Company says analysis of 121,000 patients finds it fails to increase survival
The pharmaceutical company Merck has admitted its eagerly awaited megablockbuster medication Keytruda does not improve survival overall, undermining its argument that the drug should be available in all parts of the world.
After promising data in the most recent clinical trial, Merck repeatedly said Keytruda improves survival when given alongside standard chemotherapy. But this statement was contradicted in the final analysis.
Keytruda “does not significantly improve overall survival when compared to chemotherapy alone or chemotherapy plus dacarbazine in a pooled analysis of 121,000 patients from more than 60 clinical trials around the world,” the company said in a statement.
Keytruda, which costs about £16,000 per patient per year, is being looked to as a potential cancer breakthrough, fighting a range of cancers – including pancreatic, lung and melanoma – at their deepest roots. The drug received unanimous approval in the US in 2015 and from UK health officials last year. Since then the company has applied for the drug to be used globally, seeking to make it available in Britain’s National Health Service.
In 2017, Keytruda was approved by the European Medicines Agency for use alongside standard cancer therapy in patients with newly diagnosed advanced melanoma. Although approval applications are pending in Japan and other countries, more than half of eligible patients are not receiving it, according to Merck.
Its New York-listed shares plunged 2.5% to $63.11 in after-hours trading on Tuesday.
Merck said it hoped to have an official application to UK health regulators in line by late May. The company has submitted its application to various governments around the world, including in Australia, South Korea, Singapore, Taiwan and Canada.
Gizelle Bouwer, a clinical pharmacist at the London hospitals of Guy’s and St Thomas’, said the results “could really open the doors for discussions about the need for additional treatment pathways – like Keytruda Plus chemo and Curim.
“We are really waiting to see what the FDA is going to do, and our early impressions are this may be an option.”
The summary of the Merck data can be found here.