Georgetown reports positive Phase I data from Inlyta and Keytruda

12th February 2018 (Last Updated February 12th, 2018 00:00)

Researchers from Georgetown Lombardi Comprehensive Cancer Centre in the US have reported positive results from a Phase I clinical trial of axitinib (Inlyta) in combination with pembrolizumab (Keytruda) to treat patients with advanced kidney cancer who had not been previously treated. 

Researchers from Georgetown Lombardi Comprehensive Cancer Centre in the US have reported positive results from a Phase I clinical trial of axitinib (Inlyta) in combination with pembrolizumab (Keytruda) to treat patients with advanced kidney cancer who had not been previously treated.

The trial has enrolled 52 patients with advanced renal cell carcinoma, the most common form of kidney cancer.

It intends to discover the dose of the drug that could be tolerated by a subset of 11 patients during the first six weeks of the trial, and then estimate the effectiveness of the therapy in all 52 patients.

During the trial, the enrolled patients were given an intravenous infusion of pembrolizumab at the beginning of the trial and in every three weeks thereafter.

Patients also received axitinib twice-daily until they could no longer tolerate the therapy or until no benefit was seen.

The tumour size was observed at the time of enrolment, then after 12 weeks and every six weeks subs.

"Specifically, over 90% of patients exhibited tumour shrinkage and the disease was kept under control for a median of over 20 months."

Georgetown Lombardi Comprehensive Cancer Centre deputy director and principal investigator for the study Michael Atkins said: “Our results are unprecedented.

“The combination doubled the efficacy of the drugs when used alone and the treatment was found to be tolerable.

“Specifically, over 90% of patients exhibited tumour shrinkage and the disease was kept under control for a median of over 20 months.”

The researcher has also noted that overall survival results are still not reported completely, as 88% of the patients were still alive at a minimum 18 months after starting therapy.

By March last year, 25 patients were receiving the treatment, with 22 patients being given the drug combination and three receiving pembrolizumab only.

The trial was sponsored by Pfizer along with Merck.