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Christy Leung2022-11-06 07:53:422022-11-07 08:56:16At the Heart of the Discussion: COVID-19 Cardiovascular Complications in Pregnant Women
Medical writer: Stijn van den Borne, MSc | Last updated: 8 December 2020 | In: Gastrointestinal Cancer, Genitourinary Cancer, Gynaecological Cancer, Haematology, Head and Neck Cancer, Lung Cancer, Oncology, Melanoma & Skin Cancer, Immunotherapy, AE Management, irAE Management
Article Keywords
tremelimumab, immune-checkpoint, CTLA4, cemiplimab, Merck, Imfinzi, mutations, bevacizumab, non-squamous cell lung cancer, PD-1, irAE, CSCC, Roche, PDR001, carboplatin, squamous cell lung cancer, PD-L1, Keytruda, Regeneron, nivolumab, spartalizumab, paediatric, TPS, MSD, REGN2810, atezolizumab, ALK, Novartis, EGFR, NSCLC, Bristol-Myers Squibb, squamous cell skin cancer, cisplatin, HER2, AstraZeneca, BCL, Opdivo, Libtayo, CPS, BMS, SHR-1210, Yervoy, autologous HSCT, avelumab, dMMR, sorafenib, PMBCL, melanoma, Genentech, BRAF V600, Pfizer, MSI-H, brentuximab vedotin, Merck KGaA, Tecentriq, FOLFOXIRI, ipilimumab, Avastin, paclitaxel, pemetrexed, Merckgroup, pembrolizumab, AZ, Imfinizi, durvalumab, cHL, Merck Serono, SCLC, RCC, Bavencio, IO-IO
U.S. APPROVED IMMUNOTHERAPIES
BRIEF OVERVIEW OF THE APPROVED IMMUNE-CHECKPOINT INHIBITORS
The information on U.S. FDA approved immune-checkpoint inhibitors is based on the FDA approved package inserts (USPI) and complete as of 8 December 2020. Countries other than the U.S. may have variations in approvals as to the overview in this article.
Patients with questions regarding their disease and treatment options are strongly encouraged to discuss these with their treating physician. Physicians are recommended to always refer to the latest U.S. FDA prescribing information for approved immunotherapies.
Since 2011, when the United States Food and Drug Administration (U.S. FDA) approved ipilimumab (Yervoy®) for malignant melanoma, several immune-checkpoint inhibitors have been granted marketing authorisation.
Immunotherapies, such as the immune-checkpoint inhibitors, chimeric antigen receptor T-cell (CAR-T cell) therapies, bispecific T-cell engagers (BiTE), and vaccines, have revolutionised the treatment of cancer over the past recent years. Immune-checkpoint inhibitors have gained approval in a multitude of solid tumours as well as for some haematologic malignancies.1-7
This article discusses which approved immunotherapies are available for patients and provides a current overview for anyone who would like to understand more on the U.S. FDA approved immune-checkpoint inhibitors, indications, and side effects.
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GRAPHIC OVERVIEW
1
2
3
4
5
6
7
8
9
10
11
1
Skin Cancers
Malignant Melanoma (MM)
Merkel Cell Carcinoma (MCC)
Cutaneous Squamous Cell Carcinoma (CSCC)
2
Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
Small Cell Lung Cancer (NSCLC)
Malignant Pleural Mesothelioma
3
Liver Cancers
Hepatocellular Carcinoma (HCC)
4
TMB-H, MSI-H, or dMMR Cancers
Colorectal Cancers (CRC)
MSI-H or dMMR Cancers
TMB-H Cancers
5
Genetourinary Cancers
Urothelial Carcinoma
BCG-unresponsive High-Risk NMIBC
Endometrial Carcinoma
Cervical Cancer
6
Head and Neck Cancers
Head and Neck Squamous Cell Carcinoma (SCCHN)
7
Gastric Cancers
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
8
Kidney Cancers
Renal Cell Carcinoma
9
Haematological Cancers
Classical Hodgkin Lymphoma (CHL)
Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
10
Breast Cancers
Triple-negative breast cancer (TNBC)
11
Oesophageal Cancer
Oesophageal Squamous Cell Carcinoma
APPROVED IMMUNOTHERAPIES
U.S. FDA APPROVED IMMUNE-CHECKPOINT INHIBITORS INDICATIONS
IPILIMUMAB (YERVOY®)
Ipilimumab (Yervoy®) was the first to achieve marketing licence of the six U.S. FDA approved immune-checkpoint targeting immunotherapies. It is also unique as it is currently the only U.S. FDA approved immunotherapy targeting CTLA4.1
Ipilimumab (Yervoy®) is indicated for:1
- Melanoma
- Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older
- Adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.
- Renal cell carcinoma (RCC)
- Treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma, in combination with nivolumab
- Colorectal cancer
- Treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in combination with nivolumab.
- This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials
- Treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in combination with nivolumab.
- Hepatocellular carcinoma
- Treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib, in combination with nivolumab
- This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials
- Treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib, in combination with nivolumab
- Non-Small Cell Lung Cancer (NSCLC)
- Treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations, as first-line treatment in combination with nivolumab
- Treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumour aberrations as first-line treatment, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy
- Malignant pleural mesothelioma
- Treatment of adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with nivolumab
Safety of Ipilimumab (Yervoy®)
- Most common adverse reactions (≥5%) with Ipilimumab (Yervoy®) as a single agent are fatigue, diarrhoea, pruritus, rash, and colitis
- Additional common adverse reactions at the 10mg/kg dose (≥5%) include nausea, vomiting, headache, weight loss, pyrexia, decreased appetite and insomnia
- Most common adverse reactions (≥20%) with Ipilimumab (Yervoy®) in combination with nivolumab (Opdivo®) are fatigue, rash, pruritus, diarrhoea, musculoskeletal ain, cough, pyrexia, decreased appetite, nausea, abdominal pain, arthralgia, headache, vomiting, dyspnoea, dizziness, hypothyroidism, and decreased weight
- Most common adverse reactions (≥20%) with Ipilimumab (Yervoy®) in combination with nivolumab (Opdivo®) and platinum-doublet chemotherapy are fatigue, musculoskeletal pain, nausea, diarrhoea, rash, decreased appetite, constipation, and pruritus
PEMBROLIZUMAB (KEYTRUDA®)
Pembrolizumab (Keytruda®)
Pembrolizumab (Keytruda®) is a programmed death receptor-1 (PD-1)-blocking antibody indicated for:2
- Melanoma
- For the treatment of patients with unresectable or metastatic melanoma
- For the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection
- Non-Small Cell Lung Cancer (NSCLC)
- In combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations
- In combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC
- As a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- Metastatic
- As a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.
- Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab (Keytruda®).
- Small Cell Lung Cancer (SCLC)
- For the treatment of patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
- Head and Neck Squamous Cell Cancer (HNSCC)
- In combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC
- As a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test
- As a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy
- Classical Hodgkin Lymphoma (cHL)
- For the treatment of adult patients with relapsed or refractory cHL
- For the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy
- Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
- For the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy
- Limitations of use: Pembrolizumab (Keytruda®) is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy
- Urothelial Carcinoma
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
- For the treatment of patients with Bacillus Calmette-Guerin (BCG)- unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy
- Microsatellite Instability-High Cancer
- For the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
- Solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
- Colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
- Limitations of use: The safety and effectiveness of Pembrolizumab (Keytruda®) in paediatric patients with MSI-H central nervous system cancers have not been established
- For the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
- Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC)
- For the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC)
- Gastric Cancer
- For the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy
- Oesophageal Cancer
- For the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
- Cervical Cancer
- For the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.
- Hepatocellular Carcinoma (HCC)
- For the treatment of patients who have been previously treated with sorafenib
- Merkel Cell Carcinoma (MCC)
- For the treatment of adult and paediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma
- Renal Cell Carcinoma (RCC)
- In combination with axitinib, for the first-line treatment of patients with advanced RCC
- Endometrial Carcinoma
- in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation
- Tumour Mutational Burden-High (TMB-H) Cancer
- For the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options
- Limitations of use: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
- Cutaneous Squamous Cell Carcinoma (cSCC)
- For the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation
- Triple-Negative Breast Cancer (TNBC)
- In combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA approved test
- Adult Indications: Additional Dosing Regimen of 400 mg Every 6 Weeks
- For use at an additional recommended dosage of 400 mg every 6 weeks for all approved adult indications
Safety of Pembrolizumab (Keytruda®)
- Most common adverse reactions (reported in ≥20% of patients) were:
- Pembrolizumab (Keytruda®) as a single agent: Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhoea, nausea, rash, pyrexia, cough, dyspnoea, constipation, pain, and abdominal pain
- Pembrolizumab (Keytruda®) in combination with chemotherapy: fatigue/asthenia, nausea, constipation, diarrhoea, decreased appetite, rash, vomiting, cough, dyspnoea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, and stomatitis
- Pembrolizumab (Keytruda®) in combination with axitinib: diarrhoea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation
- Pembrolizumab (Keytruda®) in combination with Lenvatinib: fatigue, hypertension, musculoskeletal pain, diarrhoea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, haemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnoea, cough, and rash
NIVOLUMAB (OPDIVO®)
Nivolumab (Opdivo®)
Nivolumab (Opdivo®) is a programmed death receptor-1 (PD-1)-blocking antibody indicated for:3
- Melanoma
- Patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab (Yervoy®)
- Patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting
- Non-Small Cell Lung Cancer (NSCLC)
- Adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations, as first-line treatment in combination with ipilimumab (Yervoy®)
- Adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumour aberrations as first-line treatment, in combination with ipilimumab (Yervoy®) and 2 cycles of platinum-doublet chemotherapy
- Patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab (Opdivo®)
- Small Cell Lung Cancer (SCLC)
- Patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy
- Renal Cell Carcinoma (RCC)
- Patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy
- Patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma, in combination with ipilimumab (Yervoy®)
- Classical Hodgkin Lymphoma (cHL)
- Adult patients with classical Hodgkin lymphoma that has relapsed or progressed after
- Autologous haematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or
- 3 or more lines of systemic therapy that includes autologous HSCT
- Adult patients with classical Hodgkin lymphoma that has relapsed or progressed after
- Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy
- Urothelial Carcinoma
- Patients with locally advanced or metastatic urothelial carcinoma who:
- Have disease progression during or following platinum-containing chemotherapy
- Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
- Patients with locally advanced or metastatic urothelial carcinoma who:
- Colorectal cancer
- Adult and paediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab (Yervoy®)
- Hepatocellular Carcinoma (HCC)
- Patients with hepatocellular carcinoma who have been previously treated with sorafenib, as a single agent or in combination with ipilimumab (Yervoy®)
- Esophageal Squamous Cell Carcinoma (ESCC)
- Patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy
Safety of nivolumab (Opdivo®)
- Most common adverse reactions (incidence ≥20%) in patients were:
- As a single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhoea, nausea, asthenia, cough, dyspnoea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, and vomiting
- In combination with ipilumumab (Yervoy®): fatigue, diarrhoea, rash, pruritus, nausea, musculoskeletal pain, pyrexia, cough, decreased appetite, vomiting, abdominal pain, dyspnoea, upper respiratory tract infection, arthralgia, headache, hypothyroidism, decreased weight, and dizziness
- In combination with ipilimumab (Yervoy®) and platinum-doublet chemotherapy: fatigue, musculoskeletal pain, nausea, diarrhoea, decreased appetite, constipation, and pruritus
ATEZOLIZUMAB (TECENTRIQ®)
Atezolizumab (Tecentriq®) is a programmed death-ligand 1 (PD-L1)-blocking antibody indicated for:4
- Urothelial Carcinoma
- For the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who:
- Are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 (PD-L1 stained tumour-infiltrating immune cells [IC] covering ≥5% of the tumour area), as determined by an FDA-approved test, or
- Are not eligible for any platinum containing chemotherapy regardless of PD-L1 status, or
- Have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy
- For the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who:
- Non-Small Cell Lung Cancer (NSCLC)
- For the first-line treatment of adult patients with metastatic NSCLC whose tumours have high PD-L1 expression (PD-L1 stained ≥50% of tumour cells [TC ≥50%] or PD-L1 stained tumour-infiltrating immune cells [IC] covering ≥10% of the tumour area [IC ≥10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations
- In combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations
- In combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations
- For the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for NSCLC harbouring these aberrations prior to receiving atezolizumab (Tecentriq®)
- Triple-Negative Breast Cancer (TNBC)
- In combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours express PD-L1 (PD-L1 stained tumour-infiltrating immune cells [IC] of any intensity covering ≥1% of the tumour area), as determined by an FDA-approved test.
- Small Cell Lung Cancer (SCLC)
- In combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)
- Hepatocellular Carcinoma (HCC)
- In combination with bevacizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy
- Melanoma
- In combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
Safety of atezolizumab (Tecentriq®)
- Most common adverse reactions (≥20%) with atezolizumab (Tecentriq®) as a single agent were fatigue/asthenia, nausea, cough, dyspnoea, and decreased appetite
- Most common adverse reactions (≥20%) with atezolizumab (Tecentriq®) in combination with other antineoplastic drugs in patients with NSCLC and SCLC were fatigue/asthenia, nausea, alopecia, constipation, diarrhoea, and decreased appetite
- The most common adverse reactions (≥20%) with atezolizumab (Tecentriq®) in combination with paclitaxel protein-bound in patients with TNB were alopecia, peripheral neuropathies, fatigue, nausea, diarrhoea, anaemia, constipation, cough, headache, neutropenia, vomiting, and decreased appetite
- The most common adverse reactions (reported in ≥20% of patients) with atezolizumab (Tecentriq®) in combination with bevacizumab in patients with HCC were hypertension, fatigue, and proteinuria
AVELUMAB (BAVENCIO®)
Avelumab (Bavencio®) is a programmed death-ligand 1 (PD-L1)-blocking antibody indicated for:5
- Adults and paediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC)
- Maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy
- Patients with locally advanced or metastatic UC who:
- Have disease progression during or following platinum-containing chemotherapy
- Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
- First-line treatment, in combination with axitinib of patients with advanced renal cell carcinoma (RCC)
Safety of avelumab (Bavencio®)
- Most common adverse reactions (≥20%) were:
- Avelumab (Bavencio®) in patients with metastatic Merkel cell carcinoma: fatigue, musculoskeletal pain, diarrhoea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral oedema
- Avelumab (Bavencio®) in patients with locally advanced or metastatic urothelial carcinoma: fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection
- Avelumab (Bavencio®) with axitinib in patients with RCC: diarrhoea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnoea, abdominal pain, and headache
DURVALUMAB (IMFINZI®)
Imfinzi is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for:6
- For the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who
- Have disease progression during or following platinum-containing chemotherapy
- Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
- For the treatment of adult patients with unresectable, stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy
- In combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer
Safety of Durvalumab (Imfinzi®)
- Most common adverse reactions (≥15% of patients with urothelial carcinoma) were fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral oedema, and urinary tract infection
- Most common adverse reactions (≥20% of patients with unresectable, stage III NSCLC) were cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnoea, and rash
- Most common adverse reactions (≥20% of patients with extensive-stage SCLC) were nausea, fatigue/asthenia, alopecia.
CEMIPLIMAB (LIBTAYO®)
Cemiplimab (Libtayo®) is a programmed death receptor-1 (P-1) blocking antibody indicated for:7
- Treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation
Safety of Cemiplimab (Libtayo®)
- Most common adverse reactions (incidence ≥20%) were fatigue, rash, and diarrhoea
REFERENCES
1. Prescribing information pembrolizumab (Keytruda®), revised: 11/2020. Available at: https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf (Accessed 7th December 2020).
2. Prescribing information nivolumab (Opdivo®), revised: 11/2020. Available at: https://packageinserts.bms.com/pi/pi_opdivo.pdf (Accessed 7th December 2020).
3. Prescribing information ipilimumab (Yervoy®), revised: 11/2020. Available at: https://packageinserts.bms.com/pi/pi_yervoy.pdf (Accessed 7th December 2020).
4. Prescribing information atezolizumab (Tecentriq®), revised: 11/2020. Available at: https://www.gene.com/download/pdf/tecentriq_prescribing.pdf (Accessed 7th December 2020).
5. Prescribing information avelumab (Bavencio®), revised: 11/2020. Available at: https://www.emdserono.com/us-en/pi/bavencio-pi.pdf (Accessed 7th December 2020).
6. Prescribing information durvalumab (Imfinzi®), revised: 11/2020. Available at: https://www.azpicentral.com/imfinzi/imfinzi.pdf (Accessed 7th December 2020).
7. Prescribing information cemiplimab (Libtayo®), revised: 11/2020. Available at: https://www.regeneron.com/sites/default/files/Libtayo_FPI.pdf (Accessed 7th December 2020).
Disclaimer
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
© Copyright 2016-2021 MediPaper Medical Communications Ltd. – U.S. FDA Approved Immune-checkpoint Inhibitors – U.S. FDA Approved Immunotherapies
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