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02-Nov-2023

Bristol Myers Squibb’s Opdivo sales to reach $14 billion by 2028, forecasts GlobalData

On 30 October, the European Medicines Agency (EMA) announced that it has validated the application of Bristol Myers Squibb’s Opdivo for the front-line treatment of metastsic urothelial carcinoma in combination with standard-of-care (SOC) cisplatin-based chemotherapy. The news comes on the heels of  Phase lll CheckMate-901 results presented recently at the European Society for Medical Oncology’s (ESMO) Congress in Madrid. The combination regimen showed a statistically significant improvement in both overall survival (OS) as well as progression-free survival (PFS) compared to SOC chemotherapy. Opdivo generated worldwide sales of $9.3 billion in 2022 and is forecast to reach $14 billion by 2028, according to GlobalData, a leading data and analytics company.

Israel Stern, MSc,  &  Analyst at GlobalData, comments: “ A significant portion of patients with urethelial carcinoma metastasize. Data from the Phase lll study could change the urethelial carcinoma treatment landscape in Europe with the chemo-immunotherapy regimen replacing the current SOC."  

At a 33-month follow-up, patients who received the combination regimen followed by Opdivo alone as a maintenance therapy had a 22% reduced risk of death with a median OS of 21.7 months vs 18.9 with chemotherapy alone (hazard ratio [HR]: .78). Notably, the PFS rates at 12 and 24-months were 34.2% and 23.5%, respectively, compared to 21.8% and 9.6% with the SOC.

Grade-three or higher adverse events (AEs) were observed in 62% of patients who received the combination regimen, while 52% of patients who received the chemotherapy alone experienced AEs. 

Stern concludes: “CheckMate 901 was not the only study at ESMO to reveal a positive outcome for advanced bladder cancer patients. Perhaps more notably, data from KEYNOTE-A39, the combination of Astella’s antibody-drug conjugate Pacdev plus Merck’s Keytruda practically doubled the OS and PFS in first-line metastatic urothelial carcinoma. The field is also anticipating Phase III NILE study results investigating the triplet therapy of  AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) and chemotherapy for this indication."

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Last Updated: 02-Nov-2023