A phase 2 study of the oral vascular endothelial growth factor receptor 2 (VEGFR2) inhibitor rivoceranib for recurrent or metastatic (R/M) adenoid cystic carcinoma (ACC).
Presented by Dr Hyunseok Kang and colleagues at ASCO22.
In this single-arm, open-label trial, patients with R/ M ACC with evidence of ≥20% progression by RECIST v1.1 or new lesions within the preceding 6 mo were eligible; there was no limit on prior tx. Pts received rivoceranib 700 mg once dailY.
Results: 80 pts (72 evaluable) were enrolled at 11 sites in the US and Korea (53% male; median age: 55 yr). Primary tumor sites: major (34%) and minor (59%) salivary glands and other (8%). 5 (6%) pts had locoregional disease only and 74 (93%) had metastatic dis- ease. Most had prior surgery (89%) and radiation (96%); 53% had prior systemic tx (44% chemother- apy; 18% VEGFR TKI). Median follow-up was 15 mo (2–19); 20 pts remain on tx. PI-assessed efficacy data are listed in the table. ORR in pts with or without prior systemic tx was 13.9% and 16.9%, re- spectively. ORR by CHOI was 50.8% overall (51% VEGFR TKI-naive and 50% VEGFR TKI treated). 18% of pts discontinued tx, 74% had at least 1 dose reduction, and 93% dose interruption for adverse events (AEs). All pts had ≥1 AE and 80% had Grade ≥3 AEs, including 3 Grade 5 AEs (2 epistaxis [1 related], 1 acute respiratory failure). Common (> 30%) AEs were hypertension (65%), fatigue (61%), nausea and headache (50%), stomatitis (46%), diarrhea (40%), decreased appetite (38%), protein- uria (36%) and palmar-plantar erythrodysesthesia syndrome (34%). Grade ≥3 AEs in ≥5% of pts were hypertension (43%), stomatitis (8%), fatigue and anemia (6%), and back pain and pneumothorax (5%).