AZN AstraZeneca PLC

Investigational data for Lynparza™ (olaparib) tablets in BRCA-mutated metastatic breast cancer to be highlighted in plenary presentation of Phase III OlympiAD trial

Key investigational trials show further evidence of Tagrisso® (osimertinib) effect in patients with EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) and central nervous system (CNS) metastases (AURA3 trial) or leptomeningeal disease (BLOOM trial)

New investigational data demonstrate advances in Immuno-Oncology, including Imfinzi™ (durvalumab) in NSCLC, bladder cancer

AstraZeneca, along with its global biologics research and development arm, MedImmune, will demonstrate how it is rapidly delivering on the Company’s science-led strategy for transformational cancer medicine development at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, June 2-6.

With three new oncology medicines addressing the unmet needs of patients with ovarian, lung, and bladder cancers approved in under three years, AstraZeneca is now halfway to delivering on its promise to launch six new medicines for cancer by 2020.

This progress is reflected in the 100 company-sponsored and supported abstracts, including five Best-of-ASCO presentations, 11 oral presentations and eight poster discussions, accepted for the meeting. These include new data on approved and potential new medicines from the Company’s pipeline across multiple scientific platforms and tumor types.

Jamie Freedman, Executive Vice President, Oncology at AstraZeneca, said: “2017 is a pivotal year for our oncology portfolio as global launch and development programs for Lynparza, Tagrisso and Imfinzi gain momentum, with further pivotal data anticipated in the coming months, in particular in 1st-line non-small cell lung cancer. We are excited to demonstrate the strength of our rapidly-expanding portfolio at ASCO, including the positive OlympiAD results for Lynparza in BRCA-mutated metastatic breast cancer.”

Growing confidence in DNA Damage Response (DDR) approach emphasized by OlympiAD results‘Late-breaker’ data from the OlympiAD trial of olaparib versus chemotherapy in HER2-negative germline BRCA1 or BRCA2 mutated breast cancer patients (Abstract #LBA4) are the first positive Phase III results for a poly ADP-ribose polymerase (PARP) inhibitor beyond ovarian cancer. They are an important next step in the development of AstraZeneca’s DDR approach to selectively targeting of tumors through deficiencies in cancer cell DNA repair mechanisms.

Additional olaparib data will include:

• SOLO-2: Oral presentation of Phase III data on the relationship between health-related quality of life (HRQOL) and patient-centered and clinical outcomes with olaparib maintenance following chemotherapy in patients with BRCA-mutated platinum-sensitive relapsed serous ovarian cancer (Abstract #5507)
• Study 19: Randomized Phase II overall survival and updated progression-free survival data for the combination of olaparib and cediranib versus olaparib alone in recurrent platinum-sensitive ovarian cancer (Abstract #5535)

AstraZeneca’s unique DDR pipeline will also be illustrated through an oral presentation of Phase I data on the WEE1 inhibitor, AZD1775, in combination with radiation therapy and temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM) and evaluation of intratumoral drug distribution in patients with recurrent GBM (Abstract #2005). Additional information will also be presented from a Phase I trial of AZD1775 in combination with neoadjuvant weekly cisplatin and docetaxel in borderline-resectable head and neck squamous cell carcinoma (HNSCC) (Abstract #6034).

Extended evidence of the effect of osimertinib on CNS metastasesLatest osimertinib investigational data from the AURA3 trial to be released during an oral presentation will provide further evidence of the response to treatment in patients with epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) and central nervous system (CNS) metastases (Abstract #9005).

Further insights into the ability of osimertinib to cross the blood-brain barrier will be provided through updated results from the BLOOM trial of osimertinib in patients with EGFR mutation-positive NSCLC and leptomeningeal disease (Abstract #2020).

New data on durvalumab as monotherapy and in combinationBuilding on exciting recent milestones for its Immuno-Oncology program, AstraZeneca will be presenting updated data from the NSCLC and bladder cancer cohorts of the Phase I/II Study 1108 of durvalumab in patients with advanced solid tumors. New data in locally advanced or metastatic urothelial carcinoma (mUC) (Abstract #4525) reinforce the May 2017 US FDA approval of Imfinzi for the treatment of patients with locally advanced or mUC who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

Updated durvalumab monotherapy Study 1108 results in Stage IIIB/IV NSCLC (Abstract #9085) will also be presented. These data underline AstraZeneca’s forward momentum in lung cancer following the positive top-line results of the Phase III PACIFIC trial of durvalumab as sequential treatment in patients with locally advanced, unresectable (Stage III) NSCLC. In an oral presentation, MedImmune will present data on a novel relationship in NSCLC between EGFR pathway activation and the immunosuppressive molecule CD73 (Abstract #11505).

LYNPARZA™ (olaparib) IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

There are no contraindications for Lynparza.

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1% of patients treated with Lynparza, and the majority of those reports were fatal. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. In a randomized placebo-controlled trial, MDS/AML occurred in 2% of patients treated with Lynparza. All of these patients had previous chemotherapy with platinum agents and/or other DNA damaging agents, including radiotherapy, and some of these patients also had a history of previous cancer or of bone marrow dysplasia.

Monitor patients for hematological toxicity at baseline and monthly thereafter. Do not start Lynparza until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). For prolonged hematological toxicities, interrupt Lynparza and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after four weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue if MDS/AML is confirmed.

Pneumonitis: Occurred in <1% of patients exposed to Lynparza, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, fever, cough, wheezing, or a radiological abnormality occurs, interrupt treatment with Lynparza and initiate prompt investigation. Discontinue if pneumonitis is confirmed.

Embryo-Fetal Toxicity: Lynparza can cause fetal harm. A pregnancy test should be performed on all pre-menopausal women prior to treatment. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose.

ADVERSE REACTIONS

In clinical studies, the most common adverse reactions (Grades 1-4) in ≥20% of patients included anemia (34%), nausea (75%), fatigue (including asthenia) (68%), vomiting (43%), diarrhea (31%), dysgeusia (21%), dyspepsia (25%), headache (25%), decreased appetite (25%), nasopharyngitis/pharyngitis/URI (43%), cough (21%), arthralgia/musculoskeletal pain (32%), myalgia (25%), back pain (25%), dermatitis/rash (25%), and abdominal pain/discomfort (47%).

Common lab abnormalities (Grades 1-4) included decrease in hemoglobin (90%), decrease in absolute neutrophil count (32%), decrease in platelets (30%), decrease in lymphocytes (56%), mean corpuscular volume elevation (85%), and increase in creatinine (30%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of Lynparza in combination with other myelosuppressive anticancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid concomitant use of strong and moderate CYP3A inhibitors. If the strong or moderate CYP3A inhibitor must be co-administered, reduce the dose of Lynparza. Advise patients to avoid grapefruit and Seville oranges during Lynparza treatment.

CYP3A Inducers: Avoid concomitant use of strong and moderate CYP3A inducers when using Lynparza. If a moderate inducer cannot be avoided, be aware of a potential for decreased efficacy of Lynparza.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, the effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with Lynparza and for one month after receiving the final dose.

Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh classification A). There are no data in patients with moderate or severe hepatic impairment.

Renal Impairment: No dosage adjustment is necessary in patients with mild renal impairment (CLcr 51-80 mL/min). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose to 300 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).

Please see complete Prescribing Information, including Patient Information (Medication Guide).

TAGRISSO® (osimertinib) IMPORTANT SAFETY INFORMATION

• There are no contraindications for Tagrisso
• Interstitial Lung Disease (ILD)/Pneumonitis occurred in 3.5% and was fatal in 0.6% of 833 Tagrisso-treated patients. Withhold Tagrisso and promptly investigate for ILD in patients who present with worsening of respiratory symptoms indicative of ILD (eg, dyspnea, cough, and fever). Permanently discontinue Tagrisso if ILD is confirmed
• Heart rate-corrected QT (QTc) interval prolongation occurred in Tagrisso-treated patients. Of the 833 Tagrisso-treated patients, 0.7% of patients were found to have a QTc > 500 msec, and 2.9% of patients had an increase from baseline QTc > 60 msec. No QTc-related arrhythmias were reported. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications 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 1.9% and was fatal in 0.1% of 833 Tagrisso-treated patients. Left Ventricular Ejection Fraction (LVEF) decline ≥ 10% and a drop to < 50% occurred in 4% of 655 Tagrisso-treated patients. Conduct cardiac monitoring, including an assessment of LVEF at baseline and during treatment in patients with cardiac risk factors. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure or persistent, asymptomatic LV dysfunction that does not resolve within 4 weeks, permanently discontinue Tagrisso
• Keratitis was reported in 0.7% of 833 Tagrisso-treated patients in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye) to an ophthalmologist
• Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during Tagrisso treatment and for 6 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose
• The most common adverse reactions (≥20%) in patients treated with Tagrisso were diarrhea (41%), rash (34%), dry skin (23%), nail toxicity (22%), and fatigue (22%)

INDICATION

Tagrisso is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy.

Please see complete Prescribing Information including Patient Information.

IMFINZI™ (durvalumab) IMPORTANT SAFETY INFORMATION

There are no contraindications for Imfinzi.

Monitor patients for clinical signs and symptoms of immune-mediated pneumonitis, hepatitis, colitis or diarrhea, endocrinopathies, nephritis, rash or dermatitis, other immune-mediated adverse reactions, and infection. Please refer to the full Prescribing Information for important dose management information specific to adverse reactions.

Immune-Mediated PneumonitisIn the combined safety database (n=1414), immune-mediated pneumonitis occurred in 32 patients (2.3%), including 1 fatal case (0.1%) and 6 Grade 3–4 cases (0.4%). In Study 1 (n=182), 1 patient (0.5%) died from immune-mediated pneumonitis. Monitor patients for signs and symptoms of pneumonitis and evaluate with radiographic imaging when suspected. Administer corticosteroids for ≥Grade 2 pneumonitis. Withhold Imfinzi for Grade 2 pneumonitis; permanently discontinue for Grade 3–4 pneumonitis.

Immune-Mediated HepatitisIn the combined safety database (n=1414), immune-mediated hepatitis occurred in 16 patients (1.1%), including 1 fatal case (<0.1%) and 9 Grade 3 cases (0.6%). Grade 3–4 elevations in ALT occurred in 40/1342 patients (3.0%), AST in 58/1336 patients (4.3%), and total bilirubin in 37/1341 patients (2.8%). In Study 1 (n=182), 1 patient (0.5%) died from immune-mediated hepatitis, and 2 patients (1.1%) experienced immune-mediated hepatitis, including 1 Grade 3 case (0.5%). Monitor patients for abnormal liver tests in each cycle during treatment with Imfinzi. Administer corticosteroids and withhold Imfinzi for Grade 2–3 ALT or AST >3–5X ULN or ≤8X ULN or total bilirubin >1.5–3X ULN or ≤5X ULN. Permanently discontinue Imfinzi in patients with Grade 3 ALT or AST >8X ULN or total bilirubin >5X ULN, or in patients with concurrent ALT or AST >3X ULN and total bilirubin >2X ULN with no other cause.

Immune-Mediated ColitisIn the combined safety database (n=1414), immune-mediated colitis or diarrhea occurred in 18 patients (1.3%), including 1 Grade 4 case (<0.1%) and 4 Grade 3 cases (0.3%). In Study 1 (n=182), 23 patients (12.6%) experienced colitis or diarrhea, including 2 Grade 3–4 cases (1.1%). Monitor patients for signs and symptoms of colitis or diarrhea. Administer corticosteroids for ≥Grade 2 colitis or diarrhea. Withhold Imfinzi for Grade 2 colitis or diarrhea; permanently discontinue for Grade 3–4 colitis or diarrhea.

Immune-Mediated Endocrinopathies

• Immune-mediated thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus and hypophysitis/hypopituitarism have occurred with Imfinzi. Monitor patients for clinical signs and symptoms of endocrinopathies. For Grade 2–4 endocrinopathies (except hypothyroidism) withhold dose until clinically stable and offer symptomatic management for hyperthyroidism. For Grade 2–4 hypothyroidism, initiate thyroid hormone replacement as needed
• Thyroid disorders— In the combined safety database (n=1414), immune-mediated hypothyroidism and hyperthyroidism occurred in 136 patients (9.6%) and 81 patients (5.7%), respectively. Thyroiditis occurred in 10 patients (0.7%), including 1 Grade 3 case (<0.1%) in a patient who had a myocardial infarction. In 9 patients with thyroiditis, transient hyperthyroidism preceded hypothyroidism. Treatment with a beta-blocker and/or thioamide was administered for hyperthyroidism in five of these patients. In Study 1 (n=182), Grade 1–2 hypothyroidism or thyroiditis occurred in 10 patients (5.5%). Grade 1–2 hyperthyroidism or thyroiditis leading to hyperthyroidism occurred in 9 patients (4.9%). Monitor patients for abnormal thyroid function tests prior to and periodically during treatment
• Immune-mediated adrenal insufficiency—In the combined safety database (n=1414), immune-mediated adrenal insufficiency occurred in 13 patients (0.9%), including 2 Grade 3 cases (0.1%). In Study 1 (n=182), Grade 1 adrenal insufficiency occurred in 1 patient (0.5%). Administer corticosteroids and hormone replacement as clinically indicated
• Type 1 diabetes mellitus—In the combined safety database (n=1414), new onset type 1 diabetes mellitus without an alternative etiology occurred in 1 patient (<0.1%). For type 1 diabetes mellitus, initiate insulin as indicated and withhold Imfinzi until clinically stable
• Hypophysitis—In the combined safety database (n=1414), hypopituitarism leading to adrenal insufficiency and diabetes insipidus occurred in 1 patient (<0.1%). Administer corticosteroids and hormone replacement as clinically indicated

Other Immune-Mediated Adverse Reactions

• Imfinzi has caused immune-mediated rash. Other immune-related adverse reactions, including aseptic meningitis, hemolytic anemia, immune thrombocytopenic purpura, myocarditis, myositis, nephritis, and ocular inflammatory toxicity including uveitis and keratitis, have occurred in ≤1.0% of patients treated with Imfinzi
• Immune-mediated rash or dermatitis—In the combined safety database (n=1414), immune-mediated rash or dermatitis occurred in 220 patients (15.6%) and 4 patients (0.3%) developed vitiligo. In Study 1 (n=182), 20 patients (11.0%) developed rash, including 1 Grade 3 case (0.5%). Patients should be monitored for signs and symptoms of rash or dermatitis. Administer corticosteroids if indicated. Withhold Imfinzi for Grade 3 rash or dermatitis or Grade 2 rash or dermatitis lasting >1 week. Permanently discontinue Imfinzi in patients with Grade 4 rash or dermatitis
• Immune thrombocytopenic purpura—In the combined safety database (n=1414), 1 fatal case (<0.1%) of immune thrombocytopenic purpura occurred. Monitor patients for signs and symptoms of immune thrombocytopenic purpura
• Nephritis—In the combined safety database (n=1414), immune-mediated nephritis occurred in 3 patients (0.2%), including 2 Grade 3 cases (0.1%). Monitor patients for abnormal renal function tests prior to and during each cycle of Imfinzi. Administer corticosteroids for ≥Grade 2 nephritis (creatinine >1.5X ULN). Withhold Imfinzi for Grade 2 nephritis; permanently discontinue for ≥Grade 3 nephritis (creatinine >3X ULN)

InfectionSevere infections, including sepsis, necrotizing fasciitis, and osteomyelitis, occurred in patients receiving Imfinzi. In the combined safety database (n=1414), infections occurred in 531 patients (37.6%). In Study 1 (n=182), infections occurred in 54 patients (29.7%). 11 patients (6.0%) experienced Grade 3–4 infection and 5 patients (2.7%) were experiencing infection at the time of death. 8 patients (4.4%) experienced urinary tract infection, the most common ≥Grade 3 infection. Monitor patients for signs and symptoms of infection and treat with anti-infectives for suspected or confirmed infections. Withhold Imfinzi for ≥Grade 3 infection.

Infusion-Related ReactionsIn the combined safety database (n=1414), severe infusion-related reactions occurred in 26 patients (1.8%). In Study 1 (n=182), infusion-related reactions occurred in 3 patients (1.6%). There were 5 Grade 3 (0.4%) and no Grade 4 or 5 reactions. Patients should be monitored for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1–2 infusion-related reactions and permanently discontinue for Grade 3–4 infusion-related reactions.

Embryo-Fetal ToxicityBased on its mechanism of action and data from animal studies, Imfinzi can cause fetal harm when administered to a pregnant woman. There are no data on the use of Imfinzi in pregnant women. Advise pregnant women of the potential risk to a fetus and advise women of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of Imfinzi.

Nursing MothersThere is no information regarding the presence of Imfinzi in human milk; however, because of the potential for adverse reactions in breastfed infants from Imfinzi, advise a lactating woman not to breastfeed during treatment and for at least 3 months after the last dose.

Most Common Adverse Reactions

• The most common adverse reactions (≥15%) were fatigue (39%), musculoskeletal pain (24%), constipation (21%), decreased appetite (19%), nausea (16%), peripheral edema (15%), and urinary tract infection (15%). The most common Grade 3 or 4 adverse reactions (≥3%) were fatigue, urinary tract infection, musculoskeletal pain, abdominal pain, dehydration, and general physical health deterioration
• Adverse reactions leading to discontinuation of Imfinzi occurred in 3.3% of patients. Serious adverse reactions occurred in 46% of patients. The most frequent serious adverse reactions (>2%) were acute kidney injury (4.9%), urinary tract infection (4.4%), musculoskeletal pain (4.4%), liver injury (3.3%), general physical health deterioration (3.3%), sepsis, abdominal pain, and pyrexia/tumor associated fever (2.7% each)

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

Approved Uses

Imfinzi is indicated for the treatment of 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.

Please see complete Prescribing Information including Patient Information.

NOTES TO EDITORS

 

AstraZeneca/MedImmune key presentations at the 2017 ASCO Annual Meeting

 

Lead author

   

Abstract title

   

Presentation details

 

DNA Damage Response (DDR)

Robson ME    

OlympiAD: Phase III Trial ofOlaparib Monotherapy VersusChemotherapy for Patients withHER2-Negative Metastatic BreastCancer and a Germline BRCAMutation

    Oral

Plenary Session Including the Science of Oncology Award and LectureSunday June 4th, 1:00-4:00 p.m. CDTPresentation Time: 3:10-3:25 p.m. CDT

Location: Hall B1Abstract #LBA4

Friedlander M    

Health-Related Quality of Life(HRQOL) and Patient-CenteredOutcomes Support the ClinicalBenefit of Prolongation ofProgression-Free Survival withOlaparib Maintenance FollowingChemotherapy in Patients withGermline BRCA-mutated Platinum-SensitiveRelapsed Serous Ovarian Cancer:SOLO-2 Phase III Trial

    Oral

Gynecologic Cancer

Friday June 2nd, 3:00-6:00 p.m. CDTPresentation Time: 5:12-5:24 p.m. CDT

Location: S406

Abstract #5507

Liu JF    

Overall Survival and UpdatedProgression-Free Survival Resultsfrom a Randomized Phase II trialComparing the Combination ofOlaparib and Cediranib AgainstOlaparib Alone in RecurrentPlatinum-Sensitive Ovarian Cancer

 

    Poster

Gynecologic OncologySaturday June 3rd, 1:15-4:45 p.m. CDTLocation: Hall AAbstract #5535

Poster #357

Alexander BM    

Phase I study of AZD1775 withRadiation Therapy and Temozolomidein Patients with Newly DiagnosedGlioblastoma (GBM) and Evaluation ofIntratumoral Drug Distribution inPatients with Recurrent GBM

    Oral

Central Nervous System TumorsSunday June 4th, 8:00-11:00 a.m. CDT

Presentation Time: 9:24-9:36 a.m. CDTLocation: S100aAbstract #2005

Mendez E    

A Phase I Clinical Trial of AZD1775 inCombination with Neoadjuvant WeeklyCisplatin and Docetaxel in BorderlineResectable Head and NeckSquamous Cell Carcinoma

    Poster

Head and Neck CancerMonday June 5th, 1:45-4:45 p.m. CDTLocation: Hall A

Abstract #6034Poster #22

 

Tumor Drivers & Resistance

Garassino M    

CNS Response to Osimertinib inPatients with T790M-PositiveAdvanced Non-Small Cell LungCancer: Data from a RandomizedPhase III Trial (AURA3)

    OralLung Cancer – Non-Small Cell MetastaticTuesday June 6th, 9:45 a.m.-12:45 p.m. CDT

Presentation Time: 11:33-11:45 a.m. CDTLocation: Hall D1Abstract #9005

Yang JC-H    

Osimertinib for Patients withLeptomeningeal Metastases fromEGFR-Mutant Non-Small Cell LungCancer: Updated Results from theBLOOM Study

    Poster DiscussionCentral Nervous System TumorsMonday June 5th, 1:15-4:45 p.m. CDT

Discussion time: 4:45-6:00 p.m. CDTPoster Location: Hall A

Discussion Location: S404Abstract #2020

Poster #262

 

Immuno-Oncology

Hahn NM    

Updated Efficacy and Tolerability ofDurvalumab in Locally Advanced orMetastatic Urothelial Carcinoma

    PosterGenitourinary (Nonprostate) CancerSunday June 4th, 8:00-11:30 a.m. CDTLocation: Hall AAbstract #4525

Poster #203

Balmanoukian A    

Updated Safety and Clinical Activity ofDurvalumab Monotherapy inPreviously-Treated patients with StageIIIB/IV Non-Small Cell Lung Cancer

    Poster

Lung Cancer – Non-Small Cell Metastatic

Saturday June 3rd, 8:00-11:30 a.m. CDTLocation: Hall AAbstract #9085

Poster #411

Streicher K    

Increased CD73 and Reduced IFNGSignature Expression in Relation toResponse Rates to Anti-PD-1(L1)Therapies in EGFR-Mutant Non-SmallCell Lung Cancer.

 

    Oral

Tumor BiologySunday June 4th, 8:00-11:00 a.m. CDTPresentation Time: 9:12-9:24 a.m. CDT

Location: S406

Abstract #11505

 

About Lynparza™ (olaparib)Lynparza™ (olaparib) was the first FDA-approved oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumor DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells. Specifically, in vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.

Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DDR mechanisms in cancer cells.

Lynparza tablets are currently being investigated in monotherapy and in combinations in a range of tumor types including breast, prostate and pancreatic cancer. Lynparza tablets are an investigational formulation and are not FDA-approved for any use.

About Tagrisso® (osimertinib)Tagrisso® (osimertinib) 40mg and 80mg once daily oral tablet has been approved in over 45 countries, including the US, EU, Japan and China, for patients with EGFR T790M mutation-positive advanced non-small cell lung cancer (NSCLC). Eligibility for treatment with Tagrisso is dependent on confirmation that the EGFR T790M mutation is present in the tumor.

Tagrisso is a third generation, irreversible EGFR tyrosine kinase inhibitor designed to inhibit both EGFR sensitizing and EGFR T790M resistance mutations and to have activity in the central nervous system (CNS). Tagrisso is also being investigated in the adjuvant and metastatic first-line settings, including in patients with and without CNS metastases, in leptomeningeal metastases, and in combination with other treatments.

About Imfinzi™ (durvalumab)Imfinzi™ (durvalumab, previously known as MEDI4736) is a human monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1 and CD80.

Durvalumab is also being tested in the first-line treatment of patients with unresectable and metastatic bladder cancer as a monotherapy and in combination with tremelimumab, a checkpoint inhibitor that targets CTLA-4, as part of the DANUBE Phase III trial, which had the last patient commenced dosing during the first quarter of 2017 (global trial, excluding China). Additional clinical trials are ongoing to investigate durvalumab as monotherapy or in combination with tremelimumab in multiple solid tumors and blood cancers.

About AstraZeneca in OncologyAstraZeneca 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 at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our 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 MedImmuneMedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, MD, one of AstraZeneca’s three global R&D centers, with additional sites in Cambridge, UK, and Mountain View, CA. For more information, please visit www.medimmune.com.

About AstraZenecaAstraZeneca 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 main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. 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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AstraZenecaMichele Meixell, +1 302-885-2677orAlexandra Engel +1 302-885-2677