Trial reportAdvances in therapy2026
Rocbrutinib, a Highly Selective Fourth-Generation Covalent and Noncovalent BTK Inhibitor, in R/R Non-GCB DLBCL: Efficacy and Safety from a Phase I Study.
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04993690 (A Phase 1 Open-Label Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of LP-168 in Adult Patients With Relapse or Refractory B-Cell Lymphoma), which is not on this map. Not yet cited in PubMed.
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A Phase 1 Open-Label Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of LP-168 in Adult Patients With Relapse or Refractory B-Cell Lymphoma
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21 authors.
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Abstract
introductionRocbrutinib is a fourth-generation Bruton's tyrosine kinase (BTK) inhibitor that binds covalently to the wild type BTK and non-covalently to the cysteine 481 mutant variant. This phase I study evaluated the pharmacokinetics (PK), safety, and efficacy of rocbrutinib in Chinese patients with relapsed or refractory (R/R) non-germinal center B cell-like (non-GCB) diffuse large B cell lymphoma (DLBCL).
methodsEligible participants were adults with non-GCB DLBCL and had received ≥ 2 prior lines of systemic therapy, including an anti-CD20 antibody-based regimen. Patients received rocbrutinib at 100, 150, 200 or 300 mg once daily (QD) as single agent till disease progression or unacceptable toxicity. Response was evaluated using computerized tomography (CT) and positron emission tomography (PET)-CT at the protocol-defined timepoints by the investigators. PK samples and adverse events were collected per protocol.
resultsA total of 45 patients were enrolled, of whom 44.4% had received ≥ 3 lines of therapy. The overall response rate (ORR) was 57.8% [95% confidence interval (CI): 42.2, 72.3], and the complete response (CR) rate was 33.3% (95% CI 20.0, 49.0). In the ≥ 200 mg QD cohort (n = 18), the ORR was 72.2% (95% CI 46.5, 90.3) and the CR rate was 44.4% (95% CI 21.5, 69.2). Treatment-emergent adverse events (TEAEs) were reported in 97.8% patients, ≥ grade 3 TEAEs in 51.1% patients. Due to TEAEs, 2 patients (4.4%) with dose reduction and 1 (2.2%) discontinued study treatment, respectively. No atrial fibrillation/flutter was reported. In the ≥ 200 mg QD cohort, the safety profile was consistent with the overall population.
conclusionRocbrutinib demonstrated promising efficacy and favorable tolerability profile in heavily pre-treated R/R non-GCB DLBCL. A 200 mg QD dose was selected as recommended phase 2 dose for monotherapy. A randomized phase II clinical trial in this population is currently enrolling.
trial registrationClinicalTrials.gov identifier, NCT04993690.
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