武田薬品工業株式会社
Takeda today announced that it has submitted a supplemental application in Japan for Vectibix® (generic name: panitumumab (rDNA), “Vectibix”) to include the efficacy or effect in combination therapy with Lumakras® (generic name: sotorasib, “Lumakras”), a KRAS G12C inhibitor, for the treatment of unresectable, advanced or recurrent KRAS G12C mutation-positive colorectal cancer.
This application is based on the results of the CodeBreaK 300 trial, a phase III, international, multicenter, randomized, open-label, active-controlled trial evaluating the efficacy and safety of combination therapy with Vectibix and two dosages of Lumakras (240 mg or 960 mg) in previously treated patients with KRAS G12C mutation-positive metastatic colorectal cancer (mCRC)1.
The current indication for Vectibix in Japan is for patients with “curatively unresectable advanced or recurrent colorectal cancer with the wild-type KRAS gene.”
CRC is the third most commonly diagnosed cancer for both men and women worldwide and the second leading cause of cancer-related deaths by site2. In Japan, the number of CRC cases in 2023 was estimated at 161,000, making it the most common cancer among men and women combined. The annual number of deaths is also estimated at 54,000, making it the second leading cause of cancer-related deaths3. While early-stage CRC can be surgically removed, mCRC still has a poor prognosis with limited treatment options, highlighting the need for new therapeutic options.
It is estimated that approximately 3% of CRC patients have the KRAS G12C mutation4,5, and it has been reported that patients with the KRAS G12C mutation have a worse prognosis compared to patients with other KRAS gene mutations6,7. Currently, there are no approved treatments targeting CRC with KRAS mutations in Japan, including the KRAS G12C mutation, and there are fewer treatment options available compared to KRAS mutation-negative CRC patients, highlighting a significant unmet medical need55,8,9.
For more than 10 years since Vectibix was approved and launched in Japan in 2010, we have been striving to advance personalized treatment for CRC. The results of the PARADIGM trial, a phase III trial in patients with RAS wild-type and left-sided primary CRC in Japan, were published as significant evidence for the treatment of RAS wild-type and left-sided primary CRC and included in the clinical guidelines for the treatment of this type of cancer. Moving forward, we will continue our work to treat CRC patients and address their unmet needs.
Vectibix® (generic name: panitumumab (rDNA)) is an anti-EGFR monoclonal antibody for the treatment of unresectable, advanced or recurrent colorectal cancer, which Takeda in-licensed in Japan from Amgen Inc. (head office: Thousand Oaks, California, USA). It functions by binding to the epidermal growth factor receptor on cancer cell surfaces, which causes tumor shrinkage. It was first approved and launched in the U.S. in September 2006 and in Japan in 2010, and its present indication is for the treatment of unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene in patients who have not been or who have been treated with chemotherapy.
As a leader in the oncology field, Takeda has been developing a range of therapies for more than 25 years to help change the lives of patients who have been underserved by conventional therapies.
Through a close collaborative approach that spans research and development to commercialization, we optimally combine our capabilities to rapidly respond to the needs of stakeholders in the oncology community and deliver innovative therapies. We lead the industry in the treatment of hematologic and solid tumors by combining cutting-edge science through diverse platforms, partnerships and approaches to treatment to bring novel medicines to cancer patients worldwide.
CRC is the most prevalent type of cancer in Japan, with an estimated 161,000 cases and 54,000 deaths in 2023, according to the National Cancer Center’s statistics. While early-stage colorectal cancer can be surgically resected, mCRC remains an area of high unmet need with patients awaiting new treatment options, given its poor prognosis and limited treatment options. For over a decade, we have contributed to the treatment of patients with late-stage colorectal cancer who have limited treatment options and to the advancement of personalized treatment through the provision of innovative medicines and the generation of relevant evidence. Moving forward, we will continue our work to treat colorectal cancer patients and address their unmet needs.
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.
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.