1stOncology™: Cancer Intelligence Service – Page 181 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Nanobiotix Announces Presentation of Part 1 Data From a Randomized Phase 2 Clinical Trial Evaluating JNJ-1900 (NBTXR3) in Stage 3 Inoperable Lung Cancer

On May 17, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported the presentation of Part 1 data from the CONVERGE study, a Johnson & Johnson-sponsored randomized Phase 2 clinical trial evaluating potential first-in-class Nanoradioenhancer JNJ-1900 (NBTXR3) for patients with stage 3 inoperable non-small cell lung cancer ("NSCLC"), at the 2026 European Society for Radiotherapy and Oncology Annual Meeting (ESTRO 2026).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

PRESENTATION #116: Radiographic Response in Patients with Stage III Unresectable Non-Small Cell Lung Cancer Treated with an Intratumoral Radioenhancer (JNJ-90301900)

Jeffrey Bradley,1 Benjamin T. Cooper,2 Sushma Patel,3 David DiBardino,4 Michael Pritchett,5 Kevin C. Ma,4 Isaac Laniado,6 Melina E. Marmarelis,7 Matthew Scarlotta,8 Joshua K. Sabari,9 Yi -Wen Ma,10 Tori Stromp,10 Yina Kuang,10 Balaji Laxmanan,10 Kiran Devisetty,10 Steven Feigenberg1

Study Conclusions

Early results suggest that intratumoral/intranodal injection of JNJ-1900 (NBTXR3) is feasible and can be performed safely in patients with stage III unresectable NSCLC
Initial efficacy responses observed in 7 patients following the full treatment regimen of concurrent chemoradiotherapy, JNJ-1900 (NBTXR3), and consolidation with durvalumab are promising:
Overall response rate ("ORR") = 85.7% (6/7 patients)
Complete response rate ("CRR") = 57.1% (4/7 patients)
With the current standard of care, concurrent chemoradiation therapy (cCRT) ± durvalumab, depth of response remains limited in Stage 3 Inoperable NSCLC with very low rates of complete response (<5%) *
Disease control rate ("DCR") = 100.0% (7/7 patients)
Absence of progressive disease and deepening response over time suggests potential for long-term durability
1Radiation Oncology, University of Pennsylvania, Philadelphia, USA; 2Radiation Oncology, NYU Langone Health, New York, USA; 3Radiation Oncology, FirstHealth of the Carolinas, Pinehurst, USA; 4University of Pennsylvania, Philadelphia, USA; 5Interventional Pulmonology, FirstHealth of the Carolinas, Pinehurst, USA; 6Interventional Pulmonology, NYU Langone Health, New York, USA; 7Medical Oncology, University of Pennsylvania, Philadelphia, USA; 8Medical Oncology, FirstHealth of the Carolinas, Pinehurst, USA; 9Medical Oncology, NYU Langone Health, New York, USA; 10Johnson & Johnson, New Brunswick, NJ, USA

* Antonia SJ, et al. N Engl J Med. 2017.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, MAY 17, 2026, View Source [SID1234665815])

New Real-World Case Series Examines Re-Induction with ADSTILADRIN® (nadofaragene firadenovec-vncg) in Clinical Practice

On May 17, 2026 Ferring Pharmaceuticals reported a new real-world case series demonstrating that re-induction with ADSTILADRIN (nadofaragene firadenovec-vncg) resulted in complete responses (CR) in approximately 31% (4/13) of patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) who did not respond to an initial dose of therapy. The study included patients with carcinoma in situ (CIS), with or without papillary tumors (±Ta/T1).

The findings – presented at the 2026 American Urological Association (AUA) Annual Meeting and scheduled for publication in Translational Andrology and Urology later in May – reflect outcomes observed following a re-induction dose (second dose overall) of ADSTILADRIN in a real-world clinical setting, including two patients (2/13) with CIS with papillary disease (T1).1

ADSTILADRIN is the first and only non-replicating intravesical gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with high-risk BCG-unresponsive NMIBC with CIS, with or without papillary tumors (±Ta/T1), and is administered once every three months.

"These findings offer a promising signal that some patients who do not achieve a complete response after an initial dose of ADSTILADRIN may still benefit from re-induction," said Chad Reichard, MD, urologic oncologist and Director of Oncology at Urology of Indiana. "Real-world evidence provides important insight into how ADSTILADRIN is being used in routine clinical practice, and the responses observed in this study support the feasibility of re-induction as a potential option for certain patients despite an initial non-response, while highlighting the need for further study."

The retrospective, observational cohort study analyzed electronic health record data from U.S. private urology practices. Thirteen patients with BCG‑unresponsive NMIBC were eligible, including eight with CIS alone, two with CIS and papillary disease (Ta), and three with CIS and papillary disease (T1). Patients had a mean age of 77.5 years; all were male and had received a mean of 11 prior BCG doses. Prior treatments included gemcitabine (n=4) and pembrolizumab (n=5). Median follow‑up following re‑induction was 379 days (range, 135–519). After re‑induction, four patients (30.8%) achieved a complete response, including two patients with CIS and T1 disease.

Among patients who achieved a complete response, three went on to receive additional doses of ADSTILADRIN; one patient has maintained a complete response at last follow‑up. One patient experienced progression to muscle‑invasive disease (T2a), and one patient underwent cystectomy approximately 51 weeks after initiation of therapy. At the time of analysis, no patient deaths had been reported.

"These new data add to the growing body of real-world evidence generated in urology practices and help inform how re-induction with ADSTILADRIN is being evaluated outside of the controlled clinical trial setting, particularly in a heavily pretreated patient population," said Daniel Shoskes, MD, MSc, FRCS(C), Vice President, Global Medical Director Uro-Oncology, Ferring Pharmaceuticals. "In the Phase 2 and Phase 3 clinical trials, patients who did not achieve a complete response at three months were not retreated with ADSTILADRIN. However, re-induction is an approach that has been used with some immune-based therapies. These real‑world findings provide insight into how re-induction may improve complete response outcomes over the course of treatment."

About Non-Muscle Invasive Bladder Cancer (NMIBC)
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.2 In the United States, bladder cancer is the sixth most common cancer,3 fourth among men,4 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.4 Historically, 75% of bladder cancer presents as NMIBC.5 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.6 Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder).7

About ADSTILADRIN
ADSTILADRIN (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1). It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer.

ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC, who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849 and final five-year follow-up analysis published in The Journal of Urology).8-9

INDICATION
ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.

WARNINGS AND PRECAUTIONS:

Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.
Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals.
DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use or oral administration.

USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.

ADVERSE REACTIONS: The most common (>10%) adverse reactions; including, laboratory abnormalities (>15%), were increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition (urination urgency), increased creatinine, hematuria (blood in urine), decreased phosphate, chills, pyrexia (fever) and dysuria (painful urination).

You are encouraged to report negative side effects of prescription drugs to FDA. Visit View Source or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.

Please click to see the full Prescribing Information.

(Press release, Ferring Pharmaceuticals, MAY 17, 2026, View Source [SID1234665813])

New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic hormone-sensitive prostate cancer

On May 17, 2026 Novartis reported new data from PSMAddition demonstrating improved prostate-specific antigen (PSA) responses with Pluvicto (lutetium (177Lu) vipivotide tetraxetan) combined with standard of care (SoC) in PSMA-positive metastatic hormone sensitive prostate cancer (mHSPC). Data were presented as a rapid oral presentation at the American Urological Association Annual Meeting 2026.

Results show that patients treated with Pluvicto experienced a higher frequency and depth of PSA response when combined with SoC (androgen receptor pathway inhibitor [ARPI] + androgen deprivation therapy [ADT]) compared to SoC alone. Risk of PSA progression was 58% lower (HR 0.42; 95% CI: 0.30-0.59) in patients treated with Pluvicto plus SoC compared to SoC alone.

"Our goal in hormone-sensitive prostate cancer is to attack and delay the cancer before it develops resistance," said Fred Saad, Professor and Chairman, Department of Surgery, University of Montreal. "The deep and durable PSA response observed by combining 177Lu-PSMA-617 with today’s standard of care, together with earlier reported rPFS data, suggest that treatment intensification with radioligand therapy may help patients delay disease progression."

Nearly all patients (>98%) in both arms had substantial declines in PSA levels. However, more patients treated with Pluvicto plus SoC achieved a deep PSA reduction than those treated with SoC alone, as measured by PSA nadir of <0.2 ng/mL.

Time from randomization Patients with PSA <0.2 ng/mL

Pluvicto + ARPI + ADT ARPI + ADT
Week 12 47.6% (235/494) 37.7% (169/448)
Week 24 73.7% (334/453) 59.7% (250/419)
Week 48 87.4% (320/366) 74.9% (295/394)
These results were observed at the second interim analysis for PSMAddition. The safety profile and tolerability of Pluvicto were consistent with its established profile in PSMAfore and VISION. Grade ≥3 adverse events (AEs) were reported in 50.7% of patients in the Pluvicto plus SoC arm, compared to 43% on SoC alone. The most common all-grade AEs were dry mouth, fatigue, nausea, hot flush and anemia.

"These data show that combining Pluvicto with today’s standard of care resulted in deeper PSA responses than ADT plus ARPI alone," said Mark Rutstein, M.D., Global Head, Oncology Development, Novartis. "As the field moves toward more precision-based approaches and earlier treatment intensification in mHSPC, we are encouraged by the potential for Pluvicto to redefine the standard of care across metastatic prostate cancer."

Novartis has filed regulatory submissions in the United States, China and Japan, with first decisions expected in H2 2026.

PSA progression signals disease resistance
PSA progression can be an early indicator of emerging disease resistance, and approximately one-third of patients do not achieve undetectable PSA levels with SOC alone3. Progression to mCRPC, which typically happens within 20 months of diagnosis, is associated with significantly worse outcomes and a life expectancy less than two years4-7. Approximately 186,000 men are diagnosed with mHSPC each year across the US, China, Japan, France, Germany, Italy, Spain and the United Kingdom1.

About Pluvicto (lutetium (177Lu) vipivotide tetraxetan)
Pluvicto is an intravenous RLT that combines a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). After administration into the bloodstream, Pluvicto binds to PSMA-expressing target cells, including prostate cancer cells that express PSMA, a transmembrane protein. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death.

Pluvicto is the only PSMA-targeted agent approved for PSMA+ mCRPC and is the first RLT to demonstrate a clinical benefit for patients with PSMA+ mHSPC in a Phase III trial. Novartis is investigating Pluvicto in oligometastatic prostate cancer, an earlier stage of disease, in the PSMA-DC trial (NCT05939414).

Educational Resources for RLT
To support the integration and safe administration of Novartis RLT products across urology and oncology, Novartis created the RLT Institute. The Institute provides educational resources on theranostics, safety and licensing, facilities and equipment, and clinical workflows to support urologists, oncologists and multidisciplinary teams as they prepare for and integrate RLT into patient care.

(Press release, Novartis, MAY 17, 2026, View Source [SID1234665811])

Long-term EORTC trial challenges assumptions about lymph node radiation therapy in breast cancer

On May 17, 2026 EORTC reported final results from a landmark EORTC randomised trial with more than 20 years of follow-up show that irradiation of the internal mammary and medial supraclavicular lymph nodes reduces breast cancer mortality but does not improve overall survival. The findings highlight the importance of very long-term follow-up when evaluating cancer treatments, particularly in patients with otherwise favourable prognosis.

The results stem from EORTC trial 22922/10925 and were presented at the ESTRO 2026 Congress in Stockholm during the plenary session: Joint Green Journal – The Lancet Oncology Top Clinical Trials. Reflecting the strength and clinical relevance of these findings, the planned 20-year analysis of the full trial population has been simultaneously published in CA: A Cancer Journal for Clinicians, while The Lancet Oncology has accepted to publish soon a complementary paper reporting an unplanned subset analysis in the patients with node-negative (pN0) breast cancer.

Between 1996 and 2004, the trial enrolled 4,004 patients with stage I–III breast cancer at 46 centres in 13 countries. Patients were randomised to receive postoperative radiation therapy with or without elective irradiation of the internal mammary and medial supraclavicular (IM-MS) lymph nodes. At final analysis, the median follow-up was 22.2 years — the longest planned, as well as median, follow-up of any randomised breast cancer radiation therapy trial.

Long‑term outcomes across the overall trial population
At 20 years, overall survival was similar in patients treated with or without IM-MS irradiation. However, breast cancer–related mortality was significantly lower among patients who received IM-MS irradiation. This benefit was counterbalanced over time by an increase in deaths from causes other than breast cancer, which emerged after approximately 15 years, resulting in no survival advantage.

Long-term cardiac and pulmonary toxicity was reported more frequently after IM-MS irradiation, although severe side effects remained very uncommon. Of note, patients were treated using radiation therapy techniques available more than two decades ago.

Outcomes in node-negative breast cancer patients
The proffered paper presented at ESTRO also included the subset analyses on the 1,778 patients with node-negative (pN0) breast cancer and centrally or medially located tumours. Despite a lower absolute risk of breast cancer death in this group, the long-term pattern closely mirrored that of the overall trial population.

Reductions in breast cancer mortality were again offset by a later increase in non–breast cancer–related deaths, resulting in no improvement in overall survival. These findings suggest that long‑term trade‑offs must be considered even in patients with a favourable prognosis and call for careful evaluation of nodal irradiation in axillary‑node‑negative disease.

"Such large, decades-long trials with rigorous quality assurance, allowing clinically meaningful subgroup analyses, are only possible thanks to the sustained support and collaboration fostered by organisations like EORTC," agreed both study coordinators.

The investigators note that advances in modern radiation therapy planning and delivery, sharply reducing radiation exposure to organs such as the heart and lungs, very likely improves the balance between benefits and risks for patients treated today.

Why this trial matters
It provides the longest planned, as well as median follow-up, of any randomised breast cancer radiation therapy trial.
It shows that treatment benefits and risks continue to evolve well beyond 15–20 years.
It demonstrates that node‑negative patients experience similar long‑term trade‑offs as the overall trial population.
It informs ongoing discussions on optimising and potentially de-escalating treatments in favourable-risk breast cancer.
Conducted by the EORTC Radiation Oncology and Breast Cancer Groups, trial 22922/10925 remains a cornerstone study for understanding the long‑term impact of locoregional treatments in breast cancer and for guiding future research aimed at improving both survival and quality of life.

ESTRO 2026 presentation number: 5580 Internal Mammary and Medial Supraclavicular irradiation in stage I-III breast cancer: 20 years results of the randomised EORTC trial 22922/10925, including in pN0 patients (Presenter: Philip Poortmans & Orit Kaidar-Person)

Funding: This study was supported by donations from the La Ligue nationale contre le cancer from France; the KWF Kanker Bestrijding from the Netherlands; and from the Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society from Belgium.

The fellowship of Lydia Champezou was financially supported by the EORTC Cancer Research Fund (ECRF).

(Press release, EORTC, MAY 17, 2026, View Source [SID1234665809])

ImmunityBio Signs Exclusive U.S. Agreement with Japan BCG Laboratory for the Tokyo Strain of BCG to Enhance BCG Supply in the United States

On May 16, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory ("JBL"), the Tokyo-based developer and manufacturer of the Tokyo strain of BCG (Tokyo-172 BCG). The agreement provides ImmunityBio exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG.

JBL’s Tokyo strain of BCG is supported by the February 2026 positive Phase III readout of SWOG S1602, a randomized Phase III study sponsored by the National Cancer Institute (NCI), which demonstrated non-inferiority of the Tokyo strain of BCG to TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer (NMIBC). The pre-specified non-inferiority margin was a hazard ratio of 1.34 (hazard ratio 0.82; 95.8% CI 0.63–1.08). The Tokyo strain of BCG is investigational in the United States and has not been approved by the FDA.

Dr. Patrick Soon-Shiong will discuss the JBL agreement and provide updates on ImmunityBio’s efforts to expand BCG access and advance research in the BCG-naïve setting during his presentation, "The Role of IL-15 in the Urological Setting," at the American Urological Association Annual Meeting on May 16, 2026 at 1:30 EDT. The presentation will also highlight the role of IL-15 in urological oncology, including mechanisms driving T cell and natural killer (NK) cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer. A livestream of the presentation will be available through the 2026 AUA Annual Meeting website.

"For more than 70 years, Japan BCG Laboratory has been dedicated to the development and manufacture of high-quality BCG products," said Seiichi Inoue, President of Japan BCG Laboratory. "We are pleased to partner with ImmunityBio to bring the Tokyo strain of BCG to patients in the United States, and we look forward to supporting ImmunityBio in its engagement with the FDA."

ImmunityBio plans to engage with the FDA to pursue U.S. approval of the Tokyo strain of BCG and will lead all regulatory submissions, clinical development, and commercialization in the United States as the sole BLA applicant. Upon any approval, ImmunityBio will be the sole Marketing Authorization Holder. The Tokyo strain of BCG has been used in Japan for almost 30 years for the treatment of high-risk NMIBC.

SWOG S1602 (NCT03091660) is a Phase III randomized controlled trial that enrolled 1,000 patients (984 eligible) between February 2017 and December 2020 with BCG-naïve high-grade NMIBC, randomized 1:1:1 to intravesical TICE BCG (n=330), intravesical Tokyo-172 BCG (n=327), or intradermal priming, followed by intravesical Tokyo-172 BCG (n=327). The pre-specified non-inferiority margin for the primary endpoint of high-grade recurrence-free survival (HGRFS) was a hazard ratio of 1.34.

At a median follow-up of 4.6 years, results presented at the February 2026 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (Svatek RS, et al. J Clin Oncol. 2026;44[7 suppl]:LBA629) demonstrated non-inferiority of intravesical Tokyo strain of BCG versus intravesical TICE BCG on the primary endpoint of HGRFS (HR 0.82; 95.8% CI 0.63–1.08), with the upper confidence bound well below the pre-specified non-inferiority margin of HR 1.34. Complete response (CR) in carcinoma in situ (CIS) at 6 months was 66.4% (Tokyo) versus 70.2% (TICE). Progression-free survival was similar across arms. The estimated 5-year HGRFS was 64% in the Tokyo arm, 58% in the TICE arm.

ImmunityBio is in discussions with the SWOG Cancer Research Network, the NCI, and Fred Hutchinson Cancer Research Center to establish a Data Use Agreement that would allow incorporation of the S1602 data into the company’s planned BLA submission.

"SWOG and the National Cancer Institute have our deep respect for designing and completing SWOG S1602, a randomized controlled trial of approximately one thousand patients in BCG-naïve high-grade NMIBC that took nearly a decade to read out," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "S1602 is the kind of rigorous, publicly funded science that should inform FDA decision-making. Its non-inferiority finding for the Tokyo strain of BCG, alongside our rBCG partnership with Serum Institute and the FDA-approved use of ANKTIVA with BCG in BCG-unresponsive disease, points to a future where U.S. patients with bladder cancer will have the supply and the treatment options they need."

With the JBL agreement, ImmunityBio now has a second potential BCG source for the United States. The Company’s ongoing partnership with Serum Institute of India, one of the world’s largest vaccine manufacturers, supports the supply of recombinant BCG (rBCG), an investigational product. ImmunityBio will continue its FDA Expanded Access Program (EAP) for rBCG, so eligible patients can receive treatment while the regulatory path for the Tokyo strain of BCG moves forward. Taken together, the two partnerships aim to give U.S. urologists and their patients a more reliable BCG supply.

"U.S. urologists and their patients have lived with a chronic BCG shortage for more than a decade," said Richard Adcock, President and Chief Executive Officer of ImmunityBio. "This agreement with Japan BCG Laboratory for the Tokyo strain of BCG gives ImmunityBio a second potential BCG source for the United States. We plan to work with the FDA on the regulatory path for the Tokyo strain of BCG. In the meantime, through our ongoing partnership with the Serum Institute of India, rBCG remains available to eligible patients through our FDA Expanded Access Program."

ANKTIVA is approved by the FDA in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in-situ (CIS), with or without papillary tumors. ImmunityBio expects to provide further updates on the U.S. regulatory pathway for the Tokyo strain of BCG, including the timing of pre-FDA interactions and any anticipated BLA submission, in future communications.

Important Safety Information

U.S. IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

Investigational Use Notice: The Tokyo strain of BCG (manufactured by Japan BCG Laboratory) and recombinant BCG or rBCG (manufactured by Serum Institute of India under ongoing partnership with ImmunityBio) are investigational in the United States and have not been approved by the FDA. The safety and effectiveness of these investigational products have not been established. Availability of rBCG is limited to ImmunityBio’s FDA Expanded Access Program for eligible patients. To enroll in the Expanded Access Program for recombinant BCG, please visit View Source

(Press release, ImmunityBio, MAY 16, 2026, View Source [SID1234665810])