BeiGene’s Phase III Waldenström’s macroglobulinemia study of BGB-3111 enrolls nearly one-third of 167 patient target in 8 months, Parexel is CRO - source
BeiGene’s (NASDAQ:BGNE) Phase III study comparing BGB-3111 against AbbVie (NYSE:ABBV)/Johnson & Johnson's (NYSE:JNJ) Imbruvica (ibrutinib) in Waldenström’s macroglobulinemia (WM) has enrolled 53 patients out of 167 as of 3 October with CRO Parexel (NASDAQ:PRXL), said a source briefed on the trial.
The trial (NCT03053440) initiated on 25 January and is recruiting across 71 global sites, with a primary completion date of June 2021, according to ClinicalTrials.gov. Enrollment has been proceeding according to schedule, the source said, though noted at some sites the trial was slow to open because of local regulatory issues, particularly with institutional review board approvals. The trial is taking place in the US, Australia and the EU.
A company spokesperson said the trial is enrolling well but did not comment further on that aspect.
If eventually approved, US and Chinese sales for the drug are forecasted to reach USD 833m by YE25, according to BioPharm Insight data. Imbruvica’s global sales were more than USD 1.8bn in 2016, according to a 27 January AbbVie earnings release, while BioPharm Insight data forecasts US and ex-US sales of USD 5.9bn by YE25. Imbruvica is currently approved for WM, as well as chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL) and chronic graft versus host disease.