InnoCare Pharma announced that three studies of its novel BCL2 inhibitor, Mesutoclax (ICP-248), were presented at the 67th Annual Meeting of the American Society of Hematology (ASH). Mesutoclax demonstrated remarkable efficacy and a favorable safety profile in the treatment of relapsed/refractory (R/R) mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and acute myeloid leukemia (AML). The study of mesutoclax in the treatment of relapsed andrefractory MCL was selected for oral presentation, while the CLL/SLL and AML studies were chosen for poster presentations.
The clinical data from mesutoclax (ICP -248) monotherapy demonstrated potential best in class efficacy in MCL patients, particularly in heavily treated patients with BTK inhibitors refractory. The overall response rate (ORR) of MCL patients treated with 125 mg mesutoclax monotherapy was 87.5%, with a complete response rate (CRR) of 46.9%. Among MCL patients who were BTK inhibitor refractory, the ORR was 84.0% and the CRR was 36.0%.
Mesutoclax was well tolerated through all dose levels (50-150mg), with no dose-limiting toxicities (DLTs) observed, and maximum tolerated dose (MTD) not reached. The clinical data of mesutoclax monotherapy showed promising safety and potential Best-in-class efficacy in MCL patients, especially for those who had received multiple prior treatments and were resistant to BTK inhibitors. Mesutoclax monotherapy or in combination with orelabrutinib demonstrated a tolerable safety profile across all dose levels tested.
82.6% of the patients achieved uMR. Most CR+CRi in TN AML was achieved by the end of cycle 1. Notably, 44% of the treatment naive AML were classified as adverse risk group and median age is 68 years old. The combination of mesutoclax and AZA also demonstrated well tolerated safety profile. There is no DLT or TLS events during the whole study.
The mortality rate within 90 days was 0%. Mesutoclax further strengthens InnoCare's pipeline of hematologic oncology products. Two registrational clinical trials are ongoing: one is the combination of mesutoclax & orelabrutinIB for the treatment of TN CLL/SLL; the other is for the treatment of MCL that is refractory to BTK inhibitors.
In addition, the clinical study of mesutoclax as first-line treatment for AML has entered the dose expansion phase in China and globally, and the clinical study for the treatment of myelodysplastic syndrome (MDS) is being launched globally.
