Immunomedics Inc. (NASDAQ:IMMU) has announced promising results from group 1 of its cisplatin-eligible patients in the Phase 2 TROPHY U-01 Trodelvy study in metastatic urothelial cancer.
Trodelvy showed significant activity in pre-treated mUC patients
Results from the study confirmed the preliminary findings and previous Phase1/2 study results. The results showed that Trodelvy had significant activity and was safe in patients with heavily pre-treated mUC and progressed on both checkpoint inhibitors and platinum-based chemotherapy. Institut de Cancerologie Gustave Roussy’s Yohann Loriot presented the results in a late-breaking oral presentation at the 2020 virtual European Society of Medical Oncology Conference.
Loriot said that considering that only 10% of the patients with mUC that have cancer progression after CPI and platinum-based therapy are expected to be responsive to Single-agent chemotherapy with around 2-3 months of median progression-free survival, the results of the study were compelling with sacituzumab offering patients hope.
Immunomedics Chief Medical officer Dr. Loretta Itri said that they are optimistic that Trodelvy can offer a new treatment alternative for mUC patients based on the study’s positive results. Itri added that as the company seeks guidance from the US FDA on the registration pathway, the new Phase 3 TROPiCS-04 trial in third-line mUC, approved by the FDA, is currently under review of the EMA and is in the commencement phase.
Trodelvy showing promising safety profile and tolerability
Trodelvy has continued to show a predictable safety profile and tolerability, consistent with prior results in mUC and other types of tumors. The treatment connected Grade 3 and 4 events were mostly gastrointestinal and hematologic related, and they included neutropenia and diarrhea. In treatment 7 patients discontinued treatment because of adverse events with three of those being neutropenia or related complications.
It is important to note that there was one treatment-related mortality resulting from sepsis due to febrile neutropenia. Also, there were no grade 2 or more events reported due to rash r neuropathy. The study didn’t report any case of interstitial lung cancer.