Data of InnoCare's Robust Hemato-Oncology Pipelines Presented at the European Hematology Association (EHA) 2025 Congress
BEIJING--(BUSINESS WIRE)--Latest data of InnoCare's (HKEX: 09969; SSE: 688428) robust oncology pipelines were presented at the ongoing European Hematology Association (EHA) 2025 Congress.
First presentation of the efficacy and safety data for first-line treatment of CLL/SLL with BCL2 inhibitor Mesutoclax in combination with BTK inhibitor orelabrutinib
Poster Presentation:
1. First Presentation of Efficacy and Safety Data for First-Line Treatment of CLL/SLL with BCL2 Inhibitor Mesutoclax in Combination with BTK Inhibitor Orelabrutinib (Abstract No.: PS1567)
The study showed that mesutoclax (100 and 125 mg) in combination with orelabrutinib was safe and well tolerated in patients with treatment naïve (TN) CLL/SLL. Substantial efficacy was observed, with early high undetectable MRD (uMRD) rate.
42 patients with TN CLL/SLL were enrolled (mesutoclax 100 mg, n=21; 125 mg, n=21). The fixed-duration treatment of mesutoclax in combination with orelabrutinib is expected to deliver deeper remissions for TN CLL/SLL patients. In all patients, the overall response rate (ORR) was 97.6%.
At week 24 of the combination therapy, in the 125 mg dose cohort, the overall response rate (ORR) was 100%, the complete remission rate (CRR) was 23.8%, the CRR in target lesions was 57.1%, and the peripheral blood (PB) uMRD rate was 48%. In the 100 mg mesutoclax dose cohort, the ORR was 95.2%, the CRR was 19.0%, the CRR in target lesions was 42.9%, and the PB uMRD rate was 19%. With the extension of the duration of treatment, the therapeutic efficacy is expected to be further improved.
All patients are still on treatment. No disease progression or death occurred, and no adverse events leading to discontinuation of treatment were reported.
Due to its favorable efficacy and safety profile, a registrational Phase III clinical study of mesutoclax (125 mg once daily) in combination with orelabrutinib for the treatment of TN CLL/SLL patients has been initiated, with patient enrollment being accelerated.
2. Orelabrutinib Combined with Bendamustine-Rituximab or Obinutuzumab followed by Orelabrutinib Maintenance in Untreated Marginal Zone Lymphoma (OPTIMIZE): A Multicenter, Single-Arm, Phase II Study (Abstract No.: PF898)
The absence of a standard first-line treatment for marginal zone lymphoma (MZL) have inspired the exploration of novel regimens. In recent years, Bruton's tyrosine kinase inhibitors (BTKis) have demonstrated durable responses with a favorable benefit-risk profile across all MZL subtypes in the relapsed/refractory setting. Orelabrutinib is a novel BTK inhibitor with higher selectivity and fewer off-target than other BTK inhibitors. Orelabrutinib combined with bendamustine-rituximab or obinutuzumab followed by orelabrutinib maintenance was effective and well-tolerated in untreated patients with MZL.
The majority of patients presented with MALT lymphoma and had Ann Arbor stage II-IV disease. At the end of induction treatment, the overall response rate (ORR) was 100.0% among all enrolled patients. At the data cutoff, the median progression-free survival (PFS) and overall survival (OS) remained immature. No BTK inhibitor-related adverse events (AEs), such as atrial fibrillation or bleeding, were observed.
3. The Rationality, Efficacy and Safety of Orelabrutinib plus Obinutuzumab (O2) in Systemic Treatment-naïve Marginal Zone Lymphoma: A Prospective Cohort Study (Abstract No.: PS1902)
The Orelabrutinib plus Obinutuzumab regimen had well rationality and demonstrated promising efficacy.
Across the entire study and during the period of induction therapy, the best objective response rate (ORR) was 100%. 3 patients who achieved partial response (PR) after the induction therapy subsequently achieved complete response (CR) in the maintenance period. The 18-month progression-free survival (PFS) and overall survival (OS) rates were both 100%.
4. Ultra-low Dose Radiotherapy Combined with Orelabrutinib Improves the Complete Response Rate of Treatment for Localized Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma (Abstract No.: PS1901)
The combination of ultra-low dose radiotherapy and orelabrutinib in the treatment of ocular adnexal extranodal marginal zone lymphoma (OA-EMZL) not only improves the effectiveness of treatment but also significantly reduces the toxic effects of radiotherapy, providing a new approach for the treatment of localized OA-EMZL.
Of all the 17 patients who completed treatment, 16 patients achieved complete response (CR) and one patient achieved a partial response. Additionally, the lesions in the patients still undergoing treatment have shrunk compared to before treatment.
5. Orelabrutinib plus Bendamustine-Rituximab (OBR) versus Bendamustine-Rituximab (BR) in Transplant-ineligible, Intermediate- to High-risk Mantle Cell Lymphoma (MCL) (Abstract No.: PS1969)
This open-label, randomized, multi-center study aims to compare the efficacy and safety of Orelabrutinib plus Bendamustine-Rituximab versus Bendamustine-Rituximab in transplant-ineligible, intermediate- to high-risk mantle cell lymphoma (MCL) patients. Early data suggest that Orelabrutinib plus Bendamustine-Rituximab could reduce disease progression events compared to Bendamustine-Rituximab in high-risk MCL. Updated outcomes on efficacy, safety, and biomarker analysis will be reported.
6. Pomalidomide, Rituximab, Orelabrutinib, and MiniCHOP-like (PRO-miniCHOP) in Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma: Updated Results from a Phase II Study (Abstract No.: PF950)
The results further support Pomalidomide, Rituximab, Orelabrutinib, and MiniCHOP-like (PRO-miniCHOP) as a potential treatment option for elderly patients with diffuse large B-cell lymphoma (DLBCL), demonstrating promising efficacy and acceptable safety, especially for those who responded to the Pomalidomide-Rituximab-Orelabrutinib (PRO) induction therapy.
A total of 32 patients were enrolled in this study, of whom 26 patients completed ≥3 cycles of the PRO-miniCHOP, resulting in a complete response rate (CRR) of 65.4% and overall response rate (ORR) of 100.0%. Among the 21 patients who completed the full 6-cycle therapy with PRO-miniCHOP, both the CRR and ORR were 95.2%. At a median follow-up of 15.6 months, the median progression-free survival (PFS) and overall survival (OS) had not yet been reached, with the 2-year PFS and OS rates being 94.7% and 100.0%, respectively.
7. Orelabrutinib Addition to R-CHOP-like Regimen Adapted to Response in Treatment-Naïve Non-GCB DLBCL: Update Results of Orient Study (Abstract No.: PS1943)
In non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL) patients who responded to orelabrutinib plus rituximab (OR) induction, orelabrutinib plus R-CHOP-like (OR-CHOP) exhibited favorable antitumor activity and manageable safety. Update results further support the orelabrutinib plus R-CHOP-like therapy as an option in this disease.
At end of 6-cycle orelabrutinib plus R-CHOP-like, response (all 100%) was independent of double-expressing lymphoma (DEL), extranodal involvement (EI), and Lymphgen subtypes. No off-target-related cardiac toxicities occurred.
8. Primary Efficacy and Safety of First-line R-MTO Regimen (Rituximab, Methotrexate, Thiotepa, and Orelabrutinib) followed by Autologous Hematopoietic Stem Cell Transplantation in PCNSL (Abstract No.: PF966)
The Rituximab, Methotrexate, Thiotepa, and Orelabrutinib (R-MTO) induction treatment has demonstrated notable efficacy in achieving higher response rate among patients with newly diagnosed primary central nervous system lymphoma (PCNSL), with a manageable safety profile.
At the data cutoff, all patients had completed four cycles of induction therapy, and the complete response (CR) rate and overall response rate (ORR) were 93.34% and 96.67%, respectively. The 12-month progression-free survival (PFS) and overall survival (OS) rates were 82.26% and 85.33%, respectively.
9. Orelabrutinib, Rituximab Combined with High-Dose Methotrexate as Induction Therapy in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: PS1917)
This study demonstrated the promising efficacy of the Orelabrutinib, Rituximab Combined with High-Dose Methotrexate induction regimen in newly diagnosed primary central nervous system lymphoma (PCNSL), with encouraging response rates and durable progression-free survival (PFS). The regimen also showed promising overall survival (OS) trends, highlighting its potential as an effective treatment. Treatment-related adverse events (TRAEs) were manageable, and no severe BTK inhibitor-related off-target toxicities (e.g., atrial fibrillation/flutter) were observed. These findings suggest that the Orelabrutinib, Rituximab Combined with High-Dose Methotrexate regimen is a well-tolerated and effective therapeutic option for PCNSL.
Except the above poster presentations, more than 10 studies were also selected as poster presentations or online publications at the meeting. For more detailed clinical data, please refer to EHA website.
About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
InnoCare Forward-looking Statements
This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
16 hours ago
- Business Wire
Cerus Corporation Celebrates World Blood Donor Day 2025
CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) is proud to announce its celebration of World Blood Donor Day 2025. In 2005, the World Health Assembly designated June 14th as World Blood Donor Day to recognize and thank blood donors across the world for their important contributions to the global blood supply. This year's theme, 'Give blood, give hope: together we save lives' is a reminder that hope is something we can all share. Cerus is proud to promote blood safety and expand donor eligibility, helping more people give, and more people receive the transfusions they need. The Company salutes the individuals, communities, and countries working together to make blood safety and availability a reality. 'A safe and reliable blood supply remains a cornerstone of every effective healthcare system around the globe, and one that would not be possible without the countless individuals that donate their time and blood. World Blood Donor Day is an opportunity to thank these individuals and to raise public awareness of the ongoing need for additional blood donations,' said Obi Greenman, Cerus' President and Chief Executive Officer. 'I am proud that Cerus is leading the development of pathogen reduction technologies for transfused blood components to help enable our blood center customers to deliver safe and effective blood components to patients.' According to the World Health Organization (WHO), more than 118.5 million blood donations are collected annually around the world, with 40% of these donations collected in high-income countries that account for only 16% of the global population. A wide variety of patients regularly receive blood transfusion, including cardiovascular surgery, transplant surgery, massive trauma, cancer, obstetric, and childhood anemia patients. 1 In recognition of World Blood Donor Day, Cerus hosted a blood drive earlier this week at its company headquarters and encourages everyone to participate in supporting blood product availability in their local communities. 1. ABOUT CERUS Cerus Corporation is dedicated solely to safeguarding the world's blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. In the U.S., the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the U.S. For more information about Cerus, visit and follow us on LinkedIn. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
Yahoo
16 hours ago
- Yahoo
Cerus Corporation Celebrates World Blood Donor Day 2025
CONCORD, Calif., June 13, 2025--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) is proud to announce its celebration of World Blood Donor Day 2025. In 2005, the World Health Assembly designated June 14th as World Blood Donor Day to recognize and thank blood donors across the world for their important contributions to the global blood supply. This year's theme, "Give blood, give hope: together we save lives" is a reminder that hope is something we can all share. Cerus is proud to promote blood safety and expand donor eligibility, helping more people give, and more people receive the transfusions they need. The Company salutes the individuals, communities, and countries working together to make blood safety and availability a reality. "A safe and reliable blood supply remains a cornerstone of every effective healthcare system around the globe, and one that would not be possible without the countless individuals that donate their time and blood. World Blood Donor Day is an opportunity to thank these individuals and to raise public awareness of the ongoing need for additional blood donations," said Obi Greenman, Cerus' President and Chief Executive Officer. "I am proud that Cerus is leading the development of pathogen reduction technologies for transfused blood components to help enable our blood center customers to deliver safe and effective blood components to patients." According to the World Health Organization (WHO), more than 118.5 million blood donations are collected annually around the world, with 40% of these donations collected in high-income countries that account for only 16% of the global population. A wide variety of patients regularly receive blood transfusion, including cardiovascular surgery, transplant surgery, massive trauma, cancer, obstetric, and childhood anemia patients.1 In recognition of World Blood Donor Day, Cerus hosted a blood drive earlier this week at its company headquarters and encourages everyone to participate in supporting blood product availability in their local communities. 1. ABOUT CERUS Cerus Corporation is dedicated solely to safeguarding the world's blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. In the U.S., the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the U.S. For more information about Cerus, visit and follow us on LinkedIn. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation. View source version on Contacts Tim Lee – Head of Investor RelationsCerus Corporation925-288-6128 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
19 hours ago
- Yahoo
Breast Cancer Canada Applauds Federal Commitment to Modernize Preventive Health Guidelines
Inclusion of experts, patient voices, and equity-focused policy reflects priorities long championed by Breast Cancer Canada TORONTO, June 13, 2025--(BUSINESS WIRE)--Breast Cancer Canada proudly celebrates the federal government's response to the External Expert Review (EER) of the Canadian Task Force on Preventive Health Care, and the sweeping reforms it recommends to ensure preventive health guidance in Canada is more equitable, expert-informed, and responsive to real-world care. "These systematic changes will save lives," said Kimberly Carson, CEO of Breast Cancer Canada. "We commend Canada's Federal Health Minister Marjorie Michel for making this a priority so early in her mandate, and we thank former Health Minister Mark Holland for working so closely with Breast Cancer Canada during his tenure. This milestone reflects years of dedicated advocacy. Bringing expert voices into task force decision-making is a long-overdue step toward ensuring that both science and lived experience shape public policy for Canadians." The EER outlines recommendations, including stronger integration of subject matter experts, patient and public voices, and structured provincial input in guideline development. For Breast Cancer Canada and the REAL Canadian Breast Cancer Alliance—a national coalition of breast cancer experts—the report validates their persistent calls to reform how health guidance is developed and delivered in Canada. It also affirms that advocacy works: the federal government listened to patients and advocates calling for change. This report embodies the transformative shift Breast Cancer Canada has relentlessly advocated for: expert-led, patient-centred, and equity-driven care informed by Canadian data and research. It signals a new era in Canadian breast cancer policy, one grounded in a national commitment to access for all. "This report is a breakthrough," said Kimberly Carson, CEO of Breast Cancer Canada. "It recognizes that science and lived experience must work together to shape public health guidance. These recommendations reflect what Breast Cancer Canada, researchers, clinicians, and patients have been saying for years." Founded by Breast Cancer Canada in 2023, REAL Canadian Breast Cancer Alliance brings together leading clinicians, patient advocates and data from across the country to advance evidence-based, equitable, and patient-informed breast cancer care. REAL Alliance was established to ensure that the latest research reaches patients faster and to help establish equitable, national standards of care for breast cancer. Breast Cancer Canada is actively addressing the critical gap in Canadian-specific data by collecting and analyzing breast cancer outcomes across all stages and subtypes, with a focus on race, age, and geographic location. "We are especially encouraged to see a formal shift toward expert engagement," said Shaniah Leduc, Chair of Breast Cancer Canada's Board of Directors. "Guidelines that impact patient outcomes must include disease-specific expertise. It's not just about input—it's about equity and access. Science moves quickly, and lives are affected when guidelines lag behind. A commitment to living guidelines ensures Canadians benefit from the most current knowledge in real-time." "As someone whose survival depended on timely diagnosis and access to targeted treatment, I know firsthand the power of evidence-based care," said Kim MacDonald, breast cancer survivor and advocate with Breast Cancer Canada. "The recommendations released today are long overdue. Including expert insight and patient experience in national health guidance isn't just the right thing to do—it's what saves lives. My story could have ended differently without access to the testing and treatment I needed. Every Canadian deserves equity and access." As the report notes, current guideline development in Canada is fragmented and often lacks the flexibility to reflect provincial realities or incorporate diverse forms of knowledge. The recommendations call for a pan-Canadian coordination hub and better integration with provincial screening programs, quality councils, and implementation bodies. "When evidence, expert insight, and lived experience come together, patients benefit," Carson added. "We look forward to seeing these recommendations put into action and continuing our role in ensuring breast cancer care is equitable, evidence-based, and patient-informed." Key Takeaways from the External Expert Review of Canada's Preventive Health Guidelines: Formal inclusion of clinical subject matter experts in the Task Force's working groups to strengthen evidence interpretation and disease-specific expertise Structured engagement of patients and community members, particularly from underrepresented groups, to bring real-world lived experience into national guideline development Equity-focused topic selection and public accountability, ensuring preventive guidance addresses the realities of all people in Canada, especially those from equity-denied populations Contextualizable and coordinated guidelines, enabling provinces and territories to implement evidence-based recommendations in a way that fits their own systems and structures A phased transition to living guidelines, so recommendations keep pace with science and practice in real-time Breast Cancer Canada remains a committed partner in this modernization effort, with ongoing investments in personalized screening research and the REAL Alliance—a multi-disciplinary expert body established to accelerate breast cancer progress through national collaboration. Breast Cancer Canada is a national charity dedicated to saving lives through science. Focused exclusively on breast cancer research, Breast Cancer Canada funds programs that advance earlier detection, better treatment, and improved outcomes for everyone affected by the disease. For more information, visit About Breast Cancer Canada Breast Cancer Canada is a national charity focused exclusively on breast cancer research, education, and awareness. Dedicated to advancing science that leads to earlier detection, more precise treatments, improved access to care, and better outcomes, the organization ensures that lived experience is reflected in research priorities. With no government funding, all progress is made possible through the generosity of donors. To learn more, visit About REAL Canadian Breast Cancer Alliance REAL (Research Excellence + Active Leadership) Canadian Breast Cancer Alliance is a national coalition of clinical and academic experts driving improvements in breast cancer care. Formed in 2023 by Breast Cancer Canada, REAL Alliance produces annual evidence-based clinical recommendations through a structured, consensus-driven process that reflects the latest in research and innovation. REAL Alliance is committed to advancing national standards of care and ensuring all Canadians benefit from the best available science. To learn more, visit View source version on Contacts Media Megan DunscombeBreast Cancer Canadamdunscombe@
