QLS32015, a Novel GPRC5D×CD3 Bispecific Antibody by Qilu Pharmaceutical, Demonstrates 75% ORR in First-in-Human Trial for Relapsed/Refractory Multiple Myeloma

The 2024 American Society of Hematology (ASH) Annual Meeting will be held in San Diego, USA, from December 7 to 10 local time. The abstracts have been published. Qilu Pharmaceutical Co., Ltd. will present the bispecific antibody QLS32015 for the first time at this meeting.First-in-Human Trial Results in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)。

Screenshot source: ASH official website

QLS32015 is a novel humanized IgG1 GPRC5D×CD3 T-cell bispecific antibody that can bring GPRC5D-expressing tumor cells close to T cells, leading to immune synapse formation and T-cell activation, thereby directing T cells to kill tumors.

This is an open-label, dose-escalation/expansion Phase I clinical trial. (NCT05920876). Enrollment of multiple myeloma with progression or intolerance to existing therapies (MM) The dose of QLS32105 was set at 2-800 mg/Kg (subcutaneous injection, QW or Q2W). The primary endpoints included DLT, MTD, RP2D, and safety.

As of May 31, 2024, a total of 11 patients were enrolled, with a median of 3.0 prior treatment lines.（1-8）; 63.6% of patients have received at least three types of drug therapies.(Proteasome inhibitors, immunomodulators, and anti-CD38 antibodies); 54.5% received one autologous stem cell transplant. (ASCT); 18.2% of patients received BCMA-CART therapy.

After a median follow-up of 2.9 months(1-8 months)Among 11 patients, 8 underwent efficacy evaluation, and 3 patients have not yet undergone the first efficacy evaluation.

• Assessed according to the IMWG criteriaORR was 75.0% (6/8), 5 names(62.5%)The patient was assessed as having a partial response. (PR)(2 PRs in the 6 mg/Kg group, 3 PRs in the 18 mg/Kg group);

• Among them, 1 patient in the 18 mg/Kg group(12.5%) The patient was assessed to have a very good partial response.(VGPR)；

• 6 mg/Kg group had 1 case（12.5%）Condition stable, 1 case in the 2 mg/Kg group（12.5%）Disease progression;

• Median duration of response, median progression-free survival, and median overall survival were not reached;

• No DLT was observed and MTD was not reached.

In terms of safety, 11 patients (100%) reported treatment-related adverse events. (TRAE), and all were ≥ Grade 3.

• The most common TRAEs were cytokine release syndrome (CRS), decreased lymphocyte count, decreased platelet count, anemia, and decreased white blood cell count.
• All CRS were grade 1 or 2, with a median duration of 2.0 days.
• No patients reported the occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
• No TRAEs leading to discontinuation or death occurred.

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