This abstract provides data on 10 patients receiving GC+A. Baseline characteristics are shown below.
The primary endpoint was safety, as assessed by the dose-limiting toxicity rate during the first cycle for the first 6 patients. There were no dose-limiting toxicities (DLTs) during the first cycle. Grade 3/4 hematologic adverse events such as neutropenia (7/10) and anemia (6/10) occurred in the majority of patients. Only 1 patient discontinued study treatment due to treatment-related adverse events including grade 4 encephalopathy and grade 3 polyneuropathy.
Of the 10, 9 patients achieved an objective response, of which 5 eventually had progressive disease.
Two patients have had very durable responses, with 1 patient without progression at 25 months and one patient status post consolidation surgery with a pathologic complete response (CR) and remains disease-free at 21 months.
After a median follow up of 23.8 months, the median PFS was 10.7 months and median OS has not yet been reached.
The results of these first 10 patients demonstrate that GC+A is relatively tolerable for patients with only one discontinuation due to toxicity. The neoadjuvant study with GC+A is ongoing. A larger single arm study had been reported for the combination of gem/cis plus ipilimumab and a similarly high number of grade 3/4 AEs were reported there as well (81%). Two large phase III studies, KEYNOTE 361 (NCT02853305) and IMvigor 130 (NCT02807636), are now underway to evaluate chemoimmunotherapy vs. chemotherapy for mUC.
Presented by: Samuel Aaron Funt, MD, Memorial Sloan Kettering, New York, NY
Written by: Jason Zhu, MD, Fellow, Division of Hematology and Oncology, Duke University, @TheRealJasonZhu at the 2019 ASCO Annual Meeting #ASCO19, May 31- June 4, 2019, Chicago, IL USA
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