Keytruda may have won the battle of European approval in metastatic esophageal cancer against Opdivo, but the war will be judged in the adjuvant setting, says GlobalData

Following today’s news (29 June) that Merck & Co’s Keytruda received EMA approval for patients with esophageal cancer (EC) or HER2-negative gastroesophageal junction (GEJ) adenocarcinoma with PD-L1 combined positive score (CPS ≥10);

Sakis Paliouras, PhD, Senior Oncology & Hematology Analyst at GlobalData, a leading data, and analytics company, offers his view:

“When combined with chemotherapy, Keytruda is expected to capture a large share of the first-line metastatic setting in EC/GEJ, having beat Bristol Myers-Squibb’s (BMS) Opdivo to the first EMA authorization as an anti-PD-1 immunotherapy agent in this setting. However, the race continues as to which can access the lucrative adjuvant setting.

“In the US, both Keytruda and Opdivo received FDA labels in 2021 in the same patient setting, with Opdivo demonstrating a similar extension of overall survival by 3.3 months over chemotherapy. This could be a cause for concern for Keytruda, as, should BMS’ now validated application for Opdivo as an adjuvant treatment for EC/GEJ patients irrespective of HER2/PD-L1 status receive marketing authorization, Opdivo will manage to enter a line of therapy in which Keytruda has not even been investigated. This will allow Opdivo a significant first-mover advantage. FDA approval in this setting was previously granted in May 2021, making an EMA approval more likely.

“GlobalData forecasts a combined incidence of 33,513 EC/GEJ patients in 2021 in the 5EU* countries. Given that the adjuvant patient segment is unrestricted, compared to the narrow patient population of EC/HER-2 negative GEJ with PD-L1 (CPS ≥10), sales of Opdivo in the post-operative + metastatic setting are expected to surpass sales of Keytruda in the metastatic disease setting only.”

* France, Germany, Italy, Spain and the UK

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