SUZHOU, China, and ROCKVILLE, MD, US, June 7, 2021—Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today released updated results from the first-in-human study of the Bcl-2 inhibitor lisaftoclax (APG-2575) in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) and other hematologic malignancies. The findings were reported in an oral presentation at the 57th American Society of Clinical Oncology (ASCO) Annual Meeting.
As one of the Chinese biotechnology companies that have been increasingly visible at international scientific congresses in recent years, Ascentage Pharma has entered the fourth year in which its clinical advances have been selected for presentations at the ASCO Annual Meeting. This year, results from four of the company’s clinical trials were selected for presentations at the meeting, and of these data, the two oral presentations have received widespread and avid interest from research and medical communities. Updated data on lisaftoclax have demonstrated favorable preliminary safety and efficacy, including an objective response rate (ORR) of 80% and a favorable tolerability profile, with manageable adverse events (AEs) in patients with R/R CLL/SLL. Moreover, no dose-limiting toxicity (DLT) was observed at the maximum tested dose of 1,200 mg. The maximum tolerated dose (MTD) has not been reached, and no laboratory or clinical tumor lysis syndrome (TLS) has been reported.
Dr. Asher Chanan-Khan, MD, of Mayo Clinic, and the Global Principal Investigator of this study, commented: “Lisaftoclax is a potent, selective Bcl-2 inhibitor which can both induce apoptosis and inhibit tumor cell growth. In this first-in-human study in the US and Australia, lisaftoclax showed a favorable safety profile and promising antitumor activity in patients with R/R CLL/SLL, and potential disease control in several other hematologic malignancies. In view of the preliminary safety and clinical activity observed in this Phase I study, we look forward to further evaluating the antitumor activity of lisaftoclax in individual hematologic malignancies and solid tumors.”
“The initial objective response rate of 80%, together with a favorable safety profile and no TLS despite a daily dose ramp-up, demonstrated by lisaftoclax in patients with R/R CLL/SLL are particularly encouraging and once again support the best-in-class potential of lisaftoclax,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “At this year’s ASCO Annual Meeting, we have announced results from multiple studies, including that of lisaftoclax, in two oral presentations and two poster presentations. I am very proud of these advances, which attest to Ascentage Pharma’s robust capabilities in global innovation. Moving forward, we will remain committed to our mission of addressing unmet clinical needs in China and around the world, and strive to accelerate our clinical programs in the hope of soon benefitting patients.”
An overview of the four abstracts presented at the 2021 ASCO Annual Meeting:
|Drug Candidate||Abstract Title||Abstract #||Format|
|First-in-human study of lisaftoclax (APG-2575), a novel Bcl-2 inhibitor (Bcl-2i), in patients (pts) with relapsed/refractory (R/R) CLL and other hematologic malignancies (HMs)||7502||Oral
|Preliminary results of a phase II study of alrizomadlin (APG-115), a novel, small-molecule MDM2 inhibitor, in combination with pembrolizumab in patients (pts) with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic (I-O) drugs||2506||Oral
|Trial in progress: A phase I/II trial of novel MDM2 inhibitor alrizomadlin (APG-115), with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma||TPS6094||Poster
|Trial in progress: A multicenter phase Ib/II study of pelcitoclax (APG-1252) in combination with paclitaxel in patients with relapsed/refractory small-cell lung cancer (R/R SCLC)||TPS8589||Poster
Highlights of the oral presentation on lisaftoclax at this year’s ASCO Annual Meeting:
First-in-human study of lisaftoclax (APG-2575), a novel Bcl-2 inhibitor (Bcl-2i), in patients (pts) with relapsed/refractory (R/R) CLL and other hematologic malignancies (HMs)
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 6855.HK.
Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Olverembatinib (HQP1351), the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA. A New Drug Application (NDA) for olverembatinib has been submitted and subsequently granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) in China. To date, Ascentage Pharma has obtained a total of 11 ODDs from the US FDA for 4 of the company’s investigational drug candidates.
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