Taiwan Greenlights BMS, Ono’s Opdivo For Frontline Esophageal Cancer

Opdivo (nivolumab), developed by Bristol-Myers Squibb and Ono Pharma, has collected yet another approval in Taiwan. The approved indication covers first-line advanced or metastatic esophageal squamous cell carcinoma (ESCC), where an intravenous infusion of Opdivo will be combined with either chemotherapy or Yervoy (ipilimumab) for treatment. 

Approval for the human anti-human PD-1 monoclonal antibody was given by the Taiwan FDA on July 15, 2022. In Taiwan, around 2,830 new cases per year are diagnosed with esophageal cancer, and around 1,980 deaths per year result from this disease. 

Related article:BeiGene Granted NMPA Approval to Treat World’s Most Prevalent Esophageal Cancer

Combination Therapy Improves Overall Survival 

The approval is based on data from the Phase 3 CheckMate-648 study evaluating Opdivo plus Yervoy and Opdivo plus chemotherapy, compared to chemo alone in late-stage ESCC. 

The Opdivo-based combination treatments showed a statistically significant improvement in overall survival (OS) compared to just chemo. In the Opdivo-Yervoy and Opdivo-fluorouracil-cisplatin arms, median OS were 13.2 months and 12.8 months respectively, compared to 10.7 months in the fluorouracil-cisplatin arm. 

The safety profile of the Opdivo combos were consistent with the known safety profile of the individual components, with common side effects being nausea, fatigue, and diarrhea among others. 

A Short Look At Opdivo’s Development And Approvals

Opdivo was originally the result of a collaboration between Japanese pharma Ono and US drugmaker Medarex in 2005. In 2009, BMS acquired Medarex for $2.4 billion, inheriting the Opdivo collaboration. The two companies agreed on additional details to co-develop and market Opdivo in 2014, with Ono retaining exclusive rights to the drug in Japan, Korea, and Taiwan. 

The PD-1 inhibitor was launched in Japan the same year, and has collected regulatory approvals in over 60 regions globally, including the US and the EU. 

Besides ESCC, Opdivo is approved in Taiwan for melanoma, non-small cell lung cancer, renal cell carcinoma, and head and neck cancer among others. 

Author

Joy Lin

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