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The phase 2 INVINCIBLE-4 clinical trial is currently underway in patients with localized triple-negative breast cancer.
The first patient has been dosed in a phase 2 clinical trial studying a potential new treatment for localized triple-negative breast cancer (TNBC).
Intensity Therapeutics, a biotechnology company, and the Swiss Group for Clinical Cancer Research SAKK, an academic research institute, have announced the start of patient dosing in the INVINCIBLE-4 study, a multicenter study which plans to eventually enroll approximately 54 patients in Switzerland and France, according to a news release.
In particular, INT230-6 is an investigational drug administered via direct intratumor injection that combined cisplatin and vinblastine, in addition to a penetration enhancer molecule, to distribute cytotoxic drugs throughout the tumors, according to the release. The effects derived from this treatment — immune system engagement and systemic antitumor effects, per the release — may be achieved without immunosuppression, which often is observed in patients undergoing systemic chemotherapy.
The INVINCIBLE-4 study is examining the use of INT230-6 given prior to administration of standard of care neoadjuvant (presurgical) immuno-chemotherapy versus standard of care. Standard of care, in this instance, consists of Keytruda (pembrolizumab), anthracyclines, carboplatin, cyclophosphamide and paclitaxel.
"Many [patients with TNBC] undergoing [standard of care] treatment alone fail to achieve a pathological complete response at the time of surgery, especially in larger tumor sizes. INT230-6 has the potential to fill this unmet need for aggressive subtypes, such as TNBC, through its anti-cancer mechanisms of action that cause tumor cell necrosis (the death of living tissues) and ignite an anti-cancer immune-based response," said Dr. Andreas Mueller, Head of Department of Medicine at the Kantonsspital in Winterthur, Switzerland, and a supporting coordinating investigator for the study, in the news release. "The ability for INT230-6 to induce necrosis and activate immune effects before a patient's surgery without increases in toxicity would be a major advance for the treatment of breast cancer and potentially many other cancers."
Immunosuppression: the body’s immune system is suppressed, which also impacts its ability to fight infections and other diseases.
Pathological complete response: the absence of signs of cancer in tissue samples removed during surgery or biopsy after treatment with radiation or chemotherapy, according to the National Cancer Institute.
Intratumoral: within a tumor.
The study will evaluate the clinical activity, safety and tolerability of INT230-6 among patients with early-stage, operable TNBC. According to its listing on clinicaltrials.gov, the study will be completed in December 2029.
"Triple-negative is a deadly and aggressive form of breast cancer, and patients having local disease currently undergo a harsh four to six-month regimen whereby a small percentage can die from the [standard of care] before their surgery. Those patients who achieve a [pathological complete response] have a lower risk of disease recurrence," said Intensity Therapeutics' founder, chairman, and CEO Lewis H. Bender in the news release. "We hope that by killing a substantial amount of the tumor upfront and increasing the immune response using INT230-6, we can increase the percentage of patients who achieve [pathological complete response] and ultimately an improved event-free survival."
It was announced earlier this year that the first patient had been dosed in the phase 3 INVINCIBLE-3 trial evaluating INT230-6 among patients with soft tissue sarcoma.
Reference: “Intensity Therapeutics, Inc. and The Swiss Group for Clinical Cancer Research SAKK Announce the First Patient Dosed in the Randomized, Presurgical Triple Negative Breast Cancer Phase 2 Clinical Trial (INVINCIBLE-4 / SAKK 66/22),” press release issued by Intensity Therapeutics, Inc.
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