Qilu Pharmaceutical Announces Positive Phase Ia Study Results of QLS32015 at ASH 2024

Positive Outcomes from Qilu Pharmaceutical's QLS32015 Study at ASH 2024

During the 66th Annual Meeting of the American Society of Hematology (ASH) in San Diego, Qilu Pharmaceutical unveiled its preliminary results for QLS32015, a novel bispecific antibody targeting GPRC5D and CD3. This drug has been designed as a promising treatment option for patients experiencing relapsed/refractory multiple myeloma (RRMM), a type of blood cancer.

QLS32015 represents a new approach in cancer therapy by activating T cells to attack tumor cells. Unlike traditional therapies that depend on MHC and TCR binding, QLS32015 creates an immune synapse that engages the immune system in a novel way to combat cancer.

The Phase I trial (NCT05920876) was structured as an open-label, dose-escalation study focusing on safety and preliminary efficacy. The study enrolled patients who had unsuccessful previous treatments, with QLS32015 being administered as a monotherapy subcutaneously at various dosages ranging from 2 to 200 μg/kg. The findings reported at ASH indicate that QLS32015 not only has an excellent safety profile but also demonstrates significant anti-cancer activity.

As of the cutoff date on August 31, 2024, 13 patients were enrolled, with a median age of 61 years and a history of multiple prior therapies. Notably, 76.9% of patients had previously undergone triple therapy. Safety assessments revealed that cytokine release syndrome (CRS) was the most common treatment-related adverse event (TRAEs), though most instances were of grade 1 or 2 severity.

Encouragingly, 12 out of the 13 patients underwent efficacy assessments, achieving an objective response rate (ORR) of 76.9%. In detail, two participants achieved complete response (CR), while three reached very good partial response (VGPR). These results suggest a promising avenue for RRMM treatment, highlighting QLS32015's potential effectiveness.

Progress continues as investigators search for the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of QLS32015, indicating ongoing commitment towards developing this innovative cancer therapeutic. The 76.9% response rate further fuels hope for patients battling this challenging disease.

In summary, the early findings on QLS32015 mark a significant advancement in the fight against multiple myeloma and underline Qilu Pharmaceutical's role as a key player in pharmaceutical innovation.

References:
1. Li J, et al. 2017;31(3)383-395.
2. Velasquez MP, et al. Blood. 2018;131(1)30-38.