Ono Pharma-BMS gastric most cancers immunotherapy shifts remedy paradigm

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Ono Pharma Korea and BMS Korea said that Opdivo (ingredient: nivolumab) has improved overall survival (OS) in gastric cancer patients and represents a turning point in the cancer immunotherapy treatment paradigm.

Professor Rha Sun-young of the Medical Oncology Department of the Yonsei Cancer Center presented the study results and emphasized the importance and value of Opdivo’s recent regulatory approval as a first-line treatment at an online conference Thursday.

From left, Choi Ho-jin, CEO of Ono Pharma Korea, Professor Rha Sun-young of the Medical Oncology Department of Yonsei Cancer Center, and Lee Choong-hoon, Medical Director of Ono Pharma Korea, explain the importance and value of Opdivo as a First-line treatment for stomach cancer on Thursday.

“In 2018, gastric cancer patients made up 12 percent of all cancer patients, but we have been lacking approved first-line treatment for more than a decade, leaving patients and healthcare providers with tremendous unmet needs,” said Professor Rha.

Rha added that the approval of Opdivo as a first-line therapy for patients with human epidermal growth factor receptor 2 (HER2) negative gastric cancer, which accounts for 90 percent of all patients with advanced gastric cancer, marked a major turning point of great interest from researchers and pharmaceutical companies.

Opdivo has received approval from the Department of Food and Drug Safety as a first-line treatment for advanced or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, and esophageal cancer in combination with fluoropyrimidine or platinum chemotherapy.

Rha said that Opdivo plus chemotherapy increased the median overall survival in the global phase 3 studies CheckMate-649 in patients with HER2-negative advanced and metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma from 11.6 months in the existing studies to 13, 8 months extended.

Of all gastric cancer patients who participated in the study, 55 percent who were treated with Opdivo combination therapy survived the first year, while 48 percent who received chemotherapy only had an OS of 12 months.

The overall response rate (ORR) of the opdivo combination therapy reached 58 percent, 12 percent more than in the mono-chemotherapy group.

The study also showed that 10 percent of patients treated with Opdivo chemotherapy achieved a complete response (CR), while 6 percent of patients treated with chemotherapy only had sustained duration of response (DoR).

Rha said the biological and clinical properties and treatments of advanced gastric cancer differ depending on HER2 expression.

She added that Opdivo plus chemotherapy was used in the CheckMate-649 study to treat HER2-negative advanced or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, and esophageal cancer. The drug significantly improved OS and reduced the risk of death by 20 percent.

“Treating stomach cancer is difficult, and Herceptin and other drugs also offer a survival benefit of about two months like Opdivo,” said Rha. “The two month extension of the OS might seem negligible, but I think this is a good place to start as improving gastric cancer survival time is challenging and we can continue to develop better drugs over time.”

She also stressed that a reimbursement was required to Opdivo because it was not easy to explain to patients the expensive cost of treatment, up to 800 million won ($ 6,590) per vial, no matter how great the drug works.

“We are pleased to offer a novel immuno-oncology first-line treatment for gastric cancer, which is particularly prevalent in Korea and other East Asian countries,” said Choi Ho-jin, CEO of Ono Pharma Korea. “We are discussing reimbursement from Opdivo as soon as possible with the government and the Health Insurance Review and Evaluation Service.”

Choi added that the company will conduct further studies on Opdivo in Asia.

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