武田薬品工業株式会社
－ Takeda plans to pursue clinical development in Japan in folate receptor-alpha(FRa) -positive ovarian cancer
－ Mirvetuximab soravtansine-gynx is the first antibody-drug conjugate developed for the treatment of ovarian cancer
OSAKA, Japan, August 29, 2023 – Takeda (TSE:4502/NYSE:TAK) announced today that it has entered into an exclusive licensing agreement with ImmunoGen, Inc. (Hereinafter referred to as ImmunoGen) to develop and commercialize mirvetuximab soravtansine-gynx (Hereinafter referred to as MIRV) for the Japanese market. MIRV is an intravenous injection antibody-drug conjugate (ADC), in which a microtubule inhibitor is linked to an anti-folate receptor-α (FRα) antibody. It is the first ADC developed for the treatment of ovarian cancer. Takeda will continue development in Japan to enable regulatory submission as a new treatment option for the treatment of FRα-positive ovarian cancer.
MIRV is approved under accelerated approval in the U.S. for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. MIRV was the first medicine to show a significant prolongation of overall survival (OS) compared with conventional chemotherapy for the treatment of platinum-resistant relapsed or refractory ovarian cancer in a phase III clinical study (MIRASOL study), conducted outside of Japan.
"We are excited to enter this agreement with ImmunoGen that enables us to expand our oncology portfolio, bringing us one step closer to achieving our aspiration to cure cancer. Ovarian cancer is diagnosed in advanced stages in many patients, is considered to be the most lethal tumor among female reproductive organ tumors, and is the ninth most common cause of cancer death in Japanese women*. We sincerely hope that MIRV, an innovative treatment developed by ImmunoGen, will be a new treatment option in this area with high unmet needs," said Satoshi Uchida, Head, Japan Oncology, Global Oncology Business Unit, Takeda.
Takeda has demonstrated a strong commitment to oncology and is committed to developing new medicines for cancer patients with limited treatment options. This license agreement serves the shared goal of our company and ImmunoGen to improve the lives of patients living with cancer worldwide.
Subject to the terms of the agreement, Takeda will obtain an exclusive license in Japan to develop and commercialize MIRV in all indications. Under the terms of the agreement, Takeda will make a one-time upfront payment and an additional payment upon conversion of US Food and Drug Administration (FDA) accelerated approval of MIRV in platinum-resistant ovarian cancer to full approval totaling 5 billion yen to ImmunoGen. In addition, milestone payments based on achievement of regulatory and sales and royalties on sales may be payable.
* Cancer Information Service: https://ganjoho.jp/public/qa_links/report/statistics/2023_jp.html
Ovarian cancer is a cancerous tumor that begins on the surface of the ovaries and in the ovaries. In Japan, approximately 13,000 cases are reported annually, of which approximately 40~50% are patients with advanced stage III or IV cancer. This type of cancer is difficult to diagnose at an early stage; in fact, 75% of patients with ovarian cancer are diagnosed with advanced cancer at the time of detection.
Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. In November 2022, the US Food and Drug Administration (FDA) granted accelerated approval to MIRV for the treatment of adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens based on ORR and duration of response data from the pivotal SORAYA trial. The results from the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of MIRV compared to chemotherapy in patients with FRα-positive platinum-resistant ovarian cancer (PROC) were presented at the American Society of Clinical Oncology Annual Meeting in June 2023 showing MIRV as the first novel therapy to extend overall survival in platinum-resistant disease.
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
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