Intensity Therapeutics, Inc.'s Phase 3 INVINCIBLE-3 Sarcoma Study Selected for Presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting
Intensity Therapeutics (NASDAQ: INTS) announced that its Phase 3 INVINCIBLE-3 clinical trial of INT230-6 for treating metastatic soft tissue sarcomas will be presented at the ASCO 2025 Annual Meeting. The presentation will be delivered by Dr. Sant P. Chawla on May 31, 2025. INT230-6, an intratumoral therapy, has shown promising results in Phase 1/2 trials, demonstrating a 93% disease control rate and 21.3 months median overall survival in refractory metastatic sarcoma patients. The drug causes significant tumor necrosis and cyst formation with minimal adverse events. However, new enrollment for the Phase 3 study has been temporarily paused due to funding constraints, though treatment continues for currently enrolled patients.
Intensity Therapeutics (NASDAQ: INTS) ha annunciato che il suo studio clinico di Fase 3 INVINCIBLE-3 su INT230-6 per il trattamento dei sarcomi dei tessuti molli metastatici sarà presentato al ASCO 2025 Annual Meeting. La presentazione sarà tenuta dal Dr. Sant P. Chawla il 31 maggio 2025. INT230-6, una terapia intratumorale, ha mostrato risultati promettenti negli studi di Fase 1/2, con un tasso di controllo della malattia del 93% e una sopravvivenza mediana globale di 21,3 mesi nei pazienti con sarcoma metastatico refrattario. Il farmaco provoca una necrosi tumorale significativa e la formazione di cisti con eventi avversi minimi. Tuttavia, l'arruolamento di nuovi pazienti per lo studio di Fase 3 è stato temporaneamente sospeso a causa di vincoli finanziari, anche se il trattamento continua per i pazienti già iscritti.
Intensity Therapeutics (NASDAQ: INTS) anunció que su ensayo clínico de Fase 3 INVINCIBLE-3 con INT230-6 para el tratamiento de sarcomas de tejidos blandos metastásicos será presentado en la Reunión Anual ASCO 2025. La presentación será realizada por el Dr. Sant P. Chawla el 31 de mayo de 2025. INT230-6, una terapia intratumoral, ha mostrado resultados prometedores en los ensayos de Fase 1/2, demostrando una tasa de control de la enfermedad del 93% y una supervivencia global mediana de 21,3 meses en pacientes con sarcoma metastásico refractario. El medicamento provoca necrosis tumoral significativa y formación de quistes con eventos adversos mínimos. Sin embargo, la inscripción de nuevos pacientes para el estudio de Fase 3 se ha pausado temporalmente debido a limitaciones financieras, aunque el tratamiento continúa para los pacientes ya inscritos.
Intensity Therapeutics (NASDAQ: INTS)는 전이성 연부 조직 육종 치료를 위한 INT230-6의 3상 임상시험 INVINCIBLE-3가 ASCO 2025 연례 회의에서 발표될 것이라고 발표했습니다. 발표는 2025년 5월 31일 Dr. Sant P. Chawla가 진행할 예정입니다. INT230-6은 종양 내 주입 치료제로, 1/2상 시험에서 93%의 질병 조절률과 21.3개월의 중앙 전체 생존 기간을 보이며 유망한 결과를 나타냈습니다. 이 약물은 최소한의 부작용으로 종양 괴사와 낭종 형성을 유도합니다. 다만, 자금 문제로 인해 3상 시험의 신규 등록은 일시 중단되었으나, 이미 등록된 환자에 대한 치료는 계속 진행 중입니다.
Intensity Therapeutics (NASDAQ : INTS) a annoncé que son essai clinique de phase 3 INVINCIBLE-3 portant sur INT230-6 pour le traitement des sarcomes des tissus mous métastatiques sera présenté lors du ASCO 2025 Annual Meeting. La présentation sera assurée par le Dr Sant P. Chawla le 31 mai 2025. INT230-6, une thérapie intratumorale, a montré des résultats prometteurs lors des phases 1/2, avec un taux de contrôle de la maladie de 93 % et une survie globale médiane de 21,3 mois chez des patients atteints de sarcome métastatique réfractaire. Le médicament induit une nécrose tumorale importante et la formation de kystes avec des effets indésirables minimes. Cependant, le recrutement de nouveaux patients pour l’étude de phase 3 est temporairement suspendu en raison de contraintes financières, bien que le traitement se poursuive pour les patients déjà inclus.
Intensity Therapeutics (NASDAQ: INTS) gab bekannt, dass die Phase-3-Studie INVINCIBLE-3 zu INT230-6 zur Behandlung von metastasierten Weichteilsarkomen auf dem ASCO 2025 Jahreskongress vorgestellt wird. Die Präsentation hält Dr. Sant P. Chawla am 31. Mai 2025. INT230-6, eine intratumorale Therapie, zeigte vielversprechende Ergebnisse in Phase-1/2-Studien mit einer 93%igen Krankheitskontrollrate und einer medianen Gesamtüberlebenszeit von 21,3 Monaten bei refraktären metastasierten Sarkompatienten. Das Medikament verursacht eine deutliche Tumornekrose und Zystenbildung bei minimalen Nebenwirkungen. Aufgrund finanzieller Engpässe wurde die Neueinschreibung für die Phase-3-Studie vorübergehend ausgesetzt, die Behandlung der bereits eingeschriebenen Patienten läuft jedoch weiter.
- None.
- Phase 3 trial enrollment has been paused due to insufficient funding
- Additional funding required to reinitiate patient recruitment
Insights
Intensity presents Phase 3 sarcoma trial at ASCO but has paused enrollment pending funding; prior Phase 1/2 showed promising survival data.
Intensity Therapeutics is presenting its Phase 3 INVINCIBLE-3 trial design for INT230-6 at the upcoming ASCO 2025 meeting. This clinical trial evaluates their innovative intratumoral therapy against standard chemotherapy for treating metastatic soft tissue sarcomas. INT230-6 represents a novel approach that directly injects drug compounds (SHAO, vinblastine, cisplatin) into tumors, causing significant necrosis while potentially triggering immune responses.
The company's presentation builds on promising Phase 1/2 results where heavily pre-treated sarcoma patients (median of three prior therapies) showed a remarkable 93% disease control rate and 21.3-month median overall survival with minimal adverse events. The data suggests potential efficacy beyond directly injected tumors, with evidence of regression in uninjected lesions and immune engagement.
Critically, while the trial design has received authorization from eight regulatory agencies including the FDA, Intensity has paused new enrollment due to funding constraints. They continue treating currently enrolled patients and maintaining site monitoring but require additional capital to fully resume recruitment. This funding pause creates uncertainty around the timeline for study completion and potential commercialization pathway. The company's ability to secure funding will determine how quickly this potentially promising treatment can advance through clinical development for this difficult-to-treat cancer population.
The poster, titled, "A Multicenter, Randomized, Global Phase 3 Study to Assess the Efficacy and Safety of Intratumoral (IT) INT230-6 (SHAO, VINblastine, Cisplatin) as Monotherapy Compared with Standard of Care Systemic Chemotherapy in Adults with Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (STS) (INVINCIBLE-3)," will be presented by Sant P. Chawla M.D., Director, Sarcoma Oncology Center of
"The INVINCIBLE-3 trial is breaking new ground in metastatic sarcoma with a unique, new, investigational product, INT230-6. Following direct intratumoral injection, this drug product results in significant necrosis and the formation of cysts within tumors, with little residual cancer remaining in those injected tumors. A successful outcome of the INVICIBLE-3 study will require practicing physicians to think differently about setting dose and disease endpoints. INT230-6's dose per tumor is set by the tumor size. In this protocol, survival advantage is the gold standard upon which the efficacy of a novel investigational agent such as INT230-6 would be ultimately based," said Dr. Chawla.
"We have designed a unique Phase 3 protocol comparing our local therapy to the best systemic standard of care based on our completed Phase 1/2 trial. In our first study, refractory, metastatic sarcoma patients whose disease continued to progress following a median of three prior lines of therapy received INT230-6 alone," said Lewis H. Bender, Intensity Therapeutics Founder, President, and CEO. "Those sarcoma patients showed immune engagement post-dose, uninjected tumors regressing, a disease control rate of
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 composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, 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, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient's malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which so often occurs with systemic chemotherapy.
About INVINCIBLE-3
INVINCIBLE-3 is a study to evaluate a novel, new drug product administered intratumorally by an interventional radiologist or an equivalently trained physician using image guidance compared to systemically dosed second- or third-line US standard of care chemotherapy. Patients will be randomized 2 to 1 to INT230-6 or pazopanib, trabectedin, or eribulin (selection of SOC depends on the sarcoma subtype). As this is a survival study, there is no crossover allowed between US SOC and INT230-6. Disease progression will be determined by the World Health Organization (WHO) Criteria in conjunction with evaluation of the post-treatment scans. Dosing beyond radiographic progression is allowed should tumors have low levels residual cancer on scans post baseline. Participants will be prospectively stratified into 1 of 3 histologically defined aSTS strata: leiomyosarcoma, liposarcoma (dedifferentiated, myxoid, round cell and pleomorphic) and undifferentiated pleomorphic sarcoma
The participants will undergo in 4 phases: screening, treatment, maintenance, and follow-up in the study. Study visits, tumor and endpoint assessments will occur as indicated in the procedural outlines as part of a schedule of events. Important inclusion criteria include: histologically proven, unresectable, locally advanced, or metastatic STS only of the following Participant must have a pathology report indicating the diagnosis of their STS. Participants must have received at least 1 line of therapy for STS and must have progressed following anthracycline-based or alternative standard therapies, except if medically contraindicated or refused by the participant. A participant cannot have received more than 2 prior regimens for unresectable, locally advanced or metastatic STS. Participants must have measurable disease per RECIST 1.1 criteria. Participants must have at least 1 target tumor ≥ 2 cm suitable for injection using routine image guidance, measurable by CT or MRI.
Key exclusion criteria include: Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable as well as off steroid therapy for at least 2 months. History of severe hypersensitivity reactions to US SOC agents and vinblastine or cisplatin or other products of the same class and their excipients. Histologically proven, unresectable, locally advanced or metastatic STS subtypes other than those specified, for example, excluded subtypes include liposarcoma (well differentiated), desmoid or dermatofibrosarcoma protuberans. Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the participant has been disease-free for at least 2 years.
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 the investigational new drug, 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
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FAQ
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