FDA Grants Fast Track Designation to Deltacel and Radiation in NSCLC

• A fast track designation has been granted to Deltacel (KB-GDT-01) in combination with low-dose radiation therapy by the FDA.
• This indication is for patients with metastatic non–small cell lung cancer (NSCLC) who have progressed on 2 or more prior lines of standard-of-care therapy.
• The agent is currently undergoing evaluation in the phase 1 Deltacel-01 trial (NCT06069570).

The FDA has granted Deltacel a fast track designation when used in combination with low-dose radiation therapy for the treatment of patients with metastatic NSCLC who have progressed on 2 or more prior lines of standard-of-care therapy. This includes platinum-based chemotherapy, immune checkpoint inhibitors, and targeted therapy.¹

Deltacel is an allogeneic, off-the-shelf gamma delta T-cell (γδT) therapy made of donor-derived, unmodified γδT cells. The agent targets solid tumors through using the natural potency of γδT cells.

Currently, the phase 1, open-label Deltacel-01 trial is evaluating Deltacel in patients with stage IV NSCLC who have not responded to standard therapies. Interim safety and efficacy data from part 1 of the trial were reported on August 9, 2024, and demonstrated a progression-free survival (PFS) of 4.8 months (range, 2-8) among 5 evaluable patients.² Data from this portion of the study support this fast track designation.

Lungs, anterior view: © 7activestudio - stock.adobe.com

“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,” said Pietro Bersani, chief executive officer 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 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.”

Findings also showed that there were no dose-limiting toxicities (DLTs) seen in the patients who completed the full course of therapy. Prior to finishing the full course of therapy, 1 patient withdrew from the trial because of an adverse effect (AE) which was linked to a preexisting comorbidity. This AE was deemed to not be associated with Deltacel treatment.²

About the Deltacel-01 Trial in NSCLC

Deltacel-01 is a phase 1 trial evaluating Deltacel given as an intravenous (IV) infusion in combination with radiotherapy in patients aged 18 years or older with cytologically or histologically confirmed stage IV metastatic NSCLC.³

Enrollment in the study is open to patients with 1 or more measurable target lesions per RECIST 1.1 criteria, those who have an ECOG performance status of 0 or 1, and those who have progressed on 2 or more prior lines of standard therapy, including platinum-based therapy and immune checkpoint inhibitors. If a patient has tumors with known actionable molecular alterations, they are required to have progressed on appropriate targeted molecular therapy.

Further, patients must have adequate hematopoietic, hepatic, and renal function; a life expectancy of 6 months or longer; and all AEs from previous therapies must be recovered to grade 1 or lower, except for alopecia.

Once enrolled, Deltacel plus low-dose, localized radiation will be given to patients over a 10-day course. Four courses of radiation will be given to patients at 1.0 Gy per fraction on days 1 and 2. This will then be followed by IV 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.

The primary end point of the trial is safety, including determining the number of patients with AEs or DLTs. Secondary end points include PFS, objective response rate, overall survival, time to response, time to progression, and disease control rate.

The study has an estimated enrollment of 48 patients and an estimated study completion date of January 2027.

According to the press release, a fifth clinical trial site for Deltacel-01 is expected to be activated on August 30, 2024.1 Early tolerability and safety results from the last enrolled patient, as well as the start of phase 2 of the study, are expected in September 2024. Moreover, the company expects to receive efficacy data from the Deltacel-01 trial in October 2024.

REFERENCES:

1. Kiromic BioPharma’s Deltacel receives FDA fast track designation. News release. Kiromic BioPharma. August 14, 2024. Accessed August 15, 2024. https://tinyurl.com/45r42ttr

2. Kiromic BioPharma provides update on part 1 of the Deltacel-01 trial. News release. Kiromic BioPharma, Inc. August 9, 2024. Accessed August 15, 2024. https://tinyurl.com/835kkuaa

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 15, 2024. https://www.clinicaltrials.gov/study/NCT06069570