On September 31, 2017 AstraZeneca and MedImmune, its global biologics research and development arm, reported it will present results of more than 40 presentations, including two pivotal clinical trial readouts selected for late-breaking abstract presentation at the ESMO (Free ESMO Whitepaper) Presidential Symposia on Saturday, 9 September, which demonstrate significant improvements over current standard-of-care treatments in lung cancer:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Results from the pivotal Phase III PACIFIC trial showing statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Imfinzi (durvalumab) in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) following standard chemoradiation therapy, a clinical setting where there are currently no approved treatments (Press release, AstraZeneca, AUG 31, 2017, View Source [SID1234520360]).
Results of the Phase III FLAURA trial showing statistically-significant and clinically-meaningful PFS with Tagrisso (osimertinib) over current standard-of-care erlotinib or gefitinib as 1st-line treatments in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) NSCLC.
Jamie Freedman, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: "The superiority of 1st-line treatment with Tagrisso in the FLAURA trial and the potentially transformative Imfinzi data from the PACIFIC trial reinforce our significant contribution to advancing medicines for patients across multiple stages of lung cancer. We are also proud to share with the medical community our progress towards addressing the needs of patients with other types of difficult-to-treat tumours, including advanced ovarian, breast, and head and neck cancers."

Pushing the boundaries of lung cancer research

In addition to the two Presidential Symposia presentations, data being presented at ESMO (Free ESMO Whitepaper) demonstrate the breadth and depth of AstraZeneca’s commitment to advancing the treatment of lung cancer:

Overall survival data on Tagrisso from the Phase II AURA trials in patients with EGFR T790M mutation-positive advanced NSCLC (Abstract #1348P)
PFS data and central nervous system (CNS) responses to Tagrisso in patients with EGFR T790M NSCLC in the Asia Pacific region (AURA17) (Abstracts #1331P, 1353P and 1354P)
Established expertise in women’s cancers

Emerging data from studies of Lynparza, Faslodex, potential new medicines and combinations within women’s cancers will include:

Latest Phase III OlympiAD efficacy and health-related quality-of-life data for Lynparza vs. chemotherapy in patients with HER2-negative metastatic breast cancer and a germline BRCA mutation (Abstract #243PD and 290P)
Phase III SOLO-2 data for Lynparza maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer (Abstract #932PD)
Sustained commitment in head and neck cancer

AstraZeneca is presenting additional evidence of the efficacy and safety of Imfinzi and the early potential of its combination strategy in head and neck cancer, including oral presentations on:

Preliminary data from the Phase II HAWK study of Imfinzi in recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) (Abstract #1042O)
Safety, tolerability and anti-tumour activity in the Phase Ib/II SCORES study of Imfinzi in combination with STAT3 inhibitor AZD9150 or CXCR2 inhibitor AZD5069, in patients with HNSCC (Abstract #1049PD)

NOTES TO EDITORS

AstraZeneca/MedImmune key presentations at the ESMO (Free ESMO Whitepaper) 2017 Congress

Lead author

Abstract title

Presentation details

Lung cancer

Paz-Ares L
PACIFIC: A double-blind, placebo-controlled Phase III study of durvalumab after chemoradiation therapy (CRT) in patients with Stage III, locally advanced, unresectable NSCLC
Oral
Lung Cancer
Saturday 9th September, 16:30-18:10
Presentation Time: 16:30-16:45
Location: Madrid Auditorium
Abstract #LBA1

Ramalingam S
Osimertinib vs SoC EGFR-TKI as first-line treatment in patients with EGFRm advanced NSCLC (FLAURA)
Oral
Lung Cancer
Saturday 9th September, 16:30-18:10
Presentation Time: 17:30-17:45
Location: Madrid Auditorium
Abstract #LBA2

Zhou C
Detection of EGFR T790M in Asia-Pacific patients (pts) with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC): circulating tumour (ct) DNA analysis across 3 platforms
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1331P
Zhou C
Osimertinib in Asia-Pacific patients (pts) with EGFR T790M-positive advanced NSCLC: updated Phase II study results including progression-free survival (PFS)
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #135P

Zhou C
CNS response to osimertinib in Asian-Pacific patients (pts) with T790M-positive advanced NSCLC: data from an open-label Phase II trial (AURA17)
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1353P
Mitsudomi T
Overall survival (OS) in patients (pts) with EGFR T790M-positive advanced non-small cell lung cancer (NSCLC) treated with osimertinib: results from two Phase II studies
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1348P
Pinotti G
EGFR T790M detection in TKI-naïve NSCLCs carrying sensitive EGFR mutations
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1335P
Postel-Vinay S
A randomized double-blind Phase II trial evaluating maintenance PARP inhibitor Olaparib versus placebo in patients with platinum-sensitive advanced non-small cell lung cancer: PIPSeN trial
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1381TiP
Kim Y C
Phase II Trial of AZD9291 in Second Line Treatment after Acquired Resistance with T790M Mutation Detected From Circulating Tumor DNA (LiquidLung-O-Cohort 2)
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1360P
Calabuig-Farinas S
Clinical value of cfDNA and CTCs in EGFR mutations detected in advanced NSCLC
Poster
Lung Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #1638P
Leduc C
Ultrasensitive detection of EGFR T790M mutation by droplet digital PCR (ddPCR) in TKI naïve non-small cell lung cancer (NSCLC) harboring EGFR mutation: results of the nationwide program Biomarkers France of the French Cooperative Thoracic Intergroup (IFCT)
Poster Discussion
Lung Cancer
Saturday 9th September, 9:00-10:45
Presentation Time: 10:16
Location: Pamplona Auditorium
Abstract #85PD
Wu Y-L
A Phase 3 study of first-line durvalumab vs platinum-based chemotherapy in patients with advanced NSCLC and high PD-L1 expression: PEARL
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1378TiP
Zhang X
Prediction of survival with durvalumab in locally advanced or metastatic NSCLC using early tumor assessments
Poster
Lung Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #1312P

Women’s cancers

Martinez Bueno A
Disruptive mutations in TP53 associate with survival benefit in a PARPi trial in Ovarian Cancer
Oral
Ovarian Cancer
Saturday 9th September, 09:15-10:45
Presentation Time: 09:15
Location: Cartagena Auditorium
Abstract #LBA42
Ruiz-Borrego M
Phase III evaluating the addition of fulvestrant (F) to Anastrozol (A) as adjuvant therapy in postmenopausal women with hormone receptor positive HER2 negative (HR+/HER2-) early breast cancer (EBC): results from the GEICAM/2006-10 study
Oral
Breast Cancer
Friday 8th September, 14:00-15:30
Presentation Time: 14:24-14:36
Location: Pamplona Auditorium
Abstract #148O
Delaloge, S.
OlympiAD: Further efficacy outcomes in patients with HER2-negative metastatic breast cancer and a germline BRCA mutation receiving olaparib monotherapy vs standard single-agent chemotherapy treatment of physician’s choice
Poster Discussion
Breast Cancer
Sunday 10th September, 09:15-10:45
Presentation Time: 09:45
Location: Sevilla Auditorium
Abstract #243PD
Wang J
FRIEND: A randomized pilot study to compare the efficacy and tolerability of fulvestrant 500mg with exemestane as first line endocrine therapy for post-m ER positive HER2 negative ABC patients relapse after adjuvant non-steroidal aromatase inhibitors (NSAI)
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #311TiP

Kawaguchi H
Factors associated with prolonged time to treatment failure with fulvestrant 500 mg in patients with postmenopausal estrogen receptor-positive advanced/metastatic breast cancer (JBCRG-C06; Safari): A subgroup analysis
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #302P
Kaufman P
Abemaciclib plus fulvestrant in patients (pts) with HR+/HER2- endocrine therapy naïve (EN) advanced breast cancer – an exploratory analysis of MONARCH 2
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #235P
Zimmer A
A Phase I PK/PD study of durvalumab (D) in combination with olaparib (O) and cediranib (C) in recurrent women’s cancers
Poster
Ovarian Cancer, Cervical, Breast, Endometrial
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #390P
Westin S
Phase I Expansion of olaparib (PARP inhibitor) and AZD5363 (AKT inhibitor) in recurrent ovarian, endometrial and triple negative breast cancer
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #391P
Turner N
BEECH: A randomised Phase 2 study assessing the efficacy of AKT inhibitor AZD5363 combined with paclitaxel in patients with ER+ve advanced or metastatic breast cancer, and in a PIK3CA mutant sub-population
Poster Discussion
Breast Cancer
Sunday 10th September, 09:15-10:45
Presentation Time: 09:55
Location: Sevilla Auditorium
Abstract #241PD
Lui JF
A pilot study to evaluate the feasibility, usability, and perceived satisfaction with eCO (eCediranib-Olaparib), a mobile application for side effect monitoring and reporting, in women with recurrent ovarian cancer
Poster
Ovarian Cancer
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #1560P
Nicum S
OCTOVA: A randomised Phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with BRCA-mutated platinum-resistant ovarian cancer
Poster
Ovarian Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #989TiP
Taylor J
N-DUR: Matched Pair Pharmacodynamics Study of Neoadjuvant Durvalumab in Combination with Chemotherapy in Frontline Ovarian Cancer
Poster
Ovarian Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #992TiP
Penson R
Efficacy of olaparib maintenance therapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by lines of prior chemotherapy: Phase III SOLO2 trial (ENGOT Ov-21)
Poster Discussion
Ovarian Cancer
Saturday 9th September, 09:15-10:45
Presentation Time: 09:15
Location: Cartagena Auditorium
Abstract #932PD
Dalvi T
BREAKOUT: a cross-sectional, prospective, observational study of germline BRCA mutation (gBRCAm) prevalence and real-world outcomes among patients (pts) with HER2-negative (HER2-ve) metastatic breast cancer (mBC)
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #316TiP
Shimomura A
Gene alteration in triple negative breast cancer patients in a phase I/II study of combination therapy with eribulin and olaparib
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #282P
Aogi K
Efficacy and safety of olaparib combined with eribulin in patients with advanced or metastatic triple negative breast cancer (TNBC) previously treated with anthracyclines and taxanes: the final analysis of a Japanese Phase I/II trial
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #251P
Robson ME
OlympiAD: Health-related quality of life (HRQoL) in patients with HER2-negative metastatic breast cancer (mBC) and a germline BRCA mutation (gBRCAm) receiving olaparib monotherapy vs standard single-agent chemotherapy treatment of physician’s choice (TPC)
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #290P

O’Connor M
Generation of a novel preclinical PK/PD model provides insights into PARP inhibitor clinical monotherapy activity
Poster
Women’s Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #393P
Tutt A
OlympiA: a randomized Phase III trial of olaparib as adjuvant therapy in patients with high-risk HER2-negative breast cancer (BC) and a germline BRCA1/2 mutation (gBRCAm)
Poster
Breast Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #216TiP
Sugiyama T
Japan CHARLOTTE: Characterizing the cross-sectional approach to ovarian cancer: Genetic testing of BRCA
Poster
Ovarian Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #984TiP
Oza A
Evaluation of tumour responses and olaparib efficacy in platinum-sensitive relapsed ovarian cancer (PSROC) patients (pts) with or without measurable disease in the SOLO2 trial (ENGOT Ov-21)
Poster
Ovarian Cancer
Saturday 9th September, 13:15-14:15
Location: Hall 8
Abstract #965P
Callens C
BRCA1&2 tumoral and germline status for ovarian cancer patients in first line setting within the PAOLA-01 trial
Poster Discussion
Ovarian Cancer
Saturday 9th September, 09:15-10:45
Location: Cartagena Auditorium
Abstract #935PD
Moore K
A Multicentre Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Poster
Ovarian Cancer
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #990TiP
Pjuade-Lauraine E
OReO/ENGOT Ov-38: A Phase IIIb trial of olaparib maintenance retreatment in patients with epithelial ovarian cancer
Poster
Ovarian Cancer
Saturday 9th September; 13:15-14:15
Location: Hall 8
Abstract #987TiP

Head and neck cancer

Cohen EE
Phase Ib/II Study (SCORES) Assessing Safety, Tolerability, and Preliminary Anti-tumor Activity of Durvalumab Plus AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Oral
Head and Neck Cancer
Monday 11th September, 11:00-12:30
Presentation Time: 11:15-11:30
Location: Madrid Auditorium
Abstract #1135O

Zandberg DP
Durvalumab for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): preliminary results from a single-arm, Phase II study
Oral
Head and Neck Cancer
Monday 11th September, 15:00-16:20
Presentation Time: 15:39-15:51
Location: Granada Auditorium
Abstract #1042O

Stokes M
Relationship between PD-L1 expression and survival in head and neck squamous cell carcinoma (HNSCC) patients (pts)
Poster Discussion
Head and Neck Cancer
Saturday 9th September, 14:45-16:15
Presentation Time: 15:07
Location: Alicante Auditorium
Abstract #1049PD
Pai S
Retrospective cohort study of PD-L1 expression in recurrent and/or metastatic squamous cell carcinoma of the head and neck (SUPREME-HN)
Poster Discussion
Head and Neck Cancer
Saturday 9th September, 14:45-16:15
Presentation Time: 15:07
Location: Alicante Auditorium
Abstract #1048PD
Even C
MEDINDUCTION: Phase I trial evaluating the safety of durvalumab in combination with Docetaxel, Cisplatin and 5-FU (DCF) in induction for locally advanced squamous cell carcinoma of the head and neck (SCCHN)
Poster
Head and Neck Cancer
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #1109TiP

Other cancers

Choueiri T
Savolitinib versus sunitinib in patients with MET-driven, unresectable and locally advanced or metastatic papillary renal cell carcinoma: SAVOIR, a randomised, Phase III trial
Poster
Urothelial Carcinoma (UC)
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #924TiP
Zheng Y
Modeling of Tumor Kinetics and Overall Survival to Identify Predictive Factors for Efficacy of Durvalumab in Patients with Urothelial Carcinoma (UC)
Poster
Urothelial Carcinoma (UC)
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #869P
Gonzalez-Cao M
A Phase II exploratory study of durvalumab (MEDI4736) in HIV-1 patients with advanced solid tumors
Poster
HIV
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #1208TiP
Wiester T
Comparison of continuous measures across diagnostic PD-L1 assays using image analysis
Poster
Biomarker Testing
Monday 11th September, 13:15-14:15
Location: Hall 8
Abstract #103P
Chen R
Efficacy and safety in first-line combined androgen blockade in advanced prostate cancer; a systematic review and meta-analysis
Poster
Prostate Cancer
Sunday 10th September, 13:15-14:15
Location: Hall 8
Abstract #805P

On August 31, 2017 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported that it had been notified by its partner, Janssen Biotech, Inc., that Janssen is terminating the collaboration and license agreement with MacroGenics relating to duvortuxizumab, a CD19 x CD3 DART molecule (Press release, MacroGenics, AUG 31, 2017, View Source [SID1234520350]). Enrollment of the Phase 1 dose-escalation study of this molecule is being discontinued.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Janssen reaffirmed its commitment to MGD015, also known as JNJ-9383, a second DART molecule licensed from MacroGenics. MGD015 is a preclinical program that targets CD3 and a non-disclosed cancer antigen expressed in hematological malignancies and lung cancer. Janssen has indicated that it anticipates initiating a first-in-human study with this molecule in 2018.

In the Phase 1 dose-escalation study of duvortuxizumab, multiple objective responses were observed in patients treated at various dosing levels tested. However, a number of patients experienced treatment-related neurotoxicity similar to that seen in patients treated with other CD19-targeted T-cell therapies. Given the recent advances in the highly competitive field for the treatment of B cell malignancies, the opportunity for development and commercialization has become less attractive.

"While this decision is disappointing, MacroGenics and its strategic partner, Janssen, continue to be fully committed to the DART platform and our ongoing collaboration on MGD015. Duvortuxizumab’s neurotoxicity profile is a CD19-targeting issue and has not been observed in our other DART clinical programs," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Given our large portfolio of product candidates currently being pursued, it is unlikely that we will continue development of this molecule at this time."