Opdivo和Yervoy组合赢得了HCC的加速批准

StephenW

Opdivo and Yervoy Combination Wins Accelerated Approval for HCC



Published: March 11, 2020

By Alex Keown

BioSpace



The U.S. Food and Drug Administration (FDA) gave an accelerated greenlight to Bristol-Myers Squibb’s combination of Opdivo and Yervoy as a treatment for hepatocellular carcinoma in patients who have been previously treated with Bayer’s Nexavar (sorafenib).

Approval for the combination treatment was based on results from the Phase I/II CheckMate-040 trial in which Opdivo and Yervoy showed an overall response rate of 33% in this patient population. Of those, 8% had a complete response and 24% showed a partial response. Duration of responses (DOR) ranged from 4.6 to 30.5 months, with 88% lasting at least six months, 56% at least 12 months and 31% at least 24 months, BMS said.

Anthony B. El-Khoueiry, BMS’ lead investigator and phase I program director at the Keck School of Medicine, University of Southern California, said the overall response rate observed in the Opdivo and Yervoy combination of the CheckMate-040 trial underscores the potential of this dual immunotherapy as a possible treatment option for patients.

Opdivo (nivolumab) and Yervoy (ipilimumab) are cornerstones of BMS immunology treatments. Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, has been approved for the treatment of multiple cancers, including patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. Yervoy targets CTLA-4, a protein receptor that regulates the immune system.

The FDA gave the nod under accelerated approval. Continued approval in this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, the company noted.  The Opdivo and Yervoy combination is the first and only dual immunotherapy approved in this setting, BMS said. The company added that this is the fourth regulatory approval for cancer from the FDA for the combination treatment. The combination treatment had been previously granted both Breakthrough Therapy Designation for this indication and a Priority Review from the FDA.

Hepatocellular carcinoma (HCC) is the most common type of liver cancer in adults. HCC represents about 80% of all primary liver cancers. The disease occurs most often in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection.

Adam Lenkowsky, general manager and head of U.S. Oncology, Immunology and Cardiovascular at Bristol-Myers Squibb, said there is a critical need to provide patients with aggressive forms of cancer such as HCC with new treatment options that may “offer clinically meaningful and ultimately durable responses.” The approval, Lenkowsky said, builds on the company’s legacy in pioneering immunotherapy treatments.

“The incidence of liver cancer is rising in the United States, and HCC is the most common and aggressive form of the disease, “Andrea Wilson, president and founder of Blue Faery: The Adrienne Wilson Liver Cancer Association, said in a statement. “Today’s approval provides a new option for patients with HCC previously treated with sorafenib, giving the community more hope.”

Last year, Eli Lilly snagged regulatory approval for Cyramza as a single agent for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) and have previously been treated with sorafenib. Also in 2019, Alameda, Calif.-based Exelixis, Inc. won approval for its HCC treatment, Cabometyx (cabozantinib).



BioSpace source:

https://www.biospace.com/article ... ocellular-carcinoma

StephenW

Opdivo和Yervoy组合赢得了HCC的加速批准



发布时间：2020年3月11日

亚历克斯·基恩（Alex Keown）

生物空间



美国食品药品监督管理局（FDA）加快了百时美施贵宝（Bristol-Myers Squibb）的Opdivo和Yervoy的组合治疗肝细胞癌的计划，该疗法以前曾用拜耳的Nexavar（索拉非尼）治疗。

联合治疗的批准基于I / II期CheckMate-040试验的结果，其中Opdivo和Yervoy在该患者人群中的总体缓解率为33％。其中，有8％的人有完全缓解，有24％的人有部分缓解。 BMS表示，反应持续时间（DOR）为4.6至30.5个月，其中88％持续至少六个月，56％至少持续12个月，31％至少持续24个月。

BMS的首席研究员兼南加州大学凯克医学院的I期计划主任Anthony B. El-Khoueiry说，在CheckMate-040试验的Opdivo和Yervoy组合中观察到的总体缓解率强调了这种双重免疫疗法可能会成为患者的治疗选择。

Opdivo（nivolumab）和Yervoy（ipilimumab）是BMS免疫学治疗的基石。 Opdivo是一种程序性死亡1（PD-1）免疫检查点抑制剂，已被批准用于治疗多种癌症，包括已接受过抗血管生成治疗的晚期肾细胞癌患者。 Yervoy靶向调节免疫系统的蛋白质受体CTLA-4。

FDA在加速批准下点头。该公司指出，这种适应症的持续批准可能取决于验证试验中对临床益处的验证和描述。 BMS说，Opdivo和Yervoy的组合是在这种情况下首个也是唯一被批准的双重免疫疗法。该公司补充说，这是FDA批准的第四种联合治疗癌症的法规。先前已为该适应症授予了突破性治疗称号和FDA的优先审查。

肝细胞癌（HCC）是成年人中最常见的肝癌类型。肝癌约占所有原发性肝癌的80％。该疾病最常发生于患有慢性肝病的人，例如由乙型肝炎或丙型肝炎引起的肝硬化。

百时美施贵宝（Bristol-Myers Squibb）美国肿瘤学，免疫学和心血管病学总经理兼总经理Adam Lenkowsky表示，迫切需要为患有侵袭性癌症的患者（例如HCC）提供新的治疗选择，这些选择可能“具有临床意义，并最终具有持久性回应。”伦科夫斯基说，这项批准是基于该公司在开创性免疫疗法治疗方面的传统。

Blue Faery主席兼创始人：Adrienne Wilson肝癌协会主席安德里亚·威尔逊（Andrea Wilson）表示：“在美国，肝癌的发病率正在上升，而肝癌是最常见和最具侵略性的疾病。 “今天的批准为以前接受索拉非尼治疗的HCC患者提供了新的选择，给社区带来了更多希望。”

去年，礼来制药（Eli Lilly）取消了Cyramza的监管批准，将其作为具有甲胎蛋白（AFP）且以前接受过索拉非尼治疗的肝细胞癌（HCC）患者的二线治疗的单一药物。同样在2019年，总部位于加利福尼亚阿拉米达的Exelixis，Inc.获得了其HCC治疗Cabometyx（cabozantinib）的批准。



BioSpace来源：

https://www.biospace.com/article ... oy-combination-for-肝细胞癌