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FDA Authorizes ImmunityBio Study of Anktiva and PD-L1 t-haNK to Increase Effectiveness of Trodelvy in Triple-Negative Breast Cancer
Open-label Phase 1b/2 study will evaluate the safety and preliminary efficacy of Anktiva (N-803) and PD-L1 t-haNK in combination with antibody-drug conjugate
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nOpen-label Phase 1b/2 study will evaluate the safety and preliminary efficacy of Anktiva (N-803) and PD-L1 t-haNK in combination with antibody-drug conjugate Trodelvy and low-dose chemotherapy in subjects with advanced triple-negative breast cancer (TNBC) after prior therapy\n\n\nThe FDA approved Trodelvy for TNBC in April 2020 based on an overall response rate of 33.3%, with a median duration of response of 7.7 months; 55.6% maintained their response for 6 or more months and 16.7% maintained their response for 12 or more months.\n\n\nStudy design is based on results of Phase 1 trial of haNK cells combined with Anktiva and low dose chemo in refractory triple negative breast cancer, where disease control rate of 78% and overall response rate of 67% was reached\n\n\nEnrollment expected to begin in Q3 2021\n\n\n CULVER CITY, Calif.--(BUSINESS WIRE)--\nImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced it has received FDA authorization to conduct a Phase 1b/2 open-label study to evaluate the safety and preliminary efficacy of its superagonist Anktiva (N-803, an IL-15 superagonist) and PD-L1 targeted high-affinity natural killer (t-haNK) cells in combination with standard chemo and Trodelvy (sacituzumab govitecan-hziy), in subjects with advanced triple-negative breast cancer (TNBC). The study may provide data indicating whether this combination can increase the effectiveness of Trodelvy in patients who have failed to respond to other treatments.\n\nTriple-negative breast cancer is a serious, aggressive cancer with a high mortality rate. While Trodelvy displayed efficacy against TNBC in phase 3 testing, only a third of third-line patients respond to it, and less than 17% of them continue to respond after a year. ImmunityBio proposed this new study based on data from a Phase 1 trial (NCT03387085) with Anktiva and the company’s haNK cells that elicited a significant response rate in refractory TNBC. Anktiva and PD-L1 t-haNK when used in combination with Trodelvy may show additive or even synergistic effects, greatly increasing the response rate and, importantly, durability of responses.\n\n“Antibody-drug conjugates like Trodelvy have made tremendous progress in giving patients with TNBC more and higher-quality time, but we believe Anktiva could potentially fill remaining treatment gaps and offe...