On December 7, 2020 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported three presentations of the most recent clinical data with orelabrutinib, its BTK inhibitor, at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, InnoCare Pharma, DEC 7, 2020, View Source [SID1234572377]). These data, contained in the three poster sessions described below, highlight both favorable objective response rates (ORR) and complete response rates (CR) as demonstrated in patients with relapsed or refractory Mantle Cell Lymphoma (MCL) and patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) /Small Cell Leukemia (SLL).

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Updated Results from the Phase II Study of Orelabrutinib Monotherapy in Chinese Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Cell Leukemia

Abstract Number：1320

This study was designed to evaluate safety and efficacy following oral daily administration. The primary endpoint was ORR. The duration of response (DOR), progression-free survival (PFS) and safety were chosen as secondary endpoints.

A total of 80 patients were enrolled, most with advanced stage disease. The median follow-up time was 14.3 months. As evaluated by an independent review committee, the ORR was 91.3%, including 10.0% of patients with CR, 63.8% with partial response (PR) and 17.5% with PR-L. Median time to first response following treatment initiation was 1.87 months. The median DOR and PFS were not reached.

Most adverse events were mild to moderate. Extended follow-up analysis did not reveal new safety concerns. The most frequent adverse events (AEs) include thrombocytopenia, neutropenia, anemia, upper respiratory tract infection, pneumonia and hypokalemia.

Dr. Wei Xu, Deputy Director of Department of Hematology, Jiangsu Province Hospital, said, "These updated data, based upon longer follow up periods, further confirm that orelabrutinib is active in treating r/r CLL/SLL patients with a higher CR rate, deeper response and improved safety profiles. As a highly selective BTK inhibitor with novel pharmacokinetic and pharmacodynamic properties, orelabrutinib provides a favorable therapeutic choice for patients with r/r CLL/SLL and a potential best candidate for combination therapy."

Long-Term Safety and Efficacy of Orelabrutinib Monotherapy in Chinese Patients with Relapsed or Refractory Mantle Cell Lymphoma: A Multicenter, Open-Label, Phase II Study

Abstract Number：2048

This study is aimed at evaluating its safety and efficacy. The primary endpoint was ORR assessed per Lugano criteria (2014). Safety and other efficacy (DOR, PFS) evaluations were chosen as secondary endpoints.

A total of 106 patients, most with advanced stage disease, were enrolled in this study, with median follow up time of 16.4 months. As per protocol analysis, ORR was 87.9% and disease control rate was 93.9%.

The CR rate, by conventional CT method, reached 34.3%. The median DOR and PFS were not reached.

Orelabrutinib demonstrated a good safety profile in r/r MCL patients. Adverse events included thrombocytopenia, neutropenia, leukopenia, and hypertension.

Dr. Yuqin Song, deputy director of the Lymphoma Department at Peking University Cancer Hospital, Beijing, said, "Orelabrutinib showed continued activity in treating patients with r/r MCL over an extended period. In addition, orelabrutinib was observed to be safe, with no treatment related grade 3 or higher diarrhea, atrial fibrillation/flutter or severe bleeding in this study. These results support orelabrutinib as a better selection for BTKi therapy for r/r MCL patients."

Pooled Analysis of Safety Data from Clinical Trials of Orelabrutinib Monotherapy in Hematologic Malignancies

Abstract Number: 1140

Safety data of 266 patients from the five ongoing orelabrutinib monotherapy studies were pooled and analyzed.

Orelabrutinib was observed to have a lower frequency of BTK off-target related adverse events, such as atrial fibrillation/flutter and diarrhea, compared with other BTK inhibitors. Among all 266 patients, one patient was reported with one episode of transient grade 1 atrial fibrillation, and no grade ≥3 atrial fibrillation was observed. One case (0.4%) was reported as grade 3 diarrhea. The second primary malignancies were reported in one patient (0.4%) with r/r MCL. Most of the adverse events occurred early in treatment and the frequency of new event occurrence was significantly decreased during the later cycles.

Dr. Song said, "Orelabrutinib shows good safety profile in long-term treatment. These data suggest that orelabrutinib may be a favorable treatment choice as a single agent for B-cell malignancies."

About Orelabrutinib

Orelabrutinib is a selective BTK inhibitor under development for the treatment of cancers and autoimmune diseases. Currently, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies. Current clinical data have demonstrated orelabrutinib’s robust efficacy and safety profile. Orelabrutinib’s two indications have been included in priority review by the NMPA.