Bevacizumab

点击蓝字 关注我们2025年欧洲肿瘤内科学会（ESMO）妇科肿瘤年会上公布的II期PICCOLO试验（NCT05041257）的最终数据显示，无论同源重组缺陷（HRD）状态如何，叶酸受体α（FRα）阳性的复发性铂敏感卵巢癌（PSOC）患者接受mirvetuximab soravtansine-gynx（索米妥昔单抗，mirv）治疗均显示出显著的疗效。[1,2]PICCOLO试验是一项全球性、开放标签、单臂研究，纳入了79例FRα阳性、既往接受过至少2线含铂方案治疗的复发性PSOC患者。先前于2024年11月发表在《肿瘤学年鉴》（Annals of Oncology）上的一项分析显示，PICCOLO试验达到了研究者评估的客观缓解率（ORR）这一主要终点，确认的ORR为51.9%（95% CI: 40.4%-63.3%）。这包括7.6%（n=6）的完全缓解（CR）率和44.3%（n=35）的部分缓解（PR）率。值得注意的是，85.5%基线后有肿瘤测量数据的患者显示出肿瘤体积缩小。[3]☆2025 ESMO妇科癌症大会报道的结果显示，在中位随访26.6个月时，中位无进展生存期（PFS）为6.9个月（95% CI: 5.9-9.6），中位总生存期（OS）为27.17个月（95% CI: 23.79-未达到）。总共有79例FRα阳性的患者在三线或更后线治疗中接受了索米妥昔单抗治疗。PICCOLO试验中索米妥昔单抗在FRα阳性铂敏感卵巢癌患者中的OS（2025 ESMO妇科癌症大会，摘要号76MO）☆索米妥昔单抗的客观缓解率（ORR）为51.9%，中位缓解持续时间（DOR）为8.25个月。MIRV在未使用过PARP抑制剂的患者中显示出比PARP抑制剂经治患者更高的ORR（75.0% vs. 46.9%）。☆重度经治亚组的疗效：①在既往接受过1-2线治疗的患者中，ORR为55.1%（n=27/49）；②在既往接受过3线治疗的患者中，ORR为50.0%（n=12/24）；③在既往接受过贝伐珠单抗的患者中，ORR为49.0%（n=25/51）；④在既接受过PARP抑制剂又接受过贝伐珠单抗治疗的患者中，ORR为43.9%（n=18/41）。☆最常见的治疗期间出现的不良事件（TEAE）是低级别胃肠道毒性、周围神经病变和可缓解的眼部不良事件（AEs），严重不良事件（SAE）发生率为22%。TEAE导致13名患者（16%）停药和2名患者（3%）死亡。☆大会还报告了PICCOLO亚组分析的补充数据[2]，强调MIRV在伴或不伴HRD的患者中均显示出疗效（摘要号72MO）。在PICCOLO试验入组的38例已知肿瘤HRD状态的患者中，19例（50%）为HRD阳性。HRD阳性和HRD阴性肿瘤患者既往接受PARP抑制剂（84% vs 79%）和贝伐珠单抗（68% vs 63%）的情况相似。与HRD阴性肿瘤患者相比，HRD阳性肿瘤患者的ORR在数值上更高（58% vs 42%），中位缓解持续时间（DOR）更短（5.8 vs 8.3个月），而中位PFS相似（6.18 vs 6.90个月）。这表明索米妥昔单抗的获益并不局限于特定的HRD亚组。“虽然索米妥昔单抗单药疗法在铂耐药卵巢癌（PROC）患者中的疗效已被研究（包括一项确证性试验），但PICCOLO试验是首次完成针对PSOC患者的索米妥昔单抗单药II期试验的结果。考虑到PSOC和PROC患者群体之间的区别，这一点非常重要，”该研究的作者之一，杜克癌症中心的妇科肿瘤专家Angeles Alvarez Secord等人在研究中写道。研究点评：PICCOLO试验最终分析证实ADC在复发性铂敏感卵巢癌中的疗效2025年ESMO妇科癌症大会公布的II期PICCOLO研究最终分析证实索米妥昔单抗在重度经治FRα阳性PSOC患者中具有显著疗效和可接受的耐受性。MIRV是一种靶向FRα的抗体偶联药物（ADC），基于III期MIRASOL试验的结果，已于2024年3月获得美国食品药品监督管理局（FDA）完全批准，用于既往接受过1-3线全身治疗的FRα阳性铂耐药上皮性卵巢癌患者。来自法国斯特拉斯堡欧洲癌症研究所（ICANS）和斯特拉斯堡大学医院的Jean-Emmanuel Kurtz教授认为，考虑到重度经治PSOC患者对新的铂类联合方案应答的可能性大约只有1/5到1/4，PICCOLO的研究结果“前景良好”。他指出：“然而，PICCOLO研究并未告诉我们MIRV是否能够通过延长无铂间期来提高后续铂类治疗的疗效以及延长至后续治疗的时间。这将是一个值得探索的有趣问题，因为它可能有助于我们在铂敏感患者中获得更好的疗效。”与HRD阴性亚组（n=19）相比，HRD阳性亚组（n=19）的ORR数值上更高，但中位DOR更短，中位PFS相似。Kurtz认为，这些数据可能表明MIRV的疗效并不局限于特定的HRD亚组，尽管研究并未提供关于既往接受和未接受PARP抑制剂患者的疗效差异。在该研究中，几乎所有患者都接受过PARP抑制剂治疗（HRD阳性患者中84%，HRD阴性患者中79%），并且没有关于PARP抑制剂治疗结束与复发之间间隔时间的数据，而该间隔时间很可能影响患者对后续治疗的应答。参考文献:（上下滑动可查看）1. Secord A, et al. Final analysis of the single-arm phase 2 PICCOLO trial of mirvetuximab soravtansine-gynx (MIRV) in folate receptor alpha (FRα)-positive, third-line and later (3L+), recurrent platinum-sensitive ovarian cancer (PSOC). ESMO Gynaecological Cancers Congress 2025, Abstract 76MO2. Oaknin A, et al. Homologous recombination deficiency (HRD) and genomic subgroup analysis in patients (pts) with platinum-sensitive ovarian cancer (PSOC) receiving mirvetuximab soravtansine-gynx (MIRV) in the PICCOLO clinical trial. ESMO Gynaecological Cancers Congress 2025, Abstract 72MO3. Alvarez Secord A, Lewin S, Murphy C, et al. The efficacy and safety of mirvetuximab soravtansine in FRα-positive, third-line and later, recurrent platinum-sensitive ovarian cancer: the single-arm phase II PICCOLO trial. Ann Oncol. 2025;36(3):321-330. doi:10.1016/j.annonc.2024.11.011 （来源：《肿瘤瞭望》编辑部）声 明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

NASHVILLE--(BUSINESS WIRE)--Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced that it has entered into a definitive agreement with Samsung Bioepis Co. Ltd. (hereafter “Samsung Bioepis”) to secure the exclusive U.S. commercial rights to the ophthalmology biosimilar portfolio of Samsung Bioepis — BYOOVIZ® (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTISi (ranibizumab), and OPUVIZ™ (aflibercept-yszy), an FDA-approved biosimilar referencing EYLEAii (aflibercept) — two of the most widely used anti-VEGF therapies for retinal diseases. BYOOVIZ has been commercialized by Biogen in the U.S. since its initial launch in June 2022. In October 2024, Biogen notified Samsung Bioepis of their decision to terminate the 2019 Development and Commercialization Agreement within the U.S. and Canada. Samsung Bioepis has been closely working with Biogen on the transfer of commercialization rights for BYOOVIZ and OPUVIZ back to Samsung Bioepis in these regions. Harrow will assume full responsibility for commercialization of BYOOVIZ in the U.S. upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis. The transition is expected to be completed by the end of 2025. This strategic acquisition enhances Harrow’s position as the leading full-spectrum ophthalmic pharmaceuticals provider in the U.S., expands its pipeline with high-value biosimilars for sight‑threatening retinal diseases, and reinforces its commitment to delivering value-oriented innovation to the U.S. eyecare market. “This transformational acquisition marks a pivotal moment for Harrow and reinforces our commitment to delivering innovation, accessibility, and value to the U.S. ophthalmology community,” said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. “We are excited to leverage our growing commercial presence within the retina specialist community, built over the past year, and partner with Samsung Bioepis, globally recognized for its scientific excellence in biologics and biosimilars. These ophthalmic assets are among the most highly regarded in the market, and we are looking forward to bringing these products to U.S. physicians and patients.” Transaction Highlights Acquired Rights : Harrow gains exclusive U.S. commercial rights to Samsung Bioepis’ portfolio of ophthalmic biosimilars, including BYOOVIZ ® (“bio-viss”) and OPUVIZ™ (“op-u-vis”): BYOOVIZ (ranibizumab-nuna) 0.05mL injection, the first FDA-approved LUCENTIS biosimilar indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). OPUVIZ (aflibercept-yszy) 0.05mL injection , an FDA-approved EYLEA biosimilar indicated for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). BYOOVIZ (ranibizumab-nuna) 0.05mL injection, the first FDA-approved LUCENTIS biosimilar indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). OPUVIZ (aflibercept-yszy) 0.05mL injection , an FDA-approved EYLEA biosimilar indicated for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). Market Opportunity : The retinal disease treatment market represents a $9 billion opportunity iii in the U.S., with biosimilars expected to expand patient access and affordability. Execution-Ready Platform: Harrow will leverage its established commercial infrastructure and national reach to accelerate the market impact of these biosimilars. Harrow is committed to reshaping the Wet AMD treatment landscape by offering an FDA-approved, on-label, and affordable alternative to existing anti-VEGF therapies. The market is dominated by EYLEA, LUCENTIS, VABYSMO, and compounded Avastin, which continues to be used off-label due to its low cost, despite not being formulated or approved for ocular administration. Current anti-VEGF therapies are among the most expensive drug categories covered under Medicare Part B, with annual spending in the U.S. exceeding $4.2 billioniv. Harrow’s acquisition of these products has the potential to substantially lower the financial burden on Medicare and commercial plans, while improving access and affordability for patients. About BYOOVIZ (ranibizumab-nuna) BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use. BYOOVIZ (ranibizumab-nuna) is biosimilar to LUCENTIS (ranibizumab injection). BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection. Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP. Please see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE. About OPUVIZ (aflibercept-yszy) OPUVIZ (aflibercept-yszy) injection, for intravitreal use. OPUVIZ (aflibercept-yszy) is biosimilar to EYLEA (aflibercept). OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. Please see Prescribing Information for OPUVIZ (aflibercept-yszy) HERE. About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the North American market. Harrow helps eyecare professionals preserve the gift of sight by making its portfolio of pharmaceutical products accessible and affordable to millions of patients each year. For more information about Harrow, please visit harrow.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks, including litigation matters, and other uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q, and other filings with the SEC. Such documents may be read free of charge on the SEC’s web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. i Lucentis is a trademark of Genentech, Inc. ii Eylea is a trademark of Regeneron Pharmaceuticals, Inc. iii Company annual reports & Biopharma AVASTIN estimates iv https://www.reviewofoptometry.com/news/article/annual-medicare-expense-for-antivegf-injections-tops-4-billion-study-finds