Ascentage Pharma Announces Olverembatinib Clinical Trial Results
Ascentage Pharma Group announced results from a Phase Ib study evaluating olverembatinib, the company's core product, in combination with bispecific T-cell engager antibody blinatumomab in patients with lymphoid blast phase chronic myeloid leukemia or Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia were presented in a rapid oral presentation at the 2026 American Society of Clinical Oncology, ASCO, Annual Meeting. Key Highlights: Efficacy Data: A total of 91% of patients achieved complete response or complete response with incomplete hematologic recovery. In addition, 67% of patients achieved BCR::ABL1 negativity by PCR, and 80% achieved minimal residual disease, MRD, negativity by flow cytometry. Conclusion: This study is the first to demonstrate the feasibility of olverembatinib combined with immunotherapy in international patients with CML-LBP and R/R Ph+ BCP-ALL.
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- Core Asset Updates: Ascentage Pharma presented 17 clinical updates at EHA2026, including 8 poster presentations, showcasing the latest research progress of its core assets, olverembatinib and lisaftoclax, highlighting the company's global innovation capabilities in hematologic malignancies.
- CML Efficacy: Olverembatinib demonstrated a complete cytogenetic response rate of 76.2% in chronic-phase CML patients, showing deep and durable clinical responses in multi-line TKI-resistant patients, further solidifying its potential as a second-line treatment option.
- ALL Prospects: In newly diagnosed Ph+ ALL patients, the combination of olverembatinib with low-intensity chemotherapy achieved a clinical response rate of 94.4%, indicating its significant application value in frontline therapy.
- Pediatric Study: In pediatric patients with relapsed/refractory Ph+ ALL, the combination of olverembatinib and lisaftoclax showed an overall response rate of 88.9%, suggesting that this chemotherapy-free regimen may provide new treatment options for this population.
- Clinical Trial Results: At the 2026 ASCO Annual Meeting, Ascentage Pharma presented data showing that the combination of olverembatinib and blinatumomab achieved a 91% complete response rate in patients with chronic myeloid leukemia (CML-LBP) and Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (Ph+ BCP-ALL), highlighting the significant efficacy of this treatment regimen.
- Safety Assessment: The combination therapy demonstrated a favorable safety profile, with most adverse events classified as grade 1-2, consistent with the known toxicities of each agent, indicating its feasibility and tolerability in clinical applications, potentially offering new treatment options for difficult-to-treat patients.
- Global Registrational Studies: Ascentage Pharma is conducting three global registrational Phase III trials to evaluate olverembatinib across multiple indications, including newly diagnosed Ph+ ALL and SDH-deficient gastrointestinal stromal tumors (GIST), which will further enhance its positioning in the international market.
- Strategic Partnership Agreement: Ascentage Pharma signed an exclusive option agreement with Takeda, granting Takeda the global rights to develop and commercialize olverembatinib outside of mainland China, Hong Kong, Macau, and Taiwan, which could provide significant market expansion opportunities for the company.
- Clinical Research Showcase: Ascentage Pharma presents six clinical study abstracts at the 2026 ASCO Annual Meeting, with three selected for rapid oral presentations and three for poster sessions, highlighting the company's ongoing innovation in cancer treatment.
- Combination Therapy: In a multicenter Phase Ib study, olverembatinib combined with blinatumomab showed promising results in chronic myeloid leukemia patients, with four out of five patients achieving complete remission, indicating the potential and safety of this combination therapy.
- Pediatric Oncology Study: Research on relapsed rhabdomyosarcoma demonstrated that the combination of alrizomadlin and lisaftoclax resulted in a 30% objective response rate and an 80% disease control rate, offering new hope for pediatric cancer treatment.
- Global Clinical Trials: Ascentage Pharma is conducting the global POLARIS-2 Phase III trial to evaluate olverembatinib's efficacy in chronic-phase chronic myeloid leukemia patients, which is expected to provide critical data for the drug's registration.
- Clinical Advances Showcase: Ascentage Pharma will present 17 clinical advances of its core assets at the 2026 European Hematology Association Congress, including 8 poster presentations, demonstrating the company's research strength and market influence in the hematology field.
- Innovative Therapies Highlighted: The conference will focus on Olverembatinib and Lisaftoclax, with the former being China's first approved third-generation BCR-ABL inhibitor and the latter the first China-developed Bcl-2 selective inhibitor, marking significant breakthroughs in cancer treatment.
- Global Academic Exchange: The EHA Congress gathers hematology professionals worldwide, providing a platform for sharing the latest research and clinical data, and Ascentage's participation will enhance its visibility and influence in the international academic community.
- Future Growth Potential: By showcasing these clinical data, Ascentage Pharma not only attracts potential investors but also lays the groundwork for future FDA registration applications and market promotions, thereby strengthening its competitiveness in the global market.
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- Clinical Study Showcase: Ascentage Pharma presents six clinical study abstracts at the 2026 ASCO Annual Meeting, including three rapid oral presentations and three poster presentations, highlighting its innovative capabilities and clinical value in cancer treatment.
- Drug Candidate Highlights: The showcased drugs include Olverembatinib, the first approved third-generation BCR-ABL inhibitor in China; Lisaftoclax, the first China-developed Bcl-2 selective inhibitor; and Alrizomadlin, an MDM2-p53 inhibitor, demonstrating the company's leadership in oncology.
- Global Recognition: The Chief Medical Officer noted that this marks the ninth consecutive year of presentations at ASCO, reflecting global scientific community recognition of the clinical value of its drug candidates, further advancing its global clinical development agenda.
- Future Development Plans: The company is conducting FDA-cleared global registrational Phase III trials aimed at accelerating the drug approval process to meet urgent patient needs for new treatment options, showcasing its strategic positioning in the global market.







