[Edaily Reporter Shin Ha-yeon ] NeoImmuneTech, Inc.(950220)announced on the 18th that it had received the Clinical Study Report (CSR) from a Contract Research Organization (CRO) regarding the Phase 1b/2a clinical trial of the combination therapy of “NT-I7” and Keytruda (pembrolizumab) in patients with recurrent or refractory advanced solid tumors.
This clinical trial was conducted at eight institutions in the United States, including the MD Anderson Cancer Center, following approval from the U.S. Food and Drug Administration (FDA).
In the Phase 1b trial, the safety and tolerability of the combination of NT-I7 and pembrolizumab were evaluated in 12 patients. The results showed good tolerability, and the recommended Phase 2 dose (RP2D) was determined to be 1,200 μg/kg. At this dose, one dose-limiting toxicity (DLT) was observed, and the maximum tolerated dose (MTD) was not reached.
A total of 203 patients were enrolled in the Phase 2a trial. Analysis of the 172 evaluable patients revealed that 7 patients achieved a partial response (PR) according to RECIST 1.1 criteria, resulting in an objective response rate (ORR) of 4.1%. According to iRECIST criteria, 11 patients achieved a partial response (iPR), resulting in an ORR of 6.4%. The median duration of response was 13.1 months and 13.0 months, respectively.
The median overall survival was 10.2 months in the overall patient population. It was 12.3 months for colorectal cancer, 7.7 months for pancreatic cancer, and 17.3 months for non-small cell lung cancer. In the biomarker cohort, the combination therapy of NT-I7 and pembrolizumab was shown to induce an increase in tumor-infiltrating lymphocytes (TILs).
The company stated that it plans to use the safety and efficacy data obtained from this clinical trial to inform future NT-I7 clinical trials and development strategies.
This clinical trial was conducted at eight institutions in the United States, including the MD Anderson Cancer Center, following approval from the U.S. Food and Drug Administration (FDA).
In the Phase 1b trial, the safety and tolerability of the combination of NT-I7 and pembrolizumab were evaluated in 12 patients. The results showed good tolerability, and the recommended Phase 2 dose (RP2D) was determined to be 1,200 μg/kg. At this dose, one dose-limiting toxicity (DLT) was observed, and the maximum tolerated dose (MTD) was not reached.
A total of 203 patients were enrolled in the Phase 2a trial. Analysis of the 172 evaluable patients revealed that 7 patients achieved a partial response (PR) according to RECIST 1.1 criteria, resulting in an objective response rate (ORR) of 4.1%. According to iRECIST criteria, 11 patients achieved a partial response (iPR), resulting in an ORR of 6.4%. The median duration of response was 13.1 months and 13.0 months, respectively.
The median overall survival was 10.2 months in the overall patient population. It was 12.3 months for colorectal cancer, 7.7 months for pancreatic cancer, and 17.3 months for non-small cell lung cancer. In the biomarker cohort, the combination therapy of NT-I7 and pembrolizumab was shown to induce an increase in tumor-infiltrating lymphocytes (TILs).
The company stated that it plans to use the safety and efficacy data obtained from this clinical trial to inform future NT-I7 clinical trials and development strategies.
