LoA Update: Roche’s Gazyvaro approval prospects in hairy cell leukaemia increases by 10 points due to Phase I/II trial completion, prior data in CLL

This LoA change is in combination with Phase I/II data showing obinutuzumab, plus Gilead Sciences’ entospletinib, is effective and well-tolerated in refractory or recurrent CLL. Credits: Medtech THAI STUDIO LAB 249/Shutterstock.com.

Roche’s Gazyvaro (obinutuzumab) has its Likelihood of Approval (LoA) jumping by 10 points in hairy cell leukaemia (HCL) on the heels of the investigator-led Phase I/II basket trial’s recruitment completion update on 29 April. This LoA change is in combination with Phase I/II data showing obinutuzumab, plus Gilead Sciences’ entospletinib, is effective and well-tolerated in refractory or recurrent chronic lymphocytic leukaemia (CLL), as presented in November 2019.

Obinutuzumab previously had an LoA of 17%, which increased to 27%, as of 5 May, as per GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. In the Phase I/II basket trial, the Phase I portion of the study recruited patients with histologically confirmed classical HCL, as per ClinicalTrials.gov. Data from this cohort is yet to be revealed.

In the trial’s Phase II portion, of the 17 evaluable CLL patients that received entospletinib plus Gazyvaro, 71% of patients remained on treatment, with a median follow-up of 9.5 months (the range was between 3–17 months), when data was collected in July 2019. Three patients reached complete response, the Phase II portion’s primary endpoint (Kittai, A, et. al, Blood (2019) 134 (Supplement_1): 4295).

CD20-directed cytolytic antibody Gazyvaro is FDA-approved in various settings for CLL and follicular lymphoma. Entospletinib is a spleen tyrosine kinase inhibitor.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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