Suzhou, China and Rockville, Maryland, October 23, 2023 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company dedicated to developing new treatments for cancer, chronic hepatitis B (CHB) and age-related diseases, today announced the release of its latest clinical data. Dual Bcl-2/Bcl-xL inhibitor APG-1252 (pelcitoclax) combined with osimertinib in a small oral form for the treatment of patients with EGFR-mutant non-small cell lung cancer (NSCLC) at the 2023 European Society for Medical Oncology (ESMO) Congress.
Pelcitoclax developed by Ascentage Pharma is a potential best-in-class new Bcl-2/Bcl-xL dual inhibitor that can restore cancer cell apoptosis by selectively inhibiting Bcl-2 and Bcl-xL proteins, thereby exerting therapeutic effect. effect. A spectrum of solid tumors and hematologic malignancies.
Clinical data announced at this year’s ESMO Congress showed that Pesitoclax combined with osimertinib has a good therapeutic effect in the treatment of patients with EGFR-mutated NSCLC. The results showed that among 26 patients who had not received EGFR tyrosine kinase inhibitor (TKI) treatment, partial response (PR) was observed in 21 patients, with an objective response rate (ORR) of 80.8%; while in 16 patients with TP53 and Among EGFR-mutated EGFR-TKI-naïve patients, 14 cases of PR were observed, with an ORR of 87.5%.
PhD. Zhai YifanChief Medical Officer, Ascentage Pharma“, said, “There are many challenges in the current treatment of NSCLC. Among them, TP53 and EGFR mutations can significantly affect the prognosis of NSCLC patients, and there is no standard care and treatment for this subtype of NSCLC. At ESMO 2023, we released updated clinical data that continue to demonstrate the encouraging therapeutic potential of pesitoclax plus osimertinib in patients with TP53 and EGFR mutant NSCLC who have not received treatment with EGFR-TKIs.
In early studies, pelcitoclax combined with osimertinib demonstrated clinical potential in the treatment of patients with EGFR-mutated advanced NSCLC who are resistant to EGFR-TKIs. The latest data released this year further enrich the evidence and reveal the clinical potential of combination therapy in patients with third-generation EGFR-TKI resistance.Going forward, we will continue to deliver on our mission to address unmet clinical needs China and accelerate our clinical programs around the world to benefit more patients. “
The key points of the pelcitoclax data announced at the 2023 ESMO Congress are as follows:
Latest study results of Pesitoclax (APG-1252) combined with osimertinib in the treatment of patients with EGFR mutated non-small cell lung cancer (NSCLC)
- Format: mini oral liquid
- Abstract#: 5586
- Date and time: October 22, 2023 (Sunday), 02:30 PM – 02:35 PM (Madrid time)/ October 22, 2023 (Sunday), 08:30 PM – 08:35 PM (Beijing time)
- category: non-small cell lung cancer, metastatic
- emphasize
- This open-label, multicenter, Phase Ib study is ongoing China To evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of pesitoclax combined with osimertinib in patients with EGFR-mutated NSCLC.
- trump card April 21, 2023, 64 patients were enrolled, with a median age of 56 years. For 13 patients entering the dose escalation phase, 160 mg (n=6) and 240 mg (n=7) of pelcitoclax were administered intravenously once weekly (QW); osimertinib was administered orally once daily (QD) at a dose of 80 mg, cycle time is 21 days. After establishing 160 mg as the recommended phase II dose (RP2D) of pelcitoclax, the study enrolled an additional 51 patients into a dose expansion phase, dividing 64 patients into 3 cohorts: Cohort 1 included patients with first-generation EGFR-resistant patients on TKIs (n=8), cohort 2 included patients who were resistant to third-generation EGFR-TKIs (n=29), and cohort 3 included patients who had not previously received EGFR-TKI treatment (n=27).
- Efficacy results: Among 26 efficacy-evaluable patients who had not received EGFR-TKI treatment, 21 partial responses (PR) were observed, with an ORR of 80.8%. Among 16 patients with TP53 and EGFR mutations who did not receive EGFR-TKI treatment, 14 cases of PR were observed, the ORR was 87.5%, and the median progression-free survival (mPFS) was 16.39 months (95%Cl, 8.11-NR) . In addition, preliminary biomarker data from patients resistant to third-generation EGFR-TKIs suggest that combination regimens may prolong PFS in patients with high Bcl-xL expression.
- Safety results: A total of 59 patients (92.2%) experienced treatment-emergent adverse events (TEAEs), of which only 13 (20.3%) experienced grade ≥3 AEs. The most common TEAEs included increased aspartate aminotransferase (68.8%) and alanine aminotransferase (64.1%), decreased platelet count (43.8%), increased serum amylase (29.7%), and increased serum creatinine (28.1%).
- Conclusion: Based on preliminary results, pelcitoclax combined with osimertinib showed good tolerability in patients with EGFR-mutated NSCLC and may improve the prognosis of TP53- and EGFR-mutated NSCLC patients who have not received EGFR-TKIs. Among patients resistant to third-generation EGFR-TKIs, patients with higher Bcl-xL expression achieved better responses. These encouraging findings warrant further clinical investigation.
(Pelcitoclax is an investigational drug and has not been approved for any indication anywhere in the world. )
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company dedicated to developing new treatments for cancer, chronic hepatitis B and age-related diseases.exist October 28, 2019Ascentage Pharmaceuticals is listed on the main board of The Stock Exchange of Hong Kong Limited, 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 established a pipeline of nine clinical candidates, including novel, highly potent Bcl-2 and dual Bcl-2/Bcl-xL inhibitors, as well as candidates targeting the IAP and MDM2-p53 pathways, as well as next-generation tyrosine Acid kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three classes of known key regulators of apoptosis. The company is conducting more than 40 Phase I/II clinical trials in the United States. Australia, Europeand China. Ascentage Pharma has been approved for a number of major national R&D projects, including 5 major new drug projects, 1 new drug incubator, 4 innovative drug projects, and 1 major infectious disease prevention and treatment project.
The company’s core drug candidate for the treatment of drug-resistant chronic myelogenous leukemia (CML) and the company’s first approved product, Olverembatinib, received priority review and breakthrough designation from the National Center for Drug Evaluation (CDE) Therapeutics Approved Medical Products Administration (NMPA). As of now, the drug has been included in the drug catalog. China 2022 National Reimbursement Drug List (NRDL). In addition, olverembatinib has received Orphan Drug Designation (ODD) and Fast Track Designation (FTD) from the US FDA, and Orphan Drug Designation from the EU EMA. As of now, Ascentage Pharma’s four drug candidates have received 16 ODD, 2 FTD, and 2 rare pediatric disease (RPD) designations from the U.S. FDA, as well as 1 orphan drug designation from the EU EMA.
With strong R&D capabilities, Ascentage Pharma owns global intellectual property rights and has established global partnerships with many well-known biotechnology and pharmaceutical companies and research institutions such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, and Dana-Farber Cancer Institute. , MSD and AstraZeneca. The company has built a talented team with global experience in innovative drug discovery and development and is building world-class commercial manufacturing and sales and marketing teams. One of Ascentage Pharma’s core goals is to continuously enhance its research and development capabilities and accelerate clinical development plans to fulfill its mission of solving unmet clinical needs. China and around the world, benefiting more patients.
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Source: Ascentage Pharma
