{"id":23598,"date":"2022-12-14T01:41:00","date_gmt":"2022-12-13T17:41:00","guid":{"rendered":"https:\/\/flcube.com\/?p=23598"},"modified":"2025-01-28T01:44:04","modified_gmt":"2025-01-27T17:44:04","slug":"ascentage-pharmas-apg-2575-shows-promising-results-in-global-phase-ii-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=23598","title":{"rendered":"Ascentage Pharma’s APG-2575 Shows Promising Results in Global Phase II Study"},"content":{"rendered":"\n

Suzhou-based Ascentage Pharma (HKG: 6855<\/a>) unveiled preliminary data from the global Phase II clinical study for its APG-2575, alone or combined with Calquence (acalabrutinib) plus rituximab, in recurrent\/refractory (R\/R) chronic lymphocytic leukemia\/small lymphocytic lymphoma (CLL\/SLL). The results were released at the 64th American Society of Hematology (ASH) annual meeting this year.<\/p>\n\n\n\n

Study Enrollment and Patient Demographics<\/strong>
As of December 5, 2022, 164 patients were enrolled in the study. There were 46 patients in the APG-2575 monotherapy group, 39 in the rituximab combination group, and 79 enrolled in the acalabrutinib combination group. In the total population, 16 patients (9.8%) were newly treated, and 19 patients (11.6%) had used BTKi previously. In the combined group (n=118), 25 patients had TP53 mutation and\/or del (17p) and 34 patients had no IGHV mutation. Median treatment time: APG-2575 monotherapy group was 16.5 (1-36) cycles, 11 (0-21) cycles in rituximab combined group, and 11 (1-24) cycles in acalabrutinib combined group.<\/p>\n\n\n\n

Efficacy Results<\/strong>
In the monotherapy group, the ORR of patients reached 67% (29\/43), of which 67% (4\/6) were patients who had previously received BTKi and were refractory or intolerant. In the acalabrutinib combination group, the ORR of patients reached 98.6% (72\/73), including 98% (56\/57) in the relapsed\/refractory population, 100% (16\/16) in the initial treatment population, and 88% (7\/8) in the past BTKi refractory or intolerant patients. In the rituximab combination group, the ORR was 79% (27\/34).<\/p>\n\n\n\n

Safety Profile<\/strong>
Common adverse events (AEs) at any level included granulocytopenia, diarrhea, and infection. No dose-limiting toxicity (DLT) was observed. No drug interaction was found in the combination therapy group.<\/p>\n\n\n\n

APG-2575 Development and Mechanism of Action<\/strong>
APG-2575 is under development to treat a variety of hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. The drug, China’s first homegrown Bcl-2 inhibitor to enter the clinics, is subject to multiple clinical studies in blood tumors.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Suzhou-based Ascentage Pharma (HKG: 6855) unveiled preliminary data from the global Phase II clinical study…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[200,16,17,985],"class_list":["post-23598","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-ascentage-pharma","tag-cancer","tag-clinical-trial-results","tag-hkg-6855"],"yoast_head":"\nAscentage Pharma's APG-2575 Shows Promising Results in Global Phase II Study - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Suzhou-based Ascentage Pharma (HKG: 6855) unveiled preliminary data from the global Phase II clinical study for its APG-2575, alone or combined with Calquence (acalabrutinib) plus rituximab, in recurrent\/refractory (R\/R) chronic lymphocytic leukemia\/small lymphocytic lymphoma (CLL\/SLL). 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