WILMINGTON, Del.--(BUSINESS WIRE)--Jan 13, 2021--

AstraZeneca will present new data from across the innovative lung cancer portfolio at the IASLC 2020 World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer, 28 to 31 January 2021.

Eleven AstraZeneca medicines and potential new medicines from the pipeline feature in 39 abstracts showcasing the Company’s leadership across different types and stages of lung cancer, including eight oral presentations with two late breakers.

Presentations include:

  • Updated data from the TROPION-PanTumor01 Phase I trial of datopotamab deruxtecan (Dato-DXd; DS-1062) with additional patients, supporting its potential to redefine treatment outcomes in advanced non-small cell lung cancer (NSCLC) Datopotamab deruxtecan is a novel trophoblast cell-surface antigen 2 (TROP2)-directedantibody drug conjugate (ADC)
  • New data from the DESTINY-Lung01 Phase II trial highlighting the potential of ENHERTU ® (trastuzumab deruxtecan) in HER2-expressing metastatic NSCLC, and data in metastatic HER2-mutant (HER2m) NSCLC, two groups of patients for whom no HER2-directed medicine is currently approved
  • New analyses from the ADAURA Phase III trial featured in two oral presentations reinforcing the unprecedented benefit of TAGRISSO ® (osimertinib) regardless of prior adjuvant chemotherapy or disease stage in the adjuvant treatment of epidermal growth factor receptor-mutated (EGFRm) NSCLC, and showing patients treated with TAGRISSO maintained their quality of life

José Baselga, Executive Vice President, Oncology R&D, said: “AstraZeneca is leading the next wave of precision-medicine innovations in lung cancer that aim to change clinical practice and ultimately alter the course of the disease. Our data at WCLC for datopotamab deruxtecan and ENHERTU (trastuzumab deruxtecan) illustrate the potentially transformative role next-generation antibody drug conjugates may play in advanced non-small cell lung cancer. New results for TAGRISSO and IMFINZI ® (durvalumab) continue to validate our strategy to treat patients earlier, as we progress the science of identifying patients most likely to respond to treatment.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “AstraZeneca is committed to advancing early detection and treatment of lung cancer - and the urgency to achieve this goal has only increased during the pandemic, which has significantly impacted cancer care for patients around the world. Our TAGRISSO and IMFINZI data at WCLC show how we are driving progress in early-stage lung cancer, while also pushing the scientific boundaries in resistant and advanced disease to identify new solutions for patients.”

Harnessing the emerging potential of ADCs to treat different types of lung cancer

Updated data from the TROPION-PanTumor01 Phase I trial of the novel ADC datopotamab deruxtecan will be featured in an oral presentation, demonstrating early antitumor activity in patients with advanced/metastatic NSCLC who had progressed on standard treatment. Additionally, two presentations on the data from the DESTINY-Lung01 Phase II trial will show results of ENHERTU patients with NSCLC, including new data from the HER2-expressing cohort and data from the HER2 mutant cohort.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and commercialize ENHERTU and datopotamab deruxtecan globally.

Treating patients with NSCLC in early stages

A late-breaking analysis from the ADAURA Phase III trial will underscore the practice-changing results for adjuvant TAGRISSO in Stage IB-IIIA EGFRm NSCLC and show the disease-free survival results for patients who had been treated with adjuvant chemotherapy prior to TAGRISSO and those who were not by stage of disease. A second exploratory analysis from the Phase III ADAURA trial will highlight the impact of treatment with adjuvant TAGRISSO on quality of life based on patient-reported outcomes. TAGRISSO was recently approved in the adjuvant setting in the US.

The ongoing NeoADAURA Phase III trial testing the benefit of treating patients with resectable EGFRm NSCLC with neoadjuvant TAGRISSO will be highlighted in a poster presentation.

The MERMAID-1 Phase III trial testing IMFINZI in patients with completely resected, Stage II and III NSCLC who show evidence of minimal residual disease (MRD), will also be highlighted in a poster. MERMAID-1 is an early-stage NSCLC Phase III trial evaluating circulating tumor DNA measurements to monitor for MRD and to identify patients at high risk of recurrence after surgery who may benefit from intervention with immunotherapy.

Progressing research in advanced lung cancer

AstraZeneca will also present data from several trials exploring targeted therapies and novel combinations for advanced lung cancer, including:

  • Additional data from the CASPIAN Phase III trial of IMFINZI in extensive-stage small cell lung cancer (ES-SCLC) showing exposure response and pharmacokinetics as well as exploratory analyses based on extent of disease
  • The biomarker-directed HUDSON Phase II platform trial of IMFINZI in combination with LYNPARZA © (olaparib) and other novel anti-cancer medicines, including danvatirsen (STAT3 antisense oligonucleotide), ceralasertib (ATR inhibitor) and oleclumab (anti-CD73), in patients with NSCLC who progressed on anti-PD(L)1 therapy
  • The ODIN BM Phase I trial assessing TAGRISSO brain exposure in patients with EGFRm NSCLC central nervous system (CNS) metastases
  • The TATTON Phase Ib trial of TAGRISSO plus savolitinib in patients with EGFRm MET-overexpressed/amplified NSCLC
  • A trial-in-progress update on the Phase I trial of TAGRISSO in combination with patritumab deruxtecan (HER3-DXd; U3-1402) in patients with locally advanced or metastatic EGFRm NSCLC

Key AstraZeneca presentations during WCLC 2020 1

Lead author

Abstract title

Presentation details

Immuno-Oncology

 

Reinmuth, N

First-line durvalumab plus platinum-etoposide in ES-SCLC: exploratory analyses based on extent of disease in CASPIAN

 

Abstract #P48.03

Poster: P48 – Small Cell Lung Cancer/NET – Chemo – IO

28 January 2021

Zheng, Y

Population pharmacokinetics and exposure-response with durvalumab plus platinum-etoposide in ES-SCLC: Results from CASPIAN

 

Abstract #P48.21

Poster: P48 – Small Cell Lung Cancer/NET – Chemo – IO
28 January 2021

Besse, B

HUDSON: An open-label, multi-drug, biomarker-directed Phase II platform study in patients with NSCLC, who progressed on anti-PD(L)1 therapy

 

Abstract #OA07.08

Oral Session: OA07 – Immuno-biology and Novel Immunotherapeutics from Bench to Bed

30 January 2021
11:05-11:10 SGT

Besse, B

Immuno-modulatory effects of ceralasertib in combination with durvalumab in NSCLC with progression on anti-PD(L)1 treatment (HUDSON)

 

Abstract #P16.07

Poster: P16 – Immuno-biology and Novel Immunotherapeutics (Phase I and Translational)

Peters, S

MERMAID-1: A Phase III study of adjuvant durvalumab plus chemotherapy in resected NSCLC patients with MRD+ post-surgery

 

Abstract #P03.03

Poster: P03 – Early Stage/Localized Disease – Clinical Trials in Progress
28 January 2021

Tumor drivers and resistance

 

Wu, Y-L

Postoperative chemotherapy use and outcomes from ADAURA: osimertinib as adjuvant therapy for resected EGFR mutated NSCLC

 

Abstract #OA06.04

Oral Session: OA06 – Updates on EGFR Targeted Perioperative Therapy​ and Precision Adjuvant Chemotherapy

29 January 2021

16:55-17:05 SGT

Majem, M

Patient-reported outcomes from ADAURA: osimertinib as adjuvant therapy in patients with resected EGFR mutated (EGFRm) NSCLC

 

Abstract #OA06.03

Oral Session: OA06 – Updates on EGFR Targeted Perioperative Therapy​ and Precision Adjuvant Chemotherapy

29 January 2021

16:45-16:55 SGT

Tsuboi, M

Neoadjuvant osimertinib with/without chemotherapy vs chemotherapy for EGFR mutated resectable NSCLC: neoADAURA

 

Abstract #P03.02

Poster: P03 – Early Stage/Localized Disease – Clinical Trials in Progress
28 January 2021

Cho, BC

ORCHARD: A biomarker-directed Phase 2 platform study in pts with advanced EGFRm NSCLC progressing on first-line osimertinib

 

Abstract #P76.27

Poster: P76 – Targeted Therapy – Clinically Focused – EGFR
28 January 2021

Jänne, PA

Phase 1 study of patritumab deruxtecan (HER3-DXd; U3-1402) in combination with osimertinib in patients with locally advanced or metastatic EGFR-mutated NSCLC 2

Abstract #P01.03

Poster: P01 – Antibody Drug Conjugates, Novel Therapeutics and Cytotoxics
28 January 2021

Han, J-Y

Osimertinib+savolitinib in pts with EGFRm MET-amplified/overexpressed NSCLC: Phase Ib TATTON parts B and D final analysis​

 

Abstract #FP14.03

Featured Poster Session: FP14 – Targeted Therapy – Clinically Focused ​

28 January 2021

Ekman, S

A PET and MRI study exploring osimertinib brain exposure and efficacy in EGFRm NSCLC CNS metastases

 

Abstract #P76.72

Poster: P76 – Targeted Therapy – Clinically Focused – EGFR

28 January 2021

Antibody drug conjugates

 

Spira, A

Datopotamab deruxtecan (dato-DXd; DS-1062), a TROP2 ADC, in patients with advanced NSCLC: updated results of TROPION-PanTumor01 Phase 1 study 3

Abstract #OA03.03

Oral Session: OA03 – Promising Antibody-Drug Conjugate and Cytotoxic Therapy in NSCLC

29 January 2021

10:30-10:40 SGT

Nakagawa, K

Trastuzumab deruxtecan in HER2-overexpressing metastatic non-small cell lung cancer: interim results of DESTINY-Lung01 3

Abstract #OA04.05

Oral Session: OA04 – New Data from Rare EGFR Alterations

29 January 2021

12:05-12:15 SGT

Smit, EF

Trastuzumab deruxtecan in HER2-mutated metastatic non-small cell lung cancer (NSCLC): interim results of DESTINY-Lung01 3

Abstract #MA11.03

Mini Oral Session: MA11 – Expanding Targetable Genetic Alterations in NSCLC

31 January 2021

14:15-14:20 SGT

1 39 abstracts at WCLC 2020 will feature AstraZeneca medicines and pipeline molecules, of which 24 are company-sponsored or supported.

2 Trial collaboration with Daiichi Sankyo which maintains exclusive rights to patritumab deruxtecan.

3 ENHERTU and datapotamab deruxtecan are developed and commercialized in collaboration with Daiichi Sankyo worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights.

U.S. FDA-APPROVED INDICATION for ENHERTU ® (trastuzumab deruxtecan)

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 TAGRISSO® (osimertinib)

  • There are no contraindications for TAGRISSO
  • TAGRISSO is associated with several serious and sometimes fatal adverse reactions, including interstitial lung disease (ILD)/pneumonitis, QTc interval prolongation, cardiomyopathy, keratitis, erythema multiforme and Stevens-Johnson syndrome, cutaneous vasculitis, and embryo-fetal toxicity
  • The most common (≥20%) adverse reactions, including lab abnormalities, were leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough

For additional information, please refer to the complete Important Safety Information.

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

For additional information, please see the complete Prescribing Information, including Patient Information.

SELECT SAFETY INFORMATION FOR IMFINZI ® (durvalumab)

Stage III:

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection. IMFINZI can cause severe or life-threatening infusion-related reactions. 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/PD-L1 blocking antibody.

Advise women not to become pregnant or breastfeed during treatment with IMFINZI and for at least 3 months after the last dose.

In the PACIFIC trial, the most frequent serious adverse reactions reported in at least 2% of patients were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%).

The most common adverse reactions were cough, fatigue, pneumonitis or radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash.

The safety and effectiveness of IMFINZI have not been established in pediatric patients.

SCLC:

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection. IMFINZI can cause severe or life-threatening infusion-related reactions. 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/PD-L1 blocking antibody.

Advise women not to become pregnant or breastfeed during treatment with IMFINZI and for at least 3 months after the last dose.

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%).

The most common adverse reactions (≥20%) were nausea, fatigue/asthenia and alopecia.

The safety and effectiveness of IMFINZI have not been established in pediatric patients.

Please refer to the complete Important Safety Information and the full Prescribing Information for important dosage modification and management information specific to adverse reactions, here.

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.

NOTES TO EDITORS

AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action.

AstraZeneca aims to address the unmet needs of patients with EGFRm tumors as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with the approved medicines gefitinib and TAGRISSO ® (osimertinib) and its ongoing LAURA, NeoADAURA and FLAURA2 Phase III trials. 1-3 AstraZeneca is committed to addressing tumor mechanisms of resistance through the ongoing SAVANNAH and ORCHARD Phase II trials, which test TAGRISSO in combination with savolitinib, a selective inhibitor of c-MET receptor tyrosine kinase, along with other potential new medicines.

The Company is also evaluating the potential of ADCs to improve patient outcomes in tumors with targetable gene alterations, including HER2m NSCLC which affects approximately 2-4% of patients with NSCLC. 4,5 ENHERTU ® (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, is in development for metastatic non-squamous HER2-overexpressing or HER2m NSCLC including trials in combination with other anticancer treatments. In addition, a broad and comprehensive clinical development program is evaluating the efficacy and safety of datopotamab deruxtecan (a TROP2-directed ADC) across multiple TROP2 cancers, as both a monotherapy and in combination with other anticancer treatments.

An extensive Immuno-Oncology (IO) development program focuses on lung cancer patients without a targetable genetic mutation, which represent up to three-quarters of all patients with lung cancer. 6 IMFINZI ® (durvalumab), an anti-PDL1 antibody, is in development for patients with advanced disease (POSEIDON and PEARL Phase III trials) and for patients in earlier stages of disease, including potentially curative settings (MERMAID-1, MERMAID-2, AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC Phase III trials) both as monotherapy and in combination with tremelimumab and/or chemotherapy. IMFINZI is also in development in the NeoCOAST, COAST and HUDSON Phase II trials in combination with potential new medicines from the early-stage pipeline, including ENHERTU.

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 seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms - Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies - 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.

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.

Reference

  1. Szumera-Ciećkiewicz A , et al. EGFR mutation testing on cytological and histological samples in non-small cell lung cancer: a Polish, single institution study and systematic review of European incidence. Int J Clin Exp Pathol. 2013;6:2800-12.
  2. Keedy VL, et al. American Society of Clinical Oncology provisional clinical opinion: epidermal growth factor receptor (EGFR) mutation testing for patients with advanced non-small-cell lung cancer considering first-line EGFR tyrosine kinase inhibitor therapy. J Clin Oncol. 2011;29:2121-27.
  3. Ellison G, et al. EGFR mutation testing in lung cancer: a review of available methods and their use for analysis of tumor tissue and cytology samples. J Clin Pathol. 2013;66:79-89.
  4. Campbell JD, et al. Distinct patterns of somatic genome alterations in lung adenocarcinomas and squamous cell carcinomas. Nat Genet. 2016;48(6):607-16.
  5. Li BT, et al. HER2 amplification and HER2 mutation are distinct molecular targets in lung cancers. J Thorac Oncol. 2016;11(3): 414-419.
  6. Pakkala, S, et al. Personalized therapy for lung cancer: striking a moving target. JCI Insight. 2018;3(15):e120858.

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