Roche moves one step closer to lupus nephritis treatment landscape with obinutuzumab phase II results, says GlobalData

Roche may be able to join the list of companies that have approved therapies for the treatment of lupus nephritis (LN), as recent results published from a post hoc analysis of the Phase II NOBILITY trial for the company’s obinutuzumab against LN reveal a positive outcome. With a significant number of patients exhibiting a reduction in the risk of developing unfavourable kidney outcomes and LN flares, in combination with obinutuzumab’s mechanism of action, as previously seen in other disease treatments such as cancer, Roche’s future in the LN treatment landscape may be promising, says GlobalData, a leading data and analytics company.

Filippos Maniatis, Healthcare Analyst at GlobalData, comments: “The exciting results from the post-hoc analysis of the NOBILITY trial results can have a huge impact on the future of Roche in the field of LN treatment. As of now, marketed therapies include inhibitors such as GlaxoSmithKline’s Benlysta (belimumab), and Aurinia’s Lupkynis (voclosporin), but Roche’s approach of wanting to expand obinutuzumab’s indications to diseases other than cancer is promising for LN patients.’’

The results of the post-hoc study of the NOBILITY Phase II trials demonstrated the ability of obinutuzumab to treat patients with LN, as a reduction in the risk of developing unfavorable kidney outcomes and LN flares was reported as 60.0% and 57.0%, respectively. In addition, the results also revealed a reduction in estimated glomerular filtration rate (eGFR) declines upon obinutuzumab administration, further highlighting obinutuzumab’s potential for this indication.

Maniatis continues: “Roche’s attempt to expand in the LN market may be finally closer to reality after these positive results, allowing the mapping of obinutuzumab in the LN treatment landscape as a strong drug candidate. NOBILITY’s results may not be a surprise for Roche, as past pre-clinical studies have already reported better efficacy and safety of obinutuzumab compared to rituximab in murine models of LN.”

With obinutuzumab currently in Phase III trials, GlobalData projects a drug-specific phase transition success rate (PTSR) of 35.0% and a likelihood of approval (LoA) of 22.0%, higher than the average PTSR for LN (25.0%) but lower than the indication-specific LoA, which is also projected at 25.0%. These estimations suggest that further clinical trial data may be required to show evidence for the agent’s efficacy in LN in comparison to the currently available therapies.

Maniatis concludes: “Although the percentages for the PTSR of obinutuzumab are higher compared to the LN-specific PTSR, the low LoA percentage estimated for obinutuzumab indicates the need for further data to obtain a clearer view of the future of obinutuzumab in the LN treatment landscape. Nevertheless, the aforementioned clinical trial results hold promise for LN patients and make it an exciting pipeline agent to keep an eye on for the LN space.’’

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