A new formulation of Genetech’s breast cancer drug Herceptin means patients could soon receive treatment via injection, rather than time consuming intravenous drip.
Currently, those receiving Herceptin – or trastuzumab – must spend 90 minutes in hospital on a drip in the first instance, followed by 30 minute dosages on site once every three weeks.
However by combining the drug with recombinant human hyaluronidase PH-20 (rHuPH-20) as an excipient the team were able to reformulate the medication so that it could be delivered subcutaneously, slashing administration time to less than five minutes.
“Potential benefits of such administration include improved patient convenience, better compliance, reduced pharmacy preparation times, and optimisation of medical resources,” the authors, led by Brazilian Amaral Carvalho Hospital’s Gustavo Ismael, said.
The team say the development also has the potential for self-administration.
Commenting on the study, Javier Cortes of the Vall d´Hebron Institute of Oncology in Spain, added: "In addition to time savings, once the drug can be administered at home, patients will be able to continue their lives with less hospital dependence, which is an important psychological aspect. This treatment will also save resources in terms of nurses and cleaning in already crowded hospitals."
End point in sight
The Phase III study – published in The Lancet Oncology journal – randomly assigned 299 patients to intravenous trastuzumab and 297 to subcutaneous delivery.
According to the pharmacokinetic results, the intravenous solution had almost exactly the same pathologic complete response (pCR) as the drip.
Furthermore, injection seemed to cause less side effects than subcutaneous delivery, such as leucopenia, and febrile neutropenia, “mainly attributable to infections and infestations in the subcutaneous group”.
And though the team has yet to compare survival times and mortality reduction in later phase studies, they are positive that pCR rates are often strong indicators of success.
Ismael said: "Our study shows that subcutaneously delivered trastuzumab offers a valid alternative to existing intravenously delivered treatments.”