Kiromic BioPharma’s NSCLC T-cell Therapy Deltacel Continues to Provide Disease Stabilization in Updated Data
Kiromic reported that the fourth patient to have been treated in the trial showed a 5.3% reduction in tumor size with regard to baseline.
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 continued to show evidence of providing disease stabilization in updated data from the study.1
Kiromic reported that the fourth patient to have been treated in the trial showed stable disease at their 6-month follow-up visit and a 5.3% reduction in tumor size with regard to baseline. In addition, the sixth patient to have been treated had stable disease at their 2-month follow-up visit, with no evidence of new lesions observed. Furthermore, Kiromic stated that the median progression-free survival (PFS) for all patients treated thus far has reached 6 months, with a median follow-up time of 7.7 months.
“The follow-up results we are seeing in the Deltacel-01 trial are encouraging, especially for patients with limited treatment options,” Afshin Eli Gabayan, MD, a medical oncologist, medical director, and the principal investigator of Deltacel-01 at the Beverly Hills Cancer Center, said in a statement.1 “The stabilization of disease, combined with early signs of tumor reduction in some cases, speaks to the potential of this therapy to make an impact in the treatment of advanced solid tumors. We are hopeful that continued follow-up will support the promising outcomes we’ve seen to date.”
Earlier this month, Kiromic also announced data from the first patient treated.2 At their 10-month follow-up visit, this patient’s tumor was decreased in size approximately 27% with regard to baseline. There were no new sites of disease observed. As such, the patient’s PFS was deemed to have reached 10 months. At the patient’s 8-month follow-up visit the tumor size reduction was measured as approximately 20% with regard to baseline and at the patient’s 6-month follow-up visit the tumor was reduced in size approximately 13% in comparison to baseline. The company noted that the patient had not experienced adverse events during the 10 months of PFS.
“As this patient is the most advanced in our ongoing Deltacel-01 clinical trial, we are particularly encouraged by these latest follow-up results that continue to validate the potential of Deltacel as a safe and effective treatment for patients with later-stage cancers,” Pietro Bersani, the chief executive officer of Kiromic BioPharma, said in a statement at the time.2 “We believe these findings underscore the promise of our allogeneic GDT therapy in providing durable clinical benefit.”
In September 2024, Kiromic announced that it had received a unanimous recommendation to move ahead dose expansion from the safety monitoring committee (SMC) for Deltacel-01.3 Kiromic noted that the SMC’s vote came after safety data from the trial’s first 2 cohorts were analyzed. Kiromic anticipates that Deltacel-01's expansion portion, which is expected to include around 9 new patients, will begin screening patients before the end of September. Although the first 6 patients in the study were treated at Beverly Hills Cancer Center, several other sites have now been activated, including Virginia Oncology Associates, PC, located in Norfolk, VA; University of Pittsburgh School of Medicine; and the University of Arizona Cancer Center (UACC).4-6
“We are delighted to receive unanimous SMC approval to move forward with the expansion phase of the Deltacel-01 trial,” Bersani said in a September 2024 statement.3 “As we enter this next phase with more activated clinical sites, we expect a solid cadence of patient enrollment. We are optimistic about the potential to further evaluate Deltacel’s impact on patient outcomes and address critical unmet needs in solid tumors.”
