Innovent Biologics Announces FDA Acceptance of NDA for Pemigatinib in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements


2019-12-02 15:21:00 prnewswire


Innovent Biologics, Inc. , a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, today announced that the new drug application submitted by Incyte to the U.S. Food and Drug Administration for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements has been accepted for Priority Review by FDA.    In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor) and parsaclisib (PI3Kδ inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. IND approvals for all three assets were granted by the National Medical Products Administration (NMPA) in November 2019. The NDA submission is based on data from Incyte's FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma. Study results, recently presented at the European Society for Medical Oncology ("ESMO") 2019 Congress, demonstrated that in patients harboring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate ("ORR") of 36 percent (primary endpoint), and median duration of response ("DOR") of 7.5 months (secondary endpoint) with a median follow-up of 15 months. Adverse events were manageable and consistent with the mechanism of action of pemigatinib. The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the review period to eight months compared to 12 months for Standard Review. The Prescription Drug User Fee Act ("PDUFA") target action date is May 30, 2020. Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma ("iCCA") occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor. The incidence of cholangiocarcinoma varies regionally and ranges between 0.3 – 3.4 per 100,000 in North America and Europe. FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16 percent of patients. About FIGHT-202 The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of pemigatinib–a selective fibroblast growth factor receptor (FGFR) inhibitor–in adult (age ≥ 18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity. The primary endpoint of FIGHT-202 is ORR in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR in Cohorts B, A plus B, and C; progression free survival ("PFS"), overall survival ("OS"), duration of response ("DOR"), disease control rate ("DCR") and safety in all cohorts. For more information about the Incyte-sponsored FIGHT-202 study, visit  About FIGHT Incyte's FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes ongoing Phase 2 and 3 studies investigating safety and efficacy of pemigatinib therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating pemigatinib in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 mutations or fusions/rearrangements; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with previously treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or fusions/rearrangements, irrespective of tumor type. FIGHT-205 is a Phase 2 study investigating pemigatinib plus pembrolizumab combination therapy and pemigatinib monotherapy in patients with previously untreated, metastatic or unresectable bladder cancer harboring FGFR3 mutations or fusions/rearrangements who are not eligible to receive cisplatin. FIGHT-302 is a recently initiated Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements. About FGFR and Pemigatinib Fibroblast growth factor receptors ("FGFRs") play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers. Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. The U.S. FDA has granted pemigatinib Breakthrough Therapy designation for the treatment of previously treated, advanced/metastatic or unresectable FGFR2 translocated cholangiocarcinoma. The FDA's Breakthrough Therapy designation is designed to expedite the development and review of drugs for serious conditions that have shown encouraging early clinical results and may demonstrate substantial improvements over available medicines. Additionally, the FDA granted pemigatinib Orphan Drug designation for the treatment of cholangiocarcinoma, a designation granted to investigational compounds intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 21 innovative assets in the fields of oncology, autoimmune, metabolic diseases and other major therapeutic areas. Sixteen have entered into clinical development, five have entered Phase III clinical trials, three monoclonal antibodies have their New Drug Application ("NDA") under review and three of them have been granted with priority review status, and one, Tyvyt® (sintilimab injection), has been approved for r/r cHL and is the only PD-1 inhibitor that has been included in the NRDL in November 2019. Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please SOURCE Innovent Biologics, Inc. You just read:
Innovation Biologics , Inc .,一家开发和商业化治疗肿瘤、自身免疫、代谢等重大疾病的高质量药物的世界级生物制药公司,今天宣布因塞特(Incyte)公司向美国食品药品监督管理局提交的治疗胃泌素的新药申请在以前的治疗中。局部晚期或转移性胆管癌与 FGFR2融合或重新排列已被 FDA 接受优先审查。 2018年12月, Innovation 与 Incyte 公司就因塞特(Incyte)公司发现并开发的三个临床阶段产品候选者展开战略合作,包括 pemiatinib ( FGFR1/2/3抑制剂)、 itacitinib ( JAK1抑制剂)和 parsacclisib ( PI3Kδ抑制剂)。根据协议条款, Innovation 已获得在中国大陆、香港、澳门和台湾地区开发和商业化三项血液肿瘤领域资产的权利。所有三项资产的 IND 批准于2019年11月由国家医药产品管理局( NMPA )授予。 NDA 的提交是基于因塞特(Incyte)的 FIGHT-202研究的数据,该研究评估了 pemigratinib 作为治疗先前治疗、局部晚期或转移性胆管癌的一种治疗方法。最近在欧洲医学肿瘤学会( ESMO )2019年大会上提出的研究结果表明,在接受 FGFR2融合或重新排列( Cohort A )的患者中, pemiatinib 单一疗法的总体反应率( ORR )为36%(主要终点)。以及平均持续时间( DOR )为7.5个月(次要终点),中位随访时间为15个月。不良事件是可控的,与 pemiatinib 的作用机制一致。 FDA 授予优先审查的药物可能提供一个重大的进步,在治疗目前没有存在。与标准审查的12个月相比,该指定将审查周期缩短为8个月。处方药用户费法(“ PDUFA ”)目标行动日期为2020年5月30日。 胆管癌是一种罕见的胆管癌。肝内胆管癌发生于肝内胆管内,肝外胆管癌发生于肝外胆管内。胆管癌患者往往被诊断在晚期或晚期时,预后不良。在北美和欧洲,胆管癌的发病率各地区不同,范围在每10万人0.3-3.4之间。FGFR2融合或重新排列几乎完全发生在 iCCA ,在10-16%的患者中观察到。 关于 FIGHT-202 FIGHT-202二期开放标签多中心研究( NCT02924376)正在评估 pemigratinib (选择性成纤维细胞生长因子受体( FGFR )抑制剂)在成人(年龄≥18岁)以前治疗、局部晚期或转移性胆管癌的 FGF / FGFR 状态的安全性和有效性。 患者被纳入三个队列之一—— Cohort A ( FGFR2融合或重新排列)、 Cohort B (其他 FGF / FGFR 基因改变)或 Cohort C (没有 FGF / FGFR 基因改变)。所有患者在21天的周期(两周/一周的休息)中每天口服一次13.5毫克培美米替尼,直到放射性疾病进展或不可接受的毒性。 FIGHT-202的主要终点是 Cohort A 中的 ORR ,根据 RECISv1.1进行独立评审。次要终点包括 Cohorts B 、 A + B 和 C 中的 ORR ;无进展生存(“ PFS ”)、整体生存(“ OS ”)、响应持续时间(“ DOR ”)、疾病控制率(“ DCR ”)和所有队列中的安全性。 有关 Incyte 资助的 FIGHT-202研究的更多信息,请访问 https://临床资料。gov / ct2/ show / NCT02924376。 关于 FIGHT 因塞特(Incyte)公司的 FIGHT (肿瘤和血液学试验中的 FIbroblast 生长因子受体)临床试验计划包括正在进行的2期和3期研究,调查 Pemigitalib 治疗多种 FGFR 驱动的恶性肿瘤的安全性和有效性。第二期单药治疗研究包括 FIGHT-202,以及 FIGHT-201对转移性或手术不能切除膀胱癌患者的 Pemigratinib 进行研究。包括激活 FGFR3突变或融合/重新排列; FIGHT-203在骨髓增生性肿瘤患者中激活 FGFR1融合/重新排列; FIGHT-207在先前治疗的、局部晚期/转移性或手术上不可切除的实体瘤恶性肿瘤患者中,无论肿瘤类型如何,都包含激活 FGFR 突变或融合/重新排列。FIGHT-205是第二期研究,研究 pemigratinib 联合 pembrolizumab 联合疗法和 pemigratinib 单药疗法在以前未经治疗、转移性或不可切除的膀胱癌患者携带 FGFR3突变或融合/重新排列不符合顺铂条件。FIGHT-302是最近启动的第三期研究,研究 pemigratinib 作为一线治疗伴 FGFR2融合或重排的胆管癌。 关于 FGFR 和 Pemiatinib 纤维细胞生长因子受体( FGFRs )在肿瘤细胞增殖、存活、迁移和血管生成(新血管的形成)中起着重要作用。FGFRs 的活化融合、重排、易位和基因扩增与多种癌症的发生密切相关。 Pemigiatinib 是一种有效的、选择性的、口服的 FGFR 等位基因1、2和3的抑制剂,在临床前研究中,已证明对 FGFR 改变的癌细胞具有选择性的药理活性。美国食品和药物管理局已批准 pemigranib 突破性治疗指定用于治疗先前治疗的晚期/转移性或不可切除的 FGFR2转移胆管癌。FDA 的突破性治疗指定是为了加快药物的开发和审查,以严重的条件已经显示出鼓励早期临床结果,并可能表现出实质性的改善现有药物。此外,美国食品和药物管理局还批准了治疗胆管癌的 pemiatinib 孤儿药物指定,这一指定用于研究化合物,旨在安全有效地治疗、诊断或预防影响不到20万人的罕见疾病或疾病。 关于创新 本着“以诚信为先,以行动成功”的精神, Innovant 的使命是开发和商业化普通百姓都能负担得起的优质生物制药产品。Innovation 成立于2011年,致力于研发、制造和商业化用于治疗肿瘤、自身免疫、代谢等重大疾病的优质创新药物。2018年10月31日, Innovation 在香港联合交易所有限公司主板上市,股票代码:01801。香港。 自成立以来, Innovation 已开发出包括研发、 CMC (化学、制造、控制)、临床开发和商业化能力在内的全集成平台。公司借助该平台,在肿瘤、自身免疫、代谢疾病等主要治疗领域构建了21项创新资产的稳健管线。16项已进入临床开发阶段,5项已进入 III 期临床试验,3项单抗药物已在审评中,3项单抗药物已获得优先审评地位,1项单抗药物 Tyvyt ®(辛蒂利亚布注射液)获得优先审评地位。已被批准用于 r / r cHL ,是2019年11月纳入 NRDL 的唯一 PD-1抑制剂。 英诺泰在高端生物药物研发和商业化方面建立了一支国际先进人才队伍,其中不乏海外专家。公司还与礼来(Eli Lilly) and Company 、 Adimab 、因塞特(Incyte)、 Hanmi 等国际制药企业进行战略合作。英诺珐公司努力与各方共同努力,帮助推进我国生物制药产业,提高老百姓的药品可获得性,提升患者生活质量。更多信息,请访问:。 SOURCE Innovate Biologics , Inc . 你刚才读到: