Phase Ib SEASTAR Study: Combining Rucaparib and Sacituzumab Govitecan in Patients With Cancer With or Without Mutations in Homologous Recombination Repair Genes
Timothy A. Yap, Erika Hamilton, Todd Bauer, Ecaterina E. Dumbrava, Rinath Jeselsohn, Aaron Enke, Sabrina Hurley, Kevin K. Lin, Jenn Habeck, Heidi Giordano, Geoffrey I. Shapiro
Abstract
Genomic alterations were identified by local testing or through central next-generation sequencing of baseline plasma or tumor tissue by Foundation Medicine (Cambridge, MA). See Supplemental Table 2 in the Data Supplement for a detailed description of local testing. The detected BRCA1/2 mutations are well-characterized germline mutations in the ClinVar database: BRCA1 N1355fs*10 19 and BRCA2 E2846fs*22. 20 On the basis of the low allele frequency detected by next-generation sequencing of plasma samples, the BARD1 mutation was likely somatic in origin. b Includes regimens from all treatment settings (neoadjuvant, adjuvant, maintenance, and metastatic), but does not include radiotherapy. c RECIST version 1.1. d Best response of SD and subsequently progressed with prior PARP inhibitor therapy. e Best response of PD with prior PARP inhibitor therapy.