Date: 2016-04-19
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the American Association for Cancer Research (AACR) Annual Meeting
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. Sacituzumab govitecan has also been granted Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer (TNBC) who have failed prior therapies for metastatic disease.
Disease: relapsed or refractory metastatic urothelial cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On April 19, 2016, Immunomedics announced that sacituzumab govitecan produced meaningful clinical benefit in patients with relapsed or refractory metastatic urothelial cancer. Among the 19 patients enrolled into the open-label Phase 2 study, at the time of analysis the interim median PFS was 6.9 months, based on RECIST 1.1, and interim mean OS was 11.4 months, with 84% of patients still alive. Expression of Trop-2, a cell-surface protein targeted by the ADC, is not a pre-selection criterion for patient enrollment. These data have been presented at the AACR conference. Of the 14 assessable patients who had received a median of 2 (range, 1 – 5) prior lines of chemotherapy, seven patients reported a partial response as their best response, yielding an
interim ORR of 50%. Importantly, six of the seven responding patients (86%) had been confirmed with a follow-up computed tomography (CT) scan, four of whom are continuing with their treatment.
As has been reported by us in patients with other types of solid cancer, sacituzumab govitecan also has an acceptable interim safety profile in 13 urothelial cancer patients reported at AACR. The notable adverse events were Grade 3 or 4 neutropenia and febrile neutropenia in 31% and 15% of patients, respectively. Severe diarrhea, commonly reported with irinotecan, was rare, with only 8% Grade 3/4 incidents. More importantly, repeated doses can be given over months without evoking interfering anti-sacituzumab govitecan antibodies from patients’ own immune system.
