MSD’s cancer immunotherapy Keytruda will soon be available as a subcutaneous injection that does away with the need to visit an infusion clinic.
Keytruda Qlex (pembrolizumab and berahyaluronidase alfa) still needs to be administered by a healthcare professional, but requires just a couple of minutes to deliver, rather than a 30-minute intravenous infusion. It is administered every three or six weeks, similar to the IV version and, according to MSD, it can cut the ‘chair and treatment’ time for patients in half.
The FDA has cleared the new version for across most of the solid tumour indications already granted for Keytruda, which is MSD’s biggest-selling drug – bringing in more than $15 billion in the first half of this year – but will start to lose patent protection from 2028 onwards.
In addition to becoming a more convenient option for patients, the subcutaneous version could help extend the patent-protected life for MSD’s Keytruda franchise after biosimilar versions of the IV form reach the market. The company has said it expects that the new version could eventually account for 30% to 40% of all patients taking pembrolizumab – which is significant, given that the drug accounts for nearly 60% of MSD’s total turnover.
“This approval is significant for patients and healthcare providers like me, who have been using immunotherapies for years to treat certain cancers,” said Dr J Thaddeus Beck, oncologist and medical director of Highlands Oncology’s Clinical Trials Office.
Keytruda Qlex “gives patients more choices of healthcare settings in which they can receive their therapy,” he added.
MSD – known as Merck & Co in the US and Canada – developed the subcutaneous formulation in alliance with Alteogen, which owns the berahyaluronidase alfa component that makes it possible to deliver larger volumes of drug material and improve dispersion and absorption through the skin.
One potential issue in the rollout of these newer versions is an ongoing patent dispute between MSD and Halozyme, which claims that berahyaluronidase alfa infringes its intellectual property covering modified human hyaluronidases for drug delivery. MSD is trying to have Halozyme’s patents struck down, arguing they are too broad.
MSD has been working to expand its pipeline to prepare for the loss of market exclusivity for Keytruda, announcing in July that it will cut thousands of jobs to save money whilst also abandoning investment programmes, including a £1 billion UK project.
Rival cancer immunotherapies, including Bristol-Myers Squibb’s Opdivo (nivolumab) and Roche’s Tecentriq (atezolizumab), have also been approved in subcutaneous versions that use Halozyme technology.
