IMPT-314: Advancing the Treatment Landscape for Aggressive B-cell Lymphoma
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ImmPACT Bio USA, Inc. has achieved a major milestone in the realm of relapsed/refractory aggressive B-cell lymphoma treatment, as the FDA grants fast track designation to their groundbreaking CD19/CD20 CAR T-cell therapy, IMPT-314. In a pivotal investigator-led phase 1 study at UCLA, IMPT-314 showcased exceptional efficacy and safety outcomes, with no instances of cytokine release syndrome (CRS) surpassing grade 1. The therapy’s full indication covers the management of relapsed or refractory aggressive B-cell lymphoma, including high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, and DLBCL arising from follicular lymphoma after two or more lines of systemic therapy. These promising results have laid the foundation for a forthcoming phase 1/2 trial to evaluate IMPT-314 in aggressive B-cell lymphoma, with initial efficacy and safety data anticipated to be unveiled in the second half of 2023.
Phase 1 Study Findings:
The investigator-led phase 1 study conducted at UCLA delivered remarkable outcomes, with IMPT-314 achieving an impressive objective response rate (ORR) of 91% in patients with relapsed/refractory non-Hodgkin lymphoma. Additionally, an impressive 73% of patients experienced durable complete responses. With a median progression-free survival (PFS) of 18.2 months, as evidenced by a median follow-up of 20.5 months, IMPT-314 exhibits the potential to provide extended treatment benefits. Notably, the study reported no neurotoxicity or immune effector cell–associated neurotoxicity syndrome, while all cases of CRS were limited to grade 1, establishing IMPT-314’s favorable safety profile.
Phase 1/2 Trial and Future Prospects:
Buoyed by the success of the phase 1 study, investigators are eagerly preparing for a phase 1/2 trial to further assess IMPT-314’s potential in aggressive B-cell lymphoma, including DLBCL. Anticipating enrollment of 24 patients, the trial is scheduled to commence in the second quarter of 2023, with the first patient receiving treatment. Initial efficacy and safety data from this trial are highly anticipated and set to be unveiled in the latter half of 2023. IMPT-314’s ability to enhance response duration, coupled with its well-tolerated profile, positions it as a promising contender to improve treatment accessibility and address the unmet medical needs of patients grappling with aggressive B-cell lymphomas.
Implications and CEO’s Perspective:
The fast track designation granted by the FDA emphasizes the pressing need for effective therapies in the realm of aggressive B-cell lymphomas. ImmPACT Bio’s President and CEO, Sumant Ramachandra, MD, PhD, lauds IMPT-314’s differentiated therapeutic potential, envisioning it as an avenue to extend response duration while maintaining a safe and well-tolerated treatment profile. The impending phase 1/2 trial injects a sense of anticipation, with ImmPACT Bio eagerly preparing to administer IMPT-314 to the first patient, all the while poised to further explore its potential in aggressive B-cell malignancies.
Study Design and Eligibility Criteria:
The phase 1 study design incorporated fludarabine phosphate and cyclophosphamide as conditioning chemotherapy before IMPT-314 cell infusion. Patients experiencing CRS were offered tocilizumab treatment at the discretion of the investigator. Primary endpoints of the trial encompassed adverse effects and dose-limiting toxicities, while secondary endpoints included ORR, PFS, overall survival, duration of remission, and T-cell phenotypic markers. Eligible patients ranged in age from 18 to 70 years, encompassing various refractory lymphoma subtypes. Specific eligibility criteria encompassed performance status, organ function, and CD19/CD20 positivity.
Conclusion:
The FDA’s fast track designation for IMPT-314 represents a monumental leap forward in the treatment of relapsed/refractory aggressive B-cell lymphoma. The positive outcomes witnessed in the investigator-led phase 1 study, underscored by a high response rate and a favorable safety profile, provide hope for addressing the unmet medical needs of patients. As the eagerly anticipated phase 1/2 trial draws near, it holds the promise of unveiling IMPT-314’s efficacy and safety in aggressive B-cell lymphomas, fueling optimism for improved treatment outcomes and heightened accessibility for patients in dire need.
Reference: FDA Track Designation
