ImmunityBio, Inc.

ImmunityBio Announces Database Lock for Registrational Trial of Locally Delivered, Chemotherapy-Free ANKTIVA® Plus BCG in BCG-Naïve Non-Muscle Invasive Bladder Cancer

ImmunityBio completed database lock for Cohort A of QUILT-2.005 (NCT02138734), its registrational trial testing ANKTIVA plus BCG versus BCG alone in 366 patients with BCG-naïve non-muscle invasive bladder cancer. A prior FDA-requested interim analysis showed statistically significant longer duration of complete response for the ANKTIVA combination, and final analysis of the primary endpoint is now underway. Topline results are expected in November 2026 with an sBLA submission on track for Q4 2026, which would expand ANKTIVA into the earlier BCG-naïve NMIBC setting as the first locally delivered, chemotherapy-free immunotherapy option.

•11d ago

ImmunityBio Reports Phase 3 Data Showing 84% Cystectomy Avoidance at Three Years and Complete Responses Beyond 53 Months with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC With CIS, With or Without Papillary Tumors

ImmunityBio published long-term data from the Phase 2/3 QUILT-3.032 study (N=100) in the Journal of Urology for ANKTIVA plus BCG in BCG-unresponsive NMIBC with CIS. The data showed a 71% complete response rate, a median CR duration of 26.6 months with responses beyond 53 months, and 84% cystectomy-free survival at 36 months, with 98.2% disease-specific survival at three years. Safety remained favorable, with only Grade 1-2 events for most patients, 4% Grade 3 treatment-related adverse events, and no Grade 4 or 5 events reported. The results support the commercial franchise: ANKTIVA was FDA-approved in 2024 and its indication was expanded in October 2026 to include BCG-unresponsive NMIBC with papillary-only disease.

•16d ago

FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease

ImmunityBio won an expanded FDA label for ANKTIVA plus BCG, covering all patients with BCG-unresponsive non-muscle-invasive bladder cancer including papillary-only tumors. This is the first FDA approval for papillary-only BCG-unresponsive NMIBC, a segment representing roughly 85% of the NMIBC population, dramatically enlarging ANKTIVA's addressable market. Supporting data from QUILT-3.032 Cohort A showed a 62% complete response rate in 77 patients, with 58% of responders maintaining response for at least 12 months.

•18d ago

ImmunityBio Appoints Dr. Jim Yong Kim, Former World Bank President and Global Health Leader, as Vice Chairman

ImmunityBio appointed Dr. Jim Yong Kim, former President of the World Bank Group, as Vice Chairman to lead international partnerships and global access initiatives. Dr. Kim will serve in the newly created Office of the Executive Chairman, reporting to Dr. Patrick Soon-Shiong, and focus on relationships with governments, health ministries, and multilateral institutions. His decades of experience in global health and development finance are expected to support the expansion of ImmunityBio's immunotherapy platform and approved therapies outside the United States.

•2mo ago

ImmunityBio Reports Record Q2 2026 Net Product Revenue of $50.7 Million, Up 92% Year-Over-Year; First-Half Revenue Up 121% to $94.8 Million

ImmunityBio reported Q2 2026 net product revenue of $50.7 million, an increase of 92% year-over-year and 15% sequentially, marking the eighth consecutive quarter of growth since the launch of ANKTIVA. The company ended the quarter with $357.4 million in cash and marketable securities and announced that the FDA accepted its supplemental Biologics License Application for ANKTIVA plus BCG with a PDUFA target action date of January 6, 2027. ImmunityBio also secured an exclusive development and supply agreement with Japan BCG Laboratory for Tokyo-172 BCG to ensure long-term supply for NMIBC patients.

•2mo ago

ImmunityBio Receives United Arab Emirates (UAE) Marketing Authorization for ANKTIVA® Across BCG-Unresponsive Non-Muscle Invasive Bladder Cancer for CIS and Papillary Disease and Metastatic Non-Small Cell Lung Cancer

ImmunityBio secured marketing authorization from the UAE’s Emirates Drug Establishment for ANKTIVA in BCG-unresponsive non-muscle invasive bladder cancer and metastatic non-small cell lung cancer, expanding its global footprint to 34 countries. The bladder cancer approval is the first globally to cover the full spectrum of BCG-unresponsive disease, including CIS and papillary tumors, while the NSCLC approval targets patients who failed checkpoint inhibitors. Clinical data supporting the approvals showed a 71% complete response rate in the bladder cancer CIS cohort and a median overall survival of 14.6 months in checkpoint-refractory NSCLC.

•3mo ago

ImmunityBio Presents New Clinical and Comparative Data Across Lung and Bladder Cancer at ASCO 2026

ImmunityBio presented new clinical and comparative data for its lead asset ANKTIVA at the ASCO 2026 Annual Meeting in Chicago. The presentations included two Phase 3 trials in non-small cell lung cancer (NSCLC) — ResQ201A and QUILT-2.023 — and a matched adjusted indirect comparison in bladder cancer. The data supports the company’s hypothesis that restoring immune competence via IL-15 receptor agonism can rescue responses to checkpoint inhibitors in solid tumors.

•5mo ago

ImmunityBio Presents Health Economic Analysis at ISPOR 2026 Showing ANKTIVA® Plus BCG Delivers Lower Cost per Sustained Complete Response Versus TAR-200 in BCG-Unresponsive NMIBC CIS

ImmunityBio presented health economic analysis at ISPOR 2026 showing ANKTIVA plus BCG delivers lower cost per sustained complete response versus TAR-200 in BCG-unresponsive NMIBC CIS. The model demonstrated cost savings of $109,622 per cystectomy avoided in Year 1 and $313,775 per complete responder in Year 1 compared to TAR-200. These findings support the economic value proposition of ANKTIVA for Medicare reimbursement, driven by higher complete response rates (49.6% vs 45.9%) and lower acquisition costs.

•5mo ago

ImmunityBio Announces Comprehensive U.S. Patents Covering Combination of ANKTIVA with BCG for Cancer Treatment, with Terms Through 2035

ImmunityBio announced the issuance of five U.S. patents covering the combination of its IL-15 receptor agonist ANKTIVA with BCG for cancer treatment, with terms extending through at least 2035. The patent portfolio protects the approved ANKTIVA plus BCG product, the specific intravesical dosing regimen, the two-vial commercial kit, and methods of treating non-muscle invasive bladder cancer (NMIBC). This intellectual property position supports the company’s commercial franchise in BCG-unresponsive NMIBC and its advancing clinical trials, including the QUILT-2.005 registrational trial. CEO Richard Adcock noted that the durable patent protection, combined with validated clinical data and supply chain diversification, positions ANKTIVA plus BCG as the standard of care in this disease for years to come.

•5mo ago