Tafasitamab-Cxix

Having an in-house PD-1 allows Incyte to test novel combinations with fewer costs and faster R&D timelines than it otherwise could, CEO Hervé Hoppenot said. Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. Yet company CEO Hervé Hoppenot views the antibody molecule not necessarily as a major revenue driver but as an aide to the company’s oncology pipeline.In a first-in-class win, Zynyz and chemotherapy slashed the risk of progression or death by 37% compared with chemo alone in patients with previously untreated, inoperable advanced squamous cell anal carcinoma (SCAC), according to results from the phase 3 POD1UM-303 trial presented at the annual European Society for Medical Oncology Congress (ESMO).Patients in the Zynyz arm went a median 9.3 months without tumor progression versus 7.4 months for the control group.Incyte plans to file Zynyz with the FDA by the end of the year in the indication, potentially making it the first PD-1 inhibitor approved for first-line anal cancer, Hoppenot said in an interview with Fierce Pharma.Anal cancer is not a large oncology market from a financial perspective, Hoppenot acknowledged. Zynyz’s target patient population in the potential use has about 10,000 new diagnoses per year across the U.S. and Europe.Even before an official FDA approval, some doctors have been using PD-1 inhibitors such as Merck & Co.’s Keytruda off label to treat anal cancer patients, Hoppenot explained. These uses aren’t always covered by insurance because of the absence of a regulatory approval. Now, Incyte hopes Zynyz can fill that niche market. The company’s original bid to get Zynyz approved as a post-chemo second-line anal cancer treatment was rejected by the FDA in 2021 because of a low tumor response rate and some patient deaths unrelated to disease progression.Besides the progression-free survival result in the POD1UM-303 trial, Zynyz has shown a preliminary trend toward improving patient survival. While the data are immature, Zynyz was linked to a 30% reduction in the risk of death, as patients who took the PD-1 agent survived a median 29.2 months versus 23 months for the control arm. Zynyz showed the advantage despite the trial allowing patients in the control arm to cross over to receive the PD-1 inhibitor after progression.Given the effect size and statistical considerations, Hoppenot said he’s confident that Zynyz will show a statistically significant overall survival benefit at the final analysis, which he said is coming “very soon” next year. The value of an in-house PD-1 drugZynyz entered the market last year with an FDA approval in Merkel cell carcinoma, another rare cancer type. In addition, Incyte announced a positive phase 3 trial, POD1UM-304, for Zynyz’s combination with chemo in first-line non-small cell lung cancer (NSCLC). But that indication faces some regulatory uncertainty given the trial’s comparator arm is chemotherapy alone, when Keytruda in combination with chemo is the current standard of care.Incyte will speak with the FDA to discuss the drug’s best path forward in first-line NSCLC, and the company is prioritizing the anal cancer filing first, Hoppenot said.Even if Zynyz eventually secures its first-line NSCLC nod, the drug’s market potential there seems limited given Keytruda’s dominance, and because the PD-1 king is nearing its patent cliff in 2028.Still, Zynyz could provide Incyte some returns in the niche indications. But, more importantly, “we believe that the optionality value of being able to develop our other pipeline products in combination with [an] approved PD-1 is very valuable,” Hoppenot said.Having an in-house PD-1 allows Incyte to test its novel agents in combinations without having to buy Keytruda, the CEO said. That translates into millions of dollars in savings and faster R&D timelines.“It’s basically giving me strategic flexibility in a way that would be very difficult if I had to do it with another product,” Hoppenot said. “So, after approval, is it going to be used with biosimilar of Keytruda? I don’t really care.” Oncology's place at IncyteGeneral oncology isn’t Incyte’s biggest business area. The company is best known for its Novartis-partnered myelofibrosis and graft-versus-host disease drug Jakafi, and that department just got bigger with the FDA approval for its Syndax-partnered CSF-1R antibody Niktimvo last month.Investors are also focused on the launch of Incyte’s Opzelura cream in autoimmune skin conditions and potential phase 3 readouts for the JAK1 inhibitor povorcitinib, which is being developed in a broad range of inflammatory diseases.In oncology beyond the bone marrow cancer myelofibrosis, Incyte in February gained full rights to CD19 antibody Monjuvi from former partner MorphoSys and in August announced a positive phase 3 readout in previously treated follicular lymphoma. At ESMO 2024, the company is also sharing for the first time early-phase data for its CDK2 inhibitor, INCB123667, in certain gynecological cancers. Still, Hoppenot argued that the three business areas are essentially equal in their importance to the company. The key is optionality, the CEO said, so that success from one of the drugs could more than compensate for the expected decline of Jakafi, which faces its own patent cliff in 2028.Incyte is interested in striking deals to access external innovations, having recently bought immunology biotech Escient Pharmaceuticals for $750 million. In oncology dealmaking, the company doesn’t have specific guardrails around tumor types but is more focused on whether the mechanism in question is unique, Hoppenot said.Being realistic about the price of a first- or best-in-class drug in late-stage development, Hoppenot said Incyte is focusing on earlier-stage assets, especially around targets where the company has done some internal research.

2024年9月12日，中国北京——2024中国国际服务贸易交易会（简称服贸会）今天开幕。作为本届服贸会健康卫生服务专题展的领军企业，诺诚健华（上交所代码：688428；香港联交所代码：09969）携创新管线持续亮相服贸会，分享公司最新进展，积极参与相关医药卫生国际交流论坛献计献策，用新质生产力造福全球患者。明星产品奥布替尼以“科学驱动创新 患者所需为本”为核心价值理念，诺诚健华自主研发的国家“重大新药创制”专项成果——新型布鲁顿酪氨酸激酶（BTK）抑制剂奥布替尼亮相2024服贸会的首钢园区6号馆健康卫生服务专题展和国家会议中心京津冀集合展区。奥布替尼已在中国和新加坡获批上市。奥布替尼在中国获批三项适应症：既往至少接受过一次治疗的CLL/SLL、套细胞淋巴瘤（MCL）以及边缘区淋巴瘤（MZL），由此成为中国首个且唯一获批针对MZL的BTK抑制剂，这三项适应症都已纳入中国国家医保。奥布替尼拥有更精准的靶点选择性，对BTK靶点占有率近100%，个体间差异小，在确保疗效的同时又有效避免了由于脱靶效应造成的不良反应。凭借良好的临床数据和强大的商业化能力，奥布替尼2024年上半年收入同比上涨30.0%，达到4.2亿元  ，其中第二季度同比增长48.8%，这主要归功于奥布替尼成为中国首个且唯一针对MZL获批上市的BTK抑制剂，这一新适应症2023年纳入医保后今年上半年实现快速放量。边缘区淋巴瘤是常见的惰性淋巴瘤，多发于老年人，约占非霍奇金淋巴瘤病例的9.4%。据悉，服贸会期间将发布中国首份MZL白皮书，致力于提升中国MZL整体诊疗水平、改善患者生存质量。同期正在西班牙举行的欧洲肿瘤内科学会（ESMO）公布了奥布替尼的五项研究数据，其中奥布替尼一线治疗MZL的前瞻性研究入选此次大会的口头报告，广受国际学术会议认可和关注。鉴于奥布替尼高选择性和良好的安全性，公司正在中国和全球开展奥布替尼治疗原发免疫性血小板减少症（ ITP）、系统性红斑狼疮（SLE）和多发性硬化（MS）等多种自身免疫性疾病的临床研究，目前开发进度在全球领先。诺诚健华近期与美国食品药品管理局（FDA）就奥布替尼治疗MS的临床开发进展成功召开临床II期结束会议（EOP2），同意启动奥布替尼治疗原发进展型多发性硬化（PPMS）的III期临床研究，FDA同时建议启动奥布替尼治疗继发进展型多发性硬化（SPMS）的III期临床研究，以解决PMS患者尚未满足的巨大医疗需求。赋能新质生产力 造福全球患者诺诚健华在2024服贸会上展示公司在血液瘤、实体瘤和自身免疫性疾病领域的最新研发进展。在血液瘤领域，诺诚健华在2024服贸会上还重点展示了抗CD19单抗坦昔妥单抗（Tafasitamab）和CD20xCD3双特异性抗体ICP-B02。诺诚健华致力于全方位覆盖血液瘤疾病领域。除了获批适应症，诺诚健华正推进奥布替尼一线适应症的注册临床试验和新药上市申请（NDA），坦昔妥单抗治疗方案预计明年上市，成为商业化团队开拓市场的又一重磅产品。与此同时，公司正加速开发的BCL2抑制剂ICP-248与奥布替尼联用潜力显著，BCL-2抑制剂是BTK抑制剂耐药后的首选治疗方案，形成最佳序贯治疗。加上分子胶ICP-490、单抗ICP-B05和双抗ICP-B02，以及通过未来潜在的内部开发和外部引进推动管线开发，诺诚健华致力于发展成为中国和全球的血液瘤领域领导者。在自身免疫性疾病领域，诺诚健华在2024服贸会上重点展示了TYK2抑制剂ICP-332。 ICP-332在中国开展的治疗中重度特应性皮炎（AD）的II期临床研究达到多个有效性终点，展示了卓越的疗效和安全性。ICP-332对比治疗 AD 患者的不同类别/MoA的疗法显示了更好的疗效（非头对头比较）。诺诚健华正进一步加强药物发现平台，通过B细胞和T细胞通路开发自身免疫性疾病领域的全球前沿靶点，打造差异化的自身免疫性疾病管线。诺诚健华联合创始人、董事长兼CEO崔霁松博士说：“我们很高兴能够连续在服贸会这一国家级平台上展示我们的创新成果。今年服贸会健康卫生服务专题展聚焦新质生产力、展示前沿成果与应用场景，为全球企业提供更多合作机遇。生物医药是新质生产力的重要力量，我们将持续深耕源头创新，瞄准国际前沿，加速推进更多创新药惠及全球患者。”9月14日下午，诺诚健华董事长兼CEO崔霁松博士和管理层将在首钢园区6号馆分享公司近期业务进展，欢迎社会各界线上线下参与。直播链接： https://wx.vzan.com/live/page/1333265304?v=1725445835611 服贸会由商务部和北京市人民政府共同主办，是全球第一个专门为服务贸易搭建的国家级、国际性、综合型服务贸易交易会。服贸会健康卫生服务专题展旨在向全球展现中国医疗技术创新水平、医药产品创新成果、医疗服务创新能力和健康服务发展质量，推动健康卫生产业扩大开放及跨境新兴医药贸易的发展。 关于诺诚健华诺诚健华（上交所代码：688428；香港联交所代码：09969）是一家商业化阶段的生物医药高科技公司，专注于恶性肿瘤及自身免疫性疾病领域的一类新药研制。公司现有多个新药产品处于商业化、临床及临床前研发阶段。公司在北京、南京、上海、广州、香港以及美国设有分支机构。