On May 24, 2018 AstraZeneca and MedImmune,reported its global biologics research and development arm, head to the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, US, 1-5 June 2018, with an expanded portfolio in Oncology (Press release, AstraZeneca, MAY 24, 2018, View Source [SID1234526873]).

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Having achieved 16 regulatory approvals across major markets (US, EU, Japan and China), AstraZeneca will be sharing its R&D momentum at ASCO (Free ASCO Whitepaper) with seven "Best of ASCO (Free ASCO Whitepaper)" presentations and 14 oral presentations from a total of 91 accepted abstracts. These presentations will showcase AstraZeneca’s four scientific platforms: Immuno-Oncology (IO), DNA Damage Response (DDR), Anti-Drug Conjugates (ADCs), and Tumour Drivers and Resistance.

Dave Fredrickson, Executive Vice President, Head of Oncology Business Unit said: "In just four years, AstraZeneca has launched four innovative medicines to treat serious cancers: Lynparza in ovarian and metastatic breast cancers, Imfinzi in bladder cancer and unresectable stage III non-small cell lung cancer, Tagrisso in epidermal growth factor receptor-mutated non-small cell lung cancer and Calquence as the first haematology medicine in mantle cell lymphoma. At this year’s ASCO (Free ASCO Whitepaper) meeting, the Company will showcase a strong portfolio, a rich pipeline and a focus on impactful industry partnerships which will fuel continued advances in oncology and haematology."

Lynparza: Study 08 data in prostate cancer

An oral presentation of Study 08, evaluating Lynparza in combination with abiraterone in metastatic castration-resistant prostate cancer, will highlight the potential of PARP inhibition beyond ovarian and metastatic breast cancers, regardless of homologous recombination repair mutation status (Abstract #5003). Lynparza is being jointly developed and commercialised by AstraZeneca and MSD, known as Merck in the US and Canada.

Progress in haematology

Response rates and safety data from the Phase III (‘1053’) multicentre trial of the investigational ADC moxetumomab pasudotox in relapsed or refractory hairy cell leukaemia (HCL) patients (Abstract #7004) will be presented. The FDA has granted the moxetumomab pasudotox Biologics License Application Priority Review status; if approved, it will be a first-in-class treatment for patients with relapsed refractory HCL.

New data will also be presented for Calquence (acalabrutinib), a selective Bruton’s tyrosine kinase (BTK) inhibitor and AstraZeneca’s first medicine approved in haematology. Findings will be shared in an oral presentation of the Phase II clinical trial (WM-001) of patients with treatment-naïve, relapsed or refractory Waldenström macroglobulinemia (Abstract #7501).

Investigator-led studies highlight the value of collaboration in new areas of unmet need

AstraZeneca’s broad network of industry and academic partners is broadening exploration of the company’s pipeline into additional tumour types where unmet patient needs remain. The US National Cancer Institute (NCI), a division of the US National Institutes of Health (NIH), will present Phase II data from the ongoing SPRINT trial evaluating MEK 1/2 inhibitor selumetinib (AZD6244, ARRY-142886), a potential new medicine within the AstraZeneca and MSD partnership, in paediatric patients with neurofibromatosis type 1 (NF1) and plexiform neurofibromas (Abstract #10503). The SPRINT abstract was awarded the 2018 Conquer Cancer Foundation of ASCO (Free ASCO Whitepaper)/Bradley Stuart Beller Special Merit Award.

Additional investigator-sponsored research includes a late-breaking oral presentation on the Phase II GeparNuevo trial of neoadjuvant treatment with Imfinzi (durvalumab) in triple-negative breast cancer (TNBC). AstraZeneca initiated this study alongside the German Breast Group and Celgene (Abstract #104), and the DREAM Phase II trial of Imfinzi in combination with chemotherapy in first-line mesothelioma (Abstract #8503).

Early pipeline powered by combinations

AstraZeneca’s early-stage pipeline will also be showcased at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting with 39 abstracts highlighting its breadth and depth.

In an oral presentation, data from PAKT, a Phase II trial of capivasertib (AZD5363), a highly selective, oral, AKT inhibitor with paclitaxel, demonstrate the impact of this combination on progression free survival and overall survival in previously untreated, metastatic TNBC (Abstract #1007). This trial was sponsored and led by Queen Mary University London and the Bart’s Cancer Institute.

Additionally, progress against PD(L)-1 insensitive tumours will be highlighted with presentations of two first-in-human studies from the early IO pipeline; the investigational anti-CD73 human monoclonal antibody oleclumab alone or in combination with Imfinzi in advanced pancreatic cancer and colorectal cancer (Abstract #4123), and monalizumab (NKG2A) in combination with Imfinzi in patients with metastatic microsatellite-stable colorectal cancer (Abstract #3540).

Key AstraZeneca/MedImmune presentations at ASCO (Free ASCO Whitepaper) 2018
Lead author

Abstract title

Presentation details

DNA Damage Response

Clarke N

Olaparib combined with abiraterone in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): a randomized Phase II trial

Oral

Genitourinary (Prostate) Cancer

Monday 4th June, 15:00-18:00

Presentation Time: 16:00-16:12

Location: Hall D1

Abstract #5003

Westin SN

Phase 1 trial of olaparib (PARP inhibitor) and vistusertib (mTORC 1/2 inhibitor) in recurrent endometrial, ovarian and triple-negative breast cancer

Oral

Gynecologic Cancer

Tuesday 5th June, 10:57-11:09

Location: S100a

Abstract #5504

Johnson M

A phase I, open-label, multicenter dose escalation study to assess the safety, tolerability, and pharmacokinetics of AZD2811 nanoparticle in patients with advanced solid tumors

Poster

Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics

Monday 4th June, 08:00-11:30

Abstract #2592

Poster #418

Heymach J

An open-label, multidrug, biomarker-directed, multicentre phase II umbrella study in patients with non-small cell lung cancer, who progressed on an anti-PD-1/PD-L1 containing therapy (HUDSON)

Poster

Developmental Therapeutics – Immunotherapy

Monday 4th June, 08:00-11:30

Location: Hall A

Abstract #TPS3120

Poster #324b

Immuno-Oncology

Loibl S

Randomized Phase II neoadjuvant study (GeparNuevo) to investigate the addition of durvalumab to a taxane-anthracycline containing chemotherapy in triple-negative breast cancer (TNBC)

Oral

Compelling Combinations: Raising the Bar With Immunotherapy

Sunday 3rd June, 09:45-11:15

Presentation Time: 09:57-10:09

Location: Hall D1

Abstract #104

Nowak AK

DREAM: A phase II study of durvalumab with first line chemotherapy in mesothelioma—First results.

Oral

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Monday 4th June, 08:00-11:00

Presentation Time: 09:00-09:12

Location: Hall B1

Abstract #8503

Garassino MC

Durvalumab in ≥3rd-line advanced NSCLC: updated results from the Phase 2 ATLANTIC study

Poster

Lung Cancer—Non-Small Cell Metastatic

Sunday 3rd June, 08:00-11:30

Location: Hall A

Abstract #9058

Poster #381

Segal NH

First-in-human dose escalation of monalizumab plus durvalumab, with expansion in patients with metastatic microsatellite-stable colorectal cancer

Poster

Gastrointestinal (Colorectal) Cancer

Sunday 3rd June, 08:00-11:30

Location: Hall A

Abstract #3540

Poster #33

Overman M

Safety, Efficacy and Pharmacodynamics (PD) of MEDI9447 (oleclumab) Alone or in Combination with Durvalumab in Advanced Pancreatic Cancer (panc) or Colorectal Cancer (CRC)

Poster

Gastrointestinal (Noncolorectal) Cancer

Sunday 3rd June, 08:00-11:30

Location: Hall A

Abstract #4123

Poster #312

Tumour Drivers & Resistance

Gross A

SPRINT: Phase II study of the MEK 1/2 inhibitor selumetinib (AZD6244, ARRY-142886) in children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN)

Oral

Pediatric Oncology I

Saturday 2nd June, 15:00-18:00

Presentation Time: 16:00-16:12

Location: S504

Abstract #10503

Owen R

Acalabrutinib in patients (pts) with Waldenström macroglobulinemia (WM)

Oral

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Sunday 3rd June, 09:45-12:45

Presentation Time: 09:57-10:09

Abstract #7501

Schmid P

AZD5363 plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (PAKT): a randomised, double-blind, placebo-controlled, phase II trial

Oral

Breast Cancer – Metastatic

Sunday 3rd June, 08:00-11:00

Presentation Time: 10:12-10:24

Location: Hall D2

Abstract #1007

Antibody-Drug Conjugates

Kreitman R

Moxetumomab pasudotox in heavily pretreated patients with relapsed/refractory hairy cell leukemia: results of a pivotal international study

Oral

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Saturday 2nd June, 15:00-18:00

Discussion Time: 16:12-16:24

Location: E450

Abstract #7004