ImmunityBio Completes ANKTIVA’s Post-Approval Enrollment of the 100th Patient in BCG Unresponsive NMIBC CIS Trial and Reports a Complete Response Rate of 71% with a Durable Duration of Response Ranging Up to 54 Months
ImmunityBio (NASDAQ: IBRX) has announced new data from its QUILT 3.032 study, where 100 patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC CIS) were treated with ANKTIVA in combination with BCG. The treatment achieved a 71% complete response rate, with durable responses extending up to 54 months. The company plans to submit this updated data to the European Medicines Agency (EMA) in Q4 2024 as part of a Marketing Authorization Application. The results align with previous findings published in the New England Journal of Medicine and demonstrate ANKTIVA's potential in treating patients with treatment options.
ImmunityBio (NASDAQ: IBRX) ha annunciato nuovi dati dal suo studio QUILT 3.032, nel quale 100 pazienti con carcinoma della vescica non muscolo-invasivo (NMIBC CIS) non reattivo al BCG sono stati trattati con ANKTIVA in combinazione con BCG. Il trattamento ha ottenuto un tasso di risposta completa del 71%, con risposte durature che si estendono fino a 54 mesi. L'azienda prevede di presentare questi dati aggiornati all'Agenzia Europea dei Medicinali (EMA) nel quarto trimestre del 2024 come parte di una domanda di Autorizzazione all'Immissione in Commercio. I risultati si allineano con precedenti scoperte pubblicate nel New England Journal of Medicine e dimostrano il potenziale di ANKTIVA nel trattare pazienti con opzioni terapeutiche.
ImmunityBio (NASDAQ: IBRX) ha anunciado nuevos datos de su estudio QUILT 3.032, en el que 100 pacientes con cáncer de vejiga no infiltrante (NMIBC CIS) que no respondieron al BCG fueron tratados con ANKTIVA en combinación con BCG. El tratamiento logró una tasa de respuesta completa del 71%, con respuestas duraderas que se extienden hasta 54 meses. La empresa planea presentar estos datos actualizados a la Agencia Europea de Medicamentos (EMA) en el cuarto trimestre de 2024 como parte de una solicitud de autorización de comercialización. Los resultados coinciden con hallazgos anteriores publicados en el New England Journal of Medicine y demuestran el potencial de ANKTIVA en el tratamiento de pacientes con opciones de tratamiento.
ImmunityBio (NASDAQ: IBRX)는 BCG에 반응하지 않는 비근육 침투성 방광암(NMIBC CIS) 환자 100명을 대상으로 한 QUILT 3.032 연구의 새로운 데이터를 발표했습니다. 이 환자들은 BCG와 함께 ANKTIVA로 치료받았습니다. 치료의 완전 반응률은 71%에 달했으며, 지속적인 반응은 54개월까지 연장되었습니다. 회사는 이번에 업데이트된 데이터를 2024년 4분기에 유럽 의약품 청(EMA)에 마케팅 허가 신청의 일환으로 제출할 계획입니다. 이 결과는 New England Journal of Medicine에 발표된 이전 연구 결과와 일치하며, ANKTIVA의 치료 잠재력을 나타냅니다.
ImmunityBio (NASDAQ: IBRX) a annoncé de nouvelles données provenant de son étude QUILT 3.032, où 100 patients atteints d'un cancer de la vessie non invasif et réfractaire au BCG (NMIBC CIS) ont été traités avec ANKTIVA en combinaison avec BCG. Le traitement a atteint un taux de réponse complète de 71%, avec des réponses durables s'étendant jusqu'à 54 mois. La société prévoit de soumettre ces données mises à jour à l'Agence européenne des médicaments (EMA) au quatrième trimestre de 2024 dans le cadre d'une demande d'autorisation de mise sur le marché. Les résultats sont cohérents avec des résultats précédemment publiés dans le New England Journal of Medicine et démontrent le potentiel d'ANKTIVA dans le traitement des patients avec des options thérapeutiques.
ImmunityBio (NASDAQ: IBRX) hat neue Daten aus seiner Studie QUILT 3.032 bekannt gegeben, in der 100 Patienten mit BCG-resistentem nicht-muskelinvasivem Blasenkarzinom (NMIBC CIS) mit ANKTIVA in Kombination mit BCG behandelt wurden. Die Behandlung erreichte eine 71% vollständige Ansprechrate, wobei die nachhaltigen Antworten bis zu 54 Monate andauerten. Das Unternehmen plant, diese aktualisierten Daten im vierten Quartal 2024 bei der Europäischen Arzneimittel-Agentur (EMA) im Rahmen eines Antrags auf Marktzulassung einzureichen. Die Ergebnisse stimmen mit früheren Feststellungen überein, die im New England Journal of Medicine veröffentlicht wurden, und zeigen das Potenzial von ANKTIVA in der Behandlung von Patienten mit Behandlungsoptionen.
- 71% complete response rate achieved in 100-patient trial
- Durable response extending up to 54 months
- Results consistent with previously published data in NEJM
- Planned EMA submission in Q4 2024 could expand market access
- None.
Insights
The completion of enrollment with 100 patients and 71% complete response rate in the QUILT 3.032 trial represents significant clinical validation for ANKTIVA. The durability of response extending up to 54 months is particularly noteworthy, as it surpasses typical response durations seen with other treatments in BCG-unresponsive NMIBC CIS.
The consistency between this expanded cohort and earlier data published in NEJM strengthens the reliability of these results. This positions ANKTIVA favorably for potential EMA approval, especially given the unmet need in this patient population where treatment options are The extended durability could significantly reduce the need for cystectomy (surgical bladder removal), which would be a major advancement in patient care.
This data strengthens ANKTIVA's market position and potential commercial success in Europe. The planned EMA submission in Q4 2024 could lead to market expansion opportunities, adding to the recent FDA approval. The 71% response rate and exceptional durability data provide compelling evidence for regulatory approval and market adoption.
For ImmunityBio, successful EMA approval would open access to the European bladder cancer market, potentially driving significant revenue growth. The strong efficacy data compared to other approved products in this indication suggests ANKTIVA could capture substantial market share, particularly given the emphasis on prolonged response duration, which is a key differentiator in this therapeutic space.
- High responder rate associated with a duration of response ranging as long as 54 months in QUILT-3.032 with 100 patients enrolled
- Updated data intended to be submitted as part of a European Medicines Agency (EMA) Submission in Q4 2024
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Complete response data in 100 patients consistent with CR rate of
71% reported for 82 patients published in NEJM
This significant milestone underscores the potential of ANKTIVA to provide durable responses in patients with limited treatment options. The QUILT 3.032 study is a single-arm, multicenter trial evaluating the safety and efficacy of ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC CIS. The observed
“We are encouraged by the consistent complete response rates observed in our expanded patient cohort,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “These results highlight the potential of ANKTIVA to transform the treatment landscape for patients with BCG-unresponsive NMIBC CIS, offering hope for improved outcomes and cystectomy avoidance, especially with the prolonged duration of response now ranging as much as 54 months in this 100-patient analysis. Duration of complete response is the key efficacy element in driving cystectomy avoidance in this BCG-unresponsive population. I am pleased that this updated ANKTIVA data confirms that one of the highest durable responses is achieved when compared to other approved products in this indication.”
The QUILT 3.032 study continues to monitor patients to assess the durability of responses and overall survival outcomes. ImmunityBio remains committed to advancing innovative immunotherapies that harness the body's immune system to combat cancer.
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.
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 anticipated 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 presentation 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 commercial launch execution, success and timing, (ii) risks and uncertainties related to the regulatory submission, filing and review process and the timing thereof, (iii) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (iv) whether clinical trials will result in registrational pathways and the risks and uncertainties regarding the regulatory submission, review and approval process, (v) whether clinical trial data, including that reported herein, will be accepted by regulatory agencies, (vi) 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, (vii) potential delays in product availability and regulatory approvals, (viii) ImmunityBio’s ability to retain and hire key personnel, (ix) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (x) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xi) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiii) 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
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Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
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Sarah Singleton
ImmunityBio
+1 415-290-8045
Sarah.Singleton@ImmunityBio.com
Source: ImmunityBio, Inc.
FAQ
What is the complete response rate for ANKTIVA in the QUILT 3.032 trial?
How long did the treatment response last in the QUILT 3.032 trial?
When will ImmunityBio (IBRX) submit ANKTIVA data to the EMA?
What type of cancer does ANKTIVA treat in the QUILT 3.032 trial?
