Minocycline

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”ELCC 2025 微专辑扫描二维码可查看更多内容随着EGFR突变晚期非小细胞肺癌（NSCLC）患者治疗标准的演进，国际研究持续探索疗效与毒性之间的平衡。2025年欧洲肺癌大会（3月26-29日，巴黎）公布的ETOP AMAZE-lung试验提供了一种无化疗方案，COCOON试验结果为减少皮肤不良事件带来希望。 ETOP AMAZE-lung试验结果 单臂II期ETOP AMAZE-lung试验旨在为奥希替尼治疗进展后患者提供埃万妥单抗联合化疗的替代方案，结果显示埃万妥单抗、兰泽替尼和贝伐珠单抗三药联合方案具有程度适中、持久的疗效（摘要9MO）。研究入组61例患者，在包括60例患者的疗效分析队列，主要终点“12周确认客观缓解率（ORR）”达到33%，符合ORR>20%的预设成功标准。针对61例可评估患者中，最佳总体疗效（BOR）为疾病稳定（SD）51%、部分缓解（PR）39%、疾病进展（PD）5%、不可评估5%，中位缓解持续时间（DoR）达13.9个月（95%CI 8.3-不可评估[NE]）。中位无进展生存期（PFS）为10.9个月（95%CI 5.3-不可估计），中位总生存期（OS）为15.5个月（95%CI 12.3-不可估计）。图1：ETOP AMAZE-lung试验中，埃万妥单抗、兰泽替尼和贝伐珠单抗在奥希替尼进展后的EGFR突变晚期NSCLC患者中显示出持续疗效（2025欧洲肺癌大会，摘要9MO）43%患者出现3-4级治疗相关不良事件（TRAEs），1/5患者因TRAEs停用任一药物。最常见的3-4级TRAEs为痤疮样皮疹和斑丘疹。法国图卢兹大学医院Julien Mazières教授指出："总体疗效虽不突出但疗效持久。令人欣慰的是贝伐珠单抗未显著增加埃万妥单抗+兰泽替尼的毒性。这种三药联合方案似乎是一个合理的无化疗替代选择，但需要更大样本量的成熟数据，理想情况下应开展埃万妥单抗+兰泽替尼+贝伐珠单抗与埃万妥单抗+化疗的头对头随机试验。" COCOON试验结果 COCOON试验结果显示，在埃万妥单抗联合兰泽替尼一线治疗EGFR突变晚期NSCLC时，采用预防性强化皮肤管理方案较标准皮肤管理可显著降低皮肤不良事件发生率和严重程度（摘要10MO）。预防性强化皮肤管理方案包括口服多西环素/米诺环素、头皮局部克林霉素洗剂、甲床氯己定护理及全身/面部神经酰胺保湿剂。首次预设中期分析（中位随访4.2个月）显示达到主要终点（前12周≥2级皮肤不良事件发生率）。≥2级皮肤不良事件发生率从标准管理的76.5%显著降至38.6%（p<0.0001），头皮不良事件降幅（70%）最大（29% vs 9%）。3级皮肤不良事件发生率从8.8%降至4.3%。值得注意的是，COCOON方案组因不良事件导致的埃万妥单抗/兰泽替尼停药率更低：COCOON方案和标准方案的皮肤相关不良事件所致停药率分别为1% vs 4%，任何不良事件导致停药的发生率分别为11% vs 19%。图2： COCOON试验达到主要终点，≥2级皮肤不良事件发生率降低（摘要10MO）Mazières指出："传统皮肤反应管理多为事后处理，而有效的预防性方案可延长患者治疗时间。鉴于MARIPOSA试验最终OS数据即将发布，埃万妥单抗联合兰泽替尼的使用预计将增加，该方案尤为重要。"但他对COCOON方案中“多西环素/米诺环素剂量（100mg每日两次）高于多国的标准用量以及12周长期用药”保持审慎态度。Mazières总结道："目前EGFR突变晚期NSCLC的多种联合方案正在临床试验中，包括酪氨酸激酶抑制剂（TKI）联合抗血管生成药物、TKI联合化疗或埃万妥单抗等双特异性抗体联合化疗。不同方案的毒性不一样，关键在于早期预防、识别和治疗。"参考文献：1. Soo RA, et al. Amivantamab, lazertinib and bevacizumab in EGFR-mutant advanced NSCLC with acquired resistance to 3rd generation EGFR-TKI - Final results from the phase II ETOP AMAZE-lung trial. European Lung Cancer Congress 2025, Abstract 9MO2. Girard N, et al. Preventing moderate to severe dermatologic adverse events in first-line EGFR-mutant advanced NSCLC treated with amivantamab plus lazertinib: Early success of the COCOON trial. European Lung Cancer Congress 2025, Abstract 10MO《肿瘤瞭望》在ELCC现场报道（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。

Initial distribution of Emrosi to pharmacies ongoing First prescriptions of Emrosi filled SCOTTSDALE, Ariz., March 24, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced the launch of and the first prescriptions filled for Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) for the treatment of inflammatory lesions of rosacea in adults. Emrosi is available by prescription at specialty pharmacy chains. Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, said, “We are thrilled that the initial distribution to pharmacies is ongoing and the first Emrosi prescriptions have been filled. Rosacea is a challenging condition that affects millions, and Emrosi, the lowest-dose oral minocycline on the market, delivers significantly superior clinical outcomes for rosacea compared to Oracea® and placebo, while maintaining a comparable safety profile, as demonstrated in clinical trials. The launch of Emrosi marks a major milestone for Journey Medical and underscores our commitment to improving the quality of life for those living with dermatology conditions such as rosacea.” The FDA approved Emrosi for the treatment of inflammatory lesions of rosacea in adults in November 2024. Important Safety Information Indication: EMROSI™ is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults. Adverse Events: The most common adverse reaction reported by ≥1% of subjects treated with EMROSI and more frequently than in subjects receiving placebo was dyspepsia. Contraindications: EMROSI should not be taken by patients who have a history of hypersensitivity to any of the tetracyclines. Warnings/Precautions: Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. If DRESS syndrome is recognized, discontinue EMROSI immediately. Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth and reversible inhibition of bone growth. Discontinue EMROSI use if Antibiotic-Associated Colitis occurs. Discontinue EMROSI if liver injury is suspected. Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery. Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue EMROSI immediately if symptoms occur. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue EMROSI immediately if symptoms occur. Patients should minimize or avoid exposure to natural or artificial sunlight while using EMROSI. Tetracycline-class antibiotics are known to cause hyperpigmentation. EMROSI may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae and heart valves. Because of the potential for drug-resistant bacteria to develop during the use of EMROSI, use EMROSI only as indicated. If superinfection occurs, discontinue EMROSI and institute appropriate therapy. Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For full prescribing information, please visit www.emrosi.com. About RosaceaRosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia). According to The National Rosacea Society, it is estimated that rosacea affects over 16 million Americans and as many as 415 million people worldwide. Rosacea is most frequently seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report that more than 90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent stated that it had caused them to avoid public contact or cancel social engagements. Among rosacea patients with severe symptoms, 88 percent said the disorder had adversely affected their professional interactions, and 51 percent said they had missed work because of their condition. About Journey Medical CorporationJourney Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets eight branded and two generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com. Forward-Looking StatementsThis press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that are without patent protection and/or are, or may become, subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance on third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization EmrosiTM and the successful development, regulatory approval and commercialization of any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and any clinical trials we may initiate for future product candidates may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; the substantial doubt expressed about our ability to continue as a going concern; Fortress controls a voting majority of our common stock, which could be detrimental to our other stockholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact:Jaclyn Jaffe (781) 652-4500ir@jmcderm.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com