Date: 2015-06-02
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Immunomedics (USA - NJ)
Product: sacituzumab govitecan - IMMU-132
Action
mechanism: antibody drug conjugate/ADC. Sacituzumab govitecan, or IMMU-132, is a first-in-class ADC developed by Immunomedics by conjugating the moderately-toxic drug, SN-38 (active metabolite of irinotecan), site-specifically and at a high ratio of drug to antibody, to a humanized antibody that targets the TROP-2 receptor expressed by many solid cancers. SN-38 is the active metabolite of irinotecan (Camptosar), which is used to treat certain solid cancers as a part of combination therapies, so its pharmacology and properties are well-known. IMMU-132 targets the TROP-2 antigen which is expressed on a variety of cancers. The ADC has received Fast Track designation from the FDA for the treatment of patients with triple-negative breast cancer, small-cell and non-small-cell lung cancers, and has also been designated an orphan drug for the treatment of patients with small-cell lung or pancreatic cancer in the U.S., and for the treatment of patients with pancreatic cancer in the European Union.
Disease: metastatic lung cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On June 2, 2015, Immunomedics announced that sacituzumab govitecan demonstrated in a mid-stage clinical study promising anti-tumor activity in patients with metastatic lung cancer. These patients had either failed to respond to their last cancer therapies or their cancer had returned or progressed. Forty-seven patients with metastatic lung cancer (25 NSCLC, 22 SCLC) have been enrolled into this multicenter study. Treatment response from these patients was assessed by computed tomography using the rules set by the Response Evaluation Criteria In Solid Tumors (RECIST 1.1). In this study, treatment with sacituzumab govitecan produced tumor shrinkage of 30% or more in 6 of 19 patients with advanced NSCLC, or 32%. The disease control rate, which includes patients with treatment response within the range of 30% tumor shrinkage and 20% tumor growth, was 74%. An interim analysis of the length of time patients were living without their cancer progressing showed a median of 5.4 months, with 44% of patients still enjoying this survival benefit.
SCLC, which accounts for 13% of new cases of lung cancer, is the more aggressive form.
Treatment options for SCLC are more limited, usually involve chemotherapy alone or combined with radiation. According to the National Cancer Institute, from 1999-2006, only 2.7% of patients diagnosed with metastatic SCLC survived for more than 5 years, which was lower than the survival rate of 3.7% for patients with metastatic NSCLC. Despite the aggressive nature of the disease, 30% of 20 patients with advanced SCLC responded to sacituzumab govitecan treatments with 30% or more tumor reduction. The disease control rate in this group of lung cancer patients was 55%. With 70% of patients having had their disease progressed, the interim progression-free survival is currently at 2.4 months.
For the 25 patients who responded to sacituzumab govitecan, all 11 SCLC patients and 12 of 14 NSCLC patients, or 86%, had a time to progression that was longer than their last therapy. These patients had previously failed a median of 2.5 (range 1-7) and 3 (range 1-8) cancer treatments, respectively.
Sacituzumab govitecan has a tolerable safety profile in these heavily-pretreated lung cancer patients at the optimal doses of 8 and 10 mg/kg, as has been reported by the Company in triplenegative breast and gastrointestinal cancers, with 18% Grades 3 and 4 neutropenia as the major toxicity and minimal Grade 3 diarrhea (7%).
