ImmunityBio’s ANKTIVA: A Paradigm Shift in Oncology Through Lymphopenia Reversal

In the evolving landscape of oncology, ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept-pmln) is emerging as a transformative therapy, addressing a critical unmet need: the reversal of lymphopenia in cancer patients. Lymphopenia, characterized by low lymphocyte counts, is a common and detrimental side effect of chemotherapy, radiation, and immunotherapies, often correlating with poor survival outcomes [1]. By stimulating natural killer (NK) cells and T cells without upregulating suppressive immune cells, ANKTIVA represents a paradigm shift in restoring immune competence and improving tumor control [2].

Clinical Value: From Survival Extension to Immune Restoration

The clinical evidence for ANKTIVA is compelling. In the Phase 2 QUILT-3.055 trial for non-small cell lung cancer (NSCLC) resistant to checkpoint inhibitors, 60% of patients reversed their lymphopenia during treatment, with 80% achieving an absolute lymphocyte count (ALC) above 1,200 cells/µL. Those who met this threshold saw a median overall survival (OS) of 15.8 months, compared to 11.5 months for those who did not [3]. Similarly, in metastatic pancreatic cancer, ANKTIVA combined with CAR-NK therapy demonstrated a hazard ratio of 0.46 for patients with ALC ≥ 1,000, significantly prolonging survival [4]. These results underscore ANKTIVA’s ability to convert lymphopenia—a marker of immunosuppression—into a therapeutic target.

Beyond solid tumors, ANKTIVA has shown promise in bladder cancer. In the QUILT-3.032 trial, the therapy combined with BCG achieved a 71% complete response rate in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with durable responses observed over 47 months [5]. The U.S. Food and Drug Administration (FDA) approved ANKTIVA for this indication in April 2024, and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) followed in 2025 [6].

Market Opportunity: A $4.1 Billion Target by 2034

The BCG-unresponsive NMIBC market alone is projected to grow from $2.5 billion in 2024 to $4.1 billion by 2034, driven by aging populations and the adoption of immune checkpoint inhibitors [7]. ImmunityBio’s commercial performance reflects this potential: in Q2 2025, the company reported $26.4 million in revenue, a 60% increase from Q1 2025, with year-to-date sales reaching $43 million [8]. The therapy’s 246% unit growth since the J-code approval highlights its rapid adoption.

Beyond bladder cancer, the broader lymphopenia reversal market is gaining traction. While specific figures for oncology indications are not yet quantified, the global immunocytokines market—of which ANKTIVA is a key player—is projected to reach $1.84 billion by 2030, growing at a 12.24% CAGR [9]. This growth is fueled by ANKTIVA’s unique mechanism as an IL-15 superagonist, which activates NK and T cells without the toxicity associated with IL-2 therapies [10].

Competitive Landscape: First-Mover Advantage in a Sparse Field

ANKTIVA’s competitive edge lies in its first-mover status. While therapies like Merck’s Keytruda and Ferring’s Adstiladrin dominate the BCG-unresponsive NMIBC space, none address lymphopenia directly [11]. ImmunityBio’s Cancer BioShield platform, which incorporates ANKTIVA, is the only approach designed to restore immune function rather than merely target tumors. The FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for ANKTIVA in metastatic pancreatic cancer further validates its potential [12].

Challenges remain, including manufacturing scalability and competition from emerging biosimilars. However, ANKTIVA’s clinical differentiation—proven survival benefits and immune restoration—positions it to capture a significant share of the $4.1 billion BCG-unresponsive NMIBC market and expand into lymphopenia-driven oncology indications.

Conclusion: A Catalyst for Immuno-Oncology

ImmunityBio’s ANKTIVA is not merely a treatment for lymphopenia but a catalyst for redefining cancer care. By addressing the root cause of immune suppression, it offers a dual benefit: restoring immune function and extending survival. With a robust clinical pipeline, regulatory momentum, and a growing market, ANKTIVA is poised to become a cornerstone of immuno-oncology—a rare example of a therapy that tackles both the disease and its systemic consequences.

Source:
[1] Lymphopenia in Cancer Patients and its Effects on Prognosis [https://pmc.ncbi.nlm.nih.gov/articles/PMC6437964/]
[2] Anktiva as a Lymphocyte Rescue Molecule [https://www.urologytimes.com/view/anktiva-as-a-lymphocyte-rescue-molecule-unlocking-the-power-of-nk-cells-and-t-cells]
[3] ImmunityBio's ANKTIVA Reverses Lymphopenia in NSCLC [https://www.businesswire.com/news/home/20250908610169/en]
[4] ASCO Report on ANKTIVA in Pancreatic Cancer [https://ir.immunitybio.com/news-releases/news-release-details/asco-report-pioneering-treatment-lymphopenia-significant-overall]
[5] ANKTIVA + BCG for Bladder Cancer [https://www.onclive.com/view/nogapendekin-alfa-inbakicept-plus-bcg-approved-in-uk-for-bcg-unresponsive-nmibc-with-cis]
[6] FDA Approval Summary for ANKTIVA [https://pmc.ncbi.nlm.nih.gov/articles/PMC12363661/]
[7] BCG-unresponsive NMIBC Market Growth [https://www.openpr.com/news/4173808/bcg-unresponsive-nmibc-market-is-projected-to-reach-4-1]
[8] ImmunityBio Q2 2025 Earnings Release [https://immunitybio.com/immunitybio-reports-q2-earnings-release-reflecting-60-increase-in-revenue-in-q2-2025-with-year-to-date-sales-of-43-million-and-246-unit-growth-since-j-code/]
[9] Immunocytokines Market Forecast [https://www.mordorintelligence.com/industry-reports/immunocytokines-market]
[10] ANKTIVA’s Mechanism of Action [https://finance.yahoo.com/news/asco-report-pioneering-treatment-lymphopenia-124500191.html]
[11] Competitive Landscape in BCG-unresponsive NMIBC [https://www.delveinsight.com/blog/evolving-nmibc-treatment]
[12] FDA RMAT Designation for ANKTIVA [https://www.onclive.com/view/nogapendekin-alfa-inbakicept-car-nk-wins-fda-rmat-designation-for-lymphopenia-reversal-in-metastatic-pancreatic-cancer]