Clinical Insights Into Genitourinary Cancer

A quick glance at a recent study examining the renal cell carcinoma immunotherapy AGS-003 and the FDA approval of a new noninvasive prostate health index test.

RCC Immunotherapy Agent Advances

to Phase III Trial

A pivotal phase III trial is moving forward for AGS-003, a dendritic cell immunotherapy agent under investigation for the treatment of metastatic renal cell carcinoma (mRCC).

The primary endpoint has been amended to focus on improving overall survival under a revised Special Protocol Assessment that the FDA has approved, according to Argos Therapeutics, which is developing the agent. The company said the results could form the basis for a Biologics License Application.

In the ADAPT study, 450 patients will be randomized 2:1 to receive AGS-003 plus sunitinib versus sunitinib alone. The study will enroll patients at approximately 100 sites.

In phase II results, the addition of AGS-003 to sunitinib delivered double the overall survival typically expected in patients with mRCC with intermediate or poor risk factors, the company said. More than 50% of patients enrolled in the study survived longer than 30 months, Argos Therapeutics reported.

AGS-003 is made by harvesting the patient’s dendritic cells through leukapheresis and then inserting RNA isolated from the patient’s tumor cells. goo.gl/hblYC

New Prostate Health Index Test Available

The FDA has approved a noninvasive screening test for prostate cancer that uses prostate-specific antigen (PSA) levels to develop an index that may help patients avoid unnecessary biopsies.

The Access Hybritech p2PSA on the Access Immunoassay Systems measures the amount of [-2]proPSA in a patient’s blood, in addition to his total PSA and free PSA. Using those values, the test calculates a man’s Prostate Health Index (phi), or the likelihood that he has prostate cancer.

The test detects prostate cancer with 2.5 times more specificity than PSA alone in men with PSA levels between 4 ng/mL and 10 ng/mL, according to its developer, Beckman Coulter, Inc. The test is indicated for men ≥50 years old with PSA levels between 4 ng/mL and 10 ng/mL whose digital rectal exams have detected no evidence of cancer.

A form of free PSA, [-2]proPSA is associated with prostate cancer, according to the FDA. goo.gl/W2IWa, goo.gl/RKUsH.