FDA Grants Fast Track Designation to Deltacel Plus Radiation for Pretreated Metastatic NSCLC

FDA Grants Fast Track Designation to Deltacel Plus Radiation for Pretreated Metastatic NSCLC

Fast track designation has been granted by the FDA to Deltacel (KB-GDT-01) with low-dose radiation therapy to potentially treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease progressed on 2 or more prior lines of standard-of-care therapy, including immune checkpoint inhibitors, platinum-based chemotherapy, and targeted therapy.¹

Deltacel, an allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy, is under evaluation in the phase 1 Deltacel-01 trial (NCT06069570) in patients with stage IV NSCLC who have not responded to standard therapies. Deltacel is composed of donor-derived, unmodified GDT cells and is designed to target solid tumors by using the natural potency of GDT cells.

“Receipt of fast track designation is a significant milestone for Kiromic [BioPharma] and underscores the potential of Deltacel to address the urgent needs of patients with advanced solid tumors,” Pietro Bersani, chief executive officer of Kiromic BioPharma, stated in a news release. “We are encouraged by the FDA’s recognition of our innovative approach and are committed to the clinical development of Deltacel. Fast track designation will enable us to work more closely with the FDA as we complete Deltacel-01 and advance this promising therapy into later-stage studies.”

The fast track designation follows interim safety and efficacy data from part 1 of the open-label Deltacel-01 trial, which were reported on August 9, 2024. Long-term follow-up data showed an average progression-free survival (PFS) of 4.8 months (range, 2-8) among 5 evaluable patients.² No dose-limiting toxicities were reported among patients who completed the full course of therapy. One patient withdrew from Deltacel-01 before finishing the full course of therapy due to an adverse effect (AE) that was determined to be related to a pre-existing comorbidity and not associated with Deltacel.

Deltacel-01 is enrolling adult patients at least 18 years of age with cytologically or histologically confirmed stage IV metastatic NSCLC.³ Patients need to have 1 or more measurable target lesions per RECIST 1.1 criteria; an ECOG performance status of 0 or 1; and progressed on 2 or more prior lines of standard therapy, including platinum-based therapy and immune checkpoint inhibitors. Patients with tumors with known actionable molecular alterations must have progressed on appropriate targeted molecular therapy. All AEs associated with prior therapies must be recovered to grade 1 or lower, excluding continuing alopecia. Patients must also have adequate hematopoietic, hepatic, and renal function, as well as a life expectancy of 6 months or longer.

In Deltacel-01, patients are receiving Deltacel plus low-dose, localized radiation over a 10-day course. Patients receive 4 courses of radiation at 1.0 Gy per fraction on days 1 and 2, followed by intravenous Deltacel at 400 x 106, 800 x 106, or 1600 x 106 cells on day 3. Radiation is repeated on days 8 and 9, followed by a second Deltacel infusion on day 10.

Safety serves as the trial’s primary end point. Secondary end points include PFS, objective response rate, overall survival, time to response, time to progression, and disease control rate.

Kiromic anticipates the activation of a fifth clinical trial site for Deltacel-01 on August 30, 2024.¹ In September 2024, the company also expects to receive early tolerability and safety results from the last enrolled patient, who was enrolled on August 6, 2024. In that same month, the company plans to begin part 2 of the trial. Kiromic expects to receive efficacy data from Deltacel-01 in October 2024.

References

1. Kiromic BioPharma’s Deltacel receives FDA fast track designation. News release. Kiromic BioPharma. August 14, 2024. Accessed August 14, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharmas-deltacel-receives-fda-fast-track-designation
2. Kiromic BioPharma provides update on part 1 of the Deltacel-01 trial. News release. Kiromic BioPharma, Inc. August 9, 2024. Accessed August 14, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-provides-update-part-1-deltacel-01-trial
3. Safety study for a gamma delta T cell product used with low dose radiotherapy in patients with stage 4 metastatic NSCLC. ClinicalTrials.gov. Updated December 15, 2023. Accessed August 14, 2024. https://www.clinicaltrials.gov/study/NCT06069570