The American Society of Hematology (ASH) 2022 annual meeting, held online and offline in New Orleans, Louisiana, USA, saw the latest updates from a string of China-based biotechs. Those included CARsgen Therapeutics Holdings Ltd (HKG: 2171), Gracell Biotechnologies Inc (Nasdaq.GRCL), Innovent Biologics Inc., (HKG: 1801), Junshi Biosciences (HKG: 1877, SHA: 688180), and Suzhou Ascentage Pharma Co., Ltd.
CARsgen Therapeutics: Phase II LUMMICAR STUDY 1 for CT053 (zevor-cel)
The Phase I/II study was carried out in patients with relapsed/refractory multiple myeloma in China. In Phase II, 102 patients received 150 × 106 CAR+T cells with CT053 injection. The median age of patients was 59.5 years, the median time of medical treatment history was 3.6 years, and the median number of lines of previous treatment was 4. As of August 16, 2022, 102 patients had completed at least 3 months of follow-up or early withdrawal, with a median follow-up of 9 months. The ORR was 92.2%, VGPR and above remission rate was 85.3%, CR/sCR rate was 45.1%, DOR rate was 86.1%, and PFS rate was 84.6%. The negative rate of MRD was 100% in patients with CR/sCR and 96.3% in patients with VGPR or above. In terms of safety, 102 patients reported treatment-related adverse events (AEs), 38 patients had treatment-related serious adverse events (SAE), and there was no AE leading to injection interruption. The overall tolerability was good, and the safety was controllable.
Gracell Bio: Phase I for BCMA/CD19 Dual-Targeting FasTCAR-T GC012F
The study is designed to assess the safety and efficacy of the drug in transplant-eligible, high-risk, newly diagnosed multiple myeloma (NDMM) patients. As of the October 14, 2022, cut-off date, 16 transplant-eligible NDMM patients had received GC012F infusion in the study. All patients had multiple high-risk features. After receiving a conditioning lymphodepletion regimen of cyclophosphamide and fludarabine, patients were treated with GC012F as a single infusion with one of three dose levels: 1×105 cells/kg, 2×105 cells/kg, and 3×105 cells/kg. Only 25% (4/16) of patients experienced Grade 1-2 cytokine release syndrome (CRS); no patients experienced Grade 3-5 CRS. No immune effector cell-associated neurotoxicity syndrome (ICANS) or other neurotoxicity of any grade had been observed.
Innovent Bio: Phase Ib Update for IBI188 (Anti-CD47 mAb) in Combination with Azacitidine (AZA) in First-Line Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS)
As of the data cut-off date (Oct 20, 2022), 93 treatment-naïve newly diagnosed higher-risk MDS patients received IBI188 (from 0.1 mg/kg priming dose to 30mg/kg maintenance, QW) combined with AZA. 30 patients had received treatment ≥ 6 cycles. The Objective Response Rate (ORR) was 100% (30/30), complete response rate (CRR) was 63.3% (19/30). 42 patients had received treatment ≥ 4 cycles, ORR was 97.6% (41/42), CRR was 45.2% (19/42). 49 patients had received treatment ≥ 3 cycles, ORR was 93.9% (46/49), CRR was 38.8% (19/49). The median duration of response was not reached yet. For safety results, 88 (94.6%) patients experienced at least 1 treatment-related adverse event (TRAE). The most common TRAEs were platelet count decreased, anemia, white blood cell count decreased, neutrophil count decreased, etc. TRAEs leading to discontinuation of IBI188 occurred in 7 (7.5%) patients.
Junshi Bio: Phase I for Anti-BTLA mAb Tifcemalimab in Recurrent or Refractory Lymphoma
The single-arm, open-label, multi-center, dosage escalation Phase I study is designed to assess the safety and efficacy of tifcemalimab in combination with PD-1 inhibitor Tuoyi (toripalimab) or as monotherapy in recurrent or refractory lymphoma. As of October 26, 2022, 63 patients with relapsed or refractory lymphoma were enrolled. The results showed that among the 25 evaluable patients receiving tifcemalimab monotherapy, one patient (follicular lymphoma) had partial remission (PR) and seven patients had stable disease (SD). Among the 28 evaluable patients who received tifcemalimab combined with Tuoyi, although 85% of the patients had progressed after anti-PD-1 antibody treatment, an ORR of 39.3% and DCR of 85.7% were still obtained, and the median DoR of all patients who got remission in this group was still not mature. In terms of safety, no dose-limiting toxicity was observed in the dose-increasing part of monotherapy and combination therapy, and no new safety signal was found in the combination therapy group. At present, tifcemalimab has entered phase II clinical trials, and several clinical studies combined with Tuoyi are being carried out simultaneously in China and the United States, covering multiple tumors.
Ascentage: Latest Developments for Olverembatinib in the US and China
- Data from the pivotal Phase II regulatory HQP1351-CC-201 and HQP1351-CC-202 studies for olverembatinib in China: Two studies showed that the drug was highly effective and well tolerated in CML-CP and CML-AP patients with T315I mutation. The results were consistent with the efficacy and safety of T135I mutation subgroup patients in Phase I study.
- Data from the 5-year follow-up study on the safety and effectiveness of olverembatinib in TKI-resistant chronic myeloid leukemia (CML) patients in China: The data shows that among CML-CP and CML-AP patients with TKI resistance, the treatment response rate of olverembatinib increases over time, and its safety is basically consistent with the previously published data. The incidence of most TRAE decreases with time.
- Preliminary data on the treatment of refractory chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with olverembatinib. The data shows that the drug has good efficacy and tolerance in patients with previously deeply treated advanced treatment/refractory chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), and even in patients with ponatinib or asciminib resistance or T315I mutation, it also shows strong efficacy.-Fineline Info & Tech
