Trastuzumab/Pertuzumab/Hyaluroniase-zzxf

A resolution between the University of Pennsylvania and Roche’s Genentech comes just days after a federal judge signed an order pausing the case. Some three years after the University of Pennsylvania claimed four of Roche’s breast cancer meds infringed its intellectual property, the parties have managed to resolve the dispute just weeks before a jury trial was set to start.Penn and Roche’s Genentech unit have settled the lawsuit Penn originally brought to a Delaware federal court in 2022, which accused the drugmaker of infringing a now-expired patent on methods of tumor treatment pioneered at the university’s Abramson Cancer Center.In turn, the case has been dismissed with prejudice, meaning neither party can retry their claims in court, according to a decision filed Friday in the U.S. District Court for the District of Delaware. The case was set to go before a jury March 31, Bloomberg Law reports. Details on the exact terms of the settlement agreement were not disclosed in Friday’s filing. The resolution comes just days after federal Judge Jennifer Hall signed an order pausing the case “pending performance of certain obligations under the settlement agreement reached by the parties,” according to a separate filing in the Delaware court.The stay on the case required that Penn and Genentech file a stipulation of dismissal or a joint update on their deliberations by March 24.Genentech confirmed with Fierce Pharma on Friday that "the parties have amicably resolved the dispute," though the company's spokesperson did not comment further on the outcome.  Penn’s 2022 complaint against Genentech revolves around a patent, dubbed ‘558, that was originally granted to the school in December 2009.The ‘558 patent covers a method developed at Penn’s Perelman School of Medicine to treat patients with ErbB protein-mediated tumors by administering an antibody followed by radiation, according to the original lawsuit.According to the university’s lawyers, the treatment approach closely resembles that outlined in the FDA approvals for four of Roche’s anti-ErbB antibodies in breast cancer: intravenous Herceptin and the drug’s subcutaneous counterpart Herceptin Hylecta, plus Perjeta and Phesgo.By marketing that quartet of cancer meds, Roche infringed Penn’s ‘558 patent, the school’s lawyers argued in the 2022 lawsuit.Further, Penn’s legal team suggested the Genentech unit was “willfully blind to the fact that its acts were infringing” and contended that the company must have been aware of the school’s patent because Roche explicitly tried blocking foreign counterparts to the intellectual property at the European Patent Office in 2007, 2016 and 2019.In addition to seeking a ruling that Roche willfully infringed the ‘558 patent, Penn was originally pursuing an unspecified sum in damages as well as an ongoing licensing fee for Roche’s alleged use of its invention. The four breast cancer drugs at the center of the lawsuit continue to rake in sizable sales for Roche, though only Phesgo—which is the youngest of the quartet with its first approval in 2020—managed to grow in 2024 overall.For the entire year, Phesgo increased (PDF) sales 62% to 1.74 billion Swiss francs (nearly $2 billion), Roche reported in late January. Herceptin sales fell 11% to 1.38 billion Swiss francs ($1.5 billion) over the same period, while Perjeta’s 2024 sales dropped to 3.6 billion Swiss francs ($4 billion) versus roughly 3.8 billion Swiss francs in 2023. 

3 月 14 日，罗氏宣布， PI3Kα 抑制剂「伊那利塞」获批上市，与哌柏西利和氟维司群（内分泌疗法）联合用药治疗内分泌治疗耐药（包括在辅助内分泌治疗期间或之后出现复发）、 PIK3CA 突变、激素受体（HR）阳性、人表皮生长因子受体 2（HER2）阴性、局部晚期或转移性乳腺癌成人患者（受理号：JXHS2400037/8）。  截图来源：罗氏官微 伊那利塞（inavolisib，研发代号：GDC-0077）由罗氏研发。据 Insight 数据库显示，该药在 2024 年中几乎同步在中美欧三大监管地区启动上市申报，同年 10 月 10 日率先获 FDA 批准在美国上市，一线治疗 HR+/HER2-/PIK3CA 突变转移性乳腺癌，商品名为 Itovebi。而在国内，伊那利塞也早在 2024 年 4 月就已经被 CDE 纳入优先审评。 项目研发关键节点 截图来自：Insight 数据库网页版 伊那利塞是一种创新口服靶向治疗药物，对 PI3Kα 的抑制有高效力和特异性，同时有独特的作用机制可降解 PI3Kα 突变体，能为 HR 阳性、PIK3CA 突变的乳腺癌患者提供良好的耐受性、持久的疾病控制并有可能改善预后。 该药此前获 FDA 批准是基于 III 期临床试验 INAVO120 研究的阳性结果。 INAVO120 是一项全球、多中心、双盲、随机对照的 III 期临床研究，旨在探索一线伊那利塞/安慰剂+哌柏西利+氟维司群用于辅助内分泌治疗期间或完成治疗 12 个月内复发的 PIK3CA 突变、HR+/HER2-局部晚期或转移性乳腺癌的疗效和安全性。 该研究共入组 325 例在辅助内分泌治疗期间或治疗完成后 12 个月内发生疾病进展、且既往针对转移性疾病未接受过系统治疗的患者。主要终点为研究者评估的 PFS。次要终点包括 OS、ORR 和 CBR。 在 2023 SABCS 上公布的临床结果显示，与哌柏西利和氟维司群的对照组相比，伊那利塞联合哌柏西利和氟维司群治疗组将疾病进展或死亡风险降低了 57%，中位 PFS 为 15.0 个月（vs 7.3 个月）。虽然 OS 数据尚不成熟，但已观察到明显的积极趋势。 安全性方面，伊那利塞联合治疗耐受性良好，不良反应与已知安全性特征一致，未观察到新的安全信号。 2024 ASCO 大会上，罗氏又再次更新了 INAVO120 研究数据。 截图来自：Insight 数据库出品《2024 ASCO：乳腺癌创新药全球竞争格局分析》 Insight 数据库显示，罗氏共登记了 4 项 III 期临床试验。除 INAVO120 研究之外，另外 3 项分别为： INAVO121 研究（NCT05646862/CTR20231292），探索伊那利塞+氟维司群 vs. 阿吡利塞（Alpelisib，诺华 PI3Kα 抑制剂）+氟维司群治疗经 CDK4/6 抑制剂和内分泌治疗后进展的 HR+/HER2-/PI3KCA 突变局部晚期或转移性乳腺癌； INAVO123 研究（NCT06790693），探索伊那利塞联用 CDK4/6 抑制剂和来曲唑治疗内分泌敏感的 PI3KCA 突变/HR+/HER2- 晚期乳腺癌； INAVO122 研究（NCT05894239/CTR20232070），探索伊那利塞联合帕妥珠曲妥珠单抗注射液（皮下注射）（Phesgo®）vs. Phesgo 作为一线 HER2 阳性乳腺癌维持治疗。 乳腺癌作为全球第二常见的癌种，也是罗氏的布局关键领域之一。 截图来自：罗氏 2024 Pharma Day PI3Kα 历来是肿瘤领域热门靶点之一。尤其是 2025 年 1 月，礼来刚刚斥资 25 亿美元收购 Scorpion Therapeutics，以获得该公司每日一次口服选择性 PI3Kα 管线 STX-478，再次点燃了这一赛道。 Insight 数据库显示，全球当前处于积极状态的在研 PI3Kα 管线高达 66 条之多，若排除临床前，仍有 22 条管线进入临床开发阶段，其中 10 条在中国有进展。 聚焦到针对乳腺癌开发的 PI3Kα 高选择性抑制剂，伊那利塞本次获批后将成为国内首款。国内企业中，豪森药业的 HS-10352、君实生物的 JS105 已经启动了 I/II 期临床，贝达药业的 BPI-21668 和罗欣药业的 LX-086 已经启动 I 期临床试验。 封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。 编辑：ccai PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验 点击阅读原文，立刻解锁！