Immunomedics Announces Results of Phase 2 Clinical Trial

Immunomedics, Inc. (Nasdaq:IMMU) has announced the results of a Phase 2 clinical study of the company’s lead investigational antibody-drug conjugate (ADC) for solid cancer therapy sacituzumab govitecan.
According to the press release:

Patients with metastatic triple-negative breast cancer (TNBC) lived for a median of seven months without tumor progression, after receiving at least 3 doses of sacituzumab govitecan, the Company’s lead investigational antibody-drug conjugate (ADC) for solid cancer therapy, in a Phase 2 clinical study. The study also indicated that the responses were very durable, showing a median time-to-progression, based on computed tomography, of 9.4 months (range of 1.8+ to 13.2+ months), which included patients with stable disease, and partial and complete responses.
“Patients in this late-stage setting usually have a median PFS of three to four months when treated with other agents,” stated Aditya Bardia, MD, MPH, Assistant Professor of Medicine at Harvard Medical School, Attending Physician at the Massachusetts General Hospital Cancer Center in Boston, and an investigator in this trial. “Sacituzumab govitecan is a promising agent that offers hope for these patients with poor prognosis,” Dr. Bardia added.
Interim results from 54 assessable patients were presented by Steven Jay Isakoff, MD, PhD, Instructor of Medicine at Harvard Medical School, Attending Physician at the Massachusetts General Hospital Cancer Center. These patients had received a median of 5 (range, 2 – 12) prior lines of therapy, which must have included a taxane, a class of chemotherapy agents used to treat solid cancers, such as breast, gastric, head and neck, lung, ovarian, pancreatic, and prostate. All patients had received sacituzumab govitecan at the optimal dose of 10 mg/kg given on days 1 and 8 of a 3-week cycle, and in some patients the therapy continued for many months.
At the time of this analysis, the interim median PFS for the 54 TNBC patients was 7.0 months, with 55% of these patients having experienced a PFS event. Median overall survival data were too early to report, with 87% of patients still alive. The overall objective response rate was 31.5% (17 of 54 patients), including 2 patients with a confirmed complete response. An additional 24 patients had stable disease, resulting in a disease control rate of 76%. Treatment response was assessed by computed tomography based on the rules set by the Response Evaluation Criteria In Solid Tumors (RECIST 1.1).

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