Pfizer Inc. (NYSE:PFE) and Alliance Foundation Trials, LLC (AFT) today announced results from the Phase 3 PATINA trial demonstrating that the addition of IBRANCE® (palbociclib) to current standard-of-care first-line maintenance therapy (following induction chemotherapy) resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). In the study, which is sponsored by AFT, median PFS was 44.3 months (95% CI: 32.4-60.9) for patients treated with IBRANCE in combination with anti-HER2 therapy (trastuzumab or trastuzumab plus pertuzumab) and endocrine therapy, and 29.1 months (95% CI: 23.3-38.6) for patients treated with anti-HER2 therapy and endocrine therapy alone [HR: 0.74 (95% CI, 0.58-0.94); unstratified 1-sided p= 0.0074]. This represents an extension in median PFS of over 15 months. Overall survival, a secondary endpoint, was not yet mature at the time of the analysis. These results are being presented during a late-breaking oral session (Abstract GS2-12) and highlighted in the press program at the 47th San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

辉瑞公司（纽约证券交易所代码：PFE）和 Alliance Foundation Trials, LLC (AFT) 今天公布了 3 期 PATINA 试验的结果，该结果表明，在目前的标准一线维持疗法（诱导化疗后）中添加 IBRANCE ® （哌柏西利）可使研究者评估的激素受体阳性 (HR+)、人类表皮生长因子受体 2 阳性 (HER2+) 转移性乳腺癌 (MBC) 患者的无进展生存期 (PFS) 出现统计学上显着和临床意义上的改善。在这项由 AFT 赞助的研究中，接受 IBRANCE 联合抗 HER2 疗法（曲妥珠单抗或曲妥珠单抗加帕妥珠单抗）和内分泌疗法治疗的患者的中位 PFS 为 44.3 个月（95% CI：32.4-60.9），仅接受抗 HER2 疗法和内分泌疗法治疗的患者的中位 PFS 为 29.1 个月（95% CI：23.3-38.6）[HR：0.74（95% CI，0.58-0.94）；未分层单侧 p=0.0074]。这意味着中位 PFS 延长了 15 个月以上。在分析时，次要终点总体生存期尚未成熟。这些结果是在德克萨斯州圣安东尼奥举行的第 47 届圣安东尼奥乳腺癌研讨会 (SABCS) 的最新口头会议 (摘要 GS2-12) 上发表的，并在新闻发布会上重点介绍。

“PATINA is the first large Phase 3 study to show the benefit of CDK4/6 inhibition in HR-positive, HER2-positive metastatic breast cancer,” said Otto Metzger, M.D., principal investigator of the trial for Alliance Foundation Trials and Medical Oncologist at the Dana-Farber Cancer Institute. “These results support the potential of this maintenance treatment to slow disease progression and improve clinical outcomes in this patient population.”

“PATINA 是首个大型 3 期研究，展示了 CDK4/6 抑制对 HR 阳性、HER2 阳性转移性乳腺癌的益处，”联盟基金会试验首席研究员、丹娜—法伯癌症研究所医学肿瘤学家 Otto Metzger 医学博士说道。“这些结果支持了这种维持治疗对减缓疾病进展和改善此类患者临床结果的潜力。”

Approximately 10% of all breast cancers are HR+, HER2+i , which is sometimes referred to as double-positive or triple-positive breast cancer. Despite advances in treatment, the development of resistance to anti-HER2 and endocrine therapy is a challenge, and novel therapeutic approaches are needed for HR+, HER2+ MBC.ii IBRANCE is not currently indicated for HR+, HER2+ MBC.

大约 10% 的乳腺癌为 HR+、HER2+ i ，有时也称为双阳性或三阳性乳腺癌。尽管治疗取得了进展，但对抗 HER2 和内分泌治疗产生耐药性仍是一个挑战，HR+、HER2+ MBC 需要新的治疗方法。ii IBRANCE 目前不适用于 HR+、HER2+ MBC。

“IBRANCE, the first CDK4/6 inhibitor, revolutionized the treatment of HR-positive, HER2-negative metastatic breast cancer, and has been prescribed to over 773,000 patients since its initial approval in 2015,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. “These results demonstrate that the addition of IBRANCE to standard of care shows promise as maintenance therapy in HR-positive, HER2-positive disease. PATINA underscores Pfizer’s ongoing commitment to addressing the unmet needs of people with breast cancer, and we look forward to discussing the results with regulatory authorities.”

辉瑞公司肿瘤学首席开发官 Roger Dansey 医学博士表示：“IBRANCE 是首个 CDK4/6 抑制剂，它彻底改变了 HR 阳性、HER2 阴性转移性乳腺癌的治疗方法，自 2015 年首次获批以来，已有超过 773,000 名患者使用该药物。这些结果表明，将 IBRANCE 添加到标准治疗中有望成为 HR 阳性、HER2 阳性疾病的维持治疗。PATINA 彰显了辉瑞公司持续致力于解决乳腺癌患者未满足的需求，我们期待与监管机构讨论结果。”

The safety and tolerability of IBRANCE in the PATINA study was consistent with its known safety profile in HR+, human epidermal growth factor receptor 2-negative (HER2-) MBC, and no new safety signals were identified. The most common adverse events observed with IBRANCE were hematologic toxicities, such as neutropenia and leukopenia. Non-hematologic adverse events included fatigue, stomatitis and diarrhea, which were generally mild to moderate in severity.

IBRANCE 在 PATINA 研究中表现出的安全性和耐受性与其在 HR+、人表皮生长因子受体 2 阴性 (HER2-) MBC 中的已知安全性一致，未发现新的安全性信号。IBRANCE 最常见的不良事件是血液学毒性，例如中性粒细胞减少症和白细胞减少症。非血液学不良事件包括疲劳、口腔炎和腹泻，严重程度一般为轻度至中度。

Since its initial regulatory approval in 2015, IBRANCE continues to be a standard-of-care first-line treatment for HR+, HER2- MBC and has been approved in more than 108 countries. Pfizer plans to share the results from PATINA with regulatory authorities.

自 2015 年首次获得监管部门批准以来，IBRANCE 一直是 HR+、HER2- MBC 的标准一线治疗药物，并已在 108 多个国家获得批准。辉瑞计划与监管机构分享 PATINA 的结果。