Published

February 7, 2025

Pembrolizumab, Pembrolizumab [PEMB31, PEMB31]

Pembrolizumab monotherapy for adjuvant treatment after complete tumour resection in adult patients with UICC/AJCC 8th edition stage IIA or IIB or IIIA or N2 only IIIB non-small cell lung cancer and whose disease has not progressed on recently completed adjuvant platinum- based chemotherapy where the following criteria have been met:, Pembrolizumab monotherapy for adjuvant treatment after complete tumour resection in adult patients with UICC/AJCC 8th edition stage IIA or IIB or IIIA or N2 only IIIB non-small cell lung cancer and whose disease has not progressed on recently completed adjuvant platinum- based chemotherapy where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with adjuvant pembrolizumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicity.
  3. The patient has a histologically documented diagnosis of non-small cell lung cancer (NSCLC). Please mark below which histology applies to this patient:
  • squamous NSCLC
  • non-squamous NSCLC
  1. The result of this patient’s NSCLC testing for PD-L1 expression on tumour cells is shown below: Please document below the actual PD-L1 expression on tumour cells (e.g. if 80%, please type just the number 80; if not known, please write ’NK’): PD-L1 expression in this patient’s tumour cells:_____________
  2. The patient‘s NSCLC genomic status either has been documented for an EGFR 19 or 21 mutation and an ALK gene fusion or the patient has a squamous cell carcinoma and a decision to not test for an EGFR 19 or 21 mutation or an ALK gene fusion and proceed with adjuvant pembrolizumab has been made following discussion at the Lung Cancer MDT and consideration of the relevant patient characteristics (including age and smoking status). Please mark below which option applies to this patient:
  • the EGFR 19 or 21 mutation test and ALK gene fusion tests are all negative
  • the EGFR 19 or 21 mutation test is positive
  • the ALK gene fusion test is positive
  • Patient has squamous NSCLC and a decision to not test for an EGFR 19 or 21 mutation or an ALK gene fusion and proceed with adjuvant pembrolizumab has been made following discussion at the Lung Cancer MDT
  1. The patient has been documented as having any other actionable NSCLC mutation or not: ROS1, RET, KRAS G12C, MET14 or BRAF. Please mark in the box below whether such an actionable mutation has been found or not:
  • genomic testing has not been done for all the other genomic alterations listed below and any results so far have been negative
  • genomic testing has been done for all the other genomic alterations listed below and results are all negative
  • the patient’s NSCLC is positive for a ROS1 gene rearrangement
  • the patient’s NSCLC is positive for a RET gene fusion
  • the patient’s NSCLC is positive for a KRAS G12C mutation
  • the patient’s NSCLC is positive for a MET exon 14 skipping mutation
  • the patient’s NSCLC is positive for a BRAF mutation
  1. The patient had M0 disease prior to surgery and has undergone a complete resection of the primary NSCLC with all surgical margins negative for tumour i.e. a R0 resection has taken place.
  2. The pathological TNM stage determined on this patient’s surgical NSCLC specimen was a stage IIA or IIB or IIIA or N2 only IIIB tumour according to the UICC/AJCC TNM 8th edition. Please mark below which stage applies to this patient:
  • stage IIA disease (T2b N0)
  • stage IIB disease (T1a N1 or T1b N1 or T1c N1 or T2a N1 or T2b N1 or T3 N0)
  • stage IIIA disease (T1a N2 or T1b N2 or T1c N2 or T2a N2 or T2b N2 or T3 N1 or T4 N0 or T4 N1)
  • N2 only stage IIIB disease (T3 N2 or T4 N2) Note: the trial included patients staged using the UICC/AJCC TNM 7th edition and hence the marketing authorisation uses the 7th edition staging system. As NSCLC surgical resection specimens are now reported using the UICC/AJCC TNM 8th edition, the corresponding 7th edition stages included in the marketing authorisation have been translated into those of the 8th edition.
  1. The patient commenced adjuvant platinum-based chemotherapy within 12 weeks of resection of the NSCLC. NB The marketing authorisation and NICE recommendation of pembrolizumab in this adjuvant NSCLC indication stipulates that patients must have received adjuvant chemotherapy prior to commencing adjuvant pembrolizumab.
  2. The patient has received a maximum of 4 cycles of adjuvant platinum-based chemotherapy. Please mark below how many cycles of adjuvant chemotherapy were received by this patient
  • 1 cycle of adjuvant chemotherapy
  • 2 cycles of adjuvant chemotherapy
  • 3 cycles of adjuvant chemotherapy
  • 4 cycles of adjuvant chemotherapy
  1. The patient has been radiologically re-staged after completion of adjuvant chemotherapy and continues to have no evidence of residual or metastatic disease.
  2. No more than 12 weeks have elapsed since the start of the last cycle of adjuvant platinum-based chemotherapy. (continues on next page)
  3. The patient has not received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
  4. The patient has not received any neoadjuvant chemotherapy for this NSCLC or any prior or planned adjuvant radiotherapy.
  5. The patient has an ECOG performance status (PS) of 0 or 1.
  6. Pembrolizumab will be stopped at whichever of the following events occurs first: disease progression or unacceptable toxicity or withdrawal of patient consent or on completion of 1 year in total duration of treatment with pembrolizumab (i.e. after a maximum of 17 x 3-weekly or 9 x 6-weekly cycles).
  7. Pembrolizumab will be administered as monotherapy.
  8. A formal medical review as to how pembrolizumab is being tolerated and whether treatment with pembrolizumab should continue or not will be scheduled to occur at least by the end of the second month of treatment.
  9. When a treatment break of more than 3 months beyond the expected 3- or 6-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
  10. Pembrolizumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 20 December 2024 - anticipated to move to NHS funding: 06 May 2025

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