ImmunityBio and BeiGene Collaborate on Phase 3 Trial of ANKTIVA and Tislelizumab in NSCLC
核心洞察
ImmunityBio and BeiGene (搜索) are collaborating on a Phase 3 trial (ResQ201A-NSCLC (搜索)) to evaluate ANKTIVA plus BeiGene's tislelizumab in advanced NSCLC patients who have progressed on CPI therapy.
The trial aims to confirm the efficacy and safety of the ANKTIVA and CPI combination, building on Phase 2 results showing prolonged overall survival in CPI-resistant NSCLC (搜索) patients.
The global Phase 3 trial will enroll 462 participants, with overall survival as the primary endpoint and secondary endpoints including disease control rate and safety.
ImmunityBio and BeiGene (搜索) have entered into a collaboration to conduct a Phase 3 clinical trial evaluating the combination of ImmunityBio's ANKTIVA (nogapendekin alfa inbakicept-pmln) and BeiGene's tislelizumab in patients with advanced or metastatic non-small cell lung cancer (搜索) (NSCLC (搜索)) who have developed resistance to checkpoint inhibitor (CPI) therapy. The ResQ201A-NSCLC study (NCT06745908) aims to confirm the efficacy and safety of this combination, potentially offering a new treatment option for patients with limited alternatives.
Rationale Behind the Combination Therapy
The Phase 3 trial design is based on the synergistic potential demonstrated in the QUILT 3.055 study, a Phase 2 trial, where the combination of a CPI and ANKTIVA prolonged overall survival (OS) compared to historical controls. ANKTIVA, an IL-15 superagonist, has shown the capability of rescuing T cells and enhancing CPI efficacy through its unique mechanism of action. It stimulates the proliferation of natural killer cells and CD4+ and CD8+ T cells, restoring MHC-1 presentation and allowing T cells to regain their cytotoxic activity.
Clinical Data and Trial Design
Multiple Phase 1 and 2 studies have demonstrated prolonged overall survival with this combination approach, in comparison to historical results with chemotherapy in this patient population. In these multi-site trials, the combination of ANKTIVA plus the CPI, with no intervening therapy when the patient progressed on the CPI, demonstrated a median OS (mOS) of 17.1 months (95% CI: 4.6, NR) in patients with PD-L1 ≥ 50% and a mOS of 19.6 months (95% CI: 6.2, NR) in patients who relapsed on checkpoint inhibitor. QUILT 3.055 confirmed these findings with a mOS of 14.1 months (95% CI: 11.7, 16.3), as presented at World Lung on Oct 2024.
The confirmatory Phase 3 trial will be conducted globally across multiple sites and is expected to include 462 participants. The primary endpoint of the study is overall survival, with secondary endpoints including disease control rate, progression-free survival, objective response rate, and safety.
Addressing Unmet Needs in NSCLC
According to the American Cancer Society, lung cancer is the second most common cancer in the U.S., with an estimated 226,650 new cases and 124,730 deaths in 2025. NSCLC (搜索) accounts for approximately 87% of all lung cancer diagnoses, and there are limited successful treatment options for patients whose cancer spreads beyond the lungs and who progress after CPI therapy.
Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, stated, "The challenge oncologists face in the next five years is how to manage the many patients who do not respond to CPI therapy after an initial response. Currently, options are limited for these second- and third-line patients with NSCLC (搜索) whose cancer continues to progress on CPIs... To our knowledge, ANKTIVA is the first approved cytokine to address low white cell count (lymphopenia), which occurs following chemo-immunotherapy and radiotherapy."
Future Outlook
ImmunityBio anticipates submitting a biologics license application (BLA) in 2025 for this indication based on the QUILT 3.055 data. The collaboration between ImmunityBio and BeiGene (搜索) reflects a shared vision to advance the next generation of oncology immunotherapies and address unmet needs in metastatic lung cancer.