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A research and development company in the clinical stage dedicated to the development of innovative drugs in the treatment of tumors, hepatitis B and aging-related diseases - Ascent Pharmaceuticals announced that the American Society of Clinical Oncology (ASCO) has announced Bcl-2 inhibitors on its official website today Summary of the first human trial of lisaftoclax (APG-2575) in the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and other hematological malignancies
.
This global phase I clinical study showed that the objective response rate (ORR) of APG-2575 in the treatment of R/R CLL/SLL patients reached 85.
The latest progress of the research will be further demonstrated in the form of an oral report at the ASCO annual meeting to be held from June 4 to 8, 2021
.
This year, Ascent Pharmaceuticals has four clinical studies of three types of apoptosis pipeline selected for the ASCO annual meeting to display and report, including two oral reports
product | Summary | Numbering | form |
lisaftoclax (APG-2575) | 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)
The first human trial of a new Bcl-2 inhibitor APG-2575 in the treatment of patients with R/R CLL and other HMs | 7502 | Oral report |
alrizomadlin (APG-115) | 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 (IO ) drugs
Preliminary results of a phase II clinical study of APG-115 combined with pembrolizumab in patients with unresectable/metastatic melanoma or advanced solid tumors who have failed immuno-oncology drug therapy | 2506 | Oral report |
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
Phase I/II clinical study of APG-115 single agent or combined with platinum chemotherapy in the treatment of p53 wild-type salivary gland carcinoma | TPS6094 | Poster display | |
pelcitoclax (APG-1252) | 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)
APG-1252 combined with paclitaxel in the treatment of relapsed/refractory small cell lung cancer (R/R SCLC) multi-center phase Ib/II clinical study | TPS8589 | Poster display |
“APG-2575 is the second Bcl-2 inhibitor in the world and the first domestic Bcl-2 inhibitor to see a clear effect
.
The data to be presented at the 2021 ASCO annual meeting again shows that APG-2575 is R/R CLL and other hematological malignancies.
The summary of the research of Ascent Pharmaceuticals selected for the 2021 ASCO annual meeting is as follows (two studies on APG-115 are listed in another press release issued at the same time):
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)
The first human trial of a new Bcl-2 inhibitor APG-2575 in the treatment of patients with R/R CLL and other HMs
Presentation format: Oral report
Abstract number: #7502
Time: Beijing time 2021.
6.
7, 23:30-02:30 / US Eastern time 2021.
- This first global phase I clinical study conducted in humans evaluated the safety, pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and maximum efficacy of APG-2575 in patients with R/R CLL and other HMs.
Tolerable dose (MTD)/Recommended dose for phase II study (RP2D)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)
APG-1252 combined with paclitaxel in the treatment of relapsed/refractory small cell lung cancer (R/R SCLC) multi-center phase Ib/II clinical study
Display format: poster display
Abstract number: #TPS8589
Time: Beijing time 2021.
6.
4, 21:00 / US Eastern time 2021.- This is an open-label, multi-center Phase Ib/II study to evaluate the safety and preliminary efficacy of APG-1252 combined with paclitaxel in treated SCLC patients
. - The study took 21 days as a cycle.
APG-1252 was administered intravenously on days 1, 8 and 15, and paclitaxel was administered at a fixed dose of 80 mg/m2 on days 1 and 8
. - The primary endpoints of the Phase Ib study are MTD and RP2D
.
The phase II study uses ORR as the primary endpoint.
The Simon two-phase design will be used to evaluate the efficacy of this combination therapy.
Other research endpoints include PK, progression-free survival and overall survival
. - The study plans to recruit 58 patients
.
As of February 8, 2021, 15 patients have been enrolled
.
- This is an open-label, multi-center Phase Ib/II study to evaluate the safety and preliminary efficacy of APG-1252 combined with paclitaxel in treated SCLC patients