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Summary
This is a phase I/II basket study of solid tumors who received SG on days 1 and 8 of 21-day cycles until progression or toxicity. Patients were radiographically restaged every 8 weeks. This abstract describes the 45 patients who were treated with SG.
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The median age was 67 and all patients had at least one prior line of systemic therapy. The majority of patients were men 41/45 and almost all patients (95%) had platinum-based chemotherapy previously. 38% of patients had been previously treated with a checkpoint inhibitor. This was a high risk population – 33/45 had visceral metastases, most commonly to the lung (15/45) and liver (27/45).
The median duration of follow up at the data cut-off was 15.7 months. Patients have had a median of 8 treatment cycles and 20% of patients have been treated for over one year. 5 patients remain on treatment, one of which was treated through progression and achieved a complete response.
The objective response rate was 31% overall, with 2/45 complete responses and 12 partial responses. In patients who had been previously treated with an immune checkpoint inhibitor, the ORR was 23% (4/17). The median duration of response was 12.6 months and 2 patients remain on therapy for over 2 years. The median overall survival was 18.9 months.
![UroToday ASCOGU2019 IMMU13201 3](/images/UroToday_ASCOGU2019-IMMU13201-3.png)
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In terms of safety, the most common grade 3/4 adverse events were neutropenia (38%), anemia (11%), hypophosphatemia (11%), diarrhea (9%), fatigue (9%), and febrile neutropenia (7%). 5/45 patients discontinued treatment due to adverse events and no treatment-related deaths have been reported.
![UroToday ASCOGU2019 IMMU13201 3](/images/UroToday_ASCOGU2019-IMMU13201-6.png)
Conclusions
SG is a promising new agent for patients with metastatic UC who have progressed after one line of therapy. The median OS described in this small study compares favorably to other second-line UC trials and a single arm, open label, global phase II study is underway to further evaluate safety and efficacy.
Presented by: Scott T. Tagawa, MD, MS, Weill Cornell Medicine, Assistant Professor of Medicine and Urology and Assistant Attending Physician in the Division of Hematology and Medical Oncology.
Written By: Jason Zhu, MD. Fellow, Division of Hematology and Oncology, Duke University, Twitter: @TheRealJasonZhu at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA
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