On May 16, 2019 AstraZeneca reported that it will present new research across an industry-leading Oncology portfolio, including data for its transformational cancer medicines Lynparza (olaparib) and Imfinzi (durvalumab) at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, US, 31 May to 4 June 2019 (Press release, AstraZeneca, MAY 16, 2019, View Source [SID1234536390]).
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In all, the Company will present 93 abstracts spanning multiple tumour types, including 12 oral presentations with one plenary session and four late-breakers. Highlights include:
Late-breaking results from the Lynparza POLO trial, the first positive Phase III trial of any PARP inhibitor in germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer, a devastating diagnosis with critical unmet medical need. This is the first Phase III trial to validate a targeted treatment in a biomarker-selected population of pancreatic cancer.
Results of the Phase III SOLO-3 trial highlighting the efficacy for Lynparza monotherapy vs. standard-of-care chemotherapy in treating patients with gBRCAm advanced ovarian cancer who had two or more prior lines of treatment. This data underscores Lynparza’s clinical benefit irrespective of line of treatment for women with BRCAm advanced ovarian cancer and the importance of knowing BRCA status at diagnosis.
Three-year overall survival (OS) data from the Phase III PACIFIC trial providing new evidence of the long-term survival benefit for Imfinzi in unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease had not progressed following chemoradiation therapy. Imfinzi is the only immunotherapy to demonstrate significant OS benefits in this curative-intent setting, and this data reaffirms the PACIFIC regimen as the standard of care for these patients.
Dave Fredrickson, Executive Vice President, Oncology, said: "AstraZeneca continues to break traditional treatment boundaries through new targeted approaches and the prioritisation of earlier intervention. This year at ASCO (Free ASCO Whitepaper), our data for Lynparza in BRCA-mutated metastatic pancreatic cancer and for Imfinzi in unresectable Stage III non-small cell lung cancer illustrate our ambition to change medical practice for better patient outcomes."
Breaking treatment boundaries
AstraZeneca is committed to redefining disease treatment for patient populations with unmet needs. This will be evidenced at the ASCO (Free ASCO Whitepaper) meeting for patients with PARP-mediated tumours, HER2-low expressing tumours, and AKT-mutated tumours.
The plenary presentation of results from the Phase III POLO trial will detail the progression-free survival (PFS) and important clinical benefit of Lynparza in patients with metastatic pancreatic cancer, a population that has seen very little treatment progress over the past 40 years (Abstract #LBA4).
New data on Lynparza will also be shared in advanced ovarian cancer, including the results of the Phase III SOLO-3 trial highlighting the efficacy for Lynparza monotherapy vs. standard-of-care chemotherapy in treating patients with gBRCAm advanced ovarian cancer who had two or more prior lines of treatment (Abstract #5506).
Furthermore, the Phase II TOPARP-B trial, sponsored by the Institute of Cancer Research (UK), will highlight the anti-tumour activity of Lynparza in patients with heavily-pretreated metastatic castration-resistant prostate cancer with DDR gene defects (Abstract #5005). The Phase II GeparOLA trial, conducted by the German Breast Group and German AGO-B Breast Study Group, will help define the safety and efficacy of Lynparza, compared to platinum-based chemotherapy, in the neoadjuvant setting in HER2-negative early breast cancer and in patients with homologous recombination deficiency (Abstract #506).
The design of the Phase III DESTINY-Breast04 trial evaluating trastuzumab deruxtecan (DS-8201) in metastatic breast cancer with HER2-low expressing tumours will be presented at this year’s ASCO (Free ASCO Whitepaper) meeting (Abstract #TPS1102). The antibody drug conjugate (ADC) co-developed with Daiichi Sankyo has the potential to redefine breast cancer treatment. Two publications in Lancet Oncology recently highlighted the Phase I dose-expansion results for trastuzumab deruxtecan in HER2-positive metastatic breast and gastric cancers.
In addition, data will be presented from the Phase II FAKTION trial, sponsored by Velindre NHS Trust, on the combination of the AKT inhibitor capivasertib (AZD5363) plus Faslodex (fulvestrant) in patients with relapsed metastatic oestrogen receptor (ER)-positive breast cancer (Abstract #1005). AKT mutations occur across several different cancers and may be a target for treatment tailored to tumour genes rather than cancer types.
Treating patients earlier in their disease
AstraZeneca made a significant breakthrough in the treatment of NSCLC beginning in 2017 with the Phase III PACIFIC trial demonstrating unprecedented PFS and subsequently OS benefits for patients with unresectable, Stage III NSCLC treated with Imfinzi vs. standard of care. At this year’s ASCO (Free ASCO Whitepaper) meeting, AstraZeneca will provide new evidence of the long-term survival benefit of Imfinzi with a three-year OS update (Abstract #8526).
Sub-analysis presentations of Phase III data from SOLO-1, the only trial of a PARP inhibitor to demonstrate improvement in PFS for women with BRCAm advanced ovarian cancer as a 1st-line maintenance treatment, will reinforce the potential of using Lynparza earlier in the treatment pathway (Abstract #5539).
Raising the bar for better outcomes
New data from the Phase III FLAURA trial will explore clinical outcomes associated with the detection of epidermal growth factor receptor (EGFR) mutations in plasma at three or six weeks after starting treatment with Tagrisso (osimertinib) (Abstract #9020). With the presentation of the Phase II SAVANNAH trial design, AstraZeneca will explain how it will explore the combination of Tagrisso and savolitinib to potentially overcome MET-driven EGFR tyrosine kinase inhibitor (TKI) resistance following Tagrisso treatment in EGFR-mutated NSCLC (Abstract #TPS9119).
Despite recent therapeutic progress, platinum-resistant ovarian cancer remains a therapeutic challenge. Results of a multicenter, double-blind Phase II trial conducted by the Princess Margaret, California, Chicago and Mayo Phase II Consortia will show for the first time increased OS data with the Wee-1 inhibitor adavosertib when associated with the antimetabolite medicine gemcitabine (Abstract #5518).
A focus on haematology
The diverse haematology pipeline aims to deliver new medicines in a range of blood cancers with critical unmet medical need
AstraZeneca has established haematology as one of its key areas of focus. At the ASCO (Free ASCO Whitepaper) meeting and the upcoming 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), 13-16 June 2019, the Company will present long-term trial follow-up data showing the promising response rate, duration of response and safety profile of the Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) in chronic lymphocytic leukaemia (CLL), including:
Three-year results from the Phase Ib/II ACE-CL-003 trial evaluating Calquence and obinutuzumab in treatment-naïve and previously-treated CLL (Abstract #7500)
19-month results from the Phase II ACE-CL-208 trial of Calquence in patients with relapsed or refractory CLL intolerant to ibrutinib (Abstract #7530)
These data are part of a robust development programme that includes two pivotal clinical trials for Calquence in CLL with full data anticipated in 2019: the Phase III ASCEND (ACE-CL-309) trial in relapsed or refractory CLL, which recently met its primary endpoint, and the ongoing Phase III ELEVATE-TN (ACE-CL-007) trial evaluating Calquence with and without obinutuzumab in front-line CLL.
Key AstraZeneca presentations at ASCO (Free ASCO Whitepaper) 2019
Lead author
Abstract title
Presentation details
Immuno-Oncology
Gray, JE
Three-year overall survival update from the PACIFIC trial.
Abstract #8526
Poster Board #282
Poster Session – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Sunday 2 June, 8:00-11:00am
Hall A
Planchard, D
First subsequent treatment after discontinuation of durvalumab in unresectable, Stage III NSCLC patients from PACIFIC.
Abstract #9054
Poster Board #377
Poster Session – Lung Cancer – Non-Small Cell Metastatic
Sunday 2 June, 8:00-11:00am
Hall A
Rizvi, NA
Blood tumor mutational burden (bTMB) and tumor PD-L1 as predictive biomarkers of survival in MYSTIC: first-line durvalumab (D) ± tremelimumab (T) vs chemotherapy (CT) in metastatic (m) NSCLC.
Abstract #9016
Poster Board #339
Poster Discussion – Lung Cancer – Non-Small Cell Metastatic
Sunday 2 June, 4:30-6:00pm
Hall D1
Garon, EB
Patient-reported outcomes (PROs) with first-line durvalumab (D) ± tremelimumab (T) vs chemotherapy (CT) in metastatic NSCLC: results from MYSTIC.
Abstract #9048
Poster Board #371
Poster Presentation – Lung Cancer – Non-Small Cell Metastatic
Sunday 2 June, 8:00-11:00am
Hall A
Bradley, JD
PACIFIC-2: phase 3 study of concurrent durvalumab and platinum-based chemoradiotherapy in patients with unresectable, stage III NSCLC.
Abstract #TPS8573
Poster Board #327a
Poster Presentation – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Sunday 2 June, 8:00-11:00am
Hall A
DNA damage response
Kindler, H
Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III POLO trial.
Abstract #LBA4
Plenary Session Including the Distinguished Achievement Award and Science of Oncology Award Lecture
Sunday 2 June, 3:15-3:30pm
Hall B1
Penson, R
Olaparib monotherapy versus (vs) chemotherapy for germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC) patients (pts): Phase III SOLO3 trial.
Abstract #5506
Oral Abstract Session – Gynecologic Cancer
Monday 3 June, 3:15-3:27pm
S406
Colombo, N
Adverse events (AEs) with maintenance olaparib in newly diagnosed patients (pts) with advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): Phase III SOLO1 trial.
Abstract #5539
Poster Board #362
Poster Session – Gynecologic Cancer
Saturday 1 June, 1:15-4:15pm
Hall A
Mateo, J
TOPARP-B: A phase II randomized trial of the poly(ADP)-ribose polymerase (PARP) inhibitor olaparib for metastatic castration resistant prostate cancers (mCRPC) with DNA damage repair (DDR) alterations.
Abstract #5005
Oral Abstract Session – Genitourinary (Prostate) Cancer
Friday 31 May, 4:09-4:21pm
Arie Crown Theater
Lheureux, S
A randomized double-blind placebo-controlled phase II trial comparing gemcitabine monotherapy to gemcitabine in combination with adavosertib in women with recurrent, platinum resistant epithelial ovarian cancer: A trial of the Princess Margaret, California, Chicago and Mayo Phase II Consortia.
Abstract #5518
Poster Board #341
Poster Session – Gynaecologic Cancer
Saturday 1 June, 4:30-6:00pm
Hall A
Fasching, P
GeparOLA: A randomized phase II trial to assess the efficacy of paclitaxel and olaparib in comparison to paclitaxel/carboplatin followed by epirubicin/cyclophosphamide as neoadjuvant chemotherapy in patients (pts) with HER2-negative early breast cancer (BC) and homologous recombination deficiency (HRD).
Abstract #506
Oral Abstract Session – Breast Cancer -Local/Regional/Adjuvant
Monday 3 June, 11:45-11:57pm
Hall D2
Tumour drivers and resistance
Oxnard, GR
SAVANNAH: A Phase II trial of osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-driven (MET+), locally advanced or metastatic non-small cell lung cancer (NSCLC), following disease progression on osimertinib.
Abstract #TPS9119
Poster Board #439b
Poster Session – Lung Cancer – Non-Small Cell Metastatic
Sunday 2 June, 8:00-11:00am
Hall A
Zhou, C
Early clearance of plasma EGFR mutations as a predictor of response to osimertinib and comparator EGFR-TKIs in the FLAURA trial.
Abstract #9020
Poster Board #343
Poster Session – Lung Cancer – Non-Small Cell Metastatic
Sunday 2 June, 8:00-11:00am
Hall A
Jones, RH
Capivasertib (AZD5363) plus fulvestrant versus placebo plus fulvestrant after relapse or progression on an aromatase inhibitor in metastatic ER-positive breast cancer (FAKTION): A randomized, double-blind, placebo-controlled, phase II trial.
Abstract #1005
Oral Abstract Session – Breast Cancer – Metastatic
Tuesday 4 June, 11:09-11:21am
Hall D1
Haematology
Woyach, J
Acalabrutinib with obinutuzumab (Ob) in treatment-naive (TN) and relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): Three-year follow-up.
Abstract #7500
Oral Abstract Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Tuesday 4 June, 9:45-9:57am
E451
Rogers, KA
Phase 2 study of acalabrutinib in ibrutinib (IBR)-intolerant patients (pts) with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).
Abstract #7530
Poster Board #284
Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Monday 3 June, 8:00-11:00am
Hall A
Trastuzumab deruxtecan (DS-8201)
Modi, S
A phase III, multicenter, randomized, open label trial of [fam-] trastuzumab deruxtecan (DS-8201a) versus investigator’s choice in HER2-low breast cancer.
Abstract #TPS1102
Poster Board #182a
Poster Session – Breast Cancer – Metastatic
Sunday 2 June, 8:00-11:00am
Hall A
In addition to the scientific presentations and press releases planned at the ASCO (Free ASCO Whitepaper) meeting, AstraZeneca and its partner MSD (MSD: known as Merck & Co., Inc. inside the US and Canada) will host a press briefing on Sunday 2 June, on Lynparza. For more information, please contact AstraZeneca Global Media Relations.
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 Oncology as a key growth driver for AstraZeneca 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 haematology.
By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.