Drug Monitoring Committee Authorizes Continuation of Intensity Therapeutics' Ongoing Global Randomized Phase 3 Sarcoma Trial ("INVINCIBLE-3 Study") Following Periodic Review
Intensity Therapeutics (INTS) announces that the Data Monitoring Committee (DMC) has authorized the continuation of its Phase 3 INVINCIBLE-3 sarcoma trial for INT230-6 without modifications following a periodic review of data from July to December 2024.
The INVINCIBLE-3 Study is a global open-label, randomized, controlled study comparing intratumoral INT230-6 administration to standard chemotherapy in approximately 333 adult patients with soft tissue sarcoma (STS). The trial focuses on patients with leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma who experienced disease progression after standard therapies.
The study's primary endpoints are overall survival and safety, with an exploratory quality of life assessment. The trial has received authorizations in the U.S., Canada, Europe, and Australia, and is currently recruiting participants across these regions.
Intensity Therapeutics (INTS) annuncia che il Comitato di Monitoraggio dei Dati (DMC) ha autorizzato la continuazione del suo trial di Fase 3 INVINCIBLE-3 per INT230-6 senza modifiche, a seguito di una revisione periodica dei dati da luglio a dicembre 2024.
Lo studio INVINCIBLE-3 è uno studio globale, a etichetta aperta, randomizzato e controllato, che confronta la somministrazione intratumorale di INT230-6 con la chemioterapia standard in circa 333 pazienti adulti con sarcoma dei tessuti molli (STS). Il trial si concentra su pazienti con leiomiosarcoma, liposarcoma e sarcoma pleomorfico indifferenziato che hanno sperimentato progressione della malattia dopo le terapie standard.
Gli obiettivi primari dello studio sono la sopravvivenza globale e la sicurezza, con una valutazione esplorativa della qualità della vita. Il trial ha ricevuto autorizzazioni negli Stati Uniti, in Canada, in Europa e in Australia, ed è attualmente in fase di reclutamento di partecipanti in queste regioni.
Intensity Therapeutics (INTS) anuncia que el Comité de Monitoreo de Datos (DMC) ha autorizado la continuación de su ensayo de Fase 3 INVINCIBLE-3 para INT230-6 sin modificaciones, tras una revisión periódica de los datos desde julio hasta diciembre de 2024.
El Estudio INVINCIBLE-3 es un estudio global, de etiqueta abierta, aleatorizado y controlado que compara la administración intratumoral de INT230-6 con la quimioterapia estándar en aproximadamente 333 pacientes adultos con sarcoma de tejidos blandos (STS). El ensayo se centra en pacientes con leiomiosarcoma, liposarcoma y sarcoma pleomórfico indiferenciado que han experimentado progresión de la enfermedad tras las terapias estándar.
Los objetivos primarios del estudio son la supervivencia general y la seguridad, con una evaluación exploratoria de la calidad de vida. El ensayo ha recibido autorizaciones en EE. UU., Canadá, Europa y Australia, y actualmente está reclutando participantes en estas regiones.
Intensity Therapeutics (INTS)는 데이터 모니터링 위원회(DMC)가 2024년 7월부터 12월까지의 데이터에 대한 정기 검토 후 INT230-6에 대한 INVINCIBLE-3 phase 3 종양 시험을 수정 없이 계속할 것을 승인했다고 발표했습니다.
INVINCIBLE-3 연구는 약 333명의 성인 환자를 대상으로 인트라투모럴 INT230-6 투여를 표준화학요법과 비교하는 글로벌 오픈 라벨 무작위 대조 연구입니다. 이 시험은 표준 치료 후 질병 진행이 있었던 레이오미오사르코마, 리포사르코마, 그리고 미분화 다형성 사르코마 환자에 초점을 맞추고 있습니다.
연구의 주요 목표는 전체 생존율 및 안전성으로, 탐색적인 삶의 질 평가가 포함됩니다. 이 시험은 미국, 캐나다, 유럽 및 호주에서 승인을 받았으며 현재 이러한 지역에서 참가자를 모집하고 있습니다.
Intensity Therapeutics (INTS) annonce que le Comité de Surveillance des Données (DMC) a autorisé la poursuite de son essai de phase 3 INVINCIBLE-3 pour INT230-6 sans modifications, à la suite d'un examen périodique des données de juillet à décembre 2024.
L'étude INVINCIBLE-3 est une étude mondiale, ouverte, randomisée et contrôlée qui compare l'administration intratumorale d'INT230-6 à la chimiothérapie standard chez environ 333 patients adultes atteints de sarcome des tissus mous (STS). L'essai se concentre sur les patients atteints de léiomyosarcome, de liposarcome et de sarcome pléomorphe indifférencié qui ont subi une progression de la maladie après des thérapies standards.
Les principaux objectifs de l'étude sont la survie globale et la sécurité, avec une évaluation exploratoire de la qualité de vie. L'essai a reçu des autorisations aux États-Unis, au Canada, en Europe et en Australie, et recrute actuellement des participants dans ces régions.
Intensity Therapeutics (INTS) gibt bekannt, dass das Data Monitoring Committee (DMC) die Fortsetzung seiner Phase 3 INVINCIBLE-3 Sarcomastudie für INT230-6 ohne Änderungen nach einer regelmäßigen Überprüfung der Daten von Juli bis Dezember 2024 genehmigt hat.
Die INVINCIBLE-3 Studie ist eine globale, offene, randomisierte und kontrollierte Studie, die die intratumorale Verabreichung von INT230-6 mit der Standard-Chemotherapie bei etwa 333 erwachsenen Patienten mit Weichgewebsarcom (STS) vergleicht. Die Studie konzentriert sich auf Patienten mit Leiomyosarkom, Liposarkom und undifferenziertem pleomorphem Sarkom, die nach Standardtherapien eine Krankheitsprogression erfahren haben.
Die primären Endpunkte der Studie sind das Gesamtüberleben und die Sicherheit, mit einer explorativen Bewertung der Lebensqualität. Der Test hat Genehmigungen in den USA, Kanada, Europa und Australien erhalten und rekrutiert derzeit Teilnehmer in diesen Regionen.
- DMC approval for trial continuation without modifications indicates positive safety profile
- Global trial authorization across major markets (US, Canada, Europe, Australia)
- Active patient recruitment ongoing in multiple countries
- None.
Insights
The DMC's authorization to continue the Phase 3 INVINCIBLE-3 trial represents a important milestone for Intensity Therapeutics' INT230-6 development program. This decision is particularly significant given the complex nature of soft tissue sarcoma treatment and the historical challenges in developing effective therapies for this indication.
Several key aspects make this trial strategically important:
- The study's design comparing INT230-6 against three established treatments (pazopanib, trabectedin and eribulin) demonstrates confidence in the therapy's potential competitive positioning
- The focus on overall survival as the primary endpoint, rather than surrogate endpoints, sets a high bar for clinical success but could lead to stronger market positioning if positive
- The global nature of the trial, with authorizations from major regulatory bodies and sites in 8 countries, suggests a well-planned commercial strategy
The DMC's review process, examining six months of data from July to December 2024, indicates the trial is progressing as planned without safety concerns. This is particularly noteworthy for an intratumoral therapy, where local administration could potentially raise unique safety considerations.
The market opportunity is substantial, considering soft tissue sarcomas represent an area of significant unmet medical need. If successful, INT230-6 could offer a novel treatment approach that potentially provides better outcomes or quality of life compared to current systemic chemotherapy options.
INVINCIBLE-3 Study continues to recruit patients with leiomyosarcoma, liposarcoma and undifferentiated pleomorphic sarcoma; authorizations for the INVINCIBLE-3 Study have been received in the
"The Data Monitoring Committee is designed to confidentially review data to determine whether safety concerns with the data collected to date exist. We are encouraged by the continuation of the trial and continue to believe that INT230-6 represents important potential in a treatment area that has significantly unmet medical need. We look forward to continuing enrollment and to providing further updates as they develop," commented Lewis H. Bender, Intensity's President and Chief Executive Officer.
INVINCIBLE-3 Study Overview
The INVINCIBLE-3 Study is a global open-label, randomized, controlled study designed to evaluate INT230-6 administered intratumorally by an interventional radiologist or an equivalently trained physician using image guidance compared to systemically dosed standard of care ("SOC") chemotherapy. The study endpoints are overall survival and safety, along with an exploratory quality of life (QoL) assessment using the EORTC-30 survey. The study is testing the efficacy and safety of INT230-6 intratumoral (IT) injection compared to any of three standard-of-care therapies (pazopanib, trabectedin, or eribulin) in approximately 333 adult participants with locally recurrent, inoperable, or metastatic soft tissue sarcoma ("STS") patients who had disease progression prior to study enrollment following standard therapies, which must have included an anthracycline-based regimen unless contraindicated. Participants may also have received a maximum of one additional regimen. Randomization will occur after screening and eligibility confirmation. As this is a survival study, there is no crossover allowed between SOC and INT230-6. Disease progression will be determined by the World Health Organization (WHO) criteria. Participants will be prospectively stratified into 1 of 3 histologically defined STS strata:
- leiomyosarcoma
- liposarcoma (dedifferentiated, myxoid, round cell and pleomorphic)
- undifferentiated pleomorphic sarcoma
The comparator agents used are all
About INT230-6
INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.
About Intensity Therapeutics
Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, SAKK (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com.
Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.
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SOURCE Intensity Therapeutics Inc.
FAQ
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