A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young Adult Patients With Recurrent Soft Tissue Sarcomas

The goal of this study is to build on the experience of the SAINT trial by evaluating the safety and efficacy of the addition of pazopanib to their published chemotherapy regimen.

Start Date31 Aug 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT07076186

/ RecruitingPhase 2IIT

Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in Uterine Leiomyosarcoma

To find out if receiving standard chemotherapy (doxorubicin and trabectedin) can extend the cancer-free survival of patients with Stage 1b/2 uterine leiomyosarcoma who had surgery that fully removed the tumor.

Start Date02 Oct 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

KCT0010391

/ Not yet recruitingPhase 2IIT

Randomized controlled trial evaluating the combination of chemotherapy and radiation therapy in gynecologic soft tissue sarcoma(Substudy 1 : Randomized comparison of trabectedin versus trabectedin plus radiation therapy in recurrent, persistent, or metastatic soft tissue sarcoma)

Start Date30 Apr 2025

Sponsor / Collaborator

Asan Medical Center

100 Clinical Results associated with Trabectedin

100 Translational Medicine associated with Trabectedin

100 Patents (Medical) associated with Trabectedin

1,172

Literatures (Medical) associated with Trabectedin

01 May 2026·Cancer pathogenesis and therapy

Exploring marine-derived compounds as potential anti-cancer agents: Mechanisms and therapeutic implications

Review

Author: Ekghara, Sumit Dilip ; Bandaru, Nagaraju ; Patil, Yash Pramod ; Patil, Kunal Sharad ; Bonthu, Mohan Gandhi

Marine-derived compounds have emerged as a promising frontier in cancer research due to their remarkable structural diversity and broad-spectrum bioactivities. The marine environment, encompassing diverse organisms (e.g., sponges, algae, tunicates, mollusks, and marine microbes), is a prolific source of novel bioactive molecules with potent anti-cancer properties. Key classes of these compounds include alkaloids, polysaccharides, peptides, terpenoids, and polyketides, which exert anti-tumor effects through diverse mechanisms, including the induction of apoptosis, inhibition of angiogenesis, modulation of immune responses, interference with cell cycle progression, and targeting of critical signaling pathways involved in tumorigenesis and metastasis. Notably, marine-derived drugs such as trabectedin, eribulin, and plitidepsin have received regulatory approval for the treatment of various malignancies, demonstrating the translational potential of these natural compounds. Ongoing clinical and preclinical investigations are exploring a wide range of marine metabolites for their cytotoxic, anti-proliferative, and chemosensitizing properties. Advances in marine biotechnology, including genome mining, synthetic biology, and fermentation technologies, have significantly facilitated the discovery, sustainable production, and structural optimization of marine natural products. However, challenges such as low yield, structural complexity, limited water solubility, and poor bioavailability hinder their broader clinical application. The integration of novel drug delivery systems, such as nanoparticles, liposomes, and conjugates, offers a viable solution to overcome these limitations and improve pharmacokinetic profiles. This review provides a comprehensive overview of the mechanisms of action, therapeutic applications, and clinical development of marine-derived anti-cancer compounds. It also emphasizes the need for deeper insights into their molecular targets and the potential for synergistic use with existing chemotherapeutic agents. Future directions should focus on exploring untapped marine biodiversity, developing eco-friendly harvesting strategies, and developing innovative delivery platforms to fully harness the therapeutic promise of the marine pharmacopeia in oncology.

01 Apr 2026·Gynecologic Oncology Reports

Acute myocardial infarction caused by coronary tumor embolism from uterine leiomyosarcoma: a case report

Article

Author: Fujiwara, Hiroyuki ; Koyanagi, Takahiro ; Takahashi, Yoshifumi ; Shinohara, Miki ; Tamura, Kohei ; Taneichi, Akiyo ; Shirasu, Yumi ; Takei, Yuji

Background:

Tumor embolism to the coronary arteries is an extremely rare cause of acute myocardial infarction (AMI). It has been reported in lung and breast cancers but not in uterine leiomyosarcoma. Herein, we present a case of AMI caused by a coronary tumor embolism from uterine leiomyosarcoma, which was successfully treated with aspiration thrombectomy.

Case presentation:

A 51-year-old woman with metastatic uterine leiomyosarcoma underwent surgical resection followed by adjuvant chemotherapy. During her second trabectedin cycle, she developed acute chest pain and dyspnea. Electrocardiography revealed anterior AMI. Emergency coronary angiography demonstrated complete occlusion of the left anterior descending and circumflex arteries. Thrombus aspiration completely restored coronary flow. Histopathological examination of the aspirated material confirmed leiomyosarcoma. Following aspiration, her symptoms subsided and she was discharged and prescribed cardioprotective medications. No recurrent cardiac events occurred.

Conclusion:

While most AMI events result from thrombotic occlusion and respond to anticoagulation, tumor emboli require mechanical intervention. Aspiration thrombectomy proved effective in this case. Clinicians should recognize that tumor embolism can induce AMI even in previously unreported cancer types, as pulmonary metastases may invade the pulmonary veins enabling tumor fragments to enter systemic circulation. Early recognition and intervention are critical for survival in these patients. Tumor embolism should be considered in the differential diagnosis of patients with cancer presenting with unexplained chest pain or dyspnea.

15 Mar 2026·INTERNATIONAL JOURNAL OF CANCER

Efficacy and safety of doxorubicin–ifosfamide versus gemcitabine–docetaxel as first‐line therapy in advanced nonuterine leiomyosarcoma: A multicenter real‐world study

Article

Abstract:

Nonuterine leiomyosarcoma (NU‐LMS) is a rare and biologically distinct subtype of soft tissue sarcoma (STS) with clinical behavior differing from that of uterine leiomyosarcoma. In advanced or metastatic STS, immunotherapy has demonstrated only modest activity, and chemotherapy remains the cornerstone of treatment. However, there is a persistent unmet need for more effective and better‐tolerated options in this population. This multicenter, retrospective study included 150 patients with histologically confirmed metastatic NU‐LMS who received first‐line doxorubicin–ifosfamide (AI) or gemcitabine–docetaxel (GD) at 26 oncology centers in Turkey between 2010 and 2024. The primary endpoint was overall survival (OS). Survival was analyzed using Kaplan–Meier estimates and Cox proportional hazards models. Of 150 patients, 79 received AI and 71 received GD. Median OS for the entire cohort was 21.0 months. Median OS was 22.0 months with AI and 19.1 months with GD ( p = .18), median progression‐free survival was 7.3 versus 6.1 months ( p = .66), and overall response rate was 25.3% versus 29.6% ( p = .58), indicating no statistically significant differences in efficacy between the two regimens. Hematologic toxicities were less frequent with GD. AI and GD demonstrated comparable efficacy as first‐line regimens for advanced or metastatic NU‐LMS, with fewer hematologic toxicities observed for GD. Tumor location may have prognostic implications. These findings support individualized treatment selection and highlight the need for prospective studies in this rare and understudied sarcoma subtype, while the recent LMS‐04 trial underscores the importance of future comparisons with doxorubicin–trabectedin to further refine first‐line strategies in LMS.

News (Medical) associated with Trabectedin

24 Feb 2026

·www.biospace.com

Iovance Announces Positive Results from the First Clinical Trial for TIL Cell Therapy in Soft Tissue Sarcomas

50% Objective Response Rate (ORR) in Advanced Sarcomas Significant Market Opportunity with More than 8,000 Patients Diagnosed Annually in the U.S. and Europe SAN CARLOS, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced positive early data from a pilot clinical trial led by Memorial Sloan Kettering Cancer Center (MSKCC) and supported by Iovance of li in patients with advanced (metastatic or unresectable) undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy. Among the first six evaluable patients treated with li monotherapy, physician-assessed confirmed ORR by RECIST v1.1 was 50%. All evaluable patients had advanced disease, were refractory to prior therapy, and had significant disease burden, with a mean sum of diameters of 117 millimeters at baseline and a mean of more than two prior lines of therapy. Patients experienced deep responses that improved over time, consistent with li in melanoma, non-small-cell lung cancer, and other solid tumors. The safety pro favorable and consistent with li therapy in other indications. Based on these results, Iovance plans to commence a single arm registrational trial in second-line advanced UPS and DDLPS in the second quarter of 2026 and will engage with the U.S. Food and Drug Administration (FDA) on an accelerated path to expedite approval. Iovance also plans to explore li in other high grade soft tissue sarcoma subtypes with high unmet need as part of its clinical development program. UPS and DDLPS are high grade, aggressive soft tissue sarcomas associated with poor prognosis that impact more than 3,000 patients in the U.S. and more than 5,000 patients in Europe annually, including more than 3,500 patients with advanced disease. 1-3 There is a high unmet medical need for new treatment options for second-line patients with recent clinical studies reporting ORRs of less than 5%, median progression-free survival (mPFS) of ~2-3 months, and median overall survival (mOS) of ~9-10 months. 4- 6 Lauren Baker Banks, MD, PhD, Sarcoma Medical Oncologist, MSKCC, stated, “In the first clinical trial of a TIL cell therapy in UPS and DDLPS, one-time treatment with li demonstrated compelling and unprecedented response rates with the potential to address a significant unmet need in patients who are refractory to frontline standard of care. Patients with UPS and DDLPS suffer from high disease burden, poor quality of life, and a lack of effective treatments, including no approved immunotherapy options. In the second-line setting, mPFS for many patients is only a few months with mOS less than a year. We look forward to presenting these results at a medical conference in 2026.” Dr. Brian Gastman, EVP Translational Medicine and Research at Iovance, stated, “The exciting clinical results show that li could offer a new, highly efficacious, and durable immunotherapy option in two aggressive forms of advanced sarcoma and further illustrate the promise of our TIL cell therapy platform to offer meaningful clinical benefit in multiple solid tumor cancers. Chemotherapy with extremely poor efficacy remains the second-line standard of care for these patients after progression on front-line chemotherapy. We look forward to bringing li to UPS and DDPLS patients as quickly as possible.” About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics , Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit . Amtagvi ® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. References 1. CancerMPact Patient Metrics for US Soft Tissue Sarcoma (accessed 02/13/2026) with custom analysis to size the UPS & DDLPS populations. 2. Incidence of UPS & DDLPS extrapolation from US to all of Europe based on Global burden of soft tissue sarcomas in 204 countries and territories from 1990 to 2021: data from the global burden of disease study 2021. 3. CancerMPact Treatment Architecture for Sarcoma for the US & EU5 (May 2025) to inform treatment rates in the US and EU5. 4. Parikh RC, et al. Treatment patterns and survival among older adults in the United States with advanced soft-tissue sarcomas. Cancer. 2018. 5. Italiano A, et al. Advanced well-differentiated/dedifferentiated liposarcomas: role of chemotherapy and survival. Ann Oncol. 2012. 6. Jones RL et al. Efficacy and safety findings from MANTRA: A global, randomized, multicenter, phase III study of the MDM2 inhibitor milademetan vs trabectedin in patients with dedifferentiated liposarcomas, Ann Oncol. 2023. Forward-Looking Statements Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our i CTC facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the risk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of ATCs, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates. CONTACTS Investors IR@iovance.com 650-260-7120 ext. 150 Media PR@iovance.com 650-260-7120 ext. 150

Clinical ResultPhase 3Cell TherapyImmunotherapy

28 Nov 2025

·www.immedica.com

Zepzelca® (lurbinectedin) in combination with atezolizumab approved as first-line maintenance therapy for extensive-stage small cell lung cancer in United Arab Emirates (UAE)

These cookies allow the website to remember choices you make and provide enhanced, more personal features. The information these cookies collect may be anonymized and they cannot track your browsing activity on other websites. These cookies allow us to recognise and count the number of visitors and to see how visitors move around our website when they are using it. This helps us to improve the way our website works, for example, by ensuring that users are finding what they are looking for easily. These cookies enable the website to provide enhanced functionality and personalisation. They may be set by us or by third party providers whose services we have added to our pages. If you do not allow these cookies then some or all of these services may not function properly. Stockholm, Sweden, November 28, 2025 – Immedica today announced that the Emirates Drug Establishment has granted approval for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. "This approval is an important milestone for people living with extensive-stage small cell lung cancer in the UAE. Access to new treatment options is essential in a disease where time is critical, and we are committed to improving the day-to-day life for patients and their families." – said Anders Edvell, CEO, Immedica. The approval is based on results from the Phase 3 IMforte trial, which showed that the lurbinectedin and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone. Following four cycles of induction therapy, from the point of randomization the median overall survival (OS) for the combination regimen was 13.2 months versus 10.6 months (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). From the point of randomization, median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54, 95% CI: 0.43–0.67; p<0.0001). Safety was consistent with the known safety profiles of both treatments. The results were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and simultaneously published in The Lancet. Immedica has a strategic partnership with PharmaMar, where Immedica holds the distribution rights to Zepzelca in the Nordics, the UK & Ireland, Central Eastern Europe as well as in the Middle East and North Africa. About Zepzelca® (lurbinectedin) Zepzelca is a synthetic analog of the natural marine-based tetrahydroisoquinoline trabectedin. It acts as an alkylating agent that inhibits oncogenic transcription leading to tumor cell death and it modulates the tumor microenvironment. On November 25, 2025, the Emirates Drug Establishment approved Zepzelca in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, as maintenance treatment for adults with ES-SCLC whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. On July 01, 2021, the United Arab Emirates Ministry of Health & Prevention issued a Product Marketing Authorization approval for Zepzelca monotherapy for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. About small cell lung cancer (SCLC) SCLC is an aggressive form of lung cancer characterized by rapid growth, early metastasis, and limited therapeutic options. It accounts for about 10–15 % of all lung cancer cases and tends to present at an advanced stage, often requiring systemic therapy. Because of its aggressive nature and propensity for relapse, the prognosis remains poor. About PharmaMar PharmaMar is a biopharmaceutical company headquartered in Madrid, Spain, specializing in the discovery, development, and commercialization of anticancer therapies derived from marine biodiversity. The company focuses its R&D efforts on rare and difficult-to-treat cancers, leveraging a proprietary platform of marine-derived compounds and strong collaborations with academic and industry partners. For more information, visit www.pharmamar.com About Immedica Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care products. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory, medical affairs and market access, as well as a global distribution network serving patients in more than 50 countries. Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica’s therapeutic areas are within RARE metabolic, RARE hematology & oncology, RARE neurology and specialty care. Immedica was founded in 2018 and employs today around 150 people across Europe, the Middle East and the United States. Immedica is backed by the investment firms KKR and Impilo. For more information visit www.immedica.com. Immedica contact: Linda Holmström VP, Head of Communication linda.holmstrom@immedica.com Press release - Zepzelca approval UAE first-line treatment Immedica Pharma AB Solnavägen 3H SE-113 63 Stockholm Follow us to stay up to date with what is happening at Immedica. We believe we have an important role to fill in society – bringing new, innovative treatments to patients with rare diseases. Focus areas are within RARE metabolic, RARE neurology, RARE hematology & oncology and specialty care. We operate products from phase 2 and all the way to mature products. ESG is an integrated part of our business model. Stay up to date with our latest news. Telephone: +46 (0) 8 533 39 500 E-mail: info@immedica.com

Clinical ResultDrug ApprovalPhase 3

29 May 2025

·ir.intensitytherapeutics.com

Intensity Therapeutics, Inc.'s Phase 3 INVINCIBLE-3 Sarcoma Study Selected for Presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting

SHELTON, Conn., May 29, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces that the Company will be presenting a Trials in Progress poster outlining its Phase 3 INVINCIBLE-3 clinical trial of INT230-6 for the treatment of metastatic soft tissue sarcomas. The poster will be shown at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting held at McCormick Place in Chicago May 30-June 5, 2025. 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 Southern California, during the "Sarcoma" session to be held on Saturday May 31, 2025 from 9:30 AM to 12 PM on panel 66a. An abstract of the poster, which outlines the Company's Phase 3 study protocol, can be found here. "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 93%, and a median overall survival of 21.3 months with minimal treatment-associated adverse events. Eight regulatory agencies, including the U.S. FDA, have authorized the Phase 3 study. Until sufficient additional funding is obtained, new enrollment for the Phase 3 has been paused. We are continuing to treat the enrolled patients, maintain pharmacovigilance, monitor sites, and look forward to reinitiating recruitment as soon as sufficient resources are available." 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 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. Investor Relations Contact: Justin Kulik Justin@coreir.com CORE IR (516) 222-2560 Media Contact: Jules Abraham CORE IR pr@coreir.com View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-incs-phase-3-invincible-3-sarcoma-study-selected-for-presentation-at-the-american-society-of-clinical-oncology-asco-2025-annual-meeting-302466668.html SOURCE Intensity Therapeutics Inc.

ASCOImmunotherapyPhase 3Phase 2Clinical Result

100 Deals associated with Trabectedin

External Link

KEGG	Wiki	ATC	Drug Bank
D06199	Trabectedin	L01CX01	DB05109

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Leiomyosarcoma	United States	Janssen Products LP	23 Oct 2015
Soft Tissue Neoplasms	Japan	Taiho Pharmaceutical Co., Ltd.	28 Sep 2015
Liposarcoma	Canada	Valeo Pharma, Inc.	05 Aug 2010
Soft Tissue Sarcoma	South Korea	Verto Korea	22 Apr 2008
Platinum-Sensitive Ovarian Carcinoma	European Union	Pharma Mar SA	17 Sep 2007
Platinum-Sensitive Ovarian Carcinoma	Iceland	Pharma Mar SA	17 Sep 2007
Platinum-Sensitive Ovarian Carcinoma	Liechtenstein	Pharma Mar SA	17 Sep 2007
Platinum-Sensitive Ovarian Carcinoma	Norway	Pharma Mar SA	17 Sep 2007
Sarcoma	European Union	Pharma Mar SA	17 Sep 2007
Sarcoma	Iceland	Pharma Mar SA	17 Sep 2007
Sarcoma	Liechtenstein	Pharma Mar SA	17 Sep 2007
Sarcoma	Norway	Pharma Mar SA	17 Sep 2007

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Myosarcoma	Phase 3	France	Pharma Mar SA	18 Aug 2016
Uterine Leiomyosarcoma	Phase 3	France	Pharma Mar SA	18 Aug 2016
Uterine Neoplasms	Phase 3	France	Pharma Mar SA	18 Aug 2016
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	United States	Pharma Mar SA	16 Oct 2013
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	United States	Janssen Research & Development LLC	16 Oct 2013
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	China	Pharma Mar SA	16 Oct 2013
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	China	Janssen Research & Development LLC	16 Oct 2013
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	Australia	Pharma Mar SA	16 Oct 2013
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	Australia	Janssen Research & Development LLC	16 Oct 2013
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	Israel	Janssen Research & Development LLC	16 Oct 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_SRC2026	Not Applicable	Leiomyosarcoma Second line	108	Trabectedin	fcwbnajwkx(jstndbqvlh) = arnodnqyrp wqaouoqiom (jwwurpmhuq, 5.5 - 15.2) View more	Positive	09 Mar 2026
				gemcitabine-based chemotherapy	fcwbnajwkx(jstndbqvlh) = cbeoyurzkg wqaouoqiom (jwwurpmhuq, 3.8 - 6.4) View more
CTIS2024-516392-33-00 (GISG 21, ESMO_SRC2026)	Phase 3	Refractory Soft Tissue Sarcoma	19	Trabectedin + Trabectedin	yhlwkqysuo(pjqtxosmcf) = difesbxugd yniqszwwjz (myvxtyhxaq ) View more	Positive	09 Mar 2026
ESMO_ASIA2025	Not Applicable	Sarcoma	9	Trabectedin	fvncpdrsyf(foqrmadfeb) = In one case of FUS::DDIT3-positive myxoid liposarcoma, fourth-line trabectedin therapy was initiated. A partial response was achieved after 12 months of treatment, and disease control has been maintained for 15 months, with therapy still ongoing. rpniqaeavd (ygpdgcewfx )	Positive	05 Dec 2025
				Trabectedin (Fusion/Rearrangement-Positive)
CTIS2024-516392-33-00 (TRABTRAP, ESMO2025)	Phase 1	Refractory Soft Tissue Sarcoma	19	Trabectedin + tTF-NGR	nvryjcrqdx(seeinexxec) = iupuchkkxj aibbkwivih (wjikrvyidb )	Positive	17 Oct 2025
NCT03085225 (TRAMUNE, CTgov)	Phase 1	Locally Advanced Soft Tissue Sarcoma \| Ovarian Cancer \| Soft Tissue Sarcoma	40	Trabectedin (Dose Escalation (Trabectedin Dose Level 1,0 mg/m²))	mvjvmcejxb = fslshfpozn lphcutzgun (rpqwlakcjf, qkryubzhlp - wjhleektiv) View more	-	04 Sep 2025
				Trabectedin (Dose Escalation (Trabectedin Dose Level 1,2 mg/m²))	mvjvmcejxb = iztzkwbwge lphcutzgun (rpqwlakcjf, pjtvjmwxqp - wtcguvjjqh) View more
NCT02234050 (EORTC-BTG-1320 \| EORTC-1320-BTG, CTgov)	Phase 2	-	90	Local standard of care (Local Standard of Care)	dkxhbqvgef(lmqjlmaogm) = mrgzjrkqxy xsxckcadxq (jtfyfaeage, cigthaoccw - kdixtuillt) View more	-	10 Jul 2025
				Trabectedin (Trabectedin)	dkxhbqvgef(lmqjlmaogm) = sbpjptafny xsxckcadxq (jtfyfaeage, ztgepgdwqz - navlklejgn) View more
T-DIS (ASCO2025)	Not Applicable	Myxoid Liposarcoma Maintenance	79	Stop-and-go strategy with Trabectedin	udomoxital(xqxcyqcenj) = qvxjdacrlp jetxcymjdi (fsbyuvnvjs, 37.1 - NA) View more	Positive	30 May 2025
				Trabectedin maintenance	udomoxital(xqxcyqcenj) = bmizkwmczs jetxcymjdi (fsbyuvnvjs, 6.6 - 17.7) View more
ESMO_SRC2025	Not Applicable	Langerhans Cell Sarcoma	332	Trabectedin RDI<80%	vuwuwzyofa(iopeulljoj) = otdfdqljdz qhgebqgqet (fqfdioidbe ) View more	Negative	21 Mar 2025
				Trabectedin RDI≥80%	vuwuwzyofa(iopeulljoj) = mcdgzjfvpz qhgebqgqet (fqfdioidbe ) View more
ESMO_SRC2025	Not Applicable	Soft Tissue Sarcoma Cytochrome P450 (CYP 3A4)	51	Trabectedin	uooxckzwgm(hddtlskvkh) = icjzxjkrgw cmnpeikyzs (duqylyfkfr )	Positive	21 Mar 2025
NCT03164980 (COMPASS, CTgov)	Phase 4	Platinum-Sensitive Primary Peritoneal Carcinoma \| Recurrent ovarian cancer \| Platinum-Sensitive Ovarian Carcinoma ... View more	89	Trabectidin (Yondelis) (Arm A)	pasiytlryj(cwuokgvxvz) = nwzjchxfth npnglpcmlt (alpqlibpnj, 15.6) View more	-	20 Mar 2025
				Trabectidin (Yondelis) (Arm B)	pasiytlryj(cwuokgvxvz) = ryfmanhybx npnglpcmlt (alpqlibpnj, 14.7) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis