First Patient Dosed With Novel Drug for Metastatic Soft Tissue Sarcoma

A phase 3 trial for patients with metastatic soft tissue sarcoma recently administered a first dose of a novel immune-based treatment to a patient.

The phase 3 trial, INVINCIBLE-3, aims to evaluate the overall survival (how long patients live, regardless of their cancer status) in patients with metastatic soft tissue sarcoma, according to a news release.

Soft tissue sarcoma is a rare cancer that forms in the body’s soft tissues, typically in the arms, legs and stomach area, according to the Mayo Clinic. Often, soft tissue sarcoma is treated with surgery, radiation and chemotherapy.

However, the novel INT230-6 monotherapy used in the trial is a type of treatment that patients receive intratumorally (injected directly into the tumor), the news release stated.

"We have now dosed our first patient in the U.S. and have filed regulatory documents to initiate this trial in Canada and Europe. Over the next several months, we anticipate initiating sites in eight countries,” Lewis H. Bender, founder and CEO of Intensity Therapeutics, the manufacturing company of INT230-6, said in the news release. “Sarcoma is a deadly cancer with a median overall survival following second and third-line drug treatments of between 10 and 15 months.”

In the trial, approximately 333 patients with metastatic soft tissue sarcoma will be enrolled, according to the listing on clinicaltrials.gov. Eligible patients must have experienced disease worsening or spreading before the trial and received less than two standard therapies, including an anthracycline-based regimen.

Of note, patients will be randomly assigned to two groups to receive either INT230-6 monotherapy or U.S. standard of care. The standard of care treatments include Halaven (eribulin; a form of chemotherapy), Yondelis (trabectedin; a form of chemotherapy) and Votrient (pazopanib; an oral tyrosine kinase inhibitor), the trial’s listing noted.

The phase 1/2 portion of the trial also evaluated INT230-6 in certain cancer types, according to the respective clinicaltrials.gov listing. These cancers included ones at the surface of the skin, such as breast cancer and head and neck cancers, and tumors within the body, such as liver, colon and lung cancers. The 110 patients in this phase 1/2 trial experienced refractory cancers, meaning the tumor resisted the given cancer treatments.

The main outcome measured during this trial was the safety and tolerability of single and multiple intratumoral doses of INT230-6, the listing noted. Specifically, trial investigators evaluated safety regarding treatment-related side effects from INT230-6 that were grade 3 (severe) or worse.

Patients were placed into one of six treatment groups, which depended on their tumor type. All patients received INT230-6. However, two treatment groups received INT230-6 plus Keytruda (pembrolizumab) and one treatment group received INT230-6 with Yervoy (ipilimumab), the listing determined.

“During our phase 1/2 metastatic dose escalation study, in a sarcoma population that had progressed following a median of three lines of therapy, we reported a median overall survival of 21.3 months with our drug alone,” Bender said in the release. “Patients, their caregivers and physicians, worldwide, desperately need improved treatment options, and we are excited to have finally begun testing our new approach in phase 3.”

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