ImmunityBio Announces European Medicines Agency Acceptance of Marketing Authorization Application for ANKTIVA® for the Treatment of Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
ImmunityBio (NASDAQ: IBRX) announced that the European Medicines Agency (EMA) has accepted its marketing authorization application for ANKTIVA® in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
The application covers 30 European countries and is based on the ongoing QUILT 3.032 study, which demonstrated a 71% complete response rate in 100 patients. The duration of response ranges up to 54 months and is ongoing, surpassing the duration of response of all approved products for this indication. This milestone comes nine months after FDA approval in the United States.
The company has also submitted an application to the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The study results exceed the International Bladder Cancer Group's benchmark of 18 months for meaningful clinical results.
ImmunityBio (NASDAQ: IBRX) ha annunciato che l'Agenzia Europea dei Medicinali (EMA) ha accettato la sua domanda di autorizzazione alla commercializzazione per ANKTIVA® in combinazione con BCG per il trattamento del cancro della vescica non muscolo-invasivo non responsivo a BCG con carcinoma in situ.
La domanda copre 30 paesi europei ed è basata sullo studio QUILT 3.032 in corso, che ha dimostrato un tasso di risposta completa del 71% in 100 pazienti. La durata della risposta arriva fino a 54 mesi ed è attualmente in corso, superando la durata della risposta di tutti i prodotti approvati per questa indicazione. Questo traguardo arriva nove mesi dopo l'approvazione della FDA negli Stati Uniti.
La società ha anche presentato una domanda all'Agenzia Regolatoria per i Medicinali e i Prodotti Sanitari del Regno Unito (MHRA). I risultati dello studio superano il benchmark del Gruppo Internazionale di Oncologia della Vescica di 18 mesi per risultati clinici significativi.
ImmunityBio (NASDAQ: IBRX) anunció que la Agencia Europea de Medicamentos (EMA) ha aceptado su solicitud de autorización de comercialización para ANKTIVA® en combinación con BCG para tratar el cáncer de vejiga no muscular invasivo que no responde al BCG y con carcinoma in situ.
La solicitud abarca 30 países europeos y se basa en el estudio QUILT 3.032, que demostró una tasa de respuesta completa del 71% en 100 pacientes. La duración de la respuesta llega hasta los 54 meses y sigue en curso, superando la duración de respuesta de todos los productos aprobados para esta indicación. Este hito llega nueve meses después de la aprobación de la FDA en los Estados Unidos.
La empresa también ha presentado una solicitud ante la Agencia Reguladora de Medicamentos y Productos de Atención Sanitaria del Reino Unido (MHRA). Los resultados del estudio superan el criterio del Grupo Internacional de Cáncer de Vejiga de 18 meses para resultados clínicos significativos.
ImmunityBio (NASDAQ: IBRX)는 유럽 의약품청(EMA)이 ANKTIVA®의 시장 승인 신청을 수락했다고 발표했습니다. 이는 BCG에 반응하지 않는 비근육 침윤성 방광암(상피내암) 치료를 위한 BCG와의 병용입니다.
신청은 30개의 유럽 국가를 포함하며, 현재 진행 중인 QUILT 3.032 연구에 기반하고 있습니다. 이 연구는 100명의 환자에게 71%의 완전 반응률을 입증했습니다. 반응의 지속 시간은 최대 54개월에 이르며, 현재 진행 중이며 이 적응증에 대해 승인된 모든 제품의 반응 지속 시간을 초과합니다. 이 이정표는 미국 FDA 승인 후 9개월 만에 이뤄진 것입니다.
회사는 또한 영국의 의약품 및 의료 제품 규제 기관(MHRA)에 신청서를 제출했습니다. 연구 결과는 국제 방광암 그룹의 18개월 기준을 초과하는 의미 있는 임상 결과를 보여줍니다.
ImmunityBio (NASDAQ: IBRX) a annoncé que l'Agence Européenne des Médicaments (EMA) a accepté sa demande d'autorisation de mise sur le marché pour ANKTIVA® en combinaison avec BCG pour traiter le cancer de la vessie non invasive, non musculaire et résistant au BCG, avec carcinome in situ.
Cette demande couvre 30 pays européens et repose sur l'étude en cours QUILT 3.032, qui a démontré un taux de réponse complet de 71% chez 100 patients. La durée de la réponse s'étend jusqu'à 54 mois et est toujours en cours, dépassant la durée de réponse de tous les produits approuvés pour cette indication. Ce jalon intervient neuf mois après l'approbation de la FDA aux États-Unis.
L'entreprise a également soumis une demande à l'Agence de Régulation des Médicaments et des Produits de Santé du Royaume-Uni (MHRA). Les résultats de l'étude dépassent le critère de référence de 18 mois du Groupe International de Cancer de la Vessie pour des résultats cliniques significatifs.
ImmunityBio (NASDAQ: IBRX) gab bekannt, dass die Europäische Arzneimittelagentur (EMA) seinen Antrag auf Marktzulassung für ANKTIVA® in Kombination mit BCG zur Behandlung von BCG-unempfindlichem nicht-muskelinvasivem Blasenkrebs mit Carcinoma in situ akzeptiert hat.
Der Antrag umfasst 30 europäische Länder und basiert auf der laufenden Studie QUILT 3.032, die eine 71% vollständige Ansprechrate bei 100 Patienten zeigte. Die Dauer der Antwort beträgt bis zu 54 Monate und ist weiterhin aktiv, was die Dauer der Antwort aller genehmigten Produkte für diese Indikation übersteigt. Dieser Meilenstein kommt neun Monate nach der FDA-Zulassung in den Vereinigten Staaten.
Das Unternehmen hat auch einen Antrag bei der britischen Arzneimittel- und Gesundheitsbehörde (MHRA) eingereicht. Die Studienergebnisse übertreffen den Benchmark der International Bladder Cancer Group von 18 Monaten für bedeutende klinische Ergebnisse.
- 71% complete response rate in QUILT 3.032 study with 100 patients
- Duration of response up to 54 months, exceeding industry benchmark of 18 months
- EMA acceptance expands potential market to 30 European countries
- Recent FDA approval demonstrates regulatory momentum
- None.
Insights
The EMA's acceptance of ANKTIVA's marketing authorization application marks a important advancement in bladder cancer treatment. The 71% complete response rate in BCG-unresponsive NMIBC patients is particularly noteworthy, but what's more impressive is the duration of response extending up to 54 months - significantly surpassing the 18-month benchmark established by the International Bladder Cancer Group.
This extended durability of response is a game-changer in the NMIBC treatment landscape. Current treatment options for BCG-unresponsive patients are , often leading to radical cystectomy - complete bladder removal - which significantly impacts quality of life. ANKTIVA's combination with BCG could potentially become the new standard of care, offering a bladder-preserving option for these challenging cases.
The European market opportunity is substantial, with the application covering 30 countries. The timing of this submission, just nine months after FDA approval, demonstrates strong execution of ImmunityBio's global commercialization strategy. With bladder cancer being the 10th most common cancer globally and approximately 20% of cases being NMIBC, this expansion into Europe could significantly boost the company's market reach and revenue potential.
- Application covers 30 countries in the European Union
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Submission is based on the ongoing QUILT 3.032 study in which 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS) have been treated with ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG, achieving a
71% (71/100) complete response (CR) rate - In these responders, the range of duration is 54 months and ongoing, exceeding all duration of response in approved products in this indication
“We are encouraged by the speed in which the EMA accepted our marketing authorization application and determined it would begin its assessment of our innovative treatment for this serious condition, just nine months after it was first approved by the FDA for use in the United States,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “Along with our submission to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), this action by the EMA is strong evidence of the momentum for putting ANKTIVA+BCG into the hands of physicians who are treating patients with NMIBC.”
The EMA submission is based on the ongoing QUILT 3.032 study in which the complete response rate for the 100 evaluable patients in Cohort A as of the July 15, 2024 cut-off was
About ANKTIVA®
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.
ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.
ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit Anktiva.com.
About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding the anticipated timing of the EMA’s review of ImmunityBio’s MAA and ultimate decision regarding whether to approve ANKTIVA for the treatment of patients with BCG-unresponsive NMIBC CIS in the countries under its jurisdiction, additional regulatory submissions and timing thereof, global expansion efforts, clinical trial data and potential results to be drawn therefrom, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the EMA regulatory review process, potential actions required in connection with the same, and whether or not the EMA will ultimately approve ImmunityBio’s MAA that has been accepted for review, (ii) risks and uncertainties regarding commercial launch execution, success and timing, (iii) risks and uncertainties related to the regulatory submission, filing and review process and the timing thereof, (iv) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (v) whether clinical trials will result in registrational pathways, (vi) whether clinical trial data will be accepted by regulatory agencies, (vii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (viii) potential delays in product availability and regulatory approvals, (ix) ImmunityBio’s ability to retain and hire key personnel, (x) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xi) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xii) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xiii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiv) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the
Indication and 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 patient 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 lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.
USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common (≥
For more information about ANKTIVA, please see the Full Prescribing Information at www.anktiva.com.
You are encouraged to report negative side effects of prescription drugs to FDA.
Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482).
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ImmunityBio, Inc.
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FAQ
What is the complete response rate for ANKTIVA in the QUILT 3.032 study for IBRX?
How long does ANKTIVA's treatment response last in bladder cancer patients?
Which European regulatory bodies are reviewing ANKTIVA for IBRX?
How many European countries are covered by IBRX's EMA application for ANKTIVA?
When did ANKTIVA receive FDA approval before the EMA application?
