On December 10, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the latest data from InnoCare’s oncology studies were presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, InnoCare Pharma, DEC 10, 2023, View Source [SID1234638392]). The study of orelabrutinib’s regimen in patients with untreated mantle cell lymphoma (MCL) was selected as an oral presentation.

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A Prospective Multicenter Phase II Study of Orelabrutinib-Lenalidomide-Rituximab (OLR) in Patients with Untreated Mantle Cell Lymphoma (MCL) in China (POLARIS Study): Preliminary Analysis on Efficacy, Safety, Mutation Spectrum and Impact of Mutation Profiling on Treatment Responses (Abstract Number: 736)

The POLARIS study is a single arm, multicenter, open-label phase II study that uses a combination regimen of orelabrutinib, lenalidomide and rituximab to treat untreated MCL patients, with a maximum duration of 24 cycles.

As of July 10, 2023, a total of 28 patients were enrolled. The overall response rate (ORR) was 100%, and the complete response rate (CRR) was 76.2%. The median time to response (TTR) was 3 months, with the estimated 12-month duration of response (DOR) rate and progression-free survival (PFS) rate of 90.9% and 92.3%, respectively.

The preliminary findings show that the Orelabrutinib-Lenalidomide-Rituximab exerted synergistic anti-tumor activity, with manageable toxicity in untreated MCL.

The first author and corresponding author of the abstract is Professor Huilai Zhang from the Tianjin Medical University Cancer Institute and Hospital.

Preliminary Safety, Pharmacological, and Efficacy Data from Patients with Relapsed or Refractory B-cell Malignancies Treated with the ICP-248, a Next Generation BCL2 Inhibitor (Abstract Number: 6149)

This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ICP-248 in patients with relapsed or refractory B-cell malignancies.

ICP-248 demonstrated a favorable PK profile, with approximate dose proportionality observed across the ramp-up stage. No dose-limiting toxicities (DLTs) were observed. All the AEs were grade 1 to 2 without dose interruption or modifications. No TLS including laboratory TLS was observed.

As of data cutoff date, three patients had been completed tumor assessment. Two patients were assessed as complete response (CR) at the end of cycle 2 with undetectable MRD, and another patient was assessed as stable disease (SD).

Preliminary results suggest that ICP-248 is safe and well tolerated in relapsed or refractory B-cell malignancies. Preliminary efficacy data demonstrated good response with deep remission. Further assessment of safety and efficacy with additional dose levels and dosing strategies will be pursued in expanded patient population and in the combination with orelabrutinib.

The first author and corresponding author of the abstract is Professor Shuhua Yi from the Chinese Academy of Medical Sciences and Peking Union Medical College.

Effectiveness and Safety of Orelabrutinib Combined with Rituximab As First-Line Treatment in Marginal Zone Lymphoma (Abstract Number: 6146)

The retrospective study evaluated the effectiveness and safety of orelabrutinib combined with rituximab as first-line treatment in marginal zone lymphoma (MZL). The primary endpoint was the overall response rate (ORR); secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety.

The ORR was 90%. After a median follow-up of 13.0 months, the median PFS was not reached and a 6-month PFS rate was 100%. Off-target related AEs such as atrial fibrillation, diarrhea, and major hemorrhage were not reported.

This retrospective data suggests that orelabrutinib in combination with rituximab has an encouraging anti-tumor activity in MZL, with a favorable safety profile. These results provide a potential first-line treatment strategy in MZL. Further verification in prospective clinical trials of orelabrutinib in first-line MZL is warranted.

The corresponding author of the abstract is Professor Peng Liu from the Zhongshan Hospital, Fudan University.

For more study results, please visit ASH (Free ASH Whitepaper) website.