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Clinical Trial
. 2017 Oct 1;23(19):5711-5719.
doi: 10.1158/1078-0432.CCR-17-0933. Epub 2017 Jul 5.

Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan

Jhanelle E Gray  1 , Rebecca S Heist  2 , Alexander N Starodub  3 , D Ross Camidge  4 , Ebenezer A Kio  3 , Gregory A Masters  5 , W Thomas Purcell  4 , Michael J Guarino  5 , Jamal Misleh  5 , Charles J Schneider  5 , Bryan J Schneider  6 , Allyson Ocean  6 , Tirrell Johnson  7 , Leena Gandhi  2 , Kevin Kalinsky  8 , Ronald Scheff  6 , Wells A Messersmith  4 , Serengulam V Govindan  9 , Pius P Maliakal  9 , Boyd Mudenda  9 , William A Wegener  9 , Robert M Sharkey  9 , David M Goldenberg  10
Affiliations
Clinical Trial

Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan

Jhanelle E Gray et al. Clin Cancer Res. .

Abstract

Purpose: We evaluated a Trop-2-targeting antibody conjugated with SN-38 in metastatic small cell lung cancer (mSCLC) patients.Experimental Design: Sacituzumab govitecan was studied in patients with pretreated (median, 2; range, 1-7) mSCLC who received either 8 or 10 mg/kg i.v. on days 1 and 8 of 21-day cycles. The primary endpoints were safety and objective response rate (ORR); duration of response, progression-free survival (PFS), and overall survival (OS) were secondary endpoints.Results: Sixty percent of patients showed tumor shrinkage from baseline CTs. On an intention-to-treat basis (N = 50), the ORR was 14% (17% for the 10-mg/kg group); the median response duration, 5.7 months; the clinical benefit rate (CBR ≥4 months), 34%; median PFS, 3.7 months; and median OS, 7.5 months. There was a suggested improvement in PR, CBR, and PFS with sacituzumab govitecan in second-line patients who were sensitive to first-line therapy, but no difference between first-line chemosensitive versus chemoresistant patients in the overall population. There was a statistically significant higher OS in those patients who received prior topotecan versus no topotecan therapy in a small subgroup. Grade ≥3 adverse events included neutropenia (34%), fatigue (13%), diarrhea (9%), and anemia (6%). Trop-2 tumor staining was not required for patient selection. No antibodies to the drug conjugate or its components were detected on serial blood collections.Conclusions: Sacituzumab govitecan appears to have a safe and effective therapeutic profile in heavily pretreated mSCLC patients, including those who are chemosensitive or chemoresistant to first-line chemotherapy. Additional studies as a monotherapy or combination therapy are warranted. Clin Cancer Res; 23(19); 5711-9. ©2017 AACR.

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