Oncology Pharma, Inc.

在 2024 年 9 月 7 日至 10 日由国际肺癌研究协会（IASLC）主办的 2024 年世界肺癌大会（WCLC）和 2024 年 9 月 13 日至 17 日举办的欧洲肿瘤内科学会（ESMO）年会上，阿斯利康将凭借其多元化、领先行业的产品及管线布局的全新研究数据，深化其变革癌症诊疗格局的雄心壮志。 在这两场大会上，阿斯利康将公布逾 130 项摘要，其中涵盖 17 款已获得批准的药物和潜在新药，包含 5 项主席研讨会和 41 项口头报告。 阿斯利康全球执行副总裁、肿瘤研发负责人 Susan Galbraith 表示：「在这两场大会上，我们的报告有力地推动了阿斯利康致力于颠覆癌症诊疗的长期战略。我们将在世界肺癌大会上展示计算病理学平台的成果，当前我们正在抗体偶联药物组合中使用该平台以研发预测生物标志物，精准提升患者筛选，并改善治疗结局。此外，我们还将分享靶向 TROP2 抗体偶联药物 datopotamab deruxtecan 联合度伐利尤单抗治疗早期肺癌的研究数据，这是我们首次公布公司自主研发的两款抗体偶联药物在相关临床试验中获取的数据，该数据令人备受鼓舞。此外，我们的下一代免疫疗法也取得了重大进展。」 阿斯利康全球执行副总裁、肿瘤业务负责人 David Fredrickson 表示：「我们在世界肺癌大会和欧洲肿瘤内科学会年会上公布的数据，将展示阿斯利康在推动当下乃至可能在未来变革癌症治疗的几项重大趋势中所取得的成果。在针对治疗肌层浸润性膀胱癌的 NIAGARA 临床试验中，度伐利尤单抗取得了阳性结果，突显出在这类人群中围手术期免疫治疗的重要性。同时，datopotamab deruxtecan 和德曲妥珠单抗对各类肺癌的研究数据将着重体现，抗体偶联药物有望在多种癌症状况的治疗中替代传统化疗。     关键趋势：早期干预，变革癌症早期治疗结局 在 ESMO 的主席专题讨论会上，阿斯利康将展示 NIAGARA III 期试验结果，这项临床试验旨在观察肌层浸润性膀胱癌患者在接受膀胱切除术之前，先接受度伐利尤单抗联合新辅助化疗，术后接受度伐利尤单抗作为辅助单药治疗的效果。这种基于度伐利尤单抗的治疗方案取得了良好效果，在无事件生存期（EFS）和总体生存期（OS）方面表现出统计学上显著且具有临床意义的改善，使其成为首个在膀胱癌 III 期试验中显示出延长生存期的围术期免疫治疗方案。 在肺癌治疗领域，两场会议中有多场报告将彰显我们在早期治疗取得的重大进展。包括： NeoCOAST-2 II 期平台型临床研究的疗效和安全性数据将在世界肺癌大会的「最新突破主席研讨会「上汇报。该研究旨在评估度伐利尤单抗在围术期的多种新型联合疗法治疗可切除的早期非小细胞肺癌（NSCLC）患者的疗效，包括与 datopotamab deruxtecan 的联合疗法。AEGEAN III 期临床研究证明了度伐利尤单抗在围手术期的疗效，且近期已在美国获批。 AEGEAN III 期临床研究的第二次中期分析结果将在 WCLC 做「最新突破的口头报告「，分析围手术期基于度伐利尤单抗的治疗方案对早期可切除（IIA-IIIB）NSCLC 患者的疗效。这些数据涵盖了亚组患者（无论是否实现病理完全缓解）的无事件生存期，以及最新的无病生存期和总生存期。在 ESMO 上的另一项口头报告中，将介绍 AEGEAN 的循环肿瘤 DNA（ctDNA）检测数据，为患者对治疗方案的应答情况提供参考。 ADRIATIC III 期临床研究将在世界肺癌大会上做简短口头报告，介绍接受同步化放疗（CRT）后未出现疾病进展的局限期小细胞肺癌患者使用度伐利尤单抗的治疗结局。此外，我们还将在 ESMO 上的口头报告中，公布主要亚组患者的治疗结局。 LAURA III 期临床研究将在世界肺癌大会上做简短口头报告，分析不可切除的 III 期 EGFR 敏感突变非小细胞肺癌患者在根治性放化疗后，使用泰瑞沙（奥希替尼）在中枢神经系统和远处转移的疗效。此外， LAURA 临床研究的安全性数据将在 WCLC 展示、中国队列的疗效和安全性将在 ESMO 上以壁报展示。    关键趋势：新型抗体偶联药物（ADC）取代全身化疗 在 WCLC 的「最新突破主席研讨会「上，通过应用阿斯利康专有的病理学计算平台——定量连续评分（QCS）对 TROPION-Lung01 所收集的组织样本进行探索性分析，将使得经 QCS 计算的 TROP2 有望成为用 datopotamab deruxtecan 治疗的预测生物标志物。 此外，TROPION-Lung01 III 期临床研究的总生存期数据将做「最新突破的口头报告「，该研究旨在评估 datopotamab deruxtecan 治疗既往经治的局部晚期或转移性 NSCLC 患者的疗效。今年 5 月，一系列高水平阳性结果显示，相较于多西他赛（目前的标准化疗药物），datopotamab deruxtecan 在既往接受过免疫治疗或靶向治疗的晚期非鳞 NSCLC 患者中，总生存期有临床意义的改善。 以及在 WCLC 上，DESTINY-Lung03 Ib 期试验第一部分的数据将做口头报告，重点介绍德曲妥珠单抗的疗效和安全性，该试验以 DESTINY-Lung01 II 期临床研究数据为基础，患者均为经治的 HER2 过表达的不可切除局部晚期或转移性 NSCLC 患者。 在 ESMO 上，德曲妥珠单抗在 DESTINY-Breast12 IIIb/IV 期临床研究中治疗经治的 HER2 阳性转移性乳腺癌患者的潜在疗效将做最新突破的口头报告，部分受试患者还伴有脑转移。此外，DESTINY-Gastric03 Ib/II 临床研究的口头报告将介绍德曲妥珠单抗联合化疗和帕博利珠单抗作为一线治疗方案，在 HER2 阳性胃和胃食管结合部（GEJ）癌症中的安全性和疗效。 在 ESMO 上还将发表简短口头报告，首次发布 datopotamab deruxtecan TROPION-PanTumour03 II 期临床研究在子宫内膜癌和卵巢癌的首次治疗结果。 阿斯利康将在 ESMO 上发布多项报告，展示公司新兴的 ADC 专有技术实力。包括： 通过优选书面报告分享 B7-H4 ADC AZD8205 在 BLUESTAR I/IIa 期临床研究治疗表达 B7-H4 的晚期实体肿瘤中的剂量递增结果。B7-H4 在多种实体肿瘤中过表达，被认为是一种有前景的 ADC 靶点。AZD8205 是首个进入临床并携带专有新型拓扑异构酶 I 抑制剂（TOP1i）的连接子载药的 ADC。此前有报道称，在多种肿瘤类型的 B7-H4 表达临床前模型中，AZD8205 具有强大的抗肿瘤活性。 通过壁报首次公布 AZD5335 FONTANA I/IIa 期人体临床研究的剂量递增结果。该研究结果显示，AZD5335 在铂耐药复发性卵巢癌患者中具有良好的临床活性、药代动力学特性和可管理的安全性。这种 ADC 通过靶向 FRα抗体与专有 TOP1i 药物弹头偶联，既往已经报道它对于 FRα表达的，对另一种带有微管抑制剂药物弹头的 FRα ADC 具有耐药性的临床前模型具有强大的抗肿瘤活性。     关键趋势：推动下一波免疫治疗药物浪潮 几项报告将强调公司致力于推进全面的双特异性抗体计划的承诺： 一项壁报首次汇报了临床 II 期试验 GEMINI-Gastric 亚研究 2 的总缓解率和安全性数据。该实验评估了 rilvegostomig（AZD2936）作为一款靶向 PD-1/TIGIT 双特异性免疫检查点抑制剂联合化疗一线治疗 HER2 阴性局部晚期不可切或转移性胃癌或胃食管结合部（GEJ）患者的疗效。 此外，在 WCLC 上，两场重磅口头报告将重点介绍 rilvegostomig 治疗转移性 NSCLC 患者的 ARTEMIDE-01 I 期试验的疗效和安全性数据，以及 volrustomig（PD-1/CTLA-4）联合化疗一线治疗晚期 NSCLC 患者的 Ib/II 期试验数据。    关键趋势：强大联合治疗方案，多角度攻克癌症 除 DESTINY-Lung03、DESTINY-Gastric03 和 NeoCOAST-2 新型疗法外，我们还在进一步评估联合疗法手段，以改善患者的治疗结局： 一项外部研究者发起的 FLOWERS II 期试验将在「最新突破主席研讨会」上做汇报，评估奥希替尼联合或不联合赛沃替尼一线治疗 EGFR 敏感突变阳性合并原发 MET 扩增或 MET 过表达的局部晚期或转移性 NSCLC 的疗效。 在 WCLC 上，两项重磅简短口头报告将重点介绍评估奥希替尼联合化疗治疗晚期 EGFR 敏感突变 NSCLC 患者的疗效的 FLAURA2 III 期试验的新数据，，包括肿瘤负荷高和基线中携带 TP35 突变的患者的疗效。 一项简短口头报告将介绍 HIMALAYA III 期实验的 5 年 OS 探索性分析数据，即 STRIDE 方案（Single Tremelimumab Regular Interval Durvalumab）在一线治疗既往未接受过全身治疗且不适合局部治疗的不可切除肝细胞癌（HCC）患者的疗效。该些数据是迄今为止治疗这类人群的 III 期临床研究中报告的最长生存期随访结果。 科学领域的合作对于改善患者的治疗结局而言至关重要。阿斯利康正在与第一三共合作开发和商业化德曲妥珠单抗和 datopotamab deruxtecan；与默沙东合作开发和商业化奥拉帕利；与和黄医药合作开发和商业化赛沃替尼。Rilvegostomig 是一款靶向 PD-1 + TIGIT 双特异性抗体药物，是由 Compugen 在研的抗 TIGIT 抗体 COM902 开发而来。阿斯利康通过 2015 年启动的共同开发和商业化协议，于 2018 年 10 月从 Innate Pharma 获得了 monalizumab 的全部肿瘤学权利。  阿斯利康在 2024 年 WCLC 期间的重要报告： 阿斯利康在 2024 年 ESMO 年会期间的重要演讲： 封面来源：企业 logo 免责声明：本文仅作消息分享，并不构成投资建议，也不代表 Insight 数据库的立场，文章观点仅供分享行业见解，请广大投资者谨慎。 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！

LOUISVILLE, Ky., Aug. 30, 2024 (GLOBE NEWSWIRE) -- Onco360 ® , the nation’s leading independent specialty pharmacy, has been selected as a pharmacy partner by Johnson & Johnson for LAZCLUZE ™ (lazertinib). LAZCLUZE ™ is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) approved for the first-line treatment, in combination with RYBREVANT ® (amivantamab-vmjw) as a chemotherapy-free regimen, of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions of exon 21 L858R mutations, as detected by an FDA-approved test. This new regimen shows superior progression-free survival versus the traditional standard of care. “Onco360 is grateful for the opportunity to partner with the Johnson and Johnson team and become a specialty pharmacy provider for LAZCLUZE ™ ,” said Benito Fernandez, Chief Commercial Officer. “We are proud to add this first-line, chemotherapy-free, targeted therapy to our portfolio to treat patients with locally advanced or metastatic EGFR-mutation non-small cell lung cancer.” Based on data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program, approximately 234,580 patients will be diagnosed with lung cancer in 2024, accounting for 11.7% of all new cancer cases, with approximately 125,070 expected patient deaths from prostate cancer in 2024, accounting for 20.4% of all cancer deaths. The five-year relative survival rate for lung cancer when considering all stages of disease is 26.7%. NSCLC cases make up 80-85% of all lung cancer diagnoses, with 47% having distant metastatic disease at the time of original diagnosis. In the Western hemisphere, 15-20% of all NSCLC patients have EGFR mutations with a five-year relative survival percentage of only 9%. 1,2,3,4 LAZCLUZE is manufactured by Janssen Biotech, Inc., part of Johnson & Johnson. The FDA approval is based on positive results from the Phase 3 MARIPOSA study showing RYBREVANT plus LAZCLUZE reduced the risk of disease progression or death by 30 percent versus osimertinib, with a nine month longer median duration of response in patients with EGFR-mutated advanced NSCLC. Patients treated with RYBREVANT plus LAZCLUZE experienced a significantly longer median progression-free survival (PFS) compared to patients treated with osimertinib (23.7 vs. 16.6 months; HR 0.70; 95% CI 0.58-0.85, P<0.001). 5 Please read the full Prescribing Information for RYBREVANT ® , and the full Prescribing Information for LAZCLUZE ™ About Onco360 Oncology Pharmacy Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com . Media Contact: Benito Fernandez, Chief Commercial Officer Benito.fernandez@onco360.com 516-640-1332 References: 1. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Accessed July 9th, 2024 Lung and Bronchus Cancer — Cancer Stat Facts 2. American Cancer Society Key Statistics for Lung Cancer. Accessed July 9, 2024 Lung Cancer Statistics | How Common is Lung Cancer? | American Cancer Society 3. Tamura T, Kurishima K, Nakazawa K, et al: Specific organ metastases and survival in metastatic non-small cell lung cancer. Mol Clin Oncol 2015 Jan; 3(1):217-221 4. Borgeaud M, Parikh K, Banna GL et al: Unveiling the landscape of uncommon EGFR mutations in NSCLC-A systematic review. J Thorac Oncol 2024 Jul; 19(7):973-983 5. Cho BC, Lu S, Felip E, et al: Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC. N Engl J Med 2024 Jun 26, online ahead of print.

SOPHIA ANTIPOLIS, France--( BUSINESS WIRE )--Regulatory News: Median Technologies ( FR0011049824, ALMDT, PEA/PME scheme eligible, “Median” or “The Company”) announces today it has signed an initial agreement with a Top 10 oncology pharmaceutical company 1 . The agreement aims at conducting AI-based imaging biomarker 2 discovery on the clinical data of a drug candidate. The agreement could lead to a broader collaboration between the pharmaceutical company and Median. The agreement involves Imaging Lab, a dedicated entity of Median’s iCRO Business Unit. Imaging Lab provides biopharma companies with advanced AI-based decision-making capabilities, leveraging patients’ imaging data to provide specific patient selection, prediction of response to therapy, accurate monitoring of disease progression, and early access to safety and efficacy. Median will apply its unique expertise, methods, and know-how in AI-based technologies to identify specific digital signatures (imaging biomarkers) from images, providing meaningful information on the drug responder/non-responder status of the patients. The drug-specific imaging biomarkers could ultimately be utilized as companion diagnostics 3 to select patients who are most likely to benefit from the drug. Fredrik Brag, CEO and Founder of Median Technologies, highlighted: “ We recently announced the selection of Median as preferred provider to a second global Top 3 pharmaceutical group. We are thrilled to announce today the launch of a collaboration with a global Top 10 pharma to support a drug development program with our AI-driven imaging technologies. Pharmaceutical companies are early adopters of AI in their drug development plans and investment in AI by large pharma is growing at a steady pace, creating very positive momentum for Median as a unique AI technology company in the imaging CRO market. AI is now everywhere in drug development and the AI in clinical trials market is expected to reach $6.55 Billion by 2030 4 . AI-driven imaging technologies applied to clinical trials unveil new insights that could determine the success of oncology trials. Providing insights for ‘Go/No-Go’ decisions at an early stage, or to discover predictive imaging biomarkers of patient response to drug candidates are two of the most compelling outcomes. Imaging AI solutions will become the new generation of companion diagnostics, opening unique opportunities in the era of precision medicine.” Nicolas Dano, COO & CCO iCRO said: “ AI-driven imaging insights are the future in oncology drug development. As a native technology company, Median is the only imaging CRO that has AI know-how and experience, giving us a unique competitive advantage to penetrate the Big Pharma market. We are eager to start the collaboration and provide valuable insights to our new partner, helping them with their drug development plans.” About Median Technologies: Pioneering innovative imaging solutions and services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and cancer treatments. Median's offerings, including iCRO for medical image analysis and management in oncology trials and eyonis™, AI/ML tech-based suite of software as medical devices (SaMD), empower biopharmaceutical entities and clinicians to advance patient care and expedite novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is eligible for the French SME equity savings plan scheme (PEA-PME). For more information: www.mediantechnologies.com 1 Arjun Murthy – Top 15 biopharma companies by Oncology Sales in 2023 2 An imaging biomarker is a “defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention, including therapeutic interventions” - https://www.ncbi.nlm.nih.gov/books/NBK326791/ 3 https://www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagnostics 4 Explosive Growth Forecasted: AI in Clinical Trials Market Set (openpr.com)