80% of Patients with Breast Cancer That Has Spread to the Skin Respond to Adgero’s REM-001 Therapy

80% of Patients with Breast Cancer That Has Spread to the Skin Respond to Adgero’s REM-001 Therapy

Eighty percent of certain patients with breast cancer that has spread to the skin respond to REM-001 Therapy, which involves a laser and a compound, according to the developer, Adgero Biopharmaceuticals.

The category of patients who benefited were those with cutaneous metastatic breast cancer whose previous radiation therapy had failed, Adgero said. They responded whether or not they were also receiving chemotherapy or hormone therapy, it added.

Adgero Vice President Steve Rychnovsky presented the findings at the American Society for Laser Medicine and Surgery 2017 Annual Conference in San Diego. The presentation was titled “Synergistic Effect of Simultaneous Chemotherapy and Photodynamic Therapy.

When breast cancer therapies fail, patients can develop metastatic breast cancer. Cutaneous metastatic breast cancer shows up in nearly 24 percent of breast cancer patients, evidence suggests.

It occurs when breast cancer tumor cells travel to the skin and form a new tumor. The skin tumor can come decades after the initial breast cancer diagnosis and treatment.

REM-001 Therapy is known as a photodynamic therapy because it includes light. There are three parts to REM-001 Therapy: a laser light source, a light delivery system, and the drug REM-001.

The first step in the treatment is injecting REM-001 into a patient’s bloodstream, which can convey it to the tumor. Then, a physician uses a fiber-optic wand to illuminate the tumor. Because the drug is photosensitive, it is activated only at the tumor site, reducing the possibility of severe side effects.

Adgero conducted four Phase 2/3 clinical trials of REM-001 Therapy in patients who failed radiation therapy. Combined analysis of the trials showed that REM-001 Therapy reduced or eliminated a substantial number of tumors. The complete response rate was 80 percent of the 148 patients in the trials.

The company recently did a retrospective analysis of the trials to evaluate whether chemotherapy influenced the response to REM-001. At the time of enrollment, some patients were receiving 5-FU chemotherapy, some Vinorelbine (navelbine) chemotherapy, some hormone therapy, and some no therapy at all.

Researchers used the retrospective study to assess lesion response, which they defined as a reduction in lesion size of 50 percent of more, in patients who were also receiving chemotherapy or hormone therapy.

After 24 to 52 weeks of follow-up, patients receiving chemotherapy or hormone therapy plus REM-001 Therapy had an overall response rate of 88%. Patients receiving REM-001 Therapy alone had a response rate of 81%.

The difference between the figures fell within the margin of statistical error, so the researchers concluded that REM-001 Therapy’s effectiveness is independent of whether a patient is also receiving chemotherapy or hormone therapy.

“The results from our analysis indicated that REM-001 provided a high lesion response rate in those patients that were evaluable and, more importantly, that the response is believed to be independent of whether or not the patient received chemotherapy,” Ron R. Allison, MD, chief medical advisor of Adgero, said in a news release.

“Our conclusion from this data is that REM-001 Therapy may be a complementary treatment to chemotherapy for metastatic breast cancer patients that have CMBC, and we believe that REM-001 Therapy holds promise as a locoregional CMBC treatment to prevent widespread lesion development,” Allison said.