Astrazeneca aims to transform cancer treatment and advance clinical practice with data presented at ESMO 2020

Pivotal overall survival data confirm benefit of LYNPARZA® use in advanced prostate cancer

Data in early treatment of lung cancer highlight potential to improve 
Patient outcomes in curative-intent settings with TAGRISSO® and IMFINZI®

AstraZeneca will present new developments in pursuit of its ambition to eliminate cancer as a cause of death at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, September 19-21, 2020.  

AstraZeneca medicines and pipeline molecules feature in 114 abstracts at ESMO, a record for the Company, including 20 oral presentations and two Presidential Symposia. The data highlight the breadth of the portfolio of cancer medicines and the early-stage pipeline. Whether it is by treating cancer early or by developing tailored medicines across all stages of disease, these data have the potential to transform patient outcomes and survival.

Key presentations include:

  • Practice-changing overall survival (OS) data from the PROfound Phase III trial presented in a Presidential Symposium confirming the long-term benefit of LYNPARZA® (olaparib) in biomarker-selected patients with metastatic castration-resistant prostate cancer (mCRPC)
  • Exploratory data from the ADAURA Phase III trial showing further support for the unprecedented patient benefit of TAGRISSO® (osimertinib) in the adjuvant treatment of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) also presented in a Presidential Symposium
  • Data from the PACIFIC Phase III trial in unresectable Stage III NSCLC and the CASPIAN Phase III trial in extensive-stage small-cell lung cancer (ES-SCLC), two late-breaking presentations strengthening the Company’s leadership in the treatment of lung cancer

José Baselga, Executive Vice President, Oncology R&D, said: “The data being presented at ESMO will reshape clinical practice in the months and years ahead. The final PROfound overall survival data show the power of biomarker-directed medicines in prostate cancer, while the ADAURA and PACIFIC data reflect our continued focus on early detection, interception and treatment of cancer. We continue to work with urgency throughout this extraordinary period to accelerate the development of medicines in our pipeline, turning innovative science into improved outcomes for patients.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Our data at ESMO reflect our vision to transform the cancer treatment landscape, achieving more durable outcomes, treating with curative intent, and changing what it means to live with and beyond a cancer diagnosis. Our ability to detect and treat cancer early is key in bringing new treatment options to later stages of disease. We are eager to translate our pivotal research into clinical practice and help patients live better, longer lives.”

Redefining Treatment Options for Advanced Disease Across Tumor Types

One Presidential Symposium will present the final OS analysis of the PROfound Phase III trial of LYNPARZA versus enzalutamide or abiraterone in patients with mCRPC and homologous recombination repair (HRR) gene mutations, including BRCA, ATM, CDK12 and 11 other HRR genes.

Beyond the PROfound trial, a presentation of five-year follow-up data from the SOLO-1 Phase III trial will highlight the sustained progression-free and recurrence-free survival benefits of LYNPARZA for patients with newly diagnosed BRCA-mutated advanced ovarian cancer. These exploratory analyses are the longest follow-up for any PARP inhibitor in this setting and expand on the positive SOLO-1 results previously published in The New England Journal of Medicine and presented at the ESMO 2018 Congress.

In addition, a late-breaking presentation of data from the PAOLA-1 Phase III trial will demonstrate that the addition of maintenance LYNPARZA to bevacizumab, a standard treatment, significantly improved the time to second disease progression (PFS2) compared with bevacizumab alone in patients with advanced ovarian cancer with homologous recombination deficiency positive (HRD+) status (defined by BRCA mutation and/or genomic instability). PFS2 is a key secondary endpoint in the PAOLA-1 trial and reinforces the positive results previously published in The New England Journal of Medicine and presented at the ESMO 2019 Congress.

Leadership in Early Lung Cancer Treatment
A second Presidential Symposium will present exploratory data from the ADAURA Phase III trial highlighting the impact of treatment with TAGRISSO on sites and types of disease recurrence, including brain metastases, in patients with early-stage (Stages IB-IIIA) EGFRm NSCLC. TAGRISSO was recently granted Breakthrough Therapy Designation in this setting in the US. This indication is not yet FDA approved.

Data will also be presented from the PACIFIC and CASPIAN Phase III trials highlighting the long-term benefit of IMFINZI® across different types of lung cancer. These include a presentation of four-year OS data in patients with unresectable Stage III NSCLC who had not progressed following concurrent chemoradiation therapy and a presentation of updated data in ES-SCLC.

Progressing the pipeline - pushing boundaries, advancing combinations
Exploratory data from the DESTINY-Gastric01 Phase II trial will show the results of ENHERTU® (trastuzumab deruxtecan) in patients with metastatic gastric cancer and low expression of HER2.

The DANUBE Phase III trial will be presented in an oral presentation showing the results for IMFINZI with and without tremelimumab in patients with advanced bladder cancer, including analyses of patients with high PD-L1 expression. The trial did not meet its primary endpoints.

AstraZeneca will also present data from several trials of the early and mid-stage pipeline, including:

  • A Phase II trial of LYNPARZA plus IMFINZI and bevacizumab (MEDIOLA): initial results in patients with non-germline BRCA-mutated platinum sensitive relapsed ovarian cancer
  • A Phase lb expansion trial of adavosertib plus LYNPARZA in patients with ES or relapsed SCLC

Collaboration in the scientific community is critical to improving outcomes for patients. LYNPARZA is developed and commercialized in collaboration with MSD (Merck & Co., Inc. in the US and Canada). AstraZeneca is collaborating with Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and commercialize ENHERTU.

Key AstraZeneca presentations during the ESMO Virtual Congress 20201

Lead author

Abstract title

Presentation details

Immuno-Oncology

 

Goldman, J

Durvalumab (D) ± tremelimumab (T) + platinum-etoposide (EP) in 1L ES-SCLC: Characterization of long-term clinical benefit and tumor mutational burden (TMB) in CASPIAN

Abstract #LBA86
Mini Oral Session – Non-metastatic NSCLC and other thoracic malignancies

Faivre-Finn, C

Durvalumab after chemoradiotherapy in Stage III NSCLC: 4-year survival update from the Phase 3 PACIFIC trial

Abstract #LBA49
Mini Oral Session – Non-metastatic NSCLC and other thoracic malignancies

Powles, T

A phase 3, randomized, open-label study of first-line durvalumab (D) with or without tremelimumab (T) vs standard of care chemotherapy in patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE)

Abstract #697O
Proffered Paper Session – Genitourinary Tumors, Non-Prostate
Saturday September 19
16:20 – 18:00 CEST
Channel 3

DNA damage response

 

Ray-Coquard, I

Maintenance olaparib + bevacizumab (bev) in patients (pts) with newly diagnosed advanced high-grade ovarian cancer (HGOC): RECIST and/or CA-125 objective response rate (ORR) in the Phase III PAOLA-1 trial

Abstract #812MO
Mini Oral Session – Gynecological Cancers

Banerjee, S

Maintenance olaparib for patients (pts) with newly diagnosed, advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): 5-year (y) follow-up (f/u) from SOLO1

Abstract #811MO
Mini Oral Session – Gynecological Cancers

Drew, Y

Phase II study of olaparib (O) plus durvalumab (D) and bevacizumab (B) (MEDIOLA): initial results in patients (pts) with non-germline BRCA-mutated (non-gBRCAm) platinum sensitive relapsed (PSR) ovarian cancer (OC)

Abstract #814MO
Mini Oral Session – Gynecological Cancers

De Bono, J

Final overall survival (OS) analysis of PROfound: olaparib vs physician’s choice of enzalutamide or abiraterone in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations

Abstract #610O
Presidential Symposium II
Saturday, September 20
19:14 – 19:26 CEST
Channel 1

Roubaud, G

Tolerability of olaparib (OLA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations: PROfound

Abstract #624P
E-Poster Display Session

Agarwal, N

Exploring the impact of treatment switching on the interim overall survival (OS) results of the PROfound study

Abstract #622P
E-Poster Display Session

Hauke, J

Germline mutation status and therapy response in patients with homologous recombination deficient, HER2-negative early breast cancer: Results of the GeparOLA study (NCT02789332)

Abstract #176P
E-Poster Display Session

Hochhauser, D

Assessing clinical benefit of olaparib maintenance treatment in subgroups of patients with germline BRCA mutation (gBRCAm) and metastatic pancreatic cancer: phase III POLO trial

Abstract #1527P
E-Poster Display Session

Li, B

Phase Ib expansion study of adavosertib plus olaparib in patients with extensive-stage or relapsed small-cell lung cancer

Abstract #1785P
E-Poster Display Session

Tumor drivers and resistance

 

Tsuboi, M

Osimertinib adjuvant therapy in patients (pts) with early stage EGFR mutated (EGFRm) NSCLC after tumor resection (ADAURA): sites of disease recurrence

Abstract #LBA1
Presidential Symposium I
Saturday, September 19
18:30 – 18:42 CEST
Channel 1

Planchard, D

Osimertinib plus platinum/pemetrexed in newly-diagnosed EGFR mutation (EGFRm)-positive advanced NSCLC: safety run-in results from the FLAURA2 study

Abstract #1401P
E-Poster Display Session

Cheng, Y

Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA China study overall survival

Abstract #1295P
E-Poster Display Session

Subramanian, J

Epidermal growth factor receptor mutation (EGFRm) testing in advanced non-small cell lung cancer (aNSCLC) in a real-world setting

Abstract #1402P
E-Poster Display Session

Hummel, M

FACILITATE: a real-world multicentre prospective study investigating the utility of a rapid, fully automated RT-PCR assay vs reference methods (RM) for detecting epidermal growth factor receptor mutations (EGFRm) in NSCLC

Abstract #1205P
E-Poster Display Session

Antibody drug conjugates

Yamaguchi, K

Trastuzumab deruxtecan in patients with HER2 low, advanced gastric or gastroesophageal junction adenocarcinoma: results of the exploratory cohorts in the phase 2, multicenter, open label DESTINY-Gastric01 study 

Abstract #1422MO
Mini Oral Session – Gastrointestinal tumors, non-colorectal
 

Modi, S

Artificial intelligence analysis of advanced breast cancer patients from a phase I trial of trastuzumab deruxtecan (T-DXd): HER2 and histopathology features as predictors of clinical benefit

Abstract #286P
E-Poster Display Session

 

Powell, C

Risk factors for interstitial lung disease in patients treated with trastuzumab deruxtecan from two interventional studies

Abstract #289P
E-Poster Display Session
 

Janjigian, YY

A phase 1b/2, multicenter, open label, dose escalation and dose expansion study evaluating trastuzumab deruxtecan monotherapy and combinations in patients with HER2 overexpressing gastric cancer (DESTINY-Gastric03)

Abstract #1500Ti
PE-Poster Display Session

1 114 abstracts at ESMO 2020 include AstraZeneca medicines and pipeline molecules, of which 75 are company sponsored or supported.

SELECT SAFETY INFORMATION FOR TAGRISSO® (osimertinib)

  • There are no contraindications for TAGRISSO
  • TAGRISSO is associated with several serious and sometimes fatal adverse reactions, including interstitial lung disease/pneumonitis, QTc interval prolongation, cardiomyopathy, keratitis, erythema multiforme and Stevens-Johnson syndrome, and embryo-fetal toxicity
  • The most common adverse reactions (≥20%) were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue, and decreased appetite

U.S. FDA-APPROVED INDICATIONS

  • TAGRISSO is indicated for the first-line treatment of 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 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.

U.S. FDA-APPROVED INDICATION for ENHERTU®
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 two or more prior anti-HER2-based regimens in the metastatic setting.

This indication is approved under accelerated approval based on tumor 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.

ENHERTU IMPORTANT SAFETY INFORMATION

WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY

  • Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms.
  • Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

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. In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 2.6% of patients treated with ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to 8.3).

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 prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg prednisolone or equivalent). Upon improvement, follow by gradual taper (e.g., 4 weeks).

Neutropenia
Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Of the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, a decrease in neutrophil count was reported in 30% of patients and 16% had Grade 3 or 4 events. Median time to first onset was 1.4 months (range: 0.3 to 18.2). Febrile neutropenia was reported in 1.7% of patients.

Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. Based on the severity of neutropenia, ENHERTU may require dose interruption or reduction. 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. Reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for more than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one level.

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. In the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF decrease were reported. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.

Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. Permanently discontinue ENHERTU if LVEF of <40% or absolute decrease from baseline of >20% is confirmed. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure.

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 at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.

Adverse Reactions
The safety of ENHERTU was evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast01 and Study DS8201-A-J101. ENHERTU was administered by intravenous infusion once every three weeks. The median duration of treatment was 7 months (range: 0.7 to 31).

Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were interstitial lung disease, pneumonia, vomiting, nausea, cellulitis, hypokalemia, and intestinal obstruction. Fatalities due to adverse reactions occurred in 4.3% of patients including interstitial lung disease (2.6%), and the following events occurred in one patient each (0.4%): acute hepatic failure/acute kidney injury, general physical health deterioration, pneumonia, and hemorrhagic shock.

ENHERTU was permanently discontinued in 9% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 33% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, thrombocytopenia, leukopenia, upper respiratory tract infection, fatigue, nausea, and ILD. Dose reductions occurred in 18% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, and neutropenia.

The most common adverse reactions (frequency ≥20%) were nausea (79%), fatigue (59%), vomiting (47%), alopecia (46%), constipation (35%), decreased appetite (32%), anemia (31%), neutropenia (29%), diarrhea (29%), leukopenia (22%), cough (20%), and thrombocytopenia (20%).

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 following 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 at least 7 months following the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months following 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 234 patients with HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, 26% were ≥65 years and 5% were ≥75 years. No overall differences in efficacy 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 (53%) as compared to younger patients (42%).
  • Hepatic Impairment: In patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor.

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 WARNING, and Medication Guide.

SELECT SAFETY INFORMATION for LYNPARZA® (olaparib) tablets
LYNPARZA is associated with serious, potentially fatal risks, including myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), pneumonitis.  Additionally, serious, potentially fatal risk of venous thromboembolic events has been reported with LYNPARZA in mCRPC. LYNPARZA can also cause fetal harm.

U.S. FDA-APPROVED INDICATIONS
LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCAm Advanced Ovarian Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab

In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:

  • a deleterious or suspected deleterious BRCA mutation, and/or
  • genomic instability

Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please see complete Prescribing Information, including Patient Information.

SELECT SAFETY INFORMATION for IMFINZI® (durvalumab) injection for intravenous use

  • Serious, potentially fatal risks were seen with IMFINZI in the CASPIAN trial. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%) and COPD (1.1%).
  • Immune-mediated adverse reactions including immune-mediated pneumonitis, hepatitis, colitis, endocrinopathies (including thyroid disorders, adrenal insufficiency, type 1 diabetes, and hypophysitis), nephritis, dermatologic reactions, other immune-mediated adverse reactions, infection, and infusion-related reactions were reported in patients receiving IMFINZI in the CASPIAN trial.
  • The most common adverse reactions (≥20%) were nausea, fatigue/asthenia and alopecia.
  • Advise women not to become pregnant or breastfeed during treatment with IMFINZI and for at least 3 months after the last dose.
  • The safety and effectiveness of IMFINZI have not been established in pediatric patients.

U.S. FDA-APPROVED INDICATIONS
IMFINZI is indicated 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.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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 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).

Please see complete Prescribing Information, including Patient Information.

NOTES TO EDITORS

About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advancing oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca's main capabilities, we are actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

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US-44507 Last Updated 9/20