FDA grants Deltacel Plus Radiation Fast Track designation for previously treated metastatic NSCLC

The FDA has granted Fast Track designation to Deltacel (KB-GDT-01) with low-dose radiotherapy for the potential treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after two or more prior lines of standard therapy, including immune checkpoint inhibitors, platinum-based chemotherapy, and targeted therapy.¹

Deltacel, an allogeneic, ready-to-use gamma delta T cell (GDT) therapy, is currently being tested in the Phase 1 Deltacel-01 trial (NCT06069570) in patients with stage IV NSCLC who have failed standard therapies. Deltacel is composed of donor-derived, unmodified GDT cells and is designed to target solid tumors by taking advantage of the natural potency of GDT cells.

“Receiving Fast Track approval is a significant milestone for Kiromic (BioPharma) and underscores Deltacel’s potential to address the urgent needs of patients with advanced solid tumors,” said Pietro Bersani, CEO of Kiromic BioPharma, in a press release. “We are encouraged by the FDA’s recognition of our innovative approach and are committed to the clinical development of Deltacel. Fast Track approval will allow us to work more closely with the FDA to finalize Deltacel-01 and advance this promising therapy into later phase trials.”

The fast-track approval follows preliminary safety and efficacy data from Part 1 of the open-label Deltacel-01 study, published on August 9, 2024. Long-term follow-up data showed a median progression-free survival (PFS) of 4.8 months (range: 2-8) in 5 evaluable patients.² No dose-limiting toxicities were reported in patients who completed the entire course of therapy. One patient discontinued treatment with Deltacel-01 prior to completion of the entire course of therapy due to an adverse reaction that was due to a pre-existing comorbidity and was not related to Deltacel.

Deltacel-01 will enroll adult patients aged at least 18 years with cytologically or histologically confirmed stage IV metastatic NSCLC.³ Patients must have 1 or more measurable target lesions according to RECIST 1.1 criteria, have an ECOG performance status of 0 or 1, and have demonstrated disease progression on 2 or more prior standard therapies, including platinum-based therapies and immune checkpoint inhibitors. Patients with tumors with known molecular alterations requiring treatment must have demonstrated disease progression on an appropriate targeted molecular therapy. All adverse reactions associated with prior therapies must have resolved to Grade 1 or lower, excluding ongoing alopecia. Patients must also have adequate hematopoietic, hepatic, and renal function and a life expectancy of 6 months or more.

In Deltacel-01, patients receive Deltacel plus low-dose, localized radiation for 10 days. Patients receive 4 cycles of radiation at 1.0 Gy per fraction on days 1 and 2, followed by intravenous Deltacel treatment with 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.

The primary outcome measure of the study is safety. Secondary outcome measures include PFS, objective response rate, overall survival, time to response, time to disease progression, and disease control rate.

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

References

1. Kiromic BioPharma’s Deltacel Receives FDA Fast Track Designation. Press release. Kiromic BioPharma. August 14, 2024. Retrieved August 14, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharmas-deltacel-receives-fda-fast-track-designation
2. Kiromic BioPharma provides an update on Part 1 of the Deltacel-01 trial. Press 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 of 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