Today, our company has submitted an application for partial changes in manufacturing and marketing approval related to the addition of efficacy or effectiveness in Japan for the combination therapy of Vectibix intravenous drip (generic name: panitumumab (recombinant), hereinafter referred to as 'Vectibix') and LUMAKRAS tablets (generic name: sotorasib, hereinafter referred to as 'LUMAKRAS'), a KRAS G12C inhibitor, for KRAS G12C mutation-positive unresectable advanced recurrent colorectal cancer. We would like to inform you.

This application for partial changes was based on the results obtained from the phase 3 international collaborative, multi-facility collaborative, randomized, non-blinded, open-label trial (CodeBreaK 300 trial) evaluating the efficacy and safety of co-administration of Vectibix and LUMAKRAS at two doses (240mg or 960mg) for previously treated metastatic colorectal cancer (CRC) patients with KRAS G12C mutation positivity1.
The current efficacy or effectiveness of Vectibix in Japan is for 'KRAS wild-type unresectable advanced recurrent colorectal cancer.'
CRC is the third most commonly diagnosed cancer in both men and women worldwide and is the second leading cause of cancer-specific mortality2. The estimated number of new CRC cases in Japan in 2023 is 0.161 million, the highest among both men and women, with an estimated annual death toll of 0.054 million, making it the second leading cause of cancer-related mortality3. Early stage CRC is amenable to surgical resection, but metastatic CRC still has a poor prognosis with limited treatment options, highlighting the unmet need for new treatment options.
Approximately 3% of CRC patients are estimated to have KRAS G12C mutations4,5, and patients with KRAS G12C mutations have been reported to have a worse prognosis compared to those with other KRAS gene mutations6,7. Currently, in Japan, there are no approved treatments specifically targeting CRC with KRAS mutations, including KRAS G12C mutations. Due to the limited treatment options compared to patients with KRAS wild-type CRC, there is a significant unmet medical need5,8,9.
Since Vectibix was approved and launched in Japan in 2010, our company has been working towards advancing personalized treatment for colorectal cancer for over 10 years. In 2022, we announced the results of the phase 3 trial 'PARADIGM trial' targeting unresectable recurrent colorectal cancer patients in Japan who were previously untreated with chemotherapy, and the results of this trial have become important evidence for the treatment of RAS wild-type left-sided primary colorectal cancer and have been included in guidelines. We will continue our efforts to advance the treatment of colorectal cancer patients and address unmet needs in the future.

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Vectibix intravenous infusion (generic name: Panitumumab (recombinant)) is an anti-EGFR monoclonal antibody that Takeda Pharmaceuticals SP ADR has introduced from Amgen Inc. (Headquarters: Thousand Oaks, California, USA) to Japan as an irreplaceable advanced recurrent colorectal cancer treatment, which binds to the receptor for epidermal growth factor expressed on the surface of cancer cells and demonstrates a tumor shrinkage effect. It was first approved and launched in the USA in September 2006, and in Japan in 2010. Its current efficacy in Japan is for 'KRAS wild-type unresectable advanced recurrent colorectal cancer,' approved for use as combination therapy with chemotherapy in chemotherapy-naive or post-chemotherapy settings.

As a leader in the oncology field, Takeda Pharmaceuticals SP ADR has been developing various therapeutic drugs for over 25 years to change the current situation of patients who have not received adequate treatment.
To promptly meet the needs of stakeholders surrounding cancer and deliver innovative therapeutic drugs, we collaborate closely from research and development to product commercialization, consolidating the organization's capabilities in the best possible way. We lead the industry in the treatment of hematologic and solid tumors, combining cutting-edge science through various platforms, partnerships, and treatment approaches to deliver new drugs to cancer patients worldwide.

Regarding Takeda Pharmaceuticals' efforts in the 'colorectal cancer area' in Japan.

In Japan, CRC is the most common type of cancer, and according to the National Cancer Center's cancer statistics, the estimated number of new cases in 2023 is 0.161 million people, with an estimated number of deaths of 0.054 million people. Early-stage CRC can be surgically removed, but metastatic CRC still has a poor prognosis, with limited treatment options, high unmet needs, and a demand for new treatment options in this area. For over a decade, we have been contributing to the treatment of late-stage colorectal cancer patients with limited treatment options and the advancement of personalized treatment through the provision of innovative pharmaceuticals and evidence generation. We will continue to advance efforts for the treatment of colorectal cancer patients and addressing unmet needs.

About Takeda Pharmaceutical

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) aims to contribute to the health of people worldwide and a bright future. They are working towards creating innovative pharmaceuticals in major disease areas and business fields such as the digestive system, inflammatory diseases, rare diseases, plasma-derived therapies, neuroscience (neuropsychiatric disorders), oncology (cancer), and vaccines. By building a strong and diverse pipeline with partners, they deliver new treatment options to improve the quality of life for patients. Takeda Pharmaceutical, headquartered in Japan, is a research and development-based bio-pharmaceutical company that values patient-centric thinking based on their corporate philosophy. Drawing on values cultivated over more than two centuries, they operate in approximately 80 countries and regions to fulfill their purpose in society. Please refer to our website for further details.

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CodeBreak300 test, which is a major test in this variation application, is being conducted by Amgen, the developer of Lumakelas and Vectibix (Amgen Inc. in Japan).
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Cancer Research Promotion Foundation. Cancer Statistics 2024. links/report/statistics/pdf/cancerstatistics2024fig_J.pdf
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Henry JT et al.'s research was published in JCO Precis Oncol in 2021, with reference to pages 613-621.