AstraZeneca Delivers New Data on Expanding Portfolio of Cancer Medicines at 2017 American Society of
Clinical Oncology (ASCO) Annual Meeting
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 metastases
Latest 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 combination
Building 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 Pneumonitis
In 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 Hepatitis
In 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 Colitis
In 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)
Infection
Severe 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 Reactions
In 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 Toxicity
Based 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 Mothers
There 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
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AstraZeneca/MedImmune key presentations at the 2017 ASCO Annual Meeting
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Lead author
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Abstract title
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Presentation details
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DNA Damage Response (DDR)
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Robson ME |
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OlympiAD: Phase III Trial of
Olaparib Monotherapy Versus
Chemotherapy for Patients with
HER2-Negative Metastatic Breast
Cancer and a Germline BRCA
Mutation
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Oral
Plenary Session Including the Science of Oncology Award and Lecture
Sunday June 4th, 1:00-4:00 p.m. CDT
Presentation Time: 3:10-3:25 p.m. CDT
Location: Hall B1
Abstract #LBA4
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Friedlander M |
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Health-Related Quality of Life
(HRQOL) and Patient-Centered
Outcomes Support the Clinical
Benefit of Prolongation of
Progression-Free Survival with
Olaparib Maintenance Following
Chemotherapy in Patients with
Germline BRCA-mutated Platinum-Sensitive
Relapsed Serous Ovarian Cancer:
SOLO-2 Phase III Trial
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Oral
Gynecologic Cancer
Friday June 2nd, 3:00-6:00 p.m. CDT
Presentation Time: 5:12-5:24 p.m. CDT
Location: S406
Abstract #5507
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Liu JF |
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Overall Survival and Updated
Progression-Free Survival Results
from a Randomized Phase II trial
Comparing the Combination of
Olaparib and Cediranib Against
Olaparib Alone in Recurrent
Platinum-Sensitive Ovarian Cancer
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Poster
Gynecologic Oncology
Saturday June 3rd, 1:15-4:45 p.m. CDT
Location: Hall A
Abstract #5535
Poster #357
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Alexander BM |
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Phase I study of AZD1775 with
Radiation Therapy and Temozolomide
in Patients with Newly Diagnosed
Glioblastoma (GBM) and Evaluation of
Intratumoral Drug Distribution in
Patients with Recurrent GBM
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Oral
Central Nervous System Tumors
Sunday June 4th, 8:00-11:00 a.m. CDT
Presentation Time: 9:24-9:36 a.m. CDT
Location: S100a
Abstract #2005
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Mendez E |
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A Phase I Clinical Trial of AZD1775 in
Combination with Neoadjuvant Weekly
Cisplatin and Docetaxel in Borderline
Resectable Head and Neck
Squamous Cell Carcinoma
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Poster
Head and Neck Cancer
Monday June 5th, 1:45-4:45 p.m. CDT
Location: Hall A
Abstract #6034
Poster #22
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Tumor Drivers & Resistance
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Garassino M |
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CNS Response to Osimertinib in
Patients with T790M-Positive
Advanced Non-Small Cell Lung
Cancer: Data from a Randomized
Phase III Trial (AURA3)
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Oral
Lung Cancer – Non-Small Cell Metastatic
Tuesday June 6th, 9:45 a.m.-12:45 p.m. CDT
Presentation Time: 11:33-11:45 a.m. CDT
Location: Hall D1
Abstract #9005
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Yang JC-H |
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Osimertinib for Patients with
Leptomeningeal Metastases from
EGFR-Mutant Non-Small Cell Lung
Cancer: Updated Results from the
BLOOM Study
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Poster Discussion
Central Nervous System Tumors
Monday June 5th, 1:15-4:45 p.m. CDT
Discussion time: 4:45-6:00 p.m. CDT
Poster Location: Hall A
Discussion Location: S404
Abstract #2020
Poster #262
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Immuno-Oncology
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Hahn NM |
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Updated Efficacy and Tolerability of
Durvalumab in Locally Advanced or
Metastatic Urothelial Carcinoma
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Poster
Genitourinary (Nonprostate) Cancer
Sunday June 4th, 8:00-11:30 a.m. CDT
Location: Hall A
Abstract #4525
Poster #203
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Balmanoukian A |
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Updated Safety and Clinical Activity of
Durvalumab Monotherapy in
Previously-Treated patients with Stage
IIIB/IV Non-Small Cell Lung Cancer
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Poster
Lung Cancer – Non-Small Cell Metastatic
Saturday June 3rd, 8:00-11:30 a.m. CDT
Location: Hall A
Abstract #9085
Poster #411
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Streicher K |
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Increased CD73 and Reduced IFNG
Signature Expression in Relation to
Response Rates to Anti-PD-1(L1)
Therapies in EGFR-Mutant Non-Small
Cell Lung Cancer.
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Oral
Tumor Biology
Sunday June 4th, 8:00-11:00 a.m. CDT
Presentation Time: 9:12-9:24 a.m. CDT
Location: S406
Abstract #11505
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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 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 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 MedImmune
MedImmune 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 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 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.
AstraZeneca
Michele Meixell, +1 302-885-2677
or
Alexandra Engel +1 302-885-2677
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