ASH 2024 Highlights: Olverembatinib Shows Promise for CML Treatment
At the 66th American Society of Hematology (ASH) Annual Meeting in San Diego, Ascentage Pharma unveiled promising data regarding olverembatinib, a novel treatment for chronic myeloid leukemia (CML) patients who show resistance to standard therapies like ponatinib or asciminib.
Olverembatinib (HQP1351) is an investigational drug positioned as a next-generation tyrosine kinase inhibitor (TKI) designed to target CML, particularly in patients with limited treatment options. It stands out as the first third-generation BCR-ABL inhibitor approved in China for CML patients who are resistant to or intolerant of earlier TKIs. With each passing year, olverembatinib's presence at ASH has solidified, marking its seventh consecutive year of presentations, demonstrating consistent interest and advancements in its clinical evaluations.
The new data presented at this year's ASH conference came from a follow-up study that tracked the effectiveness of olverembatinib over a 1.5-year period. Conducted under the guidance of leading hematology experts, including Prof. Hagop Kantarjian and Prof. Elias Jabbour from The University of Texas MD Anderson Cancer Center, the study aimed to determine the drug’s efficacy in heavily pretreated patients with chronic-phase CML (CP-CML). Results indicated strong, durable, and consistent antileukemic activity in this patient cohort, which previously had limited options.
As of the data cut-off on July 28, 2024, 67 patients were enrolled in the study. Their median age was 50, and the follow-up period for these patients was 74.3 weeks. Notably, the results showed that 58.3% of evaluable patients achieved a complete cytogenetic response (CCyR), while 45.3% accomplished a major molecular response (MMR). In patients specifically resistant to ponatinib, 53.6% achieved CCyR, and among those resistant to asciminib, 37.5% achieved CCyR.
Moreover, data indicated that olverembatinib displayed favorable tolerability profiles, with 93.9% of recipients experiencing treatment-emergent adverse events (TEAEs), highlighting its potential as a manageable treatment option for difficult cases of CML.
The results underscore the promise of olverembatinib to address unmet needs in CML therapy, particularly for patients who have previously struggled with multiple lines of treatment. Dr. Yifan Zhai, the Chief Medical Officer at Ascentage Pharma, expressed optimism about the drug's future, emphasizing its potential benefits for patients worldwide as the global Phase III trial progresses, having recently gained FDA clearance.
Overall, the advancements in olverembatinib's clinical development are set to bring hope to patients battling chronic myeloid leukemia with limited treatment options. The strong response rates noted in heavily pretreated populations reaffirm the need for continued research and commitment to developing effective therapies for those in need.
Background on Olverembatinib
Olverembatinib (HQP1351) is an investigational drug positioned as a next-generation tyrosine kinase inhibitor (TKI) designed to target CML, particularly in patients with limited treatment options. It stands out as the first third-generation BCR-ABL inhibitor approved in China for CML patients who are resistant to or intolerant of earlier TKIs. With each passing year, olverembatinib's presence at ASH has solidified, marking its seventh consecutive year of presentations, demonstrating consistent interest and advancements in its clinical evaluations.
Study Overview
The new data presented at this year's ASH conference came from a follow-up study that tracked the effectiveness of olverembatinib over a 1.5-year period. Conducted under the guidance of leading hematology experts, including Prof. Hagop Kantarjian and Prof. Elias Jabbour from The University of Texas MD Anderson Cancer Center, the study aimed to determine the drug’s efficacy in heavily pretreated patients with chronic-phase CML (CP-CML). Results indicated strong, durable, and consistent antileukemic activity in this patient cohort, which previously had limited options.
Key Findings
As of the data cut-off on July 28, 2024, 67 patients were enrolled in the study. Their median age was 50, and the follow-up period for these patients was 74.3 weeks. Notably, the results showed that 58.3% of evaluable patients achieved a complete cytogenetic response (CCyR), while 45.3% accomplished a major molecular response (MMR). In patients specifically resistant to ponatinib, 53.6% achieved CCyR, and among those resistant to asciminib, 37.5% achieved CCyR.
Moreover, data indicated that olverembatinib displayed favorable tolerability profiles, with 93.9% of recipients experiencing treatment-emergent adverse events (TEAEs), highlighting its potential as a manageable treatment option for difficult cases of CML.
Conclusions and Future Directions
The results underscore the promise of olverembatinib to address unmet needs in CML therapy, particularly for patients who have previously struggled with multiple lines of treatment. Dr. Yifan Zhai, the Chief Medical Officer at Ascentage Pharma, expressed optimism about the drug's future, emphasizing its potential benefits for patients worldwide as the global Phase III trial progresses, having recently gained FDA clearance.
Overall, the advancements in olverembatinib's clinical development are set to bring hope to patients battling chronic myeloid leukemia with limited treatment options. The strong response rates noted in heavily pretreated populations reaffirm the need for continued research and commitment to developing effective therapies for those in need.
Topics Health）
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