The AKT is over: Roche finally dumps phase 3 prostate cancer prospect

The AKT is over: Roche finally dumps phase 3 prostate cancer prospect

Roche’s long-stuttering attempt to bring the cancer drug candidate ipatasertib to market has run out of steam. After multiple clinical setbacks, the Swiss pharma giant has dropped (PDF) a phase 3 prostate cancer trial—and sent its acute graft-versus-host disease (aGVHD) prospect packing at the same time.

Ipatasertib is a small molecule inhibitor of AKT, part of a signaling pathway implicated in the progression of prostate cancer and other tumor types. The candidate, which emerged from a collaboration between Array BioPharma and Roche’s Genentech unit, advanced into phase 3 trials in breast and prostate cancer but delivered underwhelming data.

Roche reported failures in two breast cancer indications in 2020 and 2021. Things went slightly better in a prostate cancer trial that delivered topline data in 2020, with the study hitting its co-primary endpoint in a subset of patients but failing in the broader population.

After the primary progression-free survival readout, Roche continued to collect overall survival (OS) data. Subsequent updates suggested ipatasertib was dead in the water, with Roche reporting no significant improvement in OS at the second interim analysis last summer. In September, the U.K. cost watchdog said Roche was working toward final OS analysis in mid-2023 but had dropped plans to seek approval.

Roche confirmed the end of ipatasertib on Thursday by listing the prostate cancer study among its newly abandoned phase 3 programs. Ipatasertib sits alongside Roche’s previously disclosed termination of the gantenerumab Alzheimer’s disease trial on the list.

The update also features one early-phase termination. Roche has pulled a phase 1 trial of efmarodocokin alfa in aGVHD from its pipeline. The drug candidate, also known as UTTR1147A, is a recombinant fusion protein that Roche took into phase 2 as a treatment for ulcerative colitis and Crohn’s disease. However, having failed to make the grade in those indications or aGVHD, the asset has landed on the scrapheap.

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