Sacituzumab Govitecan in Metastatic NSCLC


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Rebecca Suk Heist, MD, MPH

Rebecca Suk Heist, MD, MPH

As reported by Rebecca Suk Heist, MD, MPH, of Massachusetts General Hospital, and colleagues in the Journal of Clinical Oncology, the antibody-drug conjugate sacituzumab govitecan showed activity in patients with previously treated metastatic non–small cell lung cancer (NSCLC). Sacituzumab targets Trop-2, present on many solid tumors; govitecan is the active metabolite of irinotecan.

In the multicenter study, 54 patients received sacituzumab govitecan at 8 (n = 8) or 10 mg/kg (n = 46) on days 1 and 8 of 21-day cycles. The primary endpoints were safety and objective response rate.

Among 47 evaluable patients, who had a median of 3 prior therapies (range = 2–7), objective response (all partial responses) occurred in 9 patients (19%). The median response duration was 6.0 months. An additional 11 patients had stable disease for ≥ 4 months, yielding a clinical benefit rate of 43%. Among 14 patients who had received prior immune checkpoint inhibitor therapy, 2 (14%) had a response and 3 had stable disease ≥ 4 months, yielding a clinical benefit rate of 36%. Among all 54 patients, median progression-free survival was 5.2 months, and median overall survival was 9.5 months.

Among 26 evaluable archived tumor specimens, 24 (92%) were strongly or moderately positive for Trop-2 on immunohistochemistry, suggesting Trop-2 is not a biomarker of response.

Grade ≥ 3 adverse events included neutropenia (28%), leukopenia (9%), pneumonia (9%), diarrhea (7%), nausea (7%), fatigue (6%), and febrile neutropenia (4%). One patient developed a transient immune response to the agent. Adverse events appeared to be similar at the two doses, except for an increase in grade 3 or 4 neutropenia at the higher dose (30% vs 13%). Adverse events led to drug discontinuation in two patients (grade 3 pneumonia and grade 3 recurrent pruritus).

The investigators concluded: “IMMU-132 [sacituzumab govitecan] was well tolerated and induced durable responses in heavily pretreated patients with metastatic NSCLC. This [antibody-drug conjugate] should be studied further in this disease and in other patients with Trop-2–expressing tumors.”

Heist RS, et al: J Clin Oncol. May 26, 2017 (early release online). ■


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