SACT Immunotherapies (Formulary: Malignant disease)

Important: Formulation and dosage details

Formulation:

Concentrate solution for infusion 840mg/14mL (hospital use only)

Dosage:

As per SMC:

• 2267: Atezolizumab in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have programmed death-ligand 1 [PD-L1] expression ≥1% and who have not received prior chemotherapy for metastatic disease.
• 2379: As monotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥50% tumour cells (TC) or ≥10% tumour-infiltrating immune cells (IC) and who do not have epidermal growth factor receptor (EGFR) mutant or anaplastic lymphoma kinase (ALK)-positive NSCLC.
• 2492: as monotherapy as adjuvant treatment following complete resection for adult patients with Stage II to IIIA (7th edition of the UICC/AJCC staging system) non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥50% of tumour cells and whose disease has not progressed following platinum-based adjuvant chemotherapy.

Important: Formulation and dosage details

Formulation:

Concentrate solution for infusion 1200mg/20mL (hospital use only)

Dosage:

As per SMC:

• 1336/18: As monotherapy for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) after prior chemotherapy. Patients with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)‑positive tumour mutations should also have received targeted therapy before receiving atezolizumab.
  SMC restriction: treatment with atezolizumab is subject to a two-year clinical stopping rule. 
• 2279: Atezolizumab, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
• 2349: in combination with bevacizumab for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
• 2379: As monotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥50% tumour cells (TC) or ≥10% tumour-infiltrating immune cells (IC) and who do not have epidermal growth factor receptor (EGFR) mutant or anaplastic lymphoma kinase (ALK)-positive NSCLC.
• 2492: as monotherapy as adjuvant treatment following complete resection for adult patients with Stage II to IIIA (7th edition of the UICC/AJCC staging system) non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥50% of tumour cells and whose disease has not progressed following platinum-based adjuvant chemotherapy.

Important: Formulation and dosage details

Formulation:

Solution for injection 1,875mg/15mL (125mg/mL) (hospital use only)

Dosage:

To be given via subcutaneous injection.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 200mg/10mL (hospital use only)

Dosage:

As per SMC:

• 1315/18: As monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC).
• 2248: in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
• 2359: as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are progression-free following platinum-based chemotherapy. 

Important: Formulation and dosage details

Formulation:

Solution for infusion 350mg (hospital use only)

Dosage:

As per SMC:

• 2216: treatment of cutaneous squamous cell carcinoma (CSCC).
• 2719: as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 500mg (hospital use only)

Dosage:

As per SMC 2404: as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen. 

and 2635: in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.

Important: Formulation and dosage details

Formulation:

Solution for infusion 50mg/ml (hospital use only)

Dosage:

As per SMC:

• 2156: as monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 [programmed cell death ligand 1] on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.
• 2582: in combination with gemcitabine and cisplatin for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer. 
• 2734: in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
• 2797: Indication under review: in combination with carboplatin and paclitaxel for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with:
  • durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
  • durvalumab in combination with olaparib in endometrial cancer that is mismatch
    repair proficient (pMMR).
• 2857: In combination with tremelimumab for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 5mg/mL (hospital use only)

Dosage:

As per SMC:

• 779/12: Treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy.
• 997/14: Treatment of advanced (unresectable or metastatic) melanoma in adults (first-line use).
• 2094: as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adolescents 12 years of age and older.

As per NCMAG 121: Nivolumab in combination with ipilimumab for the neoadjuvant treatment of resectable stage III melanoma.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 10 mg/mL (40 mg/4mL, 100 mg/10 mL, 120 mg/12 mL, 240 mg/12 mL) (Restricted: Hospital use only)

Dosage:

First choice for indication as per SMC 2112: As monotherapy for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Also as per SMC:

• 1120/16: as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults.
• 1144/16: Treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
  SMC restriction: patients previously untreated with ipilimumab.
• 1180/16: treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
  SMC restriction: treatment with nivolumab is subject to a two-year clinical stopping rule. 
• 1187/16: in combination with ipilimumab for the treatment of advanced (unresectable or metastatic) melanoma in adults.
  SMC restriction: for the first-line treatment of advanced melanoma.
• 1240/17: the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
• 1261/17: As monotherapy, for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy.
  SMC restriction: treatment with nivolumab is subject to a two year clinical stopping rule. 
• 1188/16: As monotherapy for the treatment of advanced renal cell carcinoma after prior therapy in adults.
• 2153: in combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC). 
• 2362: as monotherapy for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. 
• 2385: in combination with ipilimumab for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
• 2394: in combination with ipilimumab for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.
• 2429: as monotherapy for the adjuvant treatment of adult patients with completely resected oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.
• 2458: In combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥5. 
• 2503: as monotherapy for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥1%, who are at high risk of recurrence after undergoing radical resection of MIUC.
• 2519: in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression ≥1%.
• 2619: in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable (tumours ≥4 cm or node positive) non-small cell lung cancer in adults.
• 2820: In combination with ipilimumab for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following setting: first-line treatment of unresectable or metastatic colorectal cancer. 

As per NCMAG 121: Nivolumab in combination with ipilimumab for the neoadjuvant treatment of resectable stage III melanoma.

Important: Formulation and dosage details

Formulation:

Solution for injection 600 mg/5 mL (Restricted: Hospital use only)

Dosage:

As per SMC:

• 1144/16: Treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
  SMC restriction: patients previously untreated with ipilimumab.
• 1187/16: in combination with ipilimumab for the treatment of advanced (unresectable or metastatic) melanoma in adults.
  SMC restriction: for the first-line treatment of advanced melanoma.
• 1261/17: As monotherapy, for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy.
  SMC restriction: treatment with nivolumab is subject to a two year clinical stopping rule. 
• 1188/16: As monotherapy for the treatment of advanced renal cell carcinoma after prior therapy in adults.
• 2362: as monotherapy for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. 
• 2394: in combination with ipilimumab for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.
• 2429: as monotherapy for the adjuvant treatment of adult patients with completely resected oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.
• 2458: In combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥5. 
• 2519: in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression ≥1%.
• 2619: in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable (tumours ≥4 cm or node positive) non-small cell lung cancer in adults.
• 2820: In combination with ipilimumab for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following setting: first-line treatment of unresectable or metastatic colorectal cancer. 

As per NCMAG 121: Nivolumab in combination with ipilimumab for the neoadjuvant treatment of resectable stage III melanoma.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 12mg nivolumab and 4mg relatlimab/mL (240mg/80mg in 20mL vial) (Restricted: Hospital use only)

Dosage:

As per SMC 2645: first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 25mg/mL (Restricted: hospital use only)

Dosage:

As per SMC:

• 1086/15: as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults. This submission relates to use in adults previously untreated with ipilimumab.
• 1204/17: The treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) and who have received at least one prior chemotherapy regimen.
  SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
• 1239/17: As monotherapy for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) with a ≥50% tumour proportion score (TPS) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumour mutations.
  SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
• 1291/18: as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.
  SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
• 1296/18: As monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.
  SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
• 2144: As monotherapy for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection. 
• 2187: In combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults.
  SMC restriction: in combination with carboplatin and paclitaxel in patients whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.
• 2207: in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma (NSCLC) in adults whose tumours have no EGFR or ALK positive mutations.
  SMC restriction: in patients whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Treatment with pembrolizumab is subject to a two-year clinical stopping
  rule.
• 2247: in combination with axitinib, for the first-line treatment of advanced renal cell carcinoma in adults.
  SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping
  rule.
• 2257: as monotherapy or in combination with platinum and fluorouracil chemotherapy, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express programmed cell death ligand-1 (PD-L1) with a combined positive score (CPS)≥1.
  SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping
  rule.
• 2375: as monotherapy for the first-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults.
  SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping
  rule.
• 2380: as monotherapy for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.
  SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
• 2420: In combination with platinum and fluoropyrimidine based chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS≥10.
  SMC Restriction: treatment with pembrolizumab is subject to a two-year clinical stopping
  rule
• 2460: in combination with chemotherapy, for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease.
  SMC restriction: for use in combination with paclitaxel or nab-paclitaxel. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.
• 2474: 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.
  SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
• 2479: As monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
• 2501: in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express programmed death ligand 1 (PD-L1) with a combined positive score (CPS)≥1.
  SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
• 2526: as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB or IIC melanoma and who have undergone complete resection.
• 2538: in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, for the treatment of adults with locally advanced, or early stage triple-negative breast cancer (TNBC) at high risk of recurrence.
• 2589: As monotherapy for adults with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in the following settings:
  • treatment of unresectable or metastatic colorectal cancer after previous
    fluoropyrimidine-based combination therapy.

As monotherapy for the treatment of the following MSI-H or dMMR tumours in adults with:

• • advanced or recurrent endometrial carcinoma, 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;
  • unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy
• 2660: in combination with fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor 2 (HER2)-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express programmed death-ligand 1 (PD-L1) with a combined positive score (CPS) ≥ 1.
• 2689: As monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
  SMC restriction: adults whose tumours express programmed death-ligand 1 (PD-L1) with less than 50% (0 to 49%) tumour proportion score (TPS).
• 2767: in combination with carboplatin and paclitaxel, for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults. 

As per NCMAG 122: Pembrolizumab for the neoadjuvant treatment of stage IIIB to IIID or oligometastatic resectable stage IV melanoma.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 300mg/15ml (Restricted: Hospital use only)

Dosage:

As per SMC 2857: In combination with durvalumab for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 100 mg (Restricted: Hospital use only)

Dosage:

Indication: SMC2839: In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive.