Thiotepa

BEIJING, Dec. 09, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that over 20 studies of its novel BTK inhibitor orelabrutinib were presented at the 67th Annual Meeting of the American Society of Hematology (ASH). Orelabrutinib has demonstrated remarkable efficacy and safety in multiple lymphoma studies, including marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), primary central nervous system lymphoma (PCNSL), and diffuse large B-cell lymphoma (DLBCL). Oral Presentation Mid-treatment CSF ctdna and MYD88 clearance outperform PET-CT in predicting response and survival to orelabrutinib-based induction in newly diagnosed PCNSL: A prospective biomarker study (Publication No.: 59) The orelabrutinib, rituximab, and high-dose methotrexate (ORM) induction is effective and well tolerated in newly diagnosed PCNSL. Early cerebrospinal fluid (CSF) ctDNA and MYD88 clearance at mid-treatment offer superior predictive and prognostic value compared to PET-CT. These molecular biomarkers enable real-time risk stratification and may guide early treatment adaptation. Incorporating CSF ctDNA monitoring into clinical workflows has the potential to improve response prediction and long-term outcomes in PCNSL. Post-cycle 6, objective response rate (ORR) was 89.5%, with 78.9% complete response rate (CR). Median time to response was 2.6 months; 2-year duration of response (DoR) 72.4%. Median follow-up was 18.9 months; estimated 2-year progression-free survival (PFS) and overall survival (OS) were 62.5% and 75.2%, respectively. Treatment was generally well tolerated. Poster 1. Preliminary analysis of orelabrutinib combined with obinutuzumab in the treatment of marginal zone lymphoma (Orion Study) (Publication No.: 5379) Orelabrutinib combined with obinutuzumab demonstrated promising antitumor activity in treatment-naïve MZL with no severe toxicities observed. These early results support orelabrutinib combined with obinutuzumab regimen as a potential chemotherapy-free first-line option for MZL. Among 27 efficacy-evaluable patients: 25 patients completed interim assessment: ORR 96.0%, CR rate 72.0%; 10 patients completed 6 cycles assessment: ORR 100%, CR rate 70.0%. 2. Preliminary study results of orelabrutinib in combination with rituximab for treatment-Naïve marginal zone lymphoma: A prospective single-arm clinical trial (Publication No.: 3580) Orelabrutinib combined with rituximab demonstrates promising preliminary efficacy in treatment-naïve MZL patients who failed or were unsuitable for local therapy, with an ORR of 81.8% and a CRR of 72.7%. Despite current limitations of small sample size and short median follow-up, the orelabrutinib in combination with rituximab regimen represents a promising chemotherapy-free option for these patients. 3. Orelabrutinib plus bendamustine-rituximab (OBR) versus bendamustine-rituximab (BR) in transplant-ineligible, intermediate- to high-risk Mantle Cell Lymphoma (MCL) (Publication No.: 3599) The orelabrutinib plus bendamustine-rituximab regimen demonstrated a promising tumor response and favorable survival outcomes compared to the bendamustine-rituximab regimen. These findings suggest that the OBR regimen may serve as a promising treatment option for patients with transplant-ineligible, intermediate- to high-risk MCL. 4. Practice pattern and outcomes in DLBCL by Genetic Subtypes: Preliminary results from a large-scale real-world study in China (Publication No.: 3689) This large-scale real-world study provides treatment patterns and outcomes across DLBCL genetic subtypes in China. Rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) plus BTKi demonstrated enhanced efficacy in MCD-like patients, supporting subtype-directed therapy. Updated survival and safety data will be presented. R-CHOP plus orelabrutinib achieved a CR rate of 81.4% in MCD-like subgroup. 5. Pomalidomide, rituximab, and orelabrutinib in combination with polatuzumab vedotin for newly diagnosed diffuse large B-cell lymphoma in elderly, unfit, or frail patients: a prospective phase II study (Publication No.: 1912) The preliminary results suggest that the PRO-Pola regimen is a potential treatment option for elderly, unfit, or frail patients with DLBCL, exhibiting promising efficacy and an acceptable safety profile - particularly in those who responded to PRO induction therapy. Among the patients completed ≥3 cycles of treatment, CRR and ORR reached 77.8% and 100.0% respectively. Among the patients who completed all 6 cycles of treatment, both the CRR and ORR reached 100.0%. Publication Only: Efficacy and safety of orelabrutinib monotherapy in patients with chronic lymphocytic leukemia: A retrospective real-world study (Abstract ID: abs25-8605) This real-world study suggested that orelabrutinib monotherapy showed promising efficacy and a favorable safety profile in patients with CLL, both as first-line and subsequent therapy. Patients receiving first-line orelabrutinib achieved both an ORR and DCR of 100%. More studies on orelabrutinib have been selected for poster presentation and publication only at the 2025 ASH Annual Meeting. The other studies selected for poster presentation are as follows: Efficacy and safety of orelabrutinib, obinutuzumab, and lenalidomide in previously untreated marginal zone lymphoma: Preliminary results from a prospective, single-arm, multicenter, Phase II study (Publication No.: 5383)Orelabrutinib combined with bendamustine-rituximab or obinutuzumab followed by orelabrutinib maintenance in untreated marginal zone lymphoma (Optimize): A multicenter, single-arm, phase II study (Publication No.: 3596)Real-world efficacy and safety of orelabrutinib-based regimens in the treatment of marginal zone lymphoma (Publication No.: 1817)Single-cell transcriptomic profiling reveals tumor-intrinsic heterogeneity and immunemicro environment dynamics in the order trial for mantle-cell lymphoma (Publication No.: 1792)Orelabrutinib combined with R-CDOP regimen for first-line treatment of diffuse large Bcell lymphoma with high-risk CNS-IPI (Publication No.: 5460)Preliminary result of first-line orelabrutinib plus R-CHOP in CD5-positive diffuse large B-cell lymphoma (Rocket trial): A single-arm, phase II trial (Publication No.: 3690)Exploration of optimal high-dose methotrexate-based therapy for patients with primary CNS lymphoma: A real-world study in China (Publication No.: 3693)Chemotherapy-free induction with pomalidomide, orelabrutinib, and rituximab (POR) followed by high-dose methotrexate,rituximab and orelabrutinin (ROM) in newly diagnosed primary CNS lymphoma: Interim analysis of a phase II study (Publication No.: 5471)Orelabrutinib plus anti-PD-1 antibody and fotemustine for newly diagnosed primary central nervous system lymphoma: Phase I/II results (Publication No.: 5465)Orelabrutinib, rituximab, and thiotepa (ORT) in combination with or without high-dose methotrexate in untreated primary central nervous system lymphoma (Publication No.: 1911)Primary efficacy and safety of first-line R-MTO regimen (rituximab, methotrexate, thiotepa, and orelabrutinib) followed by autologous hematopoietic stem cell transplantation in PCNSL (Publication No.: 3687)Orelabrutinib, sintilimab, and temozolomide (OST) in relapsed/refractory primary central nervous system lymphoma (Publication No.: 5461) 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. Contact Media InvestorsChunhua Lu 86-10-66609879 86-10-66609999chunhua.lu@innocarepharma.com ir@innocarepharma.com

MENLO PARK, Calif.--(BUSINESS WIRE)--Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced new data presented on its lead investigational allogeneic T-cell immunotherapy, Orca-T, at the 67th American Society of Hematology (ASH) Annual Meeting. Orca-T with Reduced Intensity Conditioning The new results of a single-center, open-label Phase 1 investigator-sponsored trial evaluating Orca-T in patients aged 60-75 (median 68 years) with a reduced intensity conditioning regimen (RIC) for the treatment of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS) and myeloproliferative neoplasm (MPN) showed a low incidence of both acute and chronic graft versus host disease (aGvHD, cGvHD) while maintaining a low rate of disease relapse. “Many older patients with hematological malignancies are not eligible for myeloablative allogeneic stem cell transplant due to the significant toxicities associated with it. A conventional reduced intensity alloHSCT can be safer and more tolerable, but it may also reduce the curative potential,” said Everett Meyer, M.D., Ph.D., hematologist and associate professor of medicine in Blood and Marrow Transplantation and Cellular Therapy at Stanford Health Care. “These early results suggest Orca-T following reduced intensity conditioning may preserve a meaningful graft-versus-leukemia effect while achieving low rates of toxicities, including acute and chronic GvHD. While additional research is needed, these findings support Orca-T as a potentially feasible option for older adults with blood cancer.” Highlighted in an oral session, patients (n=46) with 8/8 matched donors were conditioned with fludarabine/melphalan/total body irradiation (TBI) (n=11) or fludarabine/thiotepa/TBI (n=12). Conditioning was further reduced where 23 patients were enrolled in a cohort eligible for outpatient treatment. Also included in the analyses was a cohort of patients (n=7) with 7/8 matched donors receiving fludarabine/thiotepa/TBI. All patients (n=53) had successful neutrophil engraftment at a median of 15 days (range 9-39). At one year, there was no aGvHD grade 3-4 observed, and the rate of aGvHD grade 2 was 12.3% (95% CI, 5-23%). The rate of moderate-to-severe cGvHD was 9.6% (95% CI, 3-21%). At one year, relapse-free survival (RFS) and graft versus host disease relapse-free survival (GRFS) were 82% (95% CI, 72-94%) and 72% (95% CI, 60-87%), respectively. The overall survival (OS) was 88% (95% CI, 79-98%) and non-relapse mortality (NRM) was 10% (95% CI, 4-20%). The outpatient-eligible cohort experienced NRM of 0%, RFS of 80% (95% CI, 65-100%) and OS of 95% (95% CI, 87-100%). “We are energized by these new data, which reinforce our belief that Orca-T has the potential to expand curative treatment options to many more people living with serious blood cancers, including those who may not be eligible for a myeloablative transplant today, and even patients treated in the outpatient setting,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. “Our Serene-T Phase 2 study evaluating Orca-T with RIC recently opened for enrollment and is the next step towards understanding if Orca-T may provide a path to treatment for more patients in need of therapeutic options.” New Analyses from the Precision-T Phase 3 Study Retrospective Comparison of Orca-T versus PTCy-Based GvHD Prophylaxis An observational analysis compared a dataset derived from patients who received Orca-T in the Precision-T Phase 3 study (n=45) to a historical PTCy patient cohort (n=475) derived from the Center for International Blood and Marrow Transplant Research (CIBMTR). At one year, OS was 94% with Orca-T compared to 81% with PTCy. RFS was 86% and 70% for Orca-T and PTCy, respectively. There was 0% NRM with Orca-T and 9.7% with PTCy, which achieved statistical significance. There was 13.8% relapse in the Orca-T cohort and 21% in the PTCy cohort. The rate of cGvHD was 14.7% with Orca-T versus 8.2% with PTCy. Of note, the OS in patients over the age of 50 was 100% with Orca-T compared to 75% with PTCy. These outcomes were achieved using only single-agent tacrolimus for pharmacological GvHD prophylaxis for Orca-T recipients, in contrast to the triple-agent regimen used with PTCy, implicating the potential role of immune reconstitution in both disease control and mitigating posttransplant complications. Orca-T Improved GvHD-free Survival Across Patient Demographics In subset analyses from the Precision-T Phase 3 study comparing Orca-T to a conventional alloHSCT plus tacrolimus and methotrexate (Tac/MTX), Orca-T demonstrated improved clinical outcomes overall and across subgroups with varied demographic and clinical features. For all patients, the rate of survival free from cGvHD (cGFS) was 78% and 38% for Orca-T and Tac/MTX, respectively. For patients over the age of 50, the rate of cGFS was 74% and 35% for Orca-T and Tac/MTX, respectively. For all patients, the rate of GRFS was 63% and 31% for Orca-T and Tac/MTX respectively, and 59% and 23% for patients over the age of 50 with Orca-T and Tac/MTX, respectively. Notably, OS and NRM were similar for patients aged 51-65 as in the entire safety population. For patients over the age of 50 at one year, OS was 94% (77%, 98%) for Orca-T patients (n=31) versus 80% (61%, 91%) for Tac/MTX patients (n=32) (HR=0.48 [0.12, 1.89]). Rates of NRM were 6.5% (1.1%, 19%) with Orca-T vs 16% with Tac/MTX (5.7%, 31%) (HR=0.49 [0.11, 2.06]). Together, these data suggest that the results of Orca-T extend to older patients and those with high-risk disease. Health-Related Quality of Life: Patient Reported Outcomes An exploratory endpoint from the Precision-T Phase 3 study evaluating health-related quality of life (HRQoL) and hospitalization patterns showed that Orca-T delivered marked improvements over conventional alloHSCT. Patients receiving Orca-T experienced faster recovery to, and higher improvement above, baseline HRQoL, fewer ICU stays, lower likelihood of rehospitalization and higher rehospitalization-free survival, suggesting better early post-treatment recovery and a lower burden of GvHD symptoms. FACT-BMT total scores were consistently higher for Orca-T recipients across all time points, with Orca-T recipients exceeding baseline scores across physical well-being, functional well-being and transplant-specific subscales by day 100, while the alloHSCT arm did not surpass baseline until day 365. By day 365, Orca-T scores across these domains were higher by a magnitude of two or more compared to the control arm. Rehospitalizations due to adverse events occurred less frequently among Orca-T recipients (27.3% [24] vs. 45.7% [43]), with fewer total hospitalization days per patient (30.6 vs. 40.8). Rehospitalization-free survival at 18 months was also significantly improved with Orca-T, reaching 66.4% (95% CI: 54.0, 76.2) compared to 33.8% (95% CI: 18.5, 49.9) for conventional alloHSCT (p=0.0096; HR 0.53 [0.32, 0.86]). “The additional analyses from our Phase 3 study further highlight Orca-T’s potential superiority across critical measures, from lower rehospitalization rates to improved outcomes in older patients,” said Scott McClellan, M.D., chief medical officer at Orca Bio. “These results continue to strengthen our conviction that Orca-T has the potential to transform the transplant experience and meaningfully raise the standard of care for patients and providers.” The safety and efficacy of Orca-T have not been determined by any regulatory authority. Orca-T is currently being evaluated under Priority Review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026. About Precision-T Precision-T (NCT05316701) is a randomized, open-label multi-center study that evaluated the safety, efficacy and tolerability of Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, compared to conventional allogeneic hematopoietic stem cell transplant (alloHSCT). Orca Bio received guidance from the U.S. Food and Drug Administration on the design of Precision-T, which evaluated Orca-T in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). There are 19 leading treatment centers participating in the trial, which enrolled 187 patients across the U.S. About Orca-T Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026. About Orca Bio Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com. Trademarks or registered trademarks used in this press release are the property of their respective owners.