On November 11, 2022 NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, reported that new data from its phase 2a clinical study NIT-110, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 annual meeting (Press release, NeoImmuneTech, NOV 11, 2022, View Source [SID1234623857]). Results showed the clinical efficacy of NT-I7 (efineptakin alfa) when combined with pembrolizumab in checkpoint-inhibitor-naïve microsatellite stable colorectal cancer (CPI-naïve MSS-CRC) and pancreatic cancer (CPI-naïve PaC).
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The oral presentation from Dr. A. Naing (University of Texas MD Anderson Cancer Center) has been focused on the follow-up of two cohorts of patients with relapsed/refractory (r/r) gastrointestinal indications: 25 patients with CPI-naïve MSS-CRC and 25 patients with CPI-naïve PaC. The presentation highlighted results of patients who did not have liver metastasis, which is usually associated with a worse prognosis and is known to be a predictable marker.
While historically anti-PD(L)1 monotherapies have shown no response in these indications[1],[2], results presented at SITC (Free SITC Whitepaper) showed an ORR of 30.8% and a DCR of 69.2% per iRECIST across the groups in patients without liver metastasis (n=13/50). Among the patients without liver metastasis, the probability of survival rate through 60 weeks was 100%, which is significantly higher than in those with liver metastasis. However, in patients with liver metastasis, the combination of NT-I7 plus pembrolizumab also showed clinical benefit. One patient had a partial response with 46% tumor reduction (per iRECIST) even though the patient had 3 liver lesions at baseline.
Immunohistochemistry (IHC) staining confirmed that the combination of NT-I7 plus pembrolizumab boosts CD8+ T cell infiltration in patients regardless of liver metastasis. Data also suggested that increased CD8+ T cell infiltration correlates with higher OS and favors a tumor microenvironment that contributes to the overall high DCR observed in these hard-to-treat CPI-resistant indications.
Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech said: "The results presented today at SITC (Free SITC Whitepaper) are very encouraging for patients with relapsed/refractory gastrointestinal indications, whose tumors have not metastasized in liver, where treatment options are very limited. The combination of NT-I7 plus pembrolizumab drives CD8 T-cell infiltration, favoring a tumor microenvironment that contributes to the overall clinical efficacy observed in the study. This is associated with longer overall survival".
NIT oral presentation at the 2022 SITC (Free SITC Whitepaper) Annual Meeting:
CD8 T-cell infiltration in immune-excluded liver metastasis in MSS-Colorectal and Pancreatic cancer in patients treated with NT-I7 and pembrolizumab
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About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7 and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.