Roche posts HCC trial results, registers five new studies across cancer, MS, flu, COPD

Roche's week featured one completed trial with results now posted and five newly registered studies spanning oncology, neurology, and infectious disease.

• Hepatocellular carcinoma, Phase Ib/II: The "MORPHEUS-NEO HCC" platform study evaluating neoadjuvant immunotherapy combinations was terminated early after the sponsor decided not to continue development of certain treatment combinations¹. Results are now posted, with the primary endpoint being Major Pathologic Response rate, estimated for each treatment cohort in the efficacy-evaluable population¹; the trial enrolled 62 participants¹.
• Multiple myeloma, Phase II: A newly registered study will test cevostamab in combination with pomalidomide and dexamethasone in patients with multiple myeloma who have received one to four prior lines of therapy and have been exposed to an anti-CD38 antibody, lenalidomide, a proteasome inhibitor, and a BCMA-targeting CAR T-cell therapy². The study is recruiting, with an estimated enrollment of 45 participants².
• Early breast cancer, Phase IIIb: The "kalitERA" study will evaluate treatment adherence, tolerability, and patient-reported outcomes of giredestrant in patients with ER-positive, HER2-negative early breast cancer³. It is not yet recruiting, with an estimated enrollment of 1500 participants³.
• Relapsing-remitting multiple sclerosis, observational: The "SONATA-MS" study will assess patient-reported satisfaction with subcutaneous ocrelizumab administration in participants with relapsing-remitting multiple sclerosis who are treatment-naive, switching from intravenous ocrelizumab to s.c. ocrelizumab, or switching from a prior disease-modifying therapy to s.c. ocrelizumab⁴. It is not yet recruiting, with an estimated enrollment of 1800 participants⁴.
• Influenza post-exposure prophylaxis, Phase III: A newly registered study will test a single dose of baloxavir marboxil compared with placebo in the post-exposure prophylaxis of influenza virus infection in household contacts of participants with influenza⁵. It is not yet recruiting, with an estimated enrollment of 325 participants⁵.
• COPD and healthy participants, Phase I/II: A newly registered study of RO7830698 will evaluate safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of single and multiple doses in healthy participants and participants with chronic obstructive pulmonary disease⁶. It is not yet recruiting, with an estimated enrollment of 104 participants⁶.