Keytruda or Lenvantinib and Keytruda for endometrial cancer – pro
The multicohort phase IB KEYNOTE-028 (NCT02054806) study was designed to evaluate the safety and efficacy of pembrolizumab, an anti-programmed death 1 monoclonal antibody, in patients with programmed death ligand 1 (PD-L1) -positive advanced solid tumors. Pembrolizumab demonstrated a favorable safety profile and durable antitumor activity in a subgroup of patients with heavily pretreated advanced PD-L1-positive endometrial cancer.
Lenvatinib plus pembrolizumab showed anti-tumour activity in patients with advanced recurrent endometrial cancer with a safety profile that was similar to those previously reported for lenvatinib and pembrolizumab monotherapies, apart from an increased frequency of hypothyroidism.
he FDA has granted a breakthrough therapy designation to the combination of lenvatinib (Lenvima) and pembrolizumab (Keytruda) for the treatment of patients with advanced and/or metastatic non-microsatellite instability -high (MSI-H)/proficient mismatch repair endometrial carcinoma who have progressed after 1 prior systemic therapy. As far as Keytruda aloen, Pembrolizumab demonstrated an acceptable safety profile and preliminary antitumor activity in heavily pretreated PD-L1+ advanced endometrial cancer pts. The clinical benefit of pembrolizumab for advanced endometrial cancer is being further investigated in the phase 2 KEYNOTE-158 trial (NCT02628067).
P. A Ott et al, Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1–Positive Endometrial Cancer: Results From the KEYNOTE-028 Study. Journal of Clinical Oncology 35, no. 22 (August 01, 2017) 2535-2541.
Patrick Alexander Ott et al, Pembrolizumab in advanced endometrial cancer: Preliminary results from the phase Ib KEYNOTE-028 study. Journal of Clinical Oncology 34, no. 15_suppl
Vicky Makker et la, Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer: an interim analysis of a multicentre, open-label, single-arm, phase 2 tria. The Lancet l20, ISSUE 5, P711-718, May 01, 2019
Makker V, Rasco DW, Dutcus CE et al. A phase Ib/II trial of lenvatinib (LEN) plus pembrolizumab (Pembro) in patients (Pts) with endometrial carcinoma. J Clin Oncol 2017;35(suppl 15):5598A