ASCENTAGE PHARMA GROUP to Unveil Multiple Clinical Advancements at 2026 ASCO Annual Meeting

Stock News05-22

ASCENTAGE PHARMA GROUP announced that abstracts for six of its clinical studies selected for presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting have been published on the ASCO website. Among the six selected studies, three have been chosen for rapid oral presentations and three for poster presentations. The studies involve three key drug candidates: olverabatini (HQP1351), the first third-generation BCR-ABL inhibitor approved for marketing in China (brand name: Nailike®); lisatocla (APG-2575), the first domestically developed and approved Bcl-2 selective inhibitor in China (brand name: Lishengtuo®); and the MDM2-p53 inhibitor alrizomadlin (APG-115). The 2026 ASCO Annual Meeting will be held in a hybrid format from May 29 to June 2, 2026 (US local time) at the McCormick Place Convention Center in Chicago, Illinois. The annual ASCO meeting is the world's most important and authoritative academic conference in the field of oncology, showcasing the latest international clinical oncology research and treatment technologies.

The core information from ASCENTAGE PHARMA GROUP's abstracts selected for the 2026 ASCO meeting is as follows:

**Olverabatini (HQP1351) combined with blinatumomab for patients with lymphoid blast phase chronic myeloid leukemia (CML-LBP) or Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (Ph+ BCP-ALL).** Core Highlights: This multicenter, open-label Phase Ib study explored the combination of olverabatini and blinatumomab in patients with relapsed/refractory (R/R) Ph+ BCP-ALL or CML-LBP. Among five patients who were enrolled with positive measurable residual disease (MRD) and not in complete remission (CR), four achieved CR, and two achieved MRD negativity. The overall safety profile was manageable. This study is the first to validate the feasibility of combining olverabatini with immunotherapy in CML-LBP and R/R Ph+ BCP-ALL in an international patient population.

**Updated efficacy and safety data of olverabatini (HQP1351) as a second-line treatment for patients with chronic phase chronic myeloid leukemia (CP-CML).** Core Highlights: This was a single-arm, multicenter, open-label study conducted in China, evaluating the efficacy and safety of olverabatini as a second-line treatment. Among 42 evaluable patients, the complete cytogenetic response (CCyR) rate was 91.3%, and the major molecular response (MMR) rate was 60.9% at cycle 24. Among 32 patients who had failed first-line treatment with a second-generation TKI, 81.3% still achieved CCyR, and 50% achieved MMR, with a favorable safety profile. Olverabatini demonstrated good tolerability and high MMR and CCyR rates in CP-CML patients who were resistant/intolerant to first-line TKIs and did not have a T315I mutation.

**Alrizomadlin (APG-115) monotherapy or in combination with lisatocla (APG-2575) for pediatric patients with relapsed/metastatic rhabdomyosarcoma (RMS) or other soft tissue sarcomas (STSs).** Core Highlights: This domestic multicenter clinical trial evaluated the safety and preliminary efficacy of alrizomadlin (APG-115) monotherapy or in combination with lisatocla for heavily pre-treated pediatric patients with relapsed/metastatic rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, and other soft tissue sarcomas. Results showed no dose-limiting toxicities (DLT) in either the monotherapy or combination groups. Adverse events were primarily gastrointestinal and hematological toxicities, with few serious adverse events, no treatment-related deaths, and no treatment discontinuations. Regarding efficacy, one patient with refractory rhabdomyosarcoma in the monotherapy group achieved CR; the combination group achieved an objective response rate (ORR) of 30% and a disease control rate (DCR) of 80%. This regimen demonstrated a manageable safety profile and preliminary antitumor activity in pediatric-related solid tumors, warranting further investigation.

**Latest clinical and translational research results of olverabatini (HQP1351) for patients with succinate dehydrogenase-deficient (SDH-) tumors (Poster Presentation).** Core Highlights: This study in SDH-deficient tumors evaluated the efficacy of olverabatini in patients with SDH-deficient GIST and paraganglioma. Among 26 patients with SDH-deficient GIST, six (23.1%) achieved a best response of partial response (PR), with a median progression-free survival (PFS) of 25.7 months. Among six patients with SDH-deficient paraganglioma, four patients achieved a best response of stable disease (SD) lasting ≥4 cycles (clinical benefit rate, CBR, 66.7%), with a median PFS of 8.25 months. This study is the first to elucidate a novel mechanism by which olverabatini inhibits fatty acid-promoted tumor cell migration via the p38-CD36 pathway, providing a new therapeutic approach for SDH-deficient tumors.

**Phase III clinical study of olverabatini (HQP1351) for patients with chronic phase chronic myeloid leukemia: Ongoing POLARIS-2 trial (Poster Presentation).** Core Highlights: POLARIS-2 is a global, multicenter, randomized, open-label Phase III registration study, approved by the FDA and EMA, designed to evaluate the efficacy of olverabatini in patients with chronic phase CML. The study consists of two independent cohorts. Part A will randomize chronic phase CML patients who have received at least two prior TKIs in a 2:1 ratio to either the olverabatini group or the bosutinib group. Part B is a single-arm study evaluating the efficacy of olverabatini in patients carrying the T315I mutation. The primary endpoint for both parts is the major molecular response rate at 24 weeks.

**Global multicenter, open-label, randomized, Phase III registration clinical study of lisatocla (APG-2575) for previously treated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): Ongoing GLORA trial (Poster Presentation).** Core Highlights: GLORA is a global, multicenter, open-label Phase III registration study. The study aims to evaluate the efficacy and safety of lisatocla in combination with a BTK inhibitor in CLL/SLL patients who have not achieved complete remission and have no disease progression after ≥12 months of BTK inhibitor monotherapy. The study plans to enroll approximately 440 patients across 126 centers in 18 countries and is currently recruiting.

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