ImmunityBio has entered into a collaboration and supply agreement with BeiGene to conduct a confirmatory randomized Phase 3 clinical trial combining BeiGene’s tislelizumab, a PD-1 checkpoint inhibitor, and ImmunityBio’s Anktiva. The Phase 3 ResQ201A-NSCLC study aims to confirm the efficacy and safety of combination ANKTIVA plus PD-1 therapy previously demonstrated in the trial QUILT 3.055 and provide evidence of the potential for these two immunotherapeutic agents to improve overall survival in patients with advanced or metastatic NSCLC who have acquired resistance to immune CPI therapy.
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ImmunityBio and Beigene to run Phase 3 of Anktiva plus PD-1 in NSCLC
CLINICAL AND REGULATORY
ImmunityBio presented positive long-term OS data in NSCLC
The Phase 3 trial design is based on the synergistic potential already demonstrated in the QUILT 3.055 study that a PD-1 and Anktiva, an IL-15 superagonist, prolongs OS in the study population compared to historical controls in this setting. In Phase 1 and 2 studies, Anktiva demonstrated the capability of rescuing T cells, and thus CPI efficacy, through the molecule’s unique mechanism of action. Anktiva is the first FDA approved molecule that has demonstrated the ability to increase lymphocytes via its proliferative IL-15 stimulatory action.
Medicenna reported MDNA11’s compelling anti-cancer activity in ABILITY-1 study
Medicenna Therapeutics announced the presentation of new clinical data from its ongoing ABILITY-1 study evaluating MDNA11 alone or in combination with Keytruda in patients with advanced solid tumors. The data was presented in a late-breaking abstract at the inaugural AACR-IO. MDNA11 significantly expands a unique population of ‘stem-like’ CD8+ T cells that leads to more persistent and effective anti-tumor activity. MDNA11 has shown durable single agent activity, with a 30% (3 of 10) ORR in the monotherapy dose expansion cohort in checkpoint-resistant patients. Disease control rate of 78% (7 of 9) in combination with Keytruda includes one complete response, one partial response and five stable disease.
