Johnson & Johnson won't file regulatory submissions for its prostate cancer combo of Erleada and Zytiga after the pair failed to reach key secondary trial goals, including overall patient survival.
The New Jersey drug giant based its decision on findings from the combo’s phase 3 ACIS study, which were presented at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium in February.
The trial tested J&J’s androgen receptor inhibitor Erleada with its aging prostate cancer med Zytiga and corticosteroid prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer. The patients had previously received androgen deprivation therapy.
The trial met its primary endpoint, showing the three-drug combo reduced the risk of radiographic progression or death in patients by 31% over Zytiga and prednisone. But it failed to show “significant benefit” in key secondary endpoints, including life extension, time to chronic opioid use, time to initiation of cytotoxic chemotherapy, and time to pain progression, J&J said.
Not all is lost, J&J says. The study generated “valuable scientific outcomes and insights in subgroups of patients" which warrant further investigation, Janssen’s Kiran Patel, vice president of clinical development, solid tumors, said in a statement.
“These data will be important in informing future programs in our pipeline, as we look to build upon our leadership and commitment in bringing transformational therapies to patients diagnosed with prostate cancer,” Patel added.
After generics launched in late 2018, copycats have been weighing on revenues for J&J’s Zytiga. The med generated $50 million in U.S. sales during the first quarter, J&J reported Tuesday, a 64% drop compared with the same quarter last year.
Meanwhile, sales for Erleada are on the rise. The company reported that U.S. sales of Erleada reached $171 million in the first quarter, a 44% increase compared with the same period last year.