1919P Nintedanib (BIBF1120) after first line therapy in progressive medullary thyroid cancer: A multicenter EORTC prospective randomized double-blind phase II study (NCT01788982)

Abstract

Twenty-seven patients were enrolled and 25 were eligible and received treatment. The median age was 60.0 years. 88.0% of patients had received other VEGFR therapy prior to lenvatinib. The median dose of lenvatinib at entry was 14 mg daily (10-24 mg). Thirty-six percent of patients had grade 3 adverse events (AEs) and no patients had grade 4 AEs. There were no treatment-related deaths. The most common grade 3 AEs were dyspnea (12%), and hypertension (12%). All other grade 3 AE were 4%. One patient had grade 3 myocarditis and heart failure that was likely related to pembrolizumab therapy. Of 20 evaluable patients, 3 (15%) had a partial response (PR) and 17 (85%) had stable disease (SD), for an ORR of 15% and CBR of 100%. Median PFS was 12.6 months (95% CI: 7.1-18.2). The PFS at 12 months was 56%. Eleven patients (44%) are still on treatment (1.6-16.8 mo). Three patients (15%) had >40% target tumor shrinkage.Conclusions: Adding pembrolizumab to lenvatinib therapy is well tolerated in patients with RAIR DTC. A preliminary primary endpoint of ORR was 15%. The addition of pembrolizumab to patients progressing on lenvatinib has a high CBR and favorable PFS in patients with RAIR DTC.Clinical trial identification: NCT02973997.

Role of FGF System in Neuroendocrine Neoplasms: Potential Therapeutic Applications

“…The study was stopped due to slow accrual with 32/67 patients enrolled, without reaching the targeted statistical power. The most common AE were diarrhea (18%), nausea (9%), GGT increase (18%) and lymphopenia (18%) ( 83 ).…”