NeoImmuneTech announced that it has received the Clinical Study Report (CSR) for its Phase 1b/2a clinical trial of NT-I7 (Efineptakin Alfa) in combination with pembrolizumab (Keytruda) in patients with recurrent or refractory advanced solid tumors. The date of confirmation was the 18th.

[Clinical Overview] The trial was approved by the U.S. Food and Drug Administration (FDA) and conducted at eight institutions in the United States, including The University of Texas MD Anderson Cancer Center.

In Phase 2a, the preliminary anti-tumor activity of NT-I7 combined with pembrolizumab was evaluated in patients with recurrent or refractory triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), and small cell lung cancer (SCLC) who had prior checkpoint inhibitor (CPI) therapy, as well as in patients with recurrent or refractory microsatellite-stable colorectal cancer (MSS-CRC) and pancreatic cancer (PC) who were CPI-naïve.

[Phase 1b: Favorable Tolerability Confirmed… RP2D Determined at 1,200 μg/kg] Twelve patients were enrolled in the Phase 1b portion. NeoImmuneTech reported that the combination of NT-I7 and pembrolizumab showed favorable tolerability in patients with recurrent or refractory tumors. The recommended Phase 2 dose (RP2D) was determined to be 1,200 μg/kg, and one dose-limiting toxicity (DLT) was observed at that dose, meaning the maximum tolerated dose (MTD) was not reached.

[Phase 2a: A Total of 203 Patients Enrolled… Objective Response Rates by Cohort Disclosed] A total of 203 patients were enrolled in Phase 2a, of whom 172 were evaluable for response.

The objective response rate (ORR) by RECIST 1.1 criteria was 13.3% in the SCLC cohort, 3.7% in the colorectal cancer cohort, 3.8% in the pancreatic cancer cohort, 3.8% in pancreatic cancer Arm Va, and 16.7% in the ovarian cancer biomarker cohort. Overall, there were 7 partial responses (PR), for an ORR of 4.1%.

By iRECIST criteria, the objective response rates were 3.8% in the NSCLC cohort, 13.3% in the SCLC cohort, 11.1% in the colorectal cancer cohort, 7.7% in the pancreatic cancer cohort, 3.8% in pancreatic cancer Arm Va, and 16.7% in the ovarian cancer biomarker cohort. Overall, there were 11 immune partial responses (iPR), for a rate of 6.4%.

[Survival Analysis: Overall Median OS of 10.2 Months] The median duration of response (DoR) was 13.1 months by RECIST 1.1 and 13.0 months by iRECIST. The median overall survival (OS) was 10.2 months overall, with 12.3 months in the colorectal cancer cohort, 7.7 months in the pancreatic cancer cohort, and 17.3 months in the NSCLC cohort.

In the biomarker cohort, the combination of NT-I7 and pembrolizumab was found to induce an increase in tumor-infiltrating lymphocytes (TILs).

[Future Plans and Investor Notice] NeoImmuneTech stated that the trial was conducted with pembrolizumab, the combination drug, provided free of charge by Merck, and that related procedures for trial closure will proceed. The company also explained that the safety and efficacy data obtained from this trial will be used to plan future clinical trials and development strategies for NT-I7.

In addition, through its investor notice, the company stated that the probability of an investigational drug ultimately receiving approval as a medicine is known to be statistically around 10%, and that clinical trials and the product approval process may yield results that fall short of expectations, meaning there is a possibility of changing or abandoning its commercialization plans.