LENVIMA® (lenvatinib) for advanced or recurrent endometrial cancer
LENVIMA® (lenvatinib) is a tyrosine kinase inhibitor (TKI) that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors: VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4), in addition to other proangiogenic and oncogenic pathway-related receptor tyrosine kinases, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet-derived growth factor (PDGF) receptor PDGFR; KIT; and RET.¹
Therapeutic Indication:
LENVIMA in combination with pembrolizumab is indicated for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.
NICE guidance:
Keytruda (pembrolizumab) plus Lenvima (lenvatinib) is recommended for treating advanced or recurrent endometrial cancer in adults whose cancer has progressed on or after platinum-based chemotherapy and who cannot have curative surgery or radiotherapy.
See full guidance here: NICE Guidance
SMC Guidance:
Pembrolizumab (Keytruda®) is accepted in combination with Lenvatinib, for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation.
See the full guidance here: SMC Guidance
Resources
References: 1 10 mg hard capsules – Summary of Product Characteristics (SmPC)
GB-KLE-00136 Date of preparation May 2023 
Study 309/KEYNOTE-775: A phase 3 study of LEMVIMA + KEYTRUDA vs. chemotherapy in patients with advanced or recurrent EC who have previously received platinum-based chemotherapy¹
Study 309/KEYNOTE-775 was a multicentre, open-label, Phase 3 trial, for patients with confirmed advanced, recurrent, or metastatic endometrial cancer of any histologic subtype, except carcinosarcoma and sarcoma.
Patients were assigned in a 1:1 ratio to receive either Lenvatinib plus pembrolizumab, or chemotherapy of the treating physician’s choice (with doxorubicin or paclitaxel chosen before randomisation in the chemotherapy group).¹
aPatients could receive up to two prior platinum-based chemotherapy regimens if one was given in the neoadjuvant or adjuvant setting; bMaximum cumulative dose of 500 mg/m2.
BICR, blinded independent central review; dMMR, mismatch repair deficient; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; HRQoL, health-related quality of life;
IV, intravenous; MMR, mismatch repair; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; pMMR, mismatch repair proficient; PO, orally; Q1W, every week;
Q3W, every 3 weeks; QD, once daily; R, randomisation.
References: ¹Makker V et al. N Engl J Med 2022;386:437–448.
Study 309/KEYNOTE-775: Lenvima + Keytruda demonstrated superior PFS vs chemotherapy in all patients (final analysis)a,1,2
Analysis cut-off date: 26 October 2020.
aBy BICR per RECIST v1.1. Figure adapted from Makker V et al. N Engl J Med 2022. Tick marks indicate censored data.
BICR, blinded independent central review; CI, confidence interval; HR, hazard ratio; ITT, intention-to-treat; mo, month; PFS, progression-free survival; pMMR, mismatch repair proficient;
RECIST v1.1, Response Evaluation Criteria in Solid Tumors Version 1.1.
References: 1. Makker V et al. N Engl J Med 2022;386:437–448; 2. KEYTRUDA (pembrolizumab) SmPC. https://www.medicines.org.uk/emc/product/2498/smpc.
Study 309/KEYNOTE-775: Lenvima + Keytruda demonstrated superior PFS vs chemotherapy in patients who were pMMR (final analysis)a,1,2
Analysis cut-off date: 26 October 2020.
a BICR per RECIST v1.1. Figure adapted from Makker V et al. N Engl J Med 2022. Tick marks indicate censored data.
BICR, blinded independent central review; CI, confidence interval; HR, hazard ratio; ITT, intention-to-treat; mo, month; PFS, progression-free survival; pMMR, mismatch repair proficient;
RECIST v1.1, Response Evaluation Criteria in Solid Tumors Version 1.1.
References: 1. Makker V et al. N Engl J Med 2022;386:437–448; 2. KEYTRUDA (pembrolizumab) SmPC. https://www.medicines.org.uk/emc/product/2498/smpc
Study 309/KEYNOTE-775: Lenvima + Keytruda demonstrated superior OS vs chemotherapy in all patients (final analysis)1,2
Analysis cut-off date: 26 October 2020.
Figure adapted from Makker V et al. N Engl J Med 2022. Tick marks indicate censored data.
CI, confidence interval; HR, hazard ratio; ITT, intention-to-treat; mo, month; OS, overall survival; pMMR, mismatch repair proficient.
References: 1. Makker V et al. N Engl J Med 2022;386:437–448; 2. KEYTRUDA (pembrolizumab) SmPC. https://www.medicines.org.uk/emc/product/2498/smpc.
Study 309/KEYNOTE-775: Lenvima + Keytruda demonstrated superior OS vs chemotherapy in patients who were pMMR (final analysis)1,2
Analysis cut-off date: 26 October 2020.
Figure adapted from Makker V et al. N Engl J Med 2022. Tick marks indicate censored data.
CI, confidence interval; HR, hazard ratio; ITT, intention-to-treat; mo, month; OS, overall survival; pMMR, mismatch repair proficient
References: 1. Makker V et al. N Engl J Med 2022;386:437–448; 2. KEYTRUDA (pembrolizumab) SmPC. https://www.medicines.org.uk/emc/product/2498/smpc.
GB-KLE-00100 Date of preparation April 2023
LENVIMA® safety profile
The full Summary of Product Characteristics should always be consulted before prescribing to complement the summary presented below and minimise the risks associated with the use of Lenvima.
References: ¹Makker V et al. N Engl J Med 2022;386:437–448.
See the Lenvima® SmPC for the complete list of adverse reactions
GB LENVIMA®4mg Summary of Product Characteristics
GB LENVIMA®10mg Summary of Product Characteristics
NI LENVIMA®4mg Summary of Product Characteristics
NI LENVIMA®10mg Summary of Product Characteristics
ROI LENVIMA® Summary of Product Characteristic
GB-KLE-00101 Date of preparation April 2023
Adverse events should be reported.
Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ (please note that the MHRA Yellow Card link will redirect you to an external website, for which MSD or Eisai does not review or control the content) or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
See the Lenvima® SmPC for the complete list of adverse reactions
GB LENVIMA®4mg Summary of Product Characteristics
GB LENVIMA®10mg Summary of Product Characteristics
NI LENVIMA®4mg Summary of Product Characteristics
NI LENVIMA®10mg Summary of Product Characteristics
ROI LENVIMA® Summary of Product Characteristic
GB-KLE-00102 Date of preparation April 2023
