Cisplatin

– Administration of PEDMARK ® Approximately Six Hours After Cisplatin was Shown to Be Safe & Easily Integrated into Care for Adults with Head & Neck Cancers (HNC) – – Early Signals of Hearing Preservation Highlight the Potential of PEDMARK ® to Address Cisplatin-Induced Hearing Loss, a Critical Survivorship Gap, Without Compromising Cisplatin’s Established Antitumor Activity – – Majority of High-Risk Patients Receiving PEDMARK ® Demonstrated No Measurable Hearing Loss During or After Treatment Despite Prevalence of Baseline Hearing Impairment – RESEARCH TRIANGLE PARK, N.C., Feb. 20, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today announced new real world data supporting potential use of PEDMARK ® (sodium thiosulfate injection) in adults with head and neck cancers were presented as a digital poster at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS) in Palm Desert, CA from February 19 – 21, 2026. Findings from a multi-institutional retrospective review of 15 adults with head and neck cancers (HNC) showed that PEDMARK ® could be safely given ≥six hours after cisplatin dosing and was easy to incorporate into the real-world care plan for adults with HNC. This strict post-cisplatin timing is a validated approach intended to preserve cisplatin antitumor activity and no disruption to curative-intent cisplatin-based treatment delivery was observed as part of the study review. “Head and neck cancer is one of the most common cancers globally, 1 underscoring why these results are encouraging for clinicians. Importantly, the data support the potential of the drug to address cisplatin-induced hearing loss – a major and often overlooked survivorship challenge – without compromising cisplatin’s proven antitumor activity,” said Maria A. Velez, M.D., M.S., coauthor of the study and clinical instructor in the Division of Hematology/Oncology at UCLA Health. “Cisplatin-induced hearing loss remains one of the most underrecognized yet deeply consequential toxicities associated with cancer treatment,” said Leslie Worona, FNP-BC, OCN, coauthor of the study and oncology nurse practitioner at Mount Sinai Hospital. “The findings that most patients – even those with high rates of pre-existing hearing impairment – who received PEDMARK ® experienced no measurable hearing loss during or after treatment supports further exploration of PEDMARK ® use in additional patient populations and tumor types such as HNC.” PEDMARK was shown to be well tolerated, with only isolated, self-limited infusion events and no grade 3 or 4 toxicities. “These new findings are critical to demonstrating the feasibility, scalability and long-term value of PEDMARK ® beyond those studied in our pivotal clinical program,” said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. “Additionally, these data may help to strengthen the case for broader clinical adoption in a sizable patient population at high risk for permanent hearing loss.” The study’s primary endpoint evaluated feasibility, defined by timing adherence (≥6 hours) and operational metrics, including administration setting (home vs. clinic infusion) and chair time for infusion-center dosing. Secondary endpoints included infusion-related events, need for antiemetic escalation, and completion of on-treatment and post-treatment audiology assessments. PEDMARK ® is currently approved for pediatric patients one month of age and older with localized, non-metastatic solid tumors, and is also recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in adolescent and young adult patients. About Cisplatin-Induced Ototoxicity Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity. 2 Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapy 3 . Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time. 4 Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently. 5 , 6 While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations. PEDMARK ® (sodium thiosulfate injection) PEDMARK ® is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6. Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement. Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy. 7 , 8 The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss. 9 10 PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors. Indications and Usage PEDMARK ® (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. Limitations of Use The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred. Important Safety Information PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components. Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma. PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers. Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L. Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m 2 . Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate. The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia. Please see full Prescribing Information for PEDMARK ® at: . About Fennec Pharmaceuticals Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK ® to reduce the risk of platinum-induced ototoxicity in cancer patients. PEDMARK received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSI. In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI ® in Europe, U.K., Australia and New Zealand. PEDMARQSI is now commercially available in the U.K. and Germany. PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. Further, Fennec has patents providing protection for PEDMARK until 2039 in both the U.S. and internationally. For more information, please visit and follow on LinkedIn . Forward Looking Statements Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans respecting PEDMARK ® / PEDMARQSI ® , the market opportunity for and market impact of PEDMARK ® / PEDMARQSI ® , its potential impact on patients and anticipated benefits associated with its use, future commercial and regulatory milestone and royalty payments from Norgine, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risks and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, our ability to obtain necessary capital when needed on acceptable terms or at all, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2024. Fennec disclaims any obligation to update these forward-looking statements except as required by law. For a more detailed discussion of related risk factors, please refer to our public filings available at and . PEDMARK ® PEDMARQSI ® and Fennec ® are registered trademarks of Fennec Pharmaceuticals Inc. ©2025 Fennec Pharmaceuticals Inc. All rights reserved. FEN-1604-v1 For further information, please contact: Investors: Robert Andrade Chief Financial Officer Fennec Pharmaceuticals Inc. +1 919-246-5299 Corporate and Media: Lindsay Rocco Elixir Health Public Relations +1 862-596-1304 lrocco@elixirhealthpr.com 1 Mody MD, Rocco JW, Yom SS, et al: Head and neck cancer. Lancet 398:2289-2299, 2021. 2 Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369. 3 Langer T, am Zehnhoff-Dinnesen A, Radtke S, Meitert J, Zolk O. Trends Pharmacol Sci. 2013;34(8):458-469 4 Landier W. Ototoxicity and Cancer Therapy. Cancer . June 2016 Vol. 122, No.11: 1647-1658. 5 Clemens E, van den Heuvel-Eibrink MM, Mulder RL, et al. Recommendations for ototoxicity surveillance for childhood, adolescent, and young adult cancer survivors: a report from the International Late Effects of Childhood Cancer Guideline Harmonization Group in collaboration with the PanCare Consortium. Lancet Oncol . 2019;20(1):e29-e41 6 . Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer . 2016;63(7):1152-1162. 7 Chattaraj A et al. Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract . 2023;19 8 Freyer DR et al. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol . 2017;18(1):63-74. 9 Rajput K, Edwards L, Brock P, Abiodun A, Simpkin P, Al-Malky G. Ototoxicity-induced hearing loss and quality of life in survivors of paediatric cancer . Int J Pediatr Otorhinolaryngol . 2020;138:110401. doi:10.1016/j.ijporl.2020.110401 10 Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.

点击蓝字 关注我们 妇科癌症涵盖卵巢癌、子宫内膜癌、宫颈癌以及外阴与阴道恶性肿瘤，是全球范围内重要的公共卫生挑战。本文重点梳理Nabil Ismaili在《Biomedicines》期刊发表的一篇综述，介绍2025年子宫内膜癌和外阴癌研究方面的最新进展，以期为同行提供参考。 生物标志物定义子宫内膜癌治疗 巩固一线免疫化疗方案的地位，MMR/MSI检测很重要 发表在《自然·医学》上的NRG GY018研究更新报告了更长随访后的次要终点数据[1]。NRG GY018旨在验证在标准化疗（紫杉醇+卡铂）基础上，联合并维持使用帕博利珠单抗治疗晚期或复发性子宫内膜癌患者，是否优于单纯化疗。虽然总生存（OS）数据仍不成熟，但帕博利珠单抗联合卡铂-紫杉醇的无进展生存（PFS）获益在错配修复正常（pMMR）人群和错配修复缺陷（dMMR）人群中均得以持续。安全性特征保持稳定，未加重化疗相关毒性。 ENGOT-EN6-NSGO/GOG-3031/RUBY试验在《妇科肿瘤学》发表了完整的错配修复功能缺陷/微卫星高度不稳定（dMMR/MSI-H）队列结果：中位随访37.2个月，dostarlimab联合化疗对比安慰剂联合化疗显示出显著的PFS改善（HR=0.28）和具有临床意义的OS获益（HR=0.32；p<0.0001），36个月OS率分别为77% vs. 52%。该方案治疗产生缓解的患者中，缓解时间持久。[2] ESMO 2025发布了AtTEnd/ENGOT-EN7试验（阿替利珠单抗）的最终OS分析：总体人群和dMMR人群中均达到主要PFS终点，但dMMR和pMMR人群最终的OS分析结果不同：阿替利珠单抗联合化疗相比对照组在dMMR亚组有显著的OS获益（HR=0.49），在pMMR亚组未观察到OS获益（HR=1.02）[3]。研究结果显示，对于dMMR/MSI-H肿瘤患者，一线免疫化疗产生显著的生存优势；而对于pMMR肿瘤患者，获益主要是延迟进展。这要求在诊断时必须进行普遍的、快速的MMR/MSI检测，以指导一线治疗选择。 生物标志物动态变化 一些研究继续探索改善患者结局的策略，特别是在pMMR疾病中。DUO-E试验（度伐利尤单抗联合化疗）的转化研究探索了纵向ctDNA变化[4]。在ASCO 2025报告的分析发现，在度伐利尤单抗组中，48%的pMMR肿瘤患者在一个治疗周期后（至C7D1→C9D1）实现了ctDNA清除，而对照组为17%，并且这种清除是加用度伐利尤单抗带来PFS和OS获益的强有力的早期预测指标。该研究发现提供了另一个动态工具来评估治疗反应，并可能用于调整治疗持续时间。 综上，2025年的子宫内膜癌研究在确立一线免疫化疗疗效的基础上，进一步通过精确的生物标志物分析来完善其应用。2025年的数据明确了晚期子宫内膜癌的治疗流程：普遍的MMR/MSI检测现在绝对必要，未来的研究必须聚焦如何克服pMMR肿瘤耐药，以及使用ctDNA清除等动态生物标志物。 外阴癌：免疫/放化疗新标准 通过免疫/放化疗建立新标准 外阴癌作为一种罕见且常被忽视的恶性肿瘤，在2025年取得了有意义的进展。Yeku等人的II期研究评估了同步帕博利珠单抗联合顺铂增敏放疗的疗效[5]。在ASCO 2025报告的主要结果显示，在接受放化疗-免疫治疗后进行手术的患者中，病理完全缓解率高达58%，并且2年PFS和OS率与单独放化疗的历史对照数据相比具有优势。该方案的主要毒性来自放疗，总体可控。 该研究提供了首个前瞻性证据，支持将免疫疗法整合到局部晚期外阴癌的根治性治疗管理中，与宫颈癌中KEYNOTE-A18研究发现相呼应。这项研究虽然是II期，但对这种罕见癌症具有重要的实践指导意义。通过证明在标准顺铂放化疗基础上加用帕博利珠单抗的可行性和高效性，它为局部晚期不可切除疾病建立了一个新的潜在基准，应推动更大规模的验证性研究。 参考文献 （上下滑动可查看） 1. Eskander, R.N. et al. Pembrolizumab plus chemotherapy in advanced or recurrent endometrial cancer: Overall survival and exploratory analyses of the NRG GY018 phase 3 randomized trial. Nat. Med. 2025, 31, 1539–1546. 2. Powell, M.A. et al. Efficacy and safety of dostarlimab in combination with chemotherapy in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in a phase 3, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY). Gynecol. Oncol. 2025, 192, 40–49.  3. Barretina Ginesta, M.P. et al. LBA39 Final Overall Survival Results from the Randomized Double-Blind Phase III AtTEnd/ENGOT-EN7 Trial Evaluating Atezolizumab in Combination with Paclitaxel and Carboplatin in Women with Advanced/Recurrent Endometrial Cancer. Ann. Oncol. 2025, 36, S1583.  4. Westin, S.N. et al. Durvalumab Plus Carboplatin/Paclitaxel Followed by Durvalumab with or without Olaparib as First-Line Treatment for Endometrial Cancer: Longitudinal Changes in Circulating Tumor DNA. J. Clin. Oncol. 2025, 43, 5512. 5. 25. Yeku, O.O. et al. Primary Results of a Phase 2 Study of Cisplatin-Sensitized Radiation Therapy and Pembrolizumab for Unresectable Vulvar Cancer. J. Clin. Oncol. 2025, 43, 5511. （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。