EU approves Merck’s treatment for oesophageal cancer

pharmafile | June 30, 2021 | News story | Research and Development  

The EU has approved Merck’s KEYTRUDA, in combination with platinum- and fluoropyrimidine-based chemotherapy, as treatment for advanced oesophageal cancer.

The treatment will be for patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumours express PD-L1 (Combined Positive Score [CPS] ≥10).

The approval is based on Phase III trial results, in which KEYTRUDA plus 5-fluorouracil (5-FU) and cisplatin demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared with 5-FU and cisplatin alone in all pre-specified study populations.

KEYTRUDA plus 5-FU and cisplatin reduced the risk of death by 27% and reduced the risk of disease progression or death by 35%.

Professor Antoine Adenis, Department of Medical Oncology, Montpellier Cancer Institute, France, said: “We have seen few advances over the last three decades that have improved historically poor survival outcomes for patients with oesophageal cancer.

“The European Commission’s approval of KEYTRUDA plus chemotherapy for the treatment of certain patients with oesophageal and HER2-negative GEJ cancer provides a new option in the first-line setting that has shown significant improvements in progression-free and overall survival.”

Dr Scot Ebbinghaus, Vice President, Clinical Research, Merck Research Laboratories, said: “KEYTRUDA plus chemotherapy is the first anti-PD1 therapy approved in Europe in this first-line setting, allowing these patients to be treated with immunotherapy earlier in the course of their treatment.

Oesophageal cancer begins in the inner layer (mucosa) of the oesophagus and grows outward.

Oesophageal cancer is the eighth most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide.

In Europe, it is estimated there were more than 52,000 new cases diagnosed and approximately 45,000 deaths resulting from the disease in 2020.

Lilly Subbotin

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