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BMS and Ono Pharma Receive Japanese Approval for Opdivo (Nivolumab) in First-Line Gastric and Esophageal Cancer with Chemotherapy, Demonstrating Significant Survival Benefit

Nov 30, 2021 23:24 CST Updated 23:24
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Gastric Cancer-Esophageal Cancer (Image source: medindia.net)

News on November 30, 2021 /BioValleyBIOON/ -- Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb (BMS) recently announced an anti-PD-1 therapyOpdivo (O'Diwo), Generic name: nivolumab, Opdivo) approved in Japan: (1)Combination chemotherapy, first-line treatment for unresectable advanced or recurrent gastric cancer; (2) Adjuvant treatment for esophageal cancer.

This approval is based on the results of two clinical studies. CheckMate-649 (ONO-4538-44) is a global, multicenter, randomized, open-label Phase 3 study conducted in previously untreated, non-HER2 positive, unresectable advanced or recurrent gastric cancer (GC), gastroesophageal junction cancer (GEJC), or esophageal adenocarcinoma (EAC) patients. The study evaluated the efficacy and safety of Opdivo + chemotherapy, Opdivo + Yervoy, and chemotherapy as first-line treatments.

The results of the CheckMate-649 study show,In the entire randomized patient population and in PD-L1 positive patients with a Combined Positive Score (CPS) ≥5, Opdivo + chemotherapy significantly extended overall survival (OS) compared to chemotherapy.In addition, among PD-L1 positive patients with CPS≥5, compared to chemotherapy alone, Opdivo + chemotherapy significantly extended progression-free survival (PFS). In this study, the safety profile of Opdivo + chemotherapy was consistent with the known safety profiles of each drug.

ATTRACTION-4 (ONO-4538-37) is a multicenter, randomized Phase 2/3 study conducted in previously untreated patients with HER-2 negative, unresectable advanced or recurrent GC or GEJC, evaluating the efficacy and safety of Opdivo + chemotherapy versus chemotherapy as first-line treatment.

The results of the ATTRACTION-4 study show:Compared with chemotherapy, Opdivo + chemotherapy significantly prolonged PFS., but did not show statistical significance in terms of OS. In the study, the safety of Opdivo + chemotherapy was consistent with the known safety profile of each drug.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to uniquely utilize the body's own capabilities by blocking the interaction between PD-1 and its ligands.AutoimmuneSystem helps restore resistanceTumorImmune response. Opdivo was first approved in Japan in July 2014 as the world's first approved PD-1 immune therapy, with treatment indications forMelanoma. By utilizing the human bodyAutoimmuneSystem fights cancer, Opdivo has now become an important treatment option for various cancers.

In Japan, Ono Pharmaceutical launched Opdivo in September 2014 for the treatment of unresectableMelanomaThereafter, Opdivo was successively approved for various cancer indications in Japan.

Ono Pharmaceutical is the original developer of Opdivo. In 2011, the company partnered with Bristol-Myers Squibb, granting it the rights to develop and commercialize Opdivo outside Japan, South Korea, and Taiwan, China. In July 2014, the two parties further expanded their strategic collaboration to develop and commercialize multiple immunotherapies (including monotherapies and combination therapies) for cancer patients in Japan, South Korea, and Taiwan, China. To date, Opdivo has been approved in more than 60 countries, including Japan, South Korea, China, the United States, and the European Union. (Bioon.com)