically/cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell, or signet cell features and with alterations in one or more HRR genes (as per HRR12 gene panel) in the trial were randomized to receive TALZENNA 0.5 mg/day plus XTANDI 160mg/day, or placebo plus XTANDI 160mg/day..

试验中，经组织学/细胞学确认为前列腺腺癌、无神经内分泌分化、小细胞或印戒细胞特征且一个或多个HRR基因（根据HRR12基因面板）发生改变的患者被随机分配接受TALZENNA 0.5毫克/天加XTANDI 160毫克/天，或安慰剂加XTANDI 160毫克/天。

The primary endpoint of the trial is investigator-assessed radiographic progression-free survival (rPFS), defined as the time from the date of randomization to radiographic progression in soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or in bone per Prostate Cancer Working Group 3 (PCWG3) criteria by investigator assessment, or death, whichever occurs first.

试验的主要终点是由研究者评估的影像学无进展生存期（rPFS），定义为从随机化日期到根据实体瘤疗效评价标准1.1版（RECIST 1.1）评估的软组织影像学进展，或根据前列腺癌工作组3（PCWG3）标准评估的骨转移进展，或死亡的时间，以先发生者为准。

Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), prostate-specific antigen (PSA) response, and patient-reported outcomes..

次要终点包括总生存期（OS）、客观缓解率（ORR）、缓解持续时间（DOR）、前列腺特异性抗原（PSA）反应以及患者报告的结局。

For more information on the TALAPRO-3 trial (

有关TALAPRO-3试验的更多信息（

NCT04821622

NCT04821622

), go to

），转到

www.clinicaltrials.gov

www.clinicaltrials.gov

.

。

About TALZENNA

关于TALZENNA

®

®

(talazoparib)

(他拉唑帕尼)

TALZENNA is an oral inhibitor of poly ADP-ribose polymerase (PARP), which plays a role in DNA damage repair. Preclinical studies have demonstrated that TALZENNA blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to decreased cancer cell growth and cancer cell death.

TALZENNA是一种口服的聚ADP核糖聚合酶（PARP）抑制剂，PARP在DNA损伤修复中起作用。临床前研究表明，TALZENNA能够阻断PARP酶活性，并将PARP固定在DNA损伤部位，从而导致癌细胞生长减缓和癌细胞死亡。

TALZENNA was initially approved in the U.S., EU, and multiple other regions as a single agent for the treatment of adult patients with deleterious or suspected deleterious gBRCAm HER2-negative locally advanced or metastatic breast cancer.

TALZENNA 最初在美国、欧盟和多个其他地区被批准作为单一药物，用于治疗携带有害或疑似有害gBRCAm、HER2阴性的局部晚期或转移性乳腺癌成年患者。

TALZENNA in combination with XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with HRR gene-mutated mCRPC in June 2023. The combination was also approved by the European Commission in January 2024 for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated.

2023年6月，TALZENNA联合XTANDI获得美国食品药品监督管理局（FDA）批准，用于治疗HRR基因突变的mCRPC成年患者。该联合疗法还于2024年1月获得欧洲委员会批准，用于治疗临床上不适用化疗的mCRPC成年患者。

TALZENNA in combination with XTANDI is approved in 60 countries, indications vary by country..

TALZENNA联合XTANDI已在60个国家获得批准，适应症因国家而异。

TALZENNA

塔尔泽纳

®

®

(talazoparib) Indication in the U.S.

(talazoparib) 在美国的适应症

TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for:

TALZENNA 是一种聚（ADP-核糖）聚合酶 (PARP) 抑制剂，适用于：

HRR gene-mutated mCRPC:

HRR基因突变的mCRPC：

In combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

与恩杂鲁胺联合用于治疗携带同源重组修复（HRR）基因突变的转移性去势抵抗性前列腺癌（mCRPC）成年患者。

Breast Cancer:

乳腺癌：

As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.

作为单一药物，用于治疗携带或疑似携带生殖系BRCA突变（gBRCAm）、HER2阴性的局部晚期或转移性乳腺癌成年患者。根据FDA批准的TALZENNA伴随诊断方法选择适合治疗的患者。

TALZENNA

塔尔泽纳

®

®

(talazoparib) Important Safety Information

（他拉唑帕尼）重要安全信息

WARNINGS and PRECAUTIONS

警告和注意事项

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML)

骨髓增生异常综合征/急性髓系白血病 (MDS/AML)

, including cases with a fatal outcome, has been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 0.4% (3 out of 788) of solid tumor patients treated with TALZENNA as a single agent in clinical studies. In TALAPRO-2, MDS/AML occurred in 2 out of 511 (0.4%) patients treated with TALZENNA and enzalutamide and in 0 out of 517 (0%) patients treated with placebo and enzalutamide.

，包括致命结局的病例，在接受TALZENNA治疗的患者中已有报告。总体而言，在临床研究中，作为单一药物治疗的实体瘤患者中有0.4%（788例中的3例）报告了MDS/AML。在TALAPRO-2研究中，接受TALZENNA和恩杂鲁胺治疗的511例患者中有2例（0.4%）发生MDS/AML，而接受安慰剂和恩杂鲁胺治疗的517例患者中则无（0%）。

The durations of TALZENNA treatment in these 5 patients prior to developing MDS/AML were 0.3, 1, 2, 3, and 5 years. Most of these patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy..

在这5名患者中，他们在发生MDS/AML之前接受TALZENNA治疗的持续时间分别为0.3年、1年、2年、3年和5年。这些患者大多曾接受过含铂剂的化疗和/或其他DNA损伤药物（包括放疗）的治疗。

Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor blood counts monthly during treatment with TALZENNA. For prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If counts do not recover within 4 weeks, refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics.

在患者从先前化疗引起的血液学毒性中充分恢复之前，不要开始使用TALZENNA。在TALZENNA治疗期间，每月监测血细胞计数。对于长期的血液学毒性，暂停使用TALZENNA，并每周监测血细胞计数直到恢复。如果计数在4周内没有恢复，将患者转诊给血液科医生进行进一步检查，包括骨髓分析和用于细胞遗传学的血液样本。

If MDS/AML is confirmed, discontinue TALZENNA..

如果确认MDS/AML，停止使用TALZENNA。

Myelosuppression

骨髓抑制

consisting of anemia, neutropenia, and/or thrombocytopenia, have been reported in patients treated with TALZENNA. In TALAPRO-2, Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 48%, 19%, and 9% of patients receiving TALZENNA and enzalutamide. Forty-two percent of patients (216/511) required a red blood cell transfusion, including 25% (127/511) who required more than one transfusion.

据报道，接受TALZENNA治疗的患者出现了贫血、中性粒细胞减少和/或血小板减少的情况。在TALAPRO-2试验中，分别有48%、19%和9%的接受TALZENNA和恩扎鲁胺治疗的患者报告了≥3级贫血、中性粒细胞减少和血小板减少。42%的患者（216/511）需要进行红细胞输注，其中25%的患者（127/511）需要多次输注。

Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 8%, 3%, and 0.4% of patients..

因贫血、中性粒细胞减少和血小板减少而停药的患者比例分别为8%、3%和0.4%。

Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. Monitor blood counts monthly during treatment with TALZENNA. If hematological toxicities do not resolve within 28 days, discontinue TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics..

在患者从先前治疗引起的血液学毒性中充分恢复之前，应暂停使用TALZENNA。在TALZENNA治疗期间，每月监测血细胞计数。如果血液学毒性在28天内未得到解决，应停止使用TALZENNA，并将患者转诊给血液科医生进行进一步检查，包括骨髓分析和细胞遗传学的血液样本检测。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

TALZENNA can cause fetal harm when administered to pregnant women. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 4 months following the last dose of TALZENNA.

TALZENNA 在给孕妇使用时可能会对胎儿造成伤害。建议有生育潜力的女性伴侣或已怀孕的男性患者在治疗期间以及在最后一次服用 TALZENNA 后的 4 个月内使用有效的避孕措施。

ADVERSE REACTIONS

不良反应

Serious adverse reactions reported in >2% of patients included anemia (9%) and fracture (3%). Fatal adverse reactions occurred in 1.5% of patients, including pneumonia, COVID infection, and sepsis (1 patient each).

报告的严重不良反应中，超过2%的患者出现贫血（9%）和骨折（3%）。1.5%的患者发生了致命的不良反应，包括肺炎、COVID感染和败血症（各1例）。

The most common adverse reactions (≥ 10%, all Grades), including laboratory abnormalities, for patients in the TALAPRO-2 study who received TALZENNA with enzalutamide vs patients receiving placebo with enzalutamide were hemoglobin decreased (79% vs 34%), neutrophils decreased (60% vs 18%), lymphocytes decreased (58% vs 36%), fatigue (49% vs 40%), platelets decreased (45% vs 8%), calcium decreased (25% vs 11%), nausea (21% vs 17%), decreased appetite (20% vs 14%), sodium decreased (22% vs 20%), phosphate decreased (17% vs 13%), fractures (14% vs 10%), magnesium decreased (14% vs 12%), dizziness (13% vs 9%), bilirubin increased (11% vs 7%), potassium decreased (11% vs 7%), and dysgeusia (10% vs 4.5%)..

在TALAPRO-2研究中，接受TALZENNA联合恩杂鲁胺治疗的患者与接受安慰剂联合恩杂鲁胺治疗的患者相比，最常见的不良反应（≥10%，所有级别），包括实验室异常，为血红蛋白减少（79% vs 34%）、中性粒细胞减少（60% vs 18%）、淋巴细胞减少（58% vs 36%）、疲劳（49% vs 40%）、血小板减少（45% vs 8%）、钙减少（25% vs 11%）、恶心（21% vs 17%）、食欲下降（20% vs 14%）、钠减少（22% vs 20%）、磷减少（17% vs 13%）、骨折（14% vs 10%）、镁减少（14% vs 12%）、头晕（13% vs 9%）、胆红素升高（11% vs 7%）、钾减少（11% vs 7%）以及味觉障碍（10% vs 4.5%）。

Clinically relevant adverse reactions in <10% of patients who received TALZENNA with enzalutamide included abdominal pain (9%), vomiting (9%), alopecia (7%), dyspepsia (4%), venous thromboembolism (3%) and stomatitis (2%).

接受TALZENNA与恩杂鲁胺治疗的患者中，不到10%的患者出现了临床相关的不良反应，包括腹痛（9%）、呕吐（9%）、脱发（7%）、消化不良（4%）、静脉血栓栓塞（3%）和口腔炎（2%）。

DRUG INTERACTIONS

药物相互作用

Coadministration with P-gp inhibitors

与P-糖蛋白抑制剂联合给药

The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken with enzalutamide has not been studied. Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a P-gp inhibitor..

当TALZENNA与恩杂鲁胺一起服用时，尚未研究P-gp抑制剂共同给药对talazoparib暴露量的影响。当TALZENNA与P-gp抑制剂共同给药时，监测患者是否出现不良反应增加，并根据推荐的不良反应调整剂量。

Coadministration with BCRP inhibitors

与BCRP抑制剂共同给药

Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a BCRP inhibitor. Coadministration of TALZENNA with BCRP inhibitors may increase talazoparib exposure, which may increase the risk of adverse reactions.

当TALZENNA与BCRP抑制剂联合使用时，应监测患者是否出现不良反应增加，并根据推荐的不良反应调整剂量。TALZENNA与BCRP抑制剂的联合使用可能会增加talazoparib的暴露量，从而可能增加不良反应的风险。

USE IN SPECIFIC POPULATIONS

特定人群中的使用

Males of Reproductive Potential

有生殖潜力的男性

Based on animal studies, TALZENNA may impair fertility.

基于动物研究，TALZENNA可能会损害生育能力。

Renal Impairment

肾功能损害

The recommended dosage of TALZENNA for patients with moderate renal impairment (CLcr 30 - 59 mL/min) is 0.35 mg taken orally once daily with enzalutamide. The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 - 29 mL/min) is 0.25 mg taken orally once daily with enzalutamide.

对于中度肾功能损害（CLcr 30 - 59 mL/min）的患者，TALZENNA的推荐剂量为每日一次口服0.35 mg，并与恩杂鲁胺同时服用。对于重度肾功能损害（CLcr 15 - 29 mL/min）的患者，TALZENNA的推荐剂量为每日一次口服0.25 mg，并与恩杂鲁胺同时服用。

No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis..

轻度肾功能损害患者无需调整剂量。TALZENNA 尚未在需要血液透析的患者中进行研究。

Please see full U.S. Prescribing Information and Patient Information for TALZENNA® (talazoparib) at

请参阅TALZENNA®（talazoparib）完整的美国处方信息和患者信息。

www.TALZENNA.com

www.TALZENNA.com

.

。

About XTANDI

关于XTANDI

®

®

(enzalutamide)

(恩杂鲁胺)

XTANDI (enzalutamide) is an androgen receptor pathway inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in people with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR).

XTANDI（恩杂鲁胺）是一种雄激素受体通路抑制剂。XTANDI 是一种标准治疗方案，已在世界范围内一个或多个国家获得监管批准，用于治疗转移性激素敏感性前列腺癌 (mHSPC)、转移性去势抵抗性前列腺癌 (mCRPC)、非转移性去势抵抗性前列腺癌 (nmCRPC)，以及具有高危生化复发 (BCR) 的非转移性激素敏感性前列腺癌 (nmHSPC) 患者。

XTANDI is currently approved for one or more of these indications in more than 80 countries, including in the United States, European Union and Japan. Over 1.5 million patients have been treated with XTANDI globally..

XTANDI目前已在80多个国家获得批准，适应症包括在美国、欧盟和日本。全球已有超过150万名患者接受了XTANDI的治疗。

7

7

About XTANDI

关于XTANDI

®

®

(enzalutamide) and Important Safety Information

（恩杂鲁胺）及重要的安全信息

XTANDI (enzalutamide) is indicated for the treatment of patients with:

XTANDI（恩杂鲁胺）适用于治疗以下患者：

castration-resistant prostate cancer (CRPC)

去势抵抗性前列腺癌 (CRPC)

metastatic castration-sensitive prostate cancer (mCSPC)

转移性去势敏感性前列腺癌 (mCSPC)

nonmetastatic castration sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)

非转移性去势敏感性前列腺癌（nmCSPC），具有高危转移风险的生化复发（高危BCR）

Important Safety Information

重要安全信息

Warnings and Precautions

警告和注意事项

Seizure

癫痫发作

occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection.

在八项随机临床试验中，接受XTANDI治疗的患者中有0.6%发生了癫痫发作。在一项针对具有癫痫发作诱因的患者的研究中，2.2%的接受XTANDI治疗的患者经历了癫痫发作。目前尚不清楚抗癫痫药物是否能够预防XTANDI引发的癫痫发作。研究中的患者具有以下一种或多种癫痫发作的诱因：使用可能降低癫痫发作阈值的药物、有脑外伤或头部受伤史、有脑血管意外或短暂性脑缺血发作史、患有阿尔茨海默病、脑膜瘤或由前列腺癌引起的软脑膜疾病、过去12个月内无法解释的意识丧失、有癫痫发作史、存在脑部占位性病变、有动静脉畸形史或脑部感染史。

Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment..

告知患者在服用XTANDI期间存在发生癫痫发作的风险，并避免从事任何因突然失去意识可能导致自身或他人严重伤害的活动。对于在治疗期间发生癫痫发作的患者，应永久停用XTANDI。

Posterior Reversible Encephalopathy Syndrome (PRES)

后部可逆性脑病综合征 (PRES)

There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI.

有报告显示接受XTANDI治疗的患者中出现了PRES。PRES是一种神经系统疾病，可能表现为迅速发展的症状，包括癫痫发作、头痛、嗜睡、意识模糊、失明及其他视觉和神经系统紊乱，伴或不伴高血压。确诊PRES需要通过脑部影像学检查，最好是MRI。

Discontinue XTANDI in patients who develop PRES..

在发生PRES的患者中停止使用XTANDI。

Hypersensitivity

超敏反应

reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care.

在八项随机临床试验中，观察到XTANDI引起的脸部（0.5%）、舌头（0.1%）或嘴唇（0.1%）水肿等反应。上市后病例报告中也有咽喉水肿的情况。建议出现任何过敏症状的患者暂时停用XTANDI，并立即寻求医疗帮助。

Permanently discontinue XTANDI for serious hypersensitivity reactions..

因严重过敏反应永久停用XTANDI。

Ischemic Heart Disease

缺血性心脏病

In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo.

在五项随机、安慰剂对照临床研究的综合数据中，与安慰剂组相比，XTANDI组患者发生缺血性心脏病的比例更高（3.5% vs 2%）。XTANDI组中有1.8%的患者发生3-4级缺血事件，而安慰剂组为1.1%。XTANDI组中有0.4%的患者因缺血事件导致死亡，而安慰剂组为0.1%。

Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease..

监测缺血性心脏病的体征和症状。优化心血管风险因素的管理，如高血压、糖尿病或血脂异常。对于3-4级缺血性心脏病，应停止使用XTANDI。

Falls and Fractures

跌倒和骨折

occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo.

接受XTANDI治疗的患者中发生了骨折和跌倒。评估患者的骨折和跌倒风险。根据既定的治疗指南监测和管理有骨折风险的患者，并考虑使用针对骨骼的药物。在五项随机、安慰剂对照临床研究的综合数据中，接受XTANDI治疗的患者中有12%发生跌倒，而接受安慰剂治疗的患者中有6%发生跌倒。

Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo..

接受XTANDI治疗的患者中有13%发生骨折，而接受安慰剂治疗的患者中有6%发生骨折。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI..

XTANDI 在女性中的安全性和有效性尚未确定。XTANDI 在用于孕妇时可能会导致胎儿伤害和妊娠丢失。建议与有生育潜力的女性伴侣的男性在 XTANDI 治疗期间以及最后一次给药后 3 个月内使用有效避孕措施。

Dysphagia or Choking

吞咽困难或窒息

Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed.

由于XTANDI产品的尺寸，可能会发生严重的吞咽困难或窒息，包括可能危及生命需要医疗干预或致命的事件。建议患者用足量的水整粒吞服每粒胶囊或药片，以确保所有药物成功下咽。

Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets..

考虑给吞咽困难的患者使用较小片剂的XTANDI。对于无法吞咽胶囊或片剂的患者，请停止使用XTANDI。

Interference with Immunoassay Measurement of Digoxin

干扰地高辛的免疫测定测量

XTANDI can interfere with certain digoxin immunoassays (e.g., Chemiluminescent Microparticle Immunoassays), resulting in falsely elevated digoxin plasma concentration results. Notify the laboratory conducting the digoxin plasma concentration assay to use an appropriate method in patients receiving XTANDI and digoxin..

XTANDI可能干扰某些地高辛免疫测定（例如，化学发光微粒免疫测定），导致地高辛血浆浓度结果假性升高。通知进行地高辛血浆浓度测定的实验室，在接受XTANDI和地高辛治疗的患者中使用适当的方法。

Adverse Reactions (ARs)

不良反应 (ARs)

In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache.

在五项随机安慰剂对照试验的数据中，XTANDI治疗患者中最常见（≥10%）且发生率比安慰剂组高（≥2%）的不良反应包括肌肉骨骼疼痛、疲劳、潮热、便秘、食欲减退、腹泻、高血压、出血、跌倒、骨折和头痛。

In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss..

在比卡鲁胺对照研究中，接受XTANDI治疗的患者报告的最常见的不良反应（≥10%）为虚弱/疲劳、背痛、肌肉骨骼疼痛、潮热、高血压、恶心、便秘、腹泻、上呼吸道感染和体重减轻。

In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide.

在EMBARK研究中，针对高危生化复发（BCR）的非转移性CSPC（nmCSPC）患者的安慰剂对照试验显示，在整个治疗期间，接受XTANDI联合亮丙瑞林治疗的患者中有46%报告了3级或更高级别的不良反应，接受XTANDI单药治疗的患者中有50%，而接受安慰剂联合亮丙瑞林治疗的患者中有43%。

Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide..

在整个治疗期间，因不良反应导致永久停止治疗的主要原因在以下患者中被报告：21%接受XTANDI联合亮丙瑞林治疗的患者、18%接受XTANDI单药治疗的患者，以及10%接受安慰剂联合亮丙瑞林的患者。

Lab Abnormalities:

实验室异常：

Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia..

在汇总的随机、安慰剂对照研究中，发生在≥5%的患者中的实验室异常，并且在XTANDI组比安慰剂组更频繁（>2%）的包括：血红蛋白减少、中性粒细胞计数减少、白细胞减少、高血糖、高镁血症、低钠血症、低磷血症和高钙血症。

Hypertension:

高血压：

In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.

在五项随机安慰剂对照临床试验的综合数据中，14.2% 的 XTANDI 患者和 7.4% 的安慰剂患者报告出现高血压。在每组中，因高血压导致研究中断的患者比例不到 1%。

Drug Interactions

药物相互作用

Effect of Other Drugs on XTANDI

其他药物对XTANDI的影响

Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI. Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.

避免与强效CYP2C8抑制剂联合使用。如果无法避免联合使用，减少XTANDI的剂量。避免与强效CYP3A4诱导剂联合使用。如果无法避免联合使用，增加XTANDI的剂量。

Effect of XTANDI on Other Drugs

XTANDI对其他药物的影响

Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites..

避免与某些CYP3A4、CYP2C9和CYP2C19底物联合使用，因为这些底物的浓度轻微降低可能导致治疗失败。如果无法避免联合使用，应根据其处方信息增加这些底物的剂量。在形成活性代谢物的情况下，可能会增加对活性代谢物的暴露。

Please access this link for

请访问此链接以获取更多信息。

XTANDI’S US Full Prescribing Information

XTANDI美国完整处方信息

for additional safety information.

获取更多安全信息。

About Pfizer Oncology

辉瑞肿瘤部简介

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 multispecific antibodies, including other immune-oncology biologics.

在辉瑞肿瘤事业部，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研发管线包括三种核心作用机制，从多个角度攻击癌症，包括小分子、抗体药物偶联物 (ADC) 和多特异性抗体，以及其他免疫肿瘤生物制品。

We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancers, genitourinary cancers, 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..

我们致力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、胃肠道癌、泌尿生殖系统癌、血液肿瘤学和胸部癌症（包括肺癌）。受科学驱动，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 Pfizer: Breakthroughs That Change Patients’ Lives

关于辉瑞：改变患者生活的突破性进展

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

在辉瑞，我们运用科学和全球资源，为人们带来能够延长生命并显著改善生活的疗法。我们努力在医疗保健产品的研发、开发和生产过程中，为质量、安全性和价值树立标杆，包括创新药物和疫苗。

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

每天，辉瑞的同事们都在发达市场和新兴市场开展工作，以促进健康、预防、治疗和攻克当今最令人恐惧的疾病。作为全球首屈一指的创新型生物制药公司之一，我们与医疗保健提供者、政府和当地社区合作，支持并扩大全球范围内对可靠且负担得起的医疗保健的获取机会。

For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at .

175 年来，我们一直努力为所有依赖我们的人带来改变。我们经常在网站上发布可能对投资者重要的信息。

www.Pfizer.com

www.Pfizer.com

. In addition, to learn more, please visit us on

此外，欲了解更多信息，请访问我们

www.Pfizer.com

www.Pfizer.com

and follow us on X at

并在X上关注我们

@Pfizer

@辉瑞

and

和

@Pfizer News

@辉瑞新闻

,

，

LinkedIn

领英

,

，

YouTube

YouTube

and like us on Facebook at

并在Facebook上关注我们

Facebook.com/Pfizer

Facebook.com/辉瑞

.

。

About the Pfizer/Astellas Collaboration

关于辉瑞/安斯泰来合作

In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize XTANDI

2009年10月，Medivation公司（现为辉瑞公司的一部分，纽约证券交易所代码：PFE）与安斯泰来（东京证券交易所代码：4503）达成了一项全球协议，共同开发和商业化XTANDI。

®

®

(enzalutamide). The companies jointly commercialize XTANDI in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.

（恩杂鲁胺）。两家公司在美国共同推广XTANDI，安斯泰来负责全球的生产和所有其他监管文件的提交，以及在美国以外地区推广XTANDI。

Disclosure Notice

披露通知

The information contained in this release is as of March 19, 2026. 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2026年3月19日。辉瑞不对因新信息、未来事件或发展而更新本新闻稿中包含的前瞻性声明承担任何责任。

This release contains forward-looking information about Pfizer Oncology, TALZENNA and XTANDI, including their potential benefits, the TALAPRO-3 results, and plans to discuss the results with global health authorities to potentially expand the TALZENNA indication, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

本发布包含有关辉瑞肿瘤学、TALZENNA 和 XTANDI 的前瞻性信息，包括它们的潜在益处、TALAPRO-3 试验结果，以及计划与全球卫生当局讨论这些结果以可能扩大 TALZENNA 的适应症，但该过程涉及重大风险和不确定性，可能导致实际结果与这些声明所表达或暗示的内容存在重大差异。

Risks and uncertainties include, among other things, uncertainties regarding the commercial success of TALZENNA in combination with XTANDI;.

风险和不确定性包括但不限于与XTANDI联合使用的TALZENNA商业成功的不确定性；。

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; whether the TALAPRO-3 trial will meet the key secondary endpoint for overall survival; risks associated with initial, preliminary or 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 applications for TALZENNA, XTANDI or a combination may be filed in any jurisdictions for any potential indications; whether and when any such applications for TALZENNA, XTANDI or a combination that may be pending or filed 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 TALZENNA, XTANDI or a combination will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of TALZENNA, XTANDI or a combination; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments..

研发固有的不确定性，包括达到预期临床终点的能力、我们临床试验的启动和/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；TALAPRO-3试验是否将达到总生存期的关键次要终点；与初始、初步或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满意；是否以及何时在任何司法管辖区为任何潜在适应症提交TALZENNA、XTANDI或其组合的申请；是否以及何时任何此类待审或已提交的TALZENNA、XTANDI或其组合的申请可能获得监管机构的批准，这将取决于众多因素，包括确定产品的益处是否超过其已知风险，以及确定产品的疗效，并且如果获得批准，TALZENNA、XTANDI或其组合是否会取得商业成功；监管机构关于标签、生产工艺、安全性及/或其他可能影响TALZENNA、XTANDI或其组合可用性或商业潜力的事项的决定；与已发布或未来行政命令、其他新法规或法律变更相关的风险和不确定性；COVID-19对辉瑞业务、运营和财务结果影响的不确定性；以及竞争进展。

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, 2025, 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.

辉瑞公司在截至2025年12月31日的财政年度的Form 10-K年报以及其后续的Form 10-Q报告中提供了风险和不确定性的进一步描述，特别是其中标题为“风险因素”和“前瞻性信息及可能影响未来结果的因素”的部分，还包括其后续提交的Form 8-K报告，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，可访问。

www.sec.gov

www.sec.gov

and

和

www.pfizer.com

www.pfizer.com

.

。

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Presented at: American Urological Association (AUA) 2025 Annual Meeting; April 26–29, 2025; Las Vegas, NV.

发表于：美国泌尿协会 (AUA) 2025 年年会；2025 年 4 月 26 日至 29 日；内华达州拉斯维加斯。

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数据存档。伊利诺伊州北布鲁克：Astellas公司。

Media Contact:

媒体联系人：

PfizerMediaRelations@Pfizer.com

辉瑞媒体关系@辉瑞.com

Investor Contact:

投资者联系人：

IR@Pfizer.com

IR@Pfizer.com

Source: Pfizer Inc.

来源：辉瑞公司