Phase I/II Study of Sonrotoclax (BGB-11417) Monotherapy in Patients With Mantle Cell Lymphoma Previously Treated With Anti-CD20 Therapy and a Bruton Tyrosine Kinase Inhibitor.

What was studied

This trial tested sonrotoclax alone in mantle cell lymphoma. The cancer had come back or had not responded. People had already had anti-CD20 therapy and a BTK inhibitor. The trial was ongoing and open-label. 125 people were enrolled. They took 160 mg or 320 mg once daily after a 4-week ramp-up. The main goal was overall response rate judged by an independent committee.

What they found

In 103 people who could be assessed, a majority responded. This was significantly higher than a historic control rate, with P < .0001. Median duration of response was 15.8 months. Median progression-free survival was 6.5 months. Median overall survival was not reached. Neutropenia, thrombocytopenia and anemia were the commonest adverse events. Tumor lysis syndrome occurred in some people, and all cases resolved.

What it means for patients

The authors say sonrotoclax gave rapid, durable responses and manageable safety. This included heavily pretreated people and high-risk groups. They say this supports further clinical study.

Why it is not certain yet

The study is ongoing and has no randomized comparison group. The comparison used a historic control rate. Median overall survival was not reached. Median follow-up was 14.2 months.

Source

Phase I/II Study of Sonrotoclax (BGB-11417) Monotherapy in Patients With Mantle Cell Lymphoma Previously Treated With Anti-CD20 Therapy and a Bruton Tyrosine Kinase Inhibitor.

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