ASCO20: Antibody-Drug Conjugate Active in CEACAM5-Expressing Nonsquamous NSCLC
Posted: Saturday, June 20, 2020
The antibody-drug conjugate SAR408701 appears to be active in patients with advanced nonsquamous non–small cell lung cancer (NSCLC) with high carcinoembryonic antigen–related cell-adhesion molecule 5 (CEACAM5) expression, according to the expansion phase of the first-in-human study. “SAR408701 was well tolerated, with minimal hematologic toxicity compared with conventional chemotherapy,” stated Anas Gazzah, MD, of Gustave Roussy, Villejuif, France, and colleagues. Updated safety and efficacy data were presented during the ASCO20 Virtual Scientific Program (Abstract 9505).
In all, 92 patients with heavily pretreated advanced nonsquamous NSCLC received treatment with SAR408701, a novel agent consisting of an anti-CEACAM5 antibody conjugated to the cytotoxic agent maytansinoid DM4. Based on CEACAM5 expression, patients were separated into two groups: moderate (n = 28) and high (n = 64) expressors. The majority of patients had an Eastern Cooperative Oncology Group (ECOG) performance score of at least 1 (71.7%) and had received a median of three prior treatments for advanced disease.
In the moderate-expressor cohort, two partial responses were observed (7.1%); in the-high expressor cohort, 13 patients had a partial response (20.3%), and 27 (42.2%) had stable disease. Additionally, the objective response rate in patients who had received prior anti–PD-1/PD-L1 therapy was 17.8%.
The most frequent treatment-emergent adverse events included asthenia (38.0%), keratopathy or keratitis (38.0%), peripheral neuropathy (26.1%), dyspnea (23.9%), and diarrhea (22.8%). A total of 6 patients discontinued SAR408701, and 31 required dose modification due to toxicity.
Currently, a phase III trial evaluating the activity of SAR408701 monotherapy compared with docetaxel in patients with high CEACAM5 expression after failure of standard first-line chemotherapy and anti–PD-1/PD-L1 is underway.
Disclosure: For full disclosures of the authors, visit coi.asco.org.
