Ocrevus higher-dose Phase 3 posts results, misses primary endpoint; two partner trials update

This week's most notable item is Roche's own dose-comparison study in primary progressive MS, which posted results showing the primary endpoint was not met.

• **Ocrelizumab (Ocrevus), Phase 3, primary progressive multiple sclerosis (GAVOTTE, NCT04548999):** Results were first posted 2026-07-24 from a randomized, double blind, controlled study that evaluated efficacy, safety and PK of a higher dose of ocrelizumab per intravenous infusion every 24 weeks in participants with PPMS, compared to the approved 600 milligram dose of ocrelizumab.¹ The trial enrolled 769 participants¹ and reached primary completion on 2025-06-30; per the sponsor's posted results, the comparison of higher dose versus the approved dose did not reach statistical significance on the primary endpoint (p=0.6376).
• **Gemcitabine, trastuzumab, pertuzumab, Phase 2, metastatic HER2-positive breast cancer (NCT02252887, Roche/Genentech as collaborator, sponsored by Memorial Sloan Kettering Cancer Center):** The trial completed with results posted 2026-07-24. The study tested whether combining gemcitabine, a standard chemotherapy, with two other drugs that target the HER2 receptor could help treat breast cancer², enrolling 45 participants², with progression-free survival at 3 months reported at 73.3² percent.
• **Obinutuzumab, Phase 2, pure class V lupus nephritis (OBLUMEN, NCT07721363, Roche-Genentech as collaborator, sponsored by Assistance Publique - Hôpitaux de Paris):** The trial was first posted 2026-07-23 and is not yet recruiting. It aims to assess the efficacy and safety of an obinutuzumab monotherapy in patients with pure class V lupus nephritis³, with a primary endpoint of complete renal response at week 52 according to 2024 KDIGO criteria³. Estimated enrollment is 65 participants³.