Darolutamide

点击上方蓝字 关注我们 编者按：前列腺癌是全球三分之二国家最常见的癌症，预计未来二十年内其发病率和死亡率都将翻倍。过去三十年，前列腺癌的诊疗快速发展，包括多参数磁共振成像（mpMRI）、PET检查、机器人手术、影像引导的大分割与立体定向放疗、新型抗雄激素药物以及放射性配体治疗等。近日，素有“神刊”之称的《临床医师癌症杂志》（CA A Cancer J Clinicians，2025年最新IF=232.4）发表的一篇综述，系统介绍了前列腺癌的诊疗现状。本文总结复发或转移性前列腺癌（以延长生存为主）的治疗进展。 01 根治性治疗后复发 PSA定义生化复发的标准取决于初始治疗方式。根治性前列腺切除术后，最能预测转移的PSA水平是＞0.4 ng/mL，但最广泛接受的生化复发定义是PSA ＞0.2 ng/mL或连续两次上升。放疗后PSA失败的定义是治疗后最低值上升超过2 ng/mL。在无症状患者中，传统影像学检查的阳性率很低。因此，对于重新分期，不建议常规使用传统影像学检查。PSMA-PET/CT在前列腺床、盆腔淋巴结和全身的检测方面具有更高的敏感性、特异性和阳性预测值。 复发性疾病的自然病程较长，在决定是否进行局部治疗时，预期寿命和生活质量是重要考量参数。虽然基于生化复发的终点指标具有预后价值，但这些指标并非总生存期的替代终点。局部治疗方式包括挽救性前列腺切除术、冷冻消融、高强度聚焦超声、外照射或近距离再放疗等，可为大多数患者提供暂时的生化控制，但需考虑重要并发症风险。因此，放疗后的局部复发应通过影像学（MRI和/或PSMA-PET）和影像学可疑时的活检确认。通常在出现症状、发生转移或PSA倍增时间短于6个月时开始ADT治疗。对于大多数患者，延迟和间歇性ADT是首选，因为早期ADT并不能改善生存。对于高风险生化复发且PSA倍增时间短于9个月的患者，EMBARK研究显示恩扎卢胺联合ADT相比单独ADT可改善无转移生存期，而对于难以耐受ADT副作用的患者，恩扎卢胺单药可能是一个选择。 02 转移性疾病的放疗 放疗在转移性疾病中的应用已被研究，并被证明在低负荷疾病中联合标准治疗可改善总生存期，预计获益超过两年。对于仅有非区域淋巴结转移（M1a）或不超过3处骨转移的患者，获益更为显著。在高负荷疾病中，放疗可减少梗阻性尿路病等并发症的发生率。PEACE-1研究表明，在标准治疗（联合阿比特龙）基础上增加放疗可改善低负荷患者的影像学无进展生存期，减少严重泌尿生殖系统事件，并延缓去势抵抗的出现，且不受疾病负荷影响。 寡转移前列腺癌通常定义为转移灶不超过5个，并根据转移出现的时间间隔进一步分为异时性或同步性。转移灶定向治疗可降低生化复发率，延长后续治疗时间，改善无进展生存期；然而在前列腺癌中尚未证实总生存期获益。有Ⅱ期随机试验显示，在开始一线去势抵抗性疾病治疗的患者中，立体定向放疗可改善生化控制和无进展生存期。对于盆腔淋巴结寡复发，全盆腔淋巴结放疗相比转移灶定向治疗可改善生化和区域控制，应被视为标准治疗。 03 转移性激素敏感性前列腺癌（mHSPC） 除传统ADT、化疗等以外，雄激素受体通路抑制剂（ARPI）已成为mHSPC的重要治疗药物。第一代药物包括氟他胺、比卡鲁胺和尼鲁米特，第二代药物包括阿帕他胺、恩扎卢胺和达罗他胺等。第二代药物被认为效力更强。达罗他胺是唯一不透过血脑屏障的ARPI，有助于减少神经系统副作用。阿比特龙是一种强效CYP17A1抑制剂，可阻断肾上腺、睾丸和肿瘤本身的雄激素生物合成。主要不良反应见下表。 在mHSPC中，已有多项临床试验证明，ADT联合多西他赛或ARPI可显著改善总生存期。在高负荷同步转移患者中，多西他赛降低死亡风险的幅度最大。然而，这些Ⅲ期临床试验排除了体能状态差或合并症严重的患者，平均年龄小于真实世界情况。已知ARPI可能增加全因心血管事件，包括高血压、心律失常或心源性死亡。大多数Ⅲ期试验中的患者为新发转移性激素敏感性前列腺癌，在将这些数据外推至初始治疗后复发的患者时应谨慎。所有适合的患者都应接受ADT联合另一种药物的双药联合治疗；在条件允许的情况下，建议选择ARPI而非多西他赛。两项Ⅲ期试验证明，在ADT+多西他赛基础上加用ARPI可改善无转移生存期和总生存期，而ADT+ARPI+多西他赛的价值尚不明确。 三药或四药联合方案在两项重要临床试验中进行了研究。2×2析因设计的PEACE-1研究显示，ADT、多西他赛和阿比特龙三联方案相比ADT联合多西他赛显著改善总生存期和影像学无进展生存期，标准治疗联合阿比特龙和放疗在影像学无进展生存期和总生存期方面结果最佳。ARASENS研究则显示，在多西他赛+ADT基础上联合达罗他胺可显著改善总生存期，但ADT+多西他赛已经不是当前临床实践的最佳治疗方案。随后的荟萃分析也未能显示三药联合方案在OS方面的获益。目前，ADT、ARPI联合前列腺放疗仍是低负荷疾病的标准治疗，作者认为多西他赛三药或四药联合最好应用于高负荷的初诊mHSPC，尽管最佳获益人群的选择仍存在争议。应告知患者，在ARPI+ADT+多西他赛可降低生活质量，且获益程度尚不明确。 新型放射性配体疗法在该领域也展现了应用潜力，靶向于PSMA的放射性配体治疗在Ⅱ期UpFrontPSMA研究中显示，在高负荷mHSPC中，相比多西他赛可改善PSA控制，延缓去势抵抗进展，改善影像学无进展生存期（rPFS）。 △不同ARPI的不良事件 △临床试验报道的mHSPC不同治疗方案 04 去势抵抗性前列腺癌（CRPC） CRPC定义为处于血清睾酮去势水平（＜50 ng/dl或1.7 nmol/l）时发生的疾病进展。进展可包括多次PSA上升或影像学进展。 非转移性CRPC（nmCRPC） nmCRPC通过传统影像学（CT和骨扫描）未发现转移灶确定。nmCRPC的发生是由于在非转移性前列腺癌中早期和长期使用ADT，或在生化失败但尚未检测到复发病灶的患者中早期启动ADT。后一种做法已不再推荐，因此这种情况在未来将更少见。许多既往分类为nmCRPC的患者在现代影像学检查中大多可发现病灶。回顾性队列研究显示，98%的nmCRPC患者可通过PSMA-PET发现病灶。 某些新型ARPI联合ADT可改善非转移性CRPC患者的无转移生存期（MFS）和总生存期（OS）。对于管腔型肿瘤或基因组分类器Decipher评分高的患者，新型ARPI阿帕他胺可能带来更持久的MFS获益。 △已报道的nmCRPC Ⅲ期临床试验 转移性CRPC（mCRPC） 选择转移性CRPC（mCRPC）的最佳系统治疗方案取决于多种因素：年龄、体能状态、疾病负荷、初诊或转移性疾病既往治疗史、DNA修复缺陷的存在以及疾病的PSMA表达。即使在去势抵抗阶段，ADT也应终身维持，因为AR信号对前列腺癌细胞的生存和增殖仍有关键作用。 新型抗雄药物阿比特龙、恩扎卢胺在多西他赛治疗前或后的ARPI初治患者中可改善OS。低剂量阿比特龙与低脂早餐同服可达到与标准剂量空腹相似的血液浓度。镭-223是一种α发射体，在骨为主的进展性mCRPC患者中显著改善总生存期，可推荐使用且不受既往多西他赛治疗影响。镭应联合双膦酸盐或地诺单抗用于骨保护。对于CRPC阶段未使用过ARPI的患者，PEACE-3结果支持镭-223联合恩扎卢胺和骨保护剂，因为相比单独恩扎卢胺显著改善总生存期。对于既往接受过ARPI的患者，第二种ARPI仅显示有限活性，不被视为标准治疗。低剂量地塞米松可使部分患者获得PSA和症状缓解。 此外，在高达20%～30%的mCRPC患者中可检测到DNA修复缺陷，如胚系或体系同源重组修复基因（BRCA1、BRCA2）或DNA损伤检查点激活因子ATM突变。对于携带同源重组修复基因突变的mCRPC患者，PARP抑制剂联合ARPI已被证实改善rPFS；对于非突变患者，没有足够证据推荐使用PARP抑制剂。 基于PSMA的放射性配体能选择性将辐射递送至PSMA阳性细胞及其周围微环境。在VISION试验中，镥-177（177Lu）-PSMA-617相比标准治疗可改善既往接受过ARPI和1-2种紫杉烷类药物治疗患者的总生存期，而在PSMAfore试验中，紫杉初治、ARPI经治患者相比第二种ARPI显示影像学无进展生存期获益且副作用更少。SPLASH试验显示，在化疗初治、ARPI经治理患者中，177Lu-PNT2002相比更换ARPI改善影像学无进展生存期，该试验的交叉率为85%。 △mCRPC领域具有里程碑意义的临床试验 目前尚无公认的这些药物最佳使用顺序共识。建议的流程图如下图所示。在前列腺癌治疗中，除临床试验外，没有足够证据推荐常规使用免疫治疗。 △mCRPC的系统治疗选择 正在进行的研究聚焦于潜在治疗靶点的临床试验和新靶点的识别：PTEN缺失中的Akt信号抑制剂、微卫星不稳定性高肿瘤中的PD-1抑制剂、选择性PARP1抑制剂、抑制类固醇合成的药物、靶向蛋白质降解的小分子、靶向PSMA的T细胞衔接器（人激肽释放酶2、STEAP1）以及神经内分泌分化潜在标志物（DLL-3、EZH2）的靶向药物。前列腺癌的自然病史和临床病程如下图所示。 △前列腺癌的自然病程 05 生存与生活质量 过去四十年，局限期前列腺癌的5年生存率已接近100%，但逾三成患者仍长期饱受根治治疗副作用之苦：尿失禁、性功能障碍、疲乏、抑郁。转移阶段虽可借新型药物与终身ADT实现“慢性病化”，却伴随骨密度下降、骨折、心血管事件及情绪障碍。ADT联合抗雄治疗使骨折风险倍增，唑来膦酸或地诺单抗可降低骨并发症。作者建议所有长期ADT者均需补钙、维生素D并定期骨密度监测，同时坚持体重管理、戒烟限酒、负重运动与心理支持，方能在“活得久”与“活得好”之间找到平衡。 ▌参考文献： Chakrabarti D, Albertsen P, Adkins A, et al. The contemporary management of prostate cancer. CA Cancer J Clin. Published online June 26, 2025. doi:10.3322/caac.70020 往期推荐 1 “神刊”综述丨当代前列腺癌的流行病学、筛查、诊断 2 “神刊”综述丨局限性前列腺癌的治疗进展 （来源：《肿瘤瞭望-泌尿时讯》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。

RedHill has received its first Talicia sales milestone payment as well as royalties and other payments, totaling $1.1 million, following the first ex-U.S. commercial launch of Talicia in 2024 Talicia is the first FDA-approved rifabutin-based product specifically designed to treat Helicobacter pylori (H. pylori), a bacterial infection with high and rising resistance rates that affects over 50% of the world's adult population[1] and is the strongest risk factor for gastric cancer and peptic ulcer disease Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[2] for treatment of H. pylori infection and was granted a Qualified Infectious Disease Product (QIDP) designation by the FDA, providing eligibility for a total of eight years of U.S. market exclusivity; Talicia is patent protected through 2042 RALEIGH, N.C., Aug. 18, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has received its first Talicia[3] ex-U.S. sales milestone, royalties and other payments totaling approximately $1.1 million. "The presence of H. pylori infection is the strongest risk factor for gastric cancer and peptic ulcer disease and there is a significant global medical need for a highly effective first-line H. pylori therapy," said Rick Scruggs, President, RedHill Biopharma Inc. & Chief Commercial Officer. "H. pylori is a major public health concern, with over 50% of the world's adult population infected. Talicia offers the best hope for patients and physicians in an era of increased resistance with clarithromycin-based therapies[4],[5]. As we work to bring Talicia to more patients globally, we continue our discussions with potential partners and expect to secure additional non-dilutive ex-US licensing revenue streams. Clarithromycin-based triple therapy continues to wane in effectiveness. A 2021 study demonstrated only 68.5% eradication with traditional clarithromycin-based triple therapy, which declined further to 32% in patients harboring resistant H. pylori organisms[6]. Clarithromycin-based treatment efficacy has also been reported to be negatively impacted by patient obesity or diabetic status, neither of which impacts Talicia's safety or efficacy, according to data from post-approval post-hoc analysis [7],[8]. In contrast, in the pivotal Phase 3 study, Talicia demonstrated up to 90% eradication of H. pylori infection in adherent patients (p<0.0001) with minimal to zero antibiotic resistance to rifabutin, a key component of Talicia, detected[9]. About H. pylori H. pylori is a bacterial infection that affects approximately 35%[10] of the U.S. population, with an estimated 1.6 million patients treated annually[11]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[12] and a major risk factor for peptic ulcer disease[13] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[14]. More than 27,000 Americans are diagnosed with gastric cancer annually[15]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[16]. About Talicia Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG and FDA in recent years. Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm. Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2042 with additional patents and applications pending and granted in various territories worldwide. Talicia is approved and commercialized in the United States and the United Arab Emirates. TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial­­, indicated for the treatment of Helicobacter pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin. Talicia is contraindicated in patients receiving rilpivirine-containing products. Talicia is contraindicated in patients receiving delavirdine or voriconazole. Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin. Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia. Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin. Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia. Talicia should not be used in patients with hepatic impairment or severe renal impairment. Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease. The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis. To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or . Full prescribing information for Talicia is available at About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults3. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (iv) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis and positive results from a U.S. Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements, including, but not limited to, statements regarding the intended use of net proceeds from the offering, may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq, the addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, non-dilutive development funding from RHB-107 and its inclusion in a key platform study. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, market and other conditions, the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107, the risk that HB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Logo: Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma [email protected] +972-54-6543-112 Category: Commercial 1. Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. 2. IQVIA XPO Data on file. 3. Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . 4. Savoldi, A., et al., Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in World Health Organization Regions. Gastroenterology, 2018. 155(5): p. 1372-1382 e17. 5. Park, J.Y., et al., Helicobacter pylori Clarithromycin Resistance and Treatment Failure Are Common in the USA. Dig Dis Sci, 2016. 61(8): p. 2373-2380. 6. Chey, W.D., et al., Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology, 2022. 163(3): p. 608-619. 7. Diabetes Data on File. 8. Kao, J.Y., Helicobacter pylori eradication by low-dose rifabutin triple therapy (RHB-105) is unaffected by high body mass index. GastroHep, 2021. 3(7): p. 426-434. 9. Graham DY, Canaan Y, Maher J, Wiener G, Hulten KG, Kalfus IN. Rifabutin-based triple therapy (RHB-105) for Helicobacter pylori eradication: a double-blind, randomized, controlled trial. Ann Intern Med. 2020;172(12):795-802. 10. Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. 11. IQVIA Custom Study for RedHill Biopharma, 2019. 12. Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497. 13. NIH – Helicobacter pylori and Cancer, September 2013. 14. Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15. 15. National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER). 16. Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45. SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED