Kiromic BioPharma’s NSCLC T-cell Therapy Deltacel Generates Favorable PFS Data in Interim Phase 1 Trial Results
For the 5 patients in long-term follow-up who have been evaluated, the average PFS is 4.8 months (range, 2-8 months).
Kiromic BioPharma’s KB-GDT-01 (Deltacel), an investigational allogeneic gamma delta T-cell (GDT) therapy being evaluated in the phase 1/2 Deltacel-01 clinical trial (NCT06069570) for the treatment of non-small cell lung cancer (NSCLC), has shown favorable progression-free survival (PFS) data in an interim update from the study.1
For the 5 patients in long-term follow-up who have been evaluated, the average PFS is 4.8 months (range, 2-8 months). In terms of safety, Kiromic noted that there were no dose-limiting toxicities among the patients who were treated with a full course of Deltacel in the trial. Although, 1 patient experienced an adverse event deemed related to a preexisting comorbidity, but not to Deltacel, and subsequently ceased participation in the trial without having completed a full course of Deltacel. This patient was not able to be evaluated for PFS. All patients treated so far have been treated in Part 1 of Deltacel-01, which is the dose escalation portion. The sixth patient in Part 1, who started receiving Deltacel on August 6, 2024, is the final patient that Kiromic intends to treat in Part 1. Part 1 includes 2 cohorts of 3 patients each.
The company noted that it expects to provide initial safety results from the aforementioned sixth patient in September and initial efficacy results for that patient in October. In July 2024, Kiromic reported that it intends to move to Part 2 of Deltacel-01, noting that the trial’sSafety Monitoring Committee had given a positive assessment.2 Part 2 of the study, which will constitute a dose expansion portion, is expected begin in September, as well.
“We are pleased to have completed enrollment in Part 1 of our clinical trial,” Pietro Bersani, CPA, the chief executive officer of Kiromic, said in a statement.1 “The favorable results of our GDT therapy, particularly with respect to PFS, in the first 2 cohorts that comprise Part 1 underscore the potential of Deltacel to treat solid tumors, and we look forward to launching Part 2 of this study.”
Deltacel is nonengineered and based on a platform that aims to utilize the natural characteristics of GDTs in the targeting of solid cancers; as such, viral vectors are not required in the manufacturing process.2 In the Deltacel-01 trial, patients receive Deltacel in 2 separate intravenous infusions alongside 4 courses of low-dose, localized radiation during a 10-day timeframe. Active trial sites for Deltacel-01 include Beverly Hills Cancer Center; Virginia Oncology Associates, PC, located in Norfolk, VA; and University of Pittsburgh School of Medicine.3,4 The study is open to patients with stage 4 metastatic NSCLC whose disease did not respond to standard therapies.1
The new announcement with regard to PFS is the most recent in a string of positive data updates regarding the therapy that have been announced by the company. Earlier this month, Kiromic announced that the first patient to have been treated in Deltacel-01 achieved a 20% reduction in tumor size on scans at 8 months posttreatment, in comparison to pretreatment observations.5 Furthermore, there were no new lesions observed, and it was noted that the patient had previously shown a 13% reduction in tumor size from baseline at their 6 month assessment.
“We are pleased to announce continued excellent clinical results from our Deltacel-01 trial, with the first patient enrolled demonstrating not only stable disease and continuing to do well, but also a 20% reduction in tumor size at the 8-month post-treatment evaluation,” Bersani said in a statement at the time.1 “This result is a promising indication of the potential for our novel GDT therapy. We remain dedicated to advancing innovative cancer treatments and are encouraged by the progress we are making toward providing new options for patients,”
