411 Novel intratumoral agent, INT230–6 induces cancer cell death, increases tumor infiltrates and results in durable benefit alone or in combination with pembrolizumab in refractory patients

• Published in: Journal for immunotherapy of cancer 2020-11, Vol.8 (Suppl 3), p.A436-A436
• Main Authors: El-Khoueiry, Anthony, Thomas, Jacob, Olszanski, Anthony, Azad, Nilofer, Bender, Lewis, Walters, Ian, Whalen, Giles, Hanna, Diana, Ingham, Matthew, Siu, Lilian
• Format: Article
• Language: English
• Subjects: Apoptosis; Breast cancer; Cancer; Cell death; Consent; Drug dosages; Immunotherapy; Monoclonal antibodies; Targeted cancer therapy; Tumors
• ISSN: 2051-1426
• DOI: 10.1136/jitc-2020-SITC2020.0411

BackgroundINT230-6 is a novel formulation of cisplatin and vinblastine with an amphiphilic cell penetration enhancer that has been shown to enhance dispersion of the drug throughout tumors and allow diffusion into cells when given intratumorally. In preclinical models, INT230-6 has resulted in cell death, dendritic cell influx, antigen presentation and T-cell engagement with strong synergy when combined with checkpoint inhibitorsMethodsThis phase 1/2 study evaluated Q2week injections of INT230-6 x 5 dosed by tumor volume alone or with 200 mg pembrolizumab IV Q3 weeks. Eligble patients had any advanced malignancy refractory to standard therapy with an injectable tumor.ResultsSixty subjects (median 3 prior therapies (range 0–10)) were enrolled (53 monotherapy, 7 combo). Median age was 60 (42–85). 19 different cancer types were accrued with breast cancer and sarcoma being the most frequent. Over 200 deep tumor injections were administered at doses of up to 172 ml of INT230-6 (86 mg of CIS, 17 mg of Vin). PK analysis revealed