Clinical Triumph: MEI Pharma's Voruciclib Demonstrates Encouraging Activity in AML Patients

MEI Pharma Inc MEIP announced an update to the Phase 1 study of voruciclib, an orally administered cyclin-dependent kinase 9 inhibitor, in patients with relapsed and refractory (R/R) acute myeloid leukemia (AML) or B-cell malignancies. 

These results demonstrate that as of the data cut-off, voruciclib alone or in combination with AbbVie Inc ABBV/Genentech's Venclexta (venetoclax) was generally well tolerated with no significant myelosuppression.

The results further demonstrated encouraging clinical activity in heavily pretreated patients administered voruciclib alone and at the initial dose level in combination with venetoclax. 

On the intermittent dosing schedule selected for further development, no dose-limiting toxicities (DLT) were observed, there were no grade 3 or higher drug-related toxicities, and dose escalation was stopped at 200 mg before reaching the maximum tolerated dose. 

Of the 10 AML patients treated at the highest dose evaluated, 200 mg daily on the intermittent schedule, the disease control rate was 50%.

In March 2023, the Safety Review Committee of the Phase 1 study evaluating voruciclib plus venetoclax completed a safety assessment of the initial dose escalation cohort evaluating the combination in AML patients and recommended opening the next cohort.

Part 2 of the study is currently evaluating the combination of voruciclib and venetoclax in patients with R/R AML.

Price Action: MEIP shares are down 0.68% at $7.29 on the last check Tuesday.