AstraZeneca Data at WCLC Advance Ambition to Have an AstraZeneca Medicine for More Than Half of All Patients Treated for Lung Cancer by 2030
- The FLAURA2 Phase III trial of TAGRISSO in combination with chemotherapy shows a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for EGFR-mutated non-small cell lung cancer patients.
- ENHERTU, a HER2-directed therapy, demonstrates potential benefit for patients with previously treated HER2-mutant metastatic lung cancer.
- Datopotamab deruxtecan, an antibody-drug conjugate, shows safety and efficacy in combination with IMFINZI for patients with previously treated or untreated NSCLC.
- IMFINZI in combination with neoadjuvant chemotherapy and as adjuvant monotherapy shows improved clinical outcomes in patients with resectable NSCLC.
- AstraZeneca is committed to increasing lung cancer screening and early diagnosis through its collaboration with the Lung Ambition Alliance.
- None.
FLAURA2 data reinforce TAGRISSO® as backbone therapy for EGFR-mutated advanced lung cancer in combination with chemotherapy; granted Breakthrough Therapy Designation in the US
Further results for ENHERTU®, IMFINZI® and datopotamab deruxtecan showcase strength of diverse ADC and IO portfolios to address unmet needs
More than 40 abstracts will feature eight approved and potential new medicines from AstraZeneca, including nine oral presentations and a late-breaking plenary Presidential Symposium presentation of results from the FLAURA2 Phase III trial of TAGRISSO® (osimertinib) in combination with chemotherapy for patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) lung cancer.
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Our data at WCLC support our ambition to have the right AstraZeneca medicine for more than half of all patients treated for lung cancer by 2030, and underscore the need to increase screening and early diagnosis to improve patient outcomes. The strong results from FLAURA2 will further establish TAGRISSO as the backbone therapy in EGFR-mutated non-small cell lung cancer, and the recent Breakthrough Therapy Designation in the US is a significant validation of the potential we see for this regimen.”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Following last year’s accelerated approval of ENHERTU as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic lung cancer, new data at WCLC will reinforce its potential benefit to patients in need of targeted options. In addition, data for datopotamab deruxtecan will further support the potential to combine this agent with immune checkpoint inhibitors and the continued investigation of these combinations in first-line settings.”
Improving outcomes across early- and late-stage EGFRm lung cancer
A late-breaking plenary Presidential Symposium presentation will showcase progression-free survival (PFS) data from the FLAURA2 Phase III trial evaluating TAGRISSO in combination with chemotherapy for patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm non-small cell lung cancer (NSCLC). In May, high-level results showed the TAGRISSO combination demonstrated a statistically significant and clinically meaningful improvement in PFS compared to standard-of-care TAGRISSO monotherapy. In August, TAGRISSO plus chemotherapy was granted Breakthrough Therapy Designation in the US for advanced EGFRm NSCLC.
An oral presentation of results from a Phase IIIb trial will show the potential of savolitinib as a 1st-line treatment for advanced or metastatic NSCLC harboring MET exon 14 mutations. Savolitinib is approved for this indication in
In addition, an e-poster on a computational pathology analysis of MET expression in patients treated with a combination of savolitinib and TAGRISSO in the SAVANNAH Phase II trial will showcase the Company’s progress in developing transformational technology solutions to identify patients who are most likely to respond to treatment. Encouraging efficacy for the combination has been previously reported in the same study in patients with high levels of MET overexpression and/or amplification whose disease progressed on treatment with TAGRISSO.
Realizing the potential of antibody drug conjugates (ADCs) in advanced lung cancer
A late-breaking oral presentation of first results from the TROPION-Lung04 Phase Ib trial will highlight the safety and efficacy of datopotamab deruxtecan (Dato-DXd) plus IMFINZI® (durvalumab) with and without carboplatin in patients with previously treated or untreated, advanced or metastatic NSCLC without actionable genomic alterations. There are currently no TROP2-directed ADCs approved for the treatment of patients with lung cancer.
A mini-oral presentation of primary results from the DESTINY-Lung02 Phase II trial will share the first overall survival and PFS data for ENHERTU® (fam-trastuzumab deruxtecan-nxki) in patients with previously treated HER2-mutant metastatic NSCLC. ENHERTU is approved for this indication in a number of countries, including in the US, where it was granted accelerated approval based on interim results from the trial.
Two posters will feature AZD9592, an EGFR/cMET bispecific ADC designed to deliver targeted chemotherapy to cancer cells expressing both EGFR and cMET with a topoisomerase inhibitor 1 warhead using the Company’s proprietary linker technology. A trial-in-progress poster will describe the EGRET Phase I trial, a first-in-human study evaluating AZD9592 in patients with advanced solid tumors including in combination with TAGRISSO in metastatic EGFRm NSCLC. In addition, a poster on translational results for AZD9592 suggests it may provide clinical benefit in areas of unmet need, including in patients with NSCLC previously treated with chemotherapy or targeted agents. This is the Company’s first bispecific ADC to enter the clinic.
Reinforcing IMFINZI benefits alone and in novel combinations across lung cancer settings
Two late-breaking oral presentations will share new data from the AEGEAN Phase III trial of IMFINZI in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery in patients with resectable NSCLC, including key surgical outcomes and exploratory analyses of clinical outcomes in a subset of patients with EGFRm disease. Previously presented primary results from AEGEAN demonstrated statistically significant and clinically meaningful improvement in event-free survival and pathologic complete response with this IMFINZI-based regimen versus neoadjuvant chemotherapy alone followed by surgery.
Another oral presentation of data from a planned subset analysis of the PACIFIC-R observational study of IMFINZI in a real-world population of patients with EGFRm disease will explore the long-term clinical outcomes of IMFINZI in patients with unresectable, Stage III NSCLC.
Data will also be shared from new exploratory subgroup analyses of the POSEIDON Phase III trial describing patients deriving long-term benefit from the combination of IMFINZI, IMJUDO® (tremelimumab-actl) and chemotherapy in the metastatic NSCLC setting.
Advancing our commitment to increase lung cancer screening and early diagnosis
An oral presentation will describe a framework to support government implementation of high-quality and impactful lung cancer screening programs. Screening is essential to early detection and reducing lung cancer mortality. Published in March 2023, the framework was developed by the Lung Cancer Policy Network, an initiative of the Lung Ambition Alliance aimed at elevating lung cancer as a policy priority worldwide. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.
Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo to develop and commercialize ENHERTU and datopotamab deruxtecan, and with HUTCHMED to develop and commercialize savolitinib.
Key AstraZeneca presentations during WCLC 2023
Lead Author |
Abstract Title |
Presentation details (SGT) |
Tumor drivers and resistance |
||
Janne, PA |
Osimertinib With/Without Platinum-Based Chemotherapy as First-line Treatment in Patients with EGFRm Advanced NSCLC (FLAURA2)
|
Abstract #PL03.13 Plenary Session 3: Presidential Symposium 11 September 2023 9:40 AM |
Lu, S |
A Phase 3b Study of 1L Savolitinib in Patients with Locally Advanced or Metastatic NSCLC Harboring MET Exon 14 Mutation
|
Abstract #OA21.03 Oral Session MET Matters in NSCLC 12 September 2023 2:32 PM |
Soo, R |
TARGET: A Phase II Study of 5-year Adjuvant Osimertinib in Completely Resected EGFR-mutated Stage II-IIIB NSCLC |
Abstract #P1.25-09 Poster Session Early-Stage Non-small Cell Lung Cancer 10 September 2023 5:30 PM |
Tan, DSW |
OSTARA: A Phase II Study of First-line Osimertinib Combined with Amivantamab in EGFRm Advanced Non-Small Cell Lung Cancer |
Abstract #P2.09-17 Poster Session Metastatic Non-small Cell Lung Cancer – Targeted Therapy 11 September 2023 6:00 PM |
Christ, S |
Computational Pathology-Based Assessment of cMET IHC Expression for Patient Selection in the Treatment of MET Overexpressing NSCLC |
Abstract #EP06.05-09 E-Poster Session Pathology and Biomarkers On-Demand |
Antibody drug conjugates |
||
Papadopoulos, KP
|
Datopotamab Deruxtecan (Dato-DXd) + Durvalumab ± Carboplatin in Advanced/mNSCLC: Initial Results from Phase 1b TROPION-Lung04 |
Abstract #OA05.06 Oral Session Antibody Drug Conjugates: The Next Tsunami 10 September 2023 3:32 PM |
Janne, P |
Trastuzumab Deruxtecan in Patients with HER2-Mutant Metastatic Non-Small Cell Lung Cancer: Primary Results of DESTINY-Lung02 |
Abstract #MA13.10 Mini Oral Session Targeted Therapy: EGFR and Her2 11 September 2023 4:25 PM |
McGrath, L |
In Vivo Efficacy of AZD9592, an EGFR-cMET Bispecific ADC, in a Broad Panel of NSCLC Patient-Derived Xenograft Models |
Abstract #P1.12-04 Poster Session Tumor Biology – Translational Biology 10 September 2023 5:30 PM |
Aggarwal, C |
AVANZAR: Phase III Study of Datopotamab Deruxtecan (Dato-DXd) + Durvalumab + Carboplatin as 1L Treatment of Advanced/mNSCLC |
Abstract #P2.04-02 Poster Session Metastatic Non-small Cell Lung Cancer – Cytotoxic Therapy 11 September 2023 6:00 PM |
Aggarwal, C |
EGRET: First-in-human Study of the Novel Antibody-drug Conjugate AZD9592 ± Anti-cancer Agents in Advanced Solid Tumors |
Abstract #P2.04-03 Poster Session Metastatic Non-small Cell Lung Cancer – Cytotoxic Therapy 11 September 2023 6:00 PM |
Zhou, C |
TROPION-Lung08: Datopotamab deruxtecan plus pembrolizumab in untreated advanced/metastatic non-small cell lung cancer (NSCLC) |
Abstract #P2.08-01 Poster Session Metastatic Non-small Cell Lung Cancer – Immunotherapy 11 September 2023 6:00 PM |
Immuno-Oncology |
||
Mitsudomi, T |
Surgical outcomes with neoadjuvant durvalumab + chemotherapy followed by adjuvant durvalumab in resectable NSCLC (AEGEAN) |
Abstract #OA12.05 Oral Session Pushing the Boundaries: Adjuvant and Neoadjuvant Approaches in Early Stage Non-small Cell Lung Cancer 11 September 2023 12:22 PM |
He, J |
Neoadjuvant Durvalumab + Chemotherapy Followed by Adjuvant Durvalumab in Resectable EGFR-mutated NSCLC (AEGEAN) |
Abstract #OA12.06 Oral Session Pushing the Boundaries: Adjuvant and Neoadjuvant Approaches in Early Stage Non-small Cell Lung Cancer 11 September 2023 12:32 PM |
Peters, S |
Real-World Outcomes with Durvalumab After Chemoradiotherapy in Unresectable Stage III EGFR-Mutated NSCLC (PACIFIC-R) |
Abstract #OA17.03 Oral Session Next Steps in Locally Advanced NSCLC: Optimizing Techniques & Choosing Populations That Benefit 11 September 2023 3:47 PM |
Cho, BC |
Durvalumab ± Tremelimumab + Chemotherapy in 1L Metastatic NSCLC: Characterisation of patients with PFS ≥12 months in POSEIDON |
Abstract #P2.06-05 Poster Session Metastatic Non-small Cell Lung Cancer – Immunotherapy 11 September 2023 6:00 PM |
Advancing lung cancer screening |
||
Lam, SC |
Taking A Health Systems Approach to Low-Dose CT Lung Cancer Screening: A Bespoke Framework to Support Implementation
|
Abstract #OA16.03 Oral Session Expanding the Scope of Lung Cancer Screening Initiatives Worldwide 11 September 2023 3:47 PM |
SELECT SAFETY INFORMATION FOR TAGRISSO® (osimertinib)
- There are no contraindications for TAGRISSO
- Interstitial lung disease (ILD)/pneumonitis occurred in patients treated with TAGRISSO, some of which were fatal. Withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening respiratory symptoms. Permanently discontinue if confirmed
- Monitor patients who have a history or predisposition for QTc prolongation or those who are taking medications that are known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia
- Cardiomyopathy occurred in TAGRISSO-treated patients, some of which were fatal. Monitor patients with cardiac risk factors and assess left ventricular ejection fraction in patients who develop symptoms during treatment. Permanently discontinue TAGRISSO in patients with symptomatic congestive heart failure
- Promptly refer patients with signs and symptoms of keratitis to an ophthalmologist
- Withhold TAGRISSO if erythema multiforme major, Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected and permanently discontinue if confirmed
- Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity
- Aplastic anemia, including fatal cases, has been reported in patients treated with TAGRISSO. Inform patients of the signs and symptoms of aplastic anemia. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated
- Verify pregnancy status of women prior to use. Advise women to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose. Advise men to use effective contraception during treatment with TAGRISSO and for 4 months after the final dose
-
Most common (≥
20% ) adverse reactions, including laboratory abnormalities, were leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough
INDICATIONS
- TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
- TAGRISSO is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
- TAGRISSO is indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy
Please see complete Prescribing Information, including Patient Information for TAGRISSO.
IMPORTANT SAFETY INFORMATION FOR ENHERTU® (fam-trastuzumab deruxtecan-nxki)
Indications
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:
-
Unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either:
– In the metastatic setting, or
– In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy
- Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
- Unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen
WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY |
|
Contraindications
None.
Warnings and Precautions
Interstitial Lung Disease / Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.
Metastatic Breast Cancer and HER2-Mutant NSCLC (5.4 mg/kg)
In patients with metastatic breast cancer and HER2-mutant NSCLC treated with ENHERTU 5.4 mg/kg, ILD occurred in
Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)
In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in
Neutropenia
Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L), interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 109/L), interrupt ENHERTU until resolved to Grade 2 or less, then reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3º C or a sustained temperature of ≥38º C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by one level.
Metastatic Breast Cancer and HER2-Mutant NSCLC (5.4 mg/kg)
In patients with metastatic breast cancer and HER2-mutant NSCLC treated with ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in
Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)
In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in
Left Ventricular Dysfunction
Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. When LVEF is >
Metastatic Breast Cancer and HER2-Mutant NSCLC (5.4 mg/kg)
In patients with metastatic breast cancer and HER2-mutant NSCLC treated with ENHERTU 5.4 mg/kg, LVEF decrease was reported in
Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)
In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were reported; however, on echocardiography,
Embryo-Fetal Toxicity
ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose of ENHERTU.
Additional Dose Modifications
Thrombocytopenia
For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less, then reduce dose by one level.
Adverse Reactions
Metastatic Breast Cancer and HER2-Mutant NSCLC (5.4 mg/kg)
The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg intravenously every 3 weeks in 984 patients in Study DS8201-A-J101 (NCT02564900), DESTINY-Breast01, DESTINY-Breast03, DESTINY-Breast04, and DESTINY-Lung02. Among these patients
HER2-Positive Metastatic Breast Cancer
DESTINY-Breast03
The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg intravenously every three weeks in DESTINY-Breast03. The median duration of treatment was 14 months (range: 0.7 to 30).
Serious adverse reactions occurred in
ENHERTU was permanently discontinued in
The most common (≥
HER2-Low Metastatic Breast Cancer
DESTINY-Breast04
The safety of ENHERTU was evaluated in 371 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who received ENHERTU 5.4 mg/kg intravenously every 3 weeks in DESTINY-Breast04. The median duration of treatment was 8 months (range: 0.2 to 33) for patients who received ENHERTU.
Serious adverse reactions occurred in
ENHERTU was permanently discontinued in
The most common (≥
Unresectable or Metastatic HER2-Mutant NSCLC (5.4 mg/kg)
DESTINY-Lung02 evaluated two dose levels (5.4 mg/kg [n=101] and 6.4 mg/kg [n=50]); however, only the results for the recommended dose of 5.4 mg/kg intravenously every 3 weeks are described below due to increased toxicity observed with the higher dose in patients with NSCLC, including ILD/pneumonitis.
The safety of ENHERTU was evaluated in 101 patients with unresectable or metastatic HER2-mutant NSCLC who received ENHERTU 5.4 mg/kg intravenously every three weeks in DESTINY‑Lung02. Nineteen percent of patients were exposed for >6 months.
Serious adverse reactions occurred in
ENHERTU was permanently discontinued in
The most common (≥
Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)
The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01. Patients intravenously received at least one dose of either ENHERTU (N=125) 6.4 mg/kg every 3 weeks or either irinotecan (N=55) 150 mg/m2 biweekly or paclitaxel (N=7) 80 mg/m2 weekly for 3 weeks. The median duration of treatment was 4.6 months (range: 0.7 to 22.3) for patients who received ENHERTU.
Serious adverse reactions occurred in
ENHERTU was permanently discontinued in
The most common (≥
Use in Specific Populations
- Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months after the last dose of ENHERTU.
- Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.
- Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for 7 months after the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose. Infertility: ENHERTU may impair male reproductive function and fertility.
- Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients.
-
Geriatric Use: Of the 883 patients with breast cancer treated with ENHERTU 5.4 mg/kg,
22% were ≥65 years and3.6% were ≥75 years. No overall differences in efficacy within clinical studies were observed between patients ≥65 years of age compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged ≥65 years (60% ) as compared to younger patients (48% ). Of the 101 patients with unresectable or metastatic HER2-mutant NSCLC treated with ENHERTU 5.4 mg/kg,40% were ≥65 years and8% were ≥75 years. No overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. Of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg in DESTINY-Gastric01,56% were ≥65 years and14% were ≥75 years. No overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. - Renal Impairment: A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Monitor patients with moderate renal impairment more frequently. The recommended dosage of ENHERTU has not been established for patients with severe renal impairment (CLcr <30 mL/min).
-
Hepatic Impairment: In patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor. The recommended dosage of ENHERTU has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.
Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
IMPORTANT SAFETY INFORMATION FOR IMFINZI® and IMJUDO®
There are no contraindications for IMFINZI® (durvalumab) or IMJUDO® (tremelimumab-actl).
Severe and Fatal Immune-Mediated Adverse Reactions
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.
-
IMFINZI as a Single Agent
-
In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was
2.4% (34/1414), including fatal (<0.1% ), and Grade 3-4 (0.4% ) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was18.3% (87/475) in patients receiving IMFINZI and12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475),1.1% were fatal and2.7% were Grade 3 adverse reactions. - The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.
-
In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was
-
IMFINZI with IMJUDO
-
Immune‑mediated pneumonitis occurred in
1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3% ) and Grade 3 (0.2% ) adverse reactions.
-
Immune‑mediated pneumonitis occurred in
-
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
-
Immune-mediated pneumonitis occurred in
3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5% ), and Grade 3 (1% ) adverse reactions.
-
Immune-mediated pneumonitis occurred in
Immune-Mediated Colitis
IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal.
IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
-
IMFINZI as a Single Agent
-
Immune-mediated colitis occurred in
2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1% ) and Grade 3 (0.4% ) adverse reactions.
-
Immune-mediated colitis occurred in
-
IMFINZI with IMJUDO
-
Immune‑mediated colitis or diarrhea occurred in
6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6% ) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.
-
Immune‑mediated colitis or diarrhea occurred in
-
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
-
Immune-mediated colitis occurred in
6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2% ) and Grade 3 (2.5% ) adverse reactions. Intestinal perforation and large intestine perforation were reported in0.1% of patients.
-
Immune-mediated colitis occurred in
Immune-Mediated Hepatitis
IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.
-
IMFINZI as a Single Agent
-
Immune-mediated hepatitis occurred in
2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2% ), Grade 4 (0.3% ) and Grade 3 (1.4% ) adverse reactions.
-
Immune-mediated hepatitis occurred in
-
IMFINZI with IMJUDO
-
Immune‑mediated hepatitis occurred in
7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8% ), Grade 4 (0.3% ) and Grade 3 (4.1% ) adverse reactions.
-
Immune‑mediated hepatitis occurred in
-
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
-
Immune-mediated hepatitis occurred in
3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3% ), Grade 4 (0.5% ), and Grade 3 (2% ) adverse reactions.
-
Immune-mediated hepatitis occurred in
Immune-Mediated Endocrinopathies
-
Adrenal Insufficiency: IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.
-
IMFINZI as a Single Agent
-
Immune-mediated adrenal insufficiency occurred in
0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1% ) adverse reactions.
-
Immune-mediated adrenal insufficiency occurred in
-
IMFINZI with IMJUDO
-
Immune-mediated adrenal insufficiency occurred in
1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3% ) adverse reactions.
-
Immune-mediated adrenal insufficiency occurred in
-
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
-
Immune-mediated adrenal insufficiency occurred in
2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8% ) adverse reactions.
-
Immune-mediated adrenal insufficiency occurred in
-
IMFINZI as a Single Agent
-
Hypophysitis: IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated.
-
IMFINZI as a Single Agent
-
Grade 3 hypophysitis/hypopituitarism occurred in <
0.1% (1/1889) of patients who received IMFINZI.
-
Grade 3 hypophysitis/hypopituitarism occurred in <
-
IMFINZI with IMJUDO
-
Immune-mediated hypophysitis/hypopituitarism occurred in
1% (4/388) of patients receiving IMFINZI and IMJUDO.
-
Immune-mediated hypophysitis/hypopituitarism occurred in
-
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
-
Immune-mediated hypophysitis occurred in
1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5% ) adverse reactions.
-
Immune-mediated hypophysitis occurred in
-
IMFINZI as a Single Agent
-
Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism): IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
-
IMFINZI as a Single Agent
-
Immune-mediated thyroiditis occurred in
0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1% ) adverse reactions. -
Immune-mediated hyperthyroidism occurred in
2.1% (39/1889) of patients receiving IMFINZI. -
Immune-mediated hypothyroidism occurred in
8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1% ) adverse reactions.
-
Immune-mediated thyroiditis occurred in
-
IMFINZI with IMJUDO
-
Immune-mediated thyroiditis occurred in
1.5% (6/388) of patients receiving IMFINZI and IMJUDO. -
Immune-mediated hyperthyroidism occurred in
4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3% ) adverse reactions. -
Immune-mediated hypothyroidism occurred in
11% (42/388) of patients receiving IMFINZI and IMJUDO.
-
Immune-mediated thyroiditis occurred in
-
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
-
Immune-mediated thyroiditis occurred in
1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. -
Immune-mediated hyperthyroidism occurred in
5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2% ) adverse reactions. -
Immune-mediated hypothyroidism occurred in
8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5% ) adverse reactions.
-
Immune-mediated thyroiditis occurred in
-
IMFINZI as a Single Agent
-
Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.
-
IMFINZI as a Single Agent
-
Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <
0.1% (1/1889) of patients receiving IMFINZI.
-
Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <
-
IMFINZI with IMJUDO
-
Two patients (
0.5% , 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.
-
Two patients (
-
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
-
Immune-mediated Type 1 diabetes mellitus occurred in
0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3% ) adverse reactions.
-
Immune-mediated Type 1 diabetes mellitus occurred in
-
IMFINZI as a Single Agent
Immune-Mediated Nephritis with Renal Dysfunction
IMFINZI and IMJUDO can cause immune-mediated nephritis.
-
IMFINZI as a Single Agent
-
Immune-mediated nephritis occurred in
0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1% ) adverse reactions.
-
Immune-mediated nephritis occurred in
-
IMFINZI with IMJUDO
-
Immune-mediated nephritis occurred in
1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5% ) adverse reactions.
-
Immune-mediated nephritis occurred in
-
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
-
Immune-mediated nephritis occurred in
0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2% ) adverse reactions.
-
Immune-mediated nephritis occurred in
Immune-Mediated Dermatology Reactions
IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
-
IMFINZI as a Single Agent
-
Immune-mediated rash or dermatitis occurred in
1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4% ) adverse reactions.
-
Immune-mediated rash or dermatitis occurred in
-
IMFINZI with IMJUDO
-
Immune-mediated rash or dermatitis occurred in
4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3% ) and Grade 3 (1.5% ) adverse reactions.
-
Immune-mediated rash or dermatitis occurred in
-
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
-
Immune-mediated rash or dermatitis occurred in
7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO in combination with platinum-based chemotherapy, including Grade 3 (0.3% ) adverse reactions.
-
Immune-mediated rash or dermatitis occurred in
Immune-Mediated Pancreatitis
IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in
Other Immune-Mediated Adverse Reactions
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than
- Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
- Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.
- Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
- Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.
- Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic.
-
Endocrine: Hypoparathyroidism.
Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection.
Infusion-Related Reactions
IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.
-
IMFINZI as a Single Agent
-
Infusion-related reactions occurred in
2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3% ) adverse reactions.
-
Infusion-related reactions occurred in
-
IMFINZI with IMJUDO
-
Infusion-related reactions occurred in 10 (
2.6% ) patients receiving IMFINZI and IMJUDO.
-
Infusion-related reactions occurred in 10 (
-
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
-
Infusion-related reactions occurred in
2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3% ) adverse reactions.
-
Infusion-related reactions occurred in
Complications of Allogeneic HSCT after IMFINZI
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.
Lactation
There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.
Adverse Reactions
-
In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥
20% ) were cough (40% ), fatigue (34% ), pneumonitis or radiation pneumonitis (34% ), upper respiratory tract infections (26% ), dyspnea (25% ), and rash (23% ). The most common Grade 3 or 4 adverse reactions (≥3% ) were pneumonia (7% ) and pneumonitis/radiation pneumonitis (3.4% ) -
In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in
15% of patients in the IMFINZI arm. Serious adverse reactions occurred in29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2% ) were pneumonitis or radiation pneumonitis (7% ) and pneumonia (6% ). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms -
In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in ≥
20% of patients) were nausea (42% ), fatigue (36% ), musculoskeletal pain (29% ), decreased appetite (28% ), rash (27% ), and diarrhea (22% ). -
In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in
17% of patients. Serious adverse reactions occurred in44% of patients, with the most frequent serious adverse reactions reported in at least2% of patients being pneumonia (11% ), anemia (5% ), diarrhea (2.4% ), thrombocytopenia (2.4% ), pyrexia (2.4% ), and febrile neutropenia (2.1% ). Fatal adverse reactions occurred in a total of4.2% of patients. -
In patients with extensive-stage SCLC in the
CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20% ) were nausea (34% ), fatigue/asthenia (32% ), and alopecia (31% ). The most common Grade 3 or 4 adverse reaction (≥3% ) was fatigue/asthenia (3.4% ) -
In patients with extensive-stage SCLC in the
CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least1% of patients were febrile neutropenia (4.5% ), pneumonia (2.3% ), anemia (1.9% ), pancytopenia (1.5% ), pneumonitis (1.1% ), and COPD (1.1% ). Fatal adverse reactions occurred in4.9% of patients receiving IMFINZI plus chemotherapy -
In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in ≥
20% of patients) were fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and pyrexia -
In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in
6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least2% of patients were cholangitis (7% ), pyrexia (3.8% ), anemia (3.6% ), sepsis (3.3% ) and acute kidney injury (2.4% ). Fatal adverse reactions occurred in3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients) -
In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO, the most common adverse reactions (occurring in ≥
20% of patients) were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain -
In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO, serious adverse reactions occurred in
41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6% ), diarrhea (4% ), sepsis (2.1% ), pneumonia (2.1% ), rash (1.5% ), vomiting (1.3% ), acute kidney injury (1.3% ), and anemia (1.3% ). Fatal adverse reactions occurred in8% of patients who received IMJUDO in combination with durvalumab, including death (1% ), hemorrhage intracranial (0.5% ), cardiac arrest (0.5% ), pneumonitis (0.5% ), hepatic failure (0.5% ), and immune-mediated hepatitis (0.5% ). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in14% of patients
The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.
Indications:
IMFINZI is indicated 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.
IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
Please see Full Prescribing Information for IMFINZI and IMJUDO, including Medication Guide.
Notes
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
About AstraZeneca
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US-79107 Last Updated 08/23
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