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Data from the PARADIGM Trial in Chemotherapy-naive Japanese Patients with Unresectable Advanced Recurrent Colorectal Cancer and Wild-type RAS Gene Presented at the ASCO 2022 Plenary Session

- Key Results presented from the PARADIGM Trial Evaluating the Efficacy and Safety of Panitumumab plus Chemotherapy in Chemotherapy-naive Patients with Unresectable Advanced Recurrent Colorectal Cancer and Wild-type RAS Gene

- Primary Endpoint of Overall Survival (OS) met in both Left-Sided Tumor and Overall Colorectal Cancer Patient Populations

- World’s First Prospective Trial of Appropriate Treatment in Patients with Colorectal Cancer with Wild-type RAS Gene and Left-sided Primary Tumor

Takeda Pharmaceutical Company (Takeda) announced today that data from the PARADIGM (Panitumumab and RAS, Diagnostically useful Gene Mutation for mCRC), Phase III clinical trial (Clinicaltrials.gov identifier: NCT02394795) of panitumumab (generic name; product name: Vectibix®) was presented at the June 5 Plenary Session (Abstract #LBA1) of the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA.

PARADIGM is a randomized, phase III trial comparing the efficacy and safety of mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab in chemotherapy-naive Japanese patients with unresectable advanced recurrent colorectal cancer with wild-type RAS gene. This is the first prospective trial to evaluate appropriate treatment options for metastatic colorectal cancer patients with wild-type RAS gene and left-side primary tumor (descending colon, sigmoid colon, and rectum).

The results of the trial showed that the mFOLFOX6 + panitumumab combination provides a statistically significant improvement in overall survival (OS) over the mFOLFOX6 + bevacizumab combination in patients with a left-sided primary tumor or regardless of tumor locations (median OS for left-sided tumors: 37.9 vs. 34.3, HR=0.82 [95.798% CI: 0.68-0.99], p=0.031, overall median OS: 36.2 vs. 31.3, HR=0.84 [95% CI: 0.72-0.98], p=0.030). The safety profile of panitumumab administration in this study was similar to clinical study results previously published.

Dr. Kei Muro, Director of Department of Clinical Oncology, and Deputy Director at Aichi Cancer Center, and Dr. Takayuki Yoshino, Chief for the Department of Gastrointestinal Oncology, and Deputy Director at the National Cancer Center Hospital East, who served as the Steering Committee Chair for the study, stated, “The fact that the results of the trial were accepted for the Plenary Session of ASCO shows the global recognition of the importance of this trial. We hope that these results will benefit colorectal cancer treatment worldwide and lead to better outcomes for as many colorectal cancer patients as possible.”

“We are pleased with these results from the PARADIGM trial, which further our understanding of the value this combination therapy may provide for patients. I would like to express my sincere gratitude to the patients, their families and the doctors who have contributed so generously to this trial. We will continue to make further contributions to patients in need of new treatments for diseases with high unmet needs,” said Takafumi Horii, Head of the Japan Oncology BU, Global Oncology Unit at Takeda Pharmaceutical. 

The PARADIGM Trial

Trial overview

The aim of the trial was to evaluate the efficacy of mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab in the first-line treatment of chemotherapy-naive patients with metastatic colorectal cancer and the wild-type RAS gene (KRAS/NRAS gene).

Trial design

Multicenter, randomized, open label

Number of patients enrolled

823

Primary endpoint

Overall survival (OS)

Secondary endpoints

Progression-free survival (PFS), response rate (RR), duration of response (DOR),
curative resection rate, safety

Place of study

Japan

Ancillary study

Analysis of circulating tumor DNA from tumor and blood samples to identify predictors of treatment response and mechanisms of treatment resistance.

 

Vectibix

Vectibix® (created by Amgen) is the first fully human monoclonal anti-EGFR antibody approved by the FDA for the treatment of metastatic colorectal cancer (mCRC). Vectibix® is approved by the FDA for the treatment of unresectable advanced or recurrent mCRC. Vectibix® was approved and launched in the U.S. in September 2006 and in Japan in 2010 after being in-licensed by Takeda from Amgen, Inc. as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression following prior therapy with chemotherapeutic agents including fluoropyrimidine, oxaliplatin and irinotecan.

Metastatic colorectal cancer (mCRC)

The cornerstone of treatment for colorectal cancer is to completely remove the primary lesion (the tumor in the colon) and metastatic lesions (tumors in other locations) by surgery. However, if the tumor cannot be removed by surgery, or if the cancer recurs after surgery and the tumor cannot be removed, the disease is classified as “unresectable” colorectal cancer. This is not based on whether the tumor can technically be resected, but whether the cancerous tissue can be completely removed and recurrence of the cancer can be controlled for a long period. If the cancer is deemed “unresectable,” systemic chemotherapy is administered to control disease progression, prolong life and control cancer-related symptoms.

See the Takeda Pharmaceutical Company Limited website for details:
https://www.takeda.co.jp/patients/mcrc/about2/

 

Takeda Pharmaceutical

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Takeda works with healthcare professionals in around 80 countries and regions to help improve quality of life for patients.
For more information, please visit https://www.takeda.com/jp/

 

Disclaimer

The drug information contained herein is intended to disclose corporate information. Nothing contained in this document should be considered a solicitation, promotion, or indication for any prescription drug, including those currently under development.