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Screen for hepatitis B virus in all cancer patients starting systemic treatment. Find out more about hepatitis B virus screening and management.

Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.

LENV+PEMB

Cancer Type:
Gynecologic, 
Endometrial
Intent: Palliative
Regimen Category: Evidence-informed
Funding:
Exceptional Access Program
    lenvatinib - In Combination with Pembrolizumab for Advanced Endometrial Cancer
New Drug Funding Program
    Pembrolizumab - In Combination with Lenvatinib for Advanced Endometrial Cancer
A - Regimen Name

LENV+PEMB Regimen
Lenvatinib-Pembrolizumab


Disease Site
Gynecologic
Endometrial


Intent
Palliative

Regimen Category
Evidence-informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully  improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.

This Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.


Rationale and Uses

For previously treated advanced, recurrent, or metastatic endometrial carcinoma in patients who had disease progression following platinum-based systemic therapy and have a good performance status.

Patients must NOT:

  • be a candidate for curative surgery or radiation
  • have MSI-H or dMMR
  • have unstable CNS metastases.

Supplementary Public Funding

lenvatinib
Exceptional Access Program (lenvatinib - In Combination with Pembrolizumab for Advanced Endometrial Cancer) (EAP Website)

pembrolizumab
New Drug Funding Program (Pembrolizumab - In Combination with Lenvatinib for Advanced Endometrial Cancer)

 
B - Drug Regimen

lenvatinib
20 mg PO Daily


AND

pembrolizumab

1

2 mg /kg IV (max 200 mg) Day 1, every 3 weeks


OR

pembrolizumab

1

4 mg /kg IV (max 400 mg) Day 1, every 6 weeks

1Dosing based on NDFP funding criteria.

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C - Cycle Frequency

Lenvatinib: Continuous treatment, until disease progression or unacceptable toxicity

Use the regimen code LENV(MNT) for single agent lenvatinib after completion of pembrolizumab treatment.


Pembrolizumab:

2 mg /kg dosing: REPEAT EVERY 3 WEEKS

4 mg /kg dosing: REPEAT EVERY 6 WEEKS

Continue until disease progression or unacceptable toxicity, up to a maximum of 2 years (up to 35 doses given every 3 weeks or 18 doses given every 6 weeks), whichever comes first.

Refer to NDFP form for details on pembrolizumab retreatment.

 
D - Premedication and Supportive Measures

Antiemetic Regimen:   Minimal; consider prophylaxis daily for lenvatinib

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
 

Pembrolizumab premedication (prophylaxis for infusion reactions):

  • Routine pre-medication is not recommended.
  • May consider antipyretic and H1-receptor antagonist in patients who experienced a grade 1-2 infusion reaction.


Other Supportive Care:

  • Avoid the use of corticosteroids or immunosuppressants before starting treatment.
 
J - Administrative Information

Approximate Patient Visit
0.75 hour
Pharmacy Workload (average time per visit)
19.75 minutes minutes
Nursing Workload (average time per visit)
40.75 minutes minutes
 
K - References

CADTH Reimbursement Recommendation: Pembrolizumab (Keytruda) in Combination With Lenvatinib (Lenvima). Canadian Journal of Health Technologies. September 2022.

Makker V, Colombo N, Casado Herráez A, et al; Study 309–KEYNOTE-775 Investigators. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. N Engl J Med. 2022 Feb 3;386(5):437-448.

Makker V, Taylor MH, Aghajanian C, et al. Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer. J Clin Oncol. 2020 Sep 10;38(26):2981-2992. 

August 2023 Updated rationale and uses, drug regimen, cycle frequency, premedication and supportive measures sections; Added NDFP (pembrolizumab) and EAP (lenvatinib) funding info


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.