2020-09-27| Trials & Approvals

BMS Enters Esophageal Cancer Therapy Area Amidst High Competition

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

Both esophageal and gastric cancers are among the top ten cancers and were responsible for over half a million new cases and deaths in 2018. According to Ronan J. Kelly M.D., Director of the Charles A. Sammons Cancer Center at Baylor University Medical Center, “Approximately 50% of patients with esophageal or gastroesophageal junction [(GEJ)] cancer who undergo neoadjuvant chemoradiation therapy followed by tumor resection will have disease recurrence within four years, and among those who do not respond completely to neoadjuvant treatment, recurrence will occur sooner.”

Dr. Kelly emphasizes that only about 25-30% of patients responded completely to chemoradiation therapy and surgery, but the remaining did not. In other words, the limited neoadjuvant treatment option jeopardizes many lives and families. Although the crisis of limited medical treatment continues, there is hope: Opdivo’s (nivolumab) success in doubling the disease-free survival (DFS) rate of placebo’s in the CheckMate-577 clinical study recently that even received Japan’s Ministry of Health, Labor and Welfare (MHLW) approval.

Co-developed and commercialized by Bristol-Myers Squibb and Ono Pharmaceuticals since 2011, Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that harnesses the body’s immune system by restoring anti-tumor immune response. Opdivo has been administered in over 35,000 patients in clinical settings and has contributed to a greater understanding of its effectiveness to patients with PD-L1 biomarkers.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval to treat metastatic melanoma. Since Opdivo has been researched and successfully administered in various instances, it gives more confidence to researchers and patients in treating esophageal or GEJ cancer and the investors to continue to fund follow-up studies.

CheckMate-577 is a Phase 3 randomized, multi-center, double-blind study evaluating Opdivo as adjuvant therapy in patients with resected esophageal or gastroesophageal junction cancer have received neoadjuvant chemoradiation therapy and have not achieved a pathological complete response. A total of 794 patients were randomized to receive 240 mg of placebo or Opdivo by intravenous infusion every two weeks for a total of 16 weeks, followed by 480 mg of Opdivo every four weeks until disease progression or unacceptable toxicity.

The DFS, which is the primary endpoint of the trial, was doubled when on Opdivo treatment as compared to placebo. Although more side-effects were seen with the drug treatment, it was still well tolerated with an acceptable safety profile, which was consistent with previously reported studies. Although the primary endpoint was a victory, the overall survival (OS) as the secondary endpoint was not discussed yet because the CheckMate-577 study is scheduled to conclude in mid-2021. Hopefully, the results of the OS rate will show that Opdivo is an effective therapy after all.

According to development lead for Gastrointestinal Cancers at Bristol Myers Squibb Ian M. Waxman, “These results make esophageal and gastroesophageal junction cancer the second cancer type – following melanoma – where Opdivo has demonstrated a benefit in the adjuvant setting, indicating the potential for Opdivo to become a new standard of care for these patients.”

“This advancement showcases our commitment to evaluating our therapies in earlier stages of (the) disease where we may be able to have a greater impact on preventing disease recurrence and improving patient outcomes. We look forward to discussing these encouraging results from CheckMate -577 with global health authorities in the coming months.”

The status that Opdivo has been gaining through its promising efficacy and safety has been a tough fight against giant pharmaceutical companies since 2015. Although Opdivo was the first checkpoint inhibitor to reach the market in 2015, it has continued to be defeated by Merck & Co’s Keytruda as Keytruda gains dominance in non-small cell lung cancer.

With this, Opdivo has forayed into gastric and gastroesophageal cancer and gradually setting its foot to become the leading therapy of this area, beating Keytruda, Roche’s Herceptin, and Eli Lilly’s Cyramza. Opdivo is anticipated to win the biggest selling drug by 2024, according to GlobalData and will continue to expand, making a glorious history in the pharmaceutical industry.

Related Article: Roche’s Multifaceted Drug, Tecentriq Registers Mixed Results in Breast Cancer Patients



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