LONDON, July 6 (APM) - Merck & Co said the U.S. Food and Drug Administration has placed a clinical hold on three multiple myeloma studies testing Keytruda in combination with other drugs after more deaths were reported in patients receiving the U.S. pharma's immunotherapy.
Merck has enjoyed considerable success with Keytruda (pembrolizumab), overtaking other immunotherapies, particularly after it extended survival as an initial treatment for advanced lung cancer, the largest oncology market.
Bristol-Myers Squibb had been the perceived leader in the field until last year, when Opdivo (nivolumab) failed to match Keytruda's lung cancer success. (APMMA 49067)
Merck last month said it had stopped enrolling patients in the trials testing Keytruda in combination with standard multiple myeloma regimens including Celgene drugs. (APMMA 53474)
The decision was taken after independent safety monitors observed more deaths in patients receiving the Keytruda combination than in the control groups in two of the studies, the company said in a late Wednesday statement.
The FDA said that based on available data, the risks of combining Keytruda with either of the Celgene medicines outweigh any potential benefit for patients with multiple myeloma.
The trials were testing Keytruda with either Revlimid (lenalidomide) or Pomalyst (pomalidomide) and dexamethasone against the regimens without Keytruda.
All patients who were receiving Keytruda in combination with a Celgene drug will no longer take the Merck drug.
The clinical hold does not apply to other studies with Keytruda, Merck said. The drug, which helps the immune system fight cancer by blocking a protein tumours use to avoid detection, is being tested in hundreds of combination trials in a wide variety of cancers.
In May, Keytruda became the first cancer drug to win U.S. approval based on a genetic biomarker, regardless of where in the body the disease originated (APMMA 53211).
Head of Merck Research Laboratories Dr Roger Pelmutter said: "Patient safety is Merck's primary concern, and we are grateful to the study investigators and patients involved in these studies for their commitment to this important research. Merck's development programme for Keytruda, spanning more than 30 different tumour types, has one priority: helping patients suffering from cancer."
Keytruda is approved in a range of cancers, either as monotherapy or in combination.
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