FDA grants Deltacel and radiation fast-track status for NSCLC
- Deltacel (KB-GDT-01) in combination with low-dose radiotherapy has been granted fast-track approval by the FDA.
- This indication applies to patients with metastatic non-small cell lung cancer (NSCLC) who have progressed after two or more prior standard therapies.
- The active ingredient is currently being evaluated in the Phase 1 study Deltacel-01 (NCT06069570).
The FDA has granted Fast Track designation to Deltacel when used in combination with low-dose radiation therapy to treat patients with metastatic NSCLC whose disease has progressed after two or more prior standard therapies, including platinum-based chemotherapy, immune checkpoint inhibitors and targeted therapies.1
Deltacel is an allogeneic, ready-to-use gamma delta T cell (γδT) therapy derived from donor-derived, unmodified γδT cells. It targets solid tumors by harnessing the natural potency of γδT cells.
Deltacel is currently being evaluated in the open-label Phase 1 Deltacel-01 study in patients with stage IV NSCLC who have failed standard therapies. Interim safety and efficacy data from Part 1 of the study were published on August 9, 2024, and demonstrated progression-free survival (PFS) of 4.8 months (range: 2-8) in 5 evaluable patients.2 Data from this part of the study support this fast-track designation.
Front view of the lungs: © 7activestudio – stock.adobe.com
“Receiving Fast Track approval is a significant milestone for Kiromic (BioPharma) and underscores the potential of Deltacel to address the urgent needs of patients with advanced solid tumors,” said Pietro Bersani, CEO of Kiromic BioPharma, in a press release.1 “We are encouraged by the FDA’s recognition of our innovative approach and are committed to the clinical development of Deltacel. Fast Track status will allow us to work more closely with the FDA to complete Deltacel-01 and advance this promising therapy into later-stage trials.”
The results also showed that no dose-limiting toxicities (DLTs) were observed in patients who completed the entire course of therapy. Before completing the entire course of therapy, one patient withdrew from the study due to an adverse event (AE) related to a pre-existing comorbidity. This AE was believed to be unrelated to Deltacel treatment.2
About the Deltacel-01 study in NSCLC
Deltacel-01 is a Phase 1 study evaluating Deltacel as an intravenous (IV) infusion in combination with radiotherapy in patients aged 18 years and older with cytologically or histologically confirmed stage IV metastatic NSCLC.3
Participation in the study is open to patients with 1 or more measurable target lesions according to RECIST 1.1 criteria, who have an ECOG performance status of 0 or 1, and who have demonstrated disease progression on 2 or more prior lines of standard therapy, including platinum-based therapies and immune checkpoint inhibitors. If a patient has tumors with known molecular alterations requiring action, the disease must have demonstrated disease progression on appropriate targeted molecular therapy.
In addition, patients must have adequate hematopoietic, liver and kidney functions, their life expectancy must be at least six months and all side effects from previous therapies, with the exception of alopecia, must have resolved to grade 1 or lower.
After enrollment, patients receive Deltacel plus low-dose, localized radiation for 10 days. Patients receive four courses 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, including determining the number of patients with AEs or DLTs. Secondary outcome measures include PFS, objective response rate, overall survival, time to response, time to disease progression, and disease control rate.
The study is expected to enroll 48 patients and is expected to end in January 2027.
According to the press release, a fifth clinical trial site for Deltacel-01 is scheduled to be activated on August 30, 2024.1 Initial tolerability and safety results from the last enrolled patient and the start of Phase 2 of the trial are expected in September 2024. In addition, the company expects to receive efficacy data from the Deltacel-01 trial in October 2024.
