Roche writes off ulcerative colitis portion of etrolizumab program, days after dissecting PhIII setback

After disappointing Phase III readouts all but decimated Roche’s expectations for etrolizumab as an ulcerative colitis treatment, the pharma giant is burying the program in its quarterly cleanup ritual.

Roche noted the change in its Q3 update, where it also disclosed scrapping two Phase I programs: RG6000, a DLK inhibitor for ALS; and RG7861, an antibody-antibiotic conjugate against S.aureus. Then there’s a discontinuation for Polivy, the Seagen-partnered ADC targeting CD79b, in follicular lymphoma for “portfolio priorities.”

Ulcerative colitis loomed large in the ambitious inflammatory bowel disease program Roche had planned for etrolizumab, taking up four of eight Phase III studies. The other half, two open-label expansion studies and two for Crohn’s disease, remain underway.

Just days ago Roche spelled out the topline data that they held back in August, revealing that etrolizumab beat Humira in one study but not the other — when you measure the primary endpoint of achieving remission at Week 10. Data on secondary endpoints were similarly mixed, and it was easy to see why Levi Garraway had called the results disappointing when considering the competitive landscape.

A separate trial comparing etrolizumab to Remicade in both induction and maintenance settings also failed its primary endpoint — and patients on Roche’s drug actually did worse on multiple scores.

All of this marked a significant setback as Roche attempted to pivot from its dependence on the established — and highly profitable — oncology portfolio in favor of novel drugs and targets, Cowen analyst Steve Scala previously noted.

That had shone a spotlight on etrolizumab alongside a slate of other projects. But while plans to launch into NMOSD with satralizumab, SMA with risdiplam, Huntington’s with ASO HTT, and lupus with Gazyva appear to be gaining momentum, Roche remains an outsider to IBD for now.

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