LONDON, 2-6-2015 — /EuropaWire/ — AstraZeneca and MedImmune, the company’s global biologics research and development arm, today presented encouraging results from their novel combination-focused immuno-oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015.
Overall, data indicated clinical activity with manageable safety profiles for the anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody MEDI4736, both as monotherapy and in combination with other immuno-oncology and small molecule therapies across different tumour types and tumour biology.
MEDI4736 and tremelimumab combination shows clinical activity and tolerability in both PD-L1 positive and PD-L1 negative advanced non-small cell lung cancer (NSCLC) patients; dose confirmed for future studies
Results from the combination study of MEDI4736 and tremelimumab, a cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody, in the treatment of advanced NSCLC demonstrated clinical activity in heavily-pretreated patients with a manageable safety profile, establishing appropriate doses to move forward into Phase III combination trials.
MEDI4736 and tremelimumab target two different tumour escape pathways; engaging the immune system to fight the cancer’s immune-evading tactics and maintaining tumour specific T-cell responses.
Data from the Phase Ib open label, dose escalation study of patients with advanced NSCLC, showed that the combination of the PD-L1 and CTLA-4 blockade helped to increase response rates in both PD-L1 biomarker positive and negative patients. 63 patients with 16 weeks or more of follow up were evaluable for clinical activity, 102 patients were evaluated for safety. Notably, the data demonstrated specific clinical activity and tolerability in PDL-1 negative patients, who make up approximately 70% of NSCLC patients and who are less likely to respond to monotherapy. In the PD-L1 negative patient subset, overall response rate (ORR) was 27% (9/33) and disease control rate (DCR) – defined as complete response (CR), partial response (PR) or stable disease (SD) for 16 weeks or more – was 48% (16/33). Overall, nearly half of patients in the study achieved a partial response or stable disease, with ORR of 27% (17/63) and DCR of 41% (26/63). (Antonia et al, abstract #3014).
Overall adverse events (AEs) were manageable and generally reversible using standard treatment guidelines. The most frequently reported treatment related grade 3/4 AEs across all dose cohorts were colitis, diarrhea, elevated lipase and elevated liver function tests. 20/102 patients discontinued the study due to drug-related AEs in this heavily-pretreated disease setting.
The combination data presented at ASCO builds on preliminary results from 18 patients presented at the European Society of Medical Oncology Congress in September 2014.
“The maturing data presented today on the combination of MEDI4736 and tremelimumab are truly exciting – we are starting to see the potential of combination therapy become a reality,” said Dr. Ed Bradley, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune. “We are particularly encouraged by the data indicating that these complementary agents can be combined to increase T-cell activity and improve the clinical activity among the broader patient population of non-small cell lung cancer patients whose tumours are PD-L1 negative and are therefore in need of better treatments.”
A range of doses were identified that provided clinical benefit with acceptable tolerability, with a specific dose and schedule of MEDI4736 20mg every four weeks (12 total doses) and tremelimumab 1mg/kg every four weeks (four total doses) selected for future Phase III combination trials in NSCLC. This decision was supported by data from the trial, which evaluated key indicators of best outcomes for patients (clinical efficacy, tolerability and biologic activity) to ensure that each molecule contributes optimally in the combination. Data indicated that the selected dose of tremelimumab is well tolerated and enhances clinical activity as efficaciously as the other doses studied.
Bahija Jallal, Executive Vice President, MedImmune, said: “We are encouraged by the immunotherapy data being presented here at ASCO 2015, but this is just the tip of the iceberg as we continue to follow the science and build on the diversity of our portfolio with smart combinations. We believe the most powerful combinations will likely target multiple mechanisms in the immune system where cancer wages its battles – T-cell activation, antigen presentation and innate immunity, and the tumour microenvironment. AstraZeneca and MedImmune are uniquely positioned to lead in this area, through our biologics and small molecule portfolio and through targeted collaborations, which allow us to explore novel combinations across this cycle of anti-tumour immunity.”
The study design for the ongoing Phase III ARCTIC trial, designed to evaluate the efficacy and safety of the combination of MEDI4736 and tremelimumab in NSCLC patients with PD-L1-negative tumours, as well as MEDI4736 versus standard of care in NSCLC patients with PD-L1-positive tumours, was also presented at ASCO. (Planchard et al, abstract #TPS8104) A Phase II study of MEDI4736 and tremelimumab as monotherapies and in combination in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN) was also recently started.
Data reinforce the potential of MEDI4736 as a cornerstone for combinations with other immunotherapies and small molecule treatments in multiple tumour types
Other data at ASCO underpinned the potential for MEDI4736 in combination with other immuno-oncology and small molecules in melanoma and lung cancer:
- Preliminary results from the first ever Phase I triple combination study of MEDI4736 with BRAF (dabrafenib) and/or MEK (trametinib)1 inhibitors in patients with advanced melanoma showed clinical activity with acceptable tolerability, with all three agents at full doses. In patients with advanced BRAF-mutation positive melanoma, confirmed partial responses were seen in 69% of patients (18/26) receiving MEDI4736 plus dabrafenib and trametinib. The disease control rate (CR, PR or SD) was 100% and 89% of responding patients (16/18) had ongoing responses after a median follow-up duration of 7.1 months. Overall, AEs were consistent with the known safety profiles of the combination components, and no exacerbation of immune-related AEs was apparent. (Ribas et al, Abstract #3003; Oral Abstract Session: Developmental Therapeutics – Immunotherapy, Monday, June 1, 2:15 pm)
- Dose escalation data from a Phase I study of MEDI4736 in combination with Iressa (gefitinib), AstraZeneca’s epidermal growth factor receptor (EGFR) mutation positive tyrosine kinase inhibitor (TKI) in advanced NSCLC showed that treatment was generally well tolerated, with early treatment activity in heavily pre-treated patients. (Creelan et al, abstract #3047)
- Preliminary results from TATTON, a multi-arm Phase Ib trial of AZD9291 combined with MEDI4736, AZD6094 or selumetinib in EGFR-mutant lung cancer patients who have progressed following therapy with an EGFR-TKI, indicated that MEDI4736 and AZD9291 were tolerated at their Phase III doses in the combination arm. (Oxnard et al, Poster #2509)
MEDI4736 monotherapy: data indicate durable responses in multiple tumour types
Increasingly mature data from an ongoing Phase I/II, multicentre, open-label study of MEDI4736 in patients with solid tumours continue to demonstrate durable anti-tumour activity and a manageable safety profile. Analysis of data from 200 response evaluable patients with NSCLC treated with MEDI4736 and with 12 weeks or more of follow-up showed ORR of 16% (27% in PD-L1 positive patients), and DCR (CR, PR or SD for 12 weeks or more) of 42% (48% in PD-L1 positive). ORR was higher in patients with squamous (21%) than non-squamous (13%) disease. Responses were durable with 66% (21/32) ongoing. Drug-related AEs at grade 3 or higher were reported in 8% of patients. (Rizvi et al, Poster #340).
Additional results were also presented on MEDI4736 monotherapy in patients with SCCHN. Of 62 response evaluable patients with 24 weeks or more of follow up, ORR was 11% (18% in PD-L1 positive patients), and DCR (CR, PR or SD for 24 weeks or more) was 15% (18% in PD-L1 positive patients). Responses are ongoing in 71% (5/7) of responding patients. Drug related AEs at grade 3 or higher were reported in 10% of patients. (Segal et al, Poster #337)
Positive progress with companion diagnostic test to help identify patients who are more likely to respond to MEDI4736, reinforcing personalised healthcare approach
A PD-L1 companion diagnostic test that is being developed jointly by Ventana Medical Systems and MedImmune has demonstrated robust, reproducible results as a biomarker to predict response to MEDI4736. Three separate pathologist reviews of 81 patients with NSCLC and 100 patients with SCCHN from MEDI4736 clinical trials showed an overall accuracy of 97% and 91% in the NSCLC and SCCHN samples respectively. The consistency of the results across the pathologist reviews shows that the selected scoring algorithm is precise, reproducible and practical in the clinical setting. In the MEDI4736 monotherapy trials, both NSCLC and SCCHN patients identified as PD-L1 positive by the scoring algorithm had a higher response to MEDI4736 than those identified as PD-L1 negative. (Rebelatto et al, abstract #8033)
NOTES TO EDITORS
1 Novartis medicines for treatment of patients with metastatic melanoma.
About AstraZeneca in Oncology
Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the Company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one-day eliminate cancer as cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.
Our broad pipeline of next-generation investigational medicines is focused on four main disease areas – ovarian, lung, breast, and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.
About MedImmune
MedImmune is the worldwide biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres. For more information, please visit www.medimmune.com.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.
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- Pierre Koukjian et Cédric Koukjian, Duo de designers en collaboration avec Bulgari
- Former Duff & Phelps EMEA Leader Yann Magnan joins 73 Strings as Co-founder and CEO
- Concern for the oceans drives consumers to 'vote with their forks' for sustainable seafood
- Digi Communications N.V.: Exercise of stock option by Marius Catalin Vărzaru, a Non-Executive Director and VP of the Board of Directors of the Company
- SecurLine Certified to Protect Classified Communications
- Digi Communications N.V. announces that a stock option programme was approved for employees and managers of the Romanian Subsidiary of the Company
- Digi Communications NV announces the exercise of stock options by the Executive Directors of the Company
- Matvil Corp. продолжает бороться с противозаконными действиями юридической системы Молдовы
- Digi Communications NV announces the release of the Q1 2020 Financial Results
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the general shareholders’ meeting approval from 30 April 2020
- MEDIS medical imaging systems acquires Advanced Medical Imaging Development S.r.l. (AMID) and secures further investment from Van Herk Ventures
- Digi Communications NV announces Investors Call on the Financial Results for Q1 2020
- Digi Communications N.V. announces the availability of the instructions on the 2019 share dividend payment
- Mono Solutions hires Chief Product Officer
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 27 – 30 Apr 2020
- Digi Communications N.V.: GSM resolutions from 30 Apr 2020 approving, amongst others, the 2019 Annual Accounts; availability of the adopted Annual Financial Report for the year ended Dec 31, 2019 for the Group
- RCH Embark on Lasting Partnership with Culinary Institute JRE
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 20 – 24 Apr 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 13 – 17 Apr 2020
- COVID-19: Digi Communications N.V. recommendation regarding participation of shareholders to the AGM convened for 30 April 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 6 – 10 Apr 2020
- DIGI COMMUNICATIONS N.V.: Exercise of stock option by a Non-Executive Director of the Company
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 30 Mar – 3 Apr 2020
- Chief Commercial Officer joins Mono Solutions
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 23 – 27 Mar 2020
- Digi Communications N.V. reports the admission to trading on the regulated market operated by the Irish Stock Exchange plc (trading as Euronext Dublin) of the senior secured notes issued by RCS & RDS S.A., its Romanian subsidiary
- Delft University of Technology Purchases its Second WebClip2Go Video Production System
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 16 – 20 Mar 2020
- Integrated Services Monitoring Capability Launched by Bridge Technologies
- Digi Communications N.V. announces Convocation of the Company’s general shareholders meeting for 30 April 2020 for the approval of, among others, the 2019 Annual Report and of the 2019 Financial Statements
- Digi Communications N.V. announces The Hungarian Competition Council’s decision to issue a new decision approving the Invitel transaction
- Digi Communications N.V. announces Business continuity in light of the novel coronavirus (“COVID-19”) outbreak
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 9 – 13 Mar 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in February 2020 or in other period but effective in February 2020, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 2 – 6 Mar 2020
- « La levée du pilon sur la plate-forme » peut faire la différence entre le saint et l’ordinaire
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 24 – 28 Feb 2020
- EH GROUP ENGINEERING awarded EU Horizon 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 17 – 21 Feb 2020
- Digi Communications NV announces the release of the Preliminary Financial Results for year ended 31 December 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 10 – 14 Feb 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in January 2020 or in other period but effective in January 2020, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Digi Communications NV announces Investor Call on the Preliminary Financial Results for the year ended 31 December 2019
- Consolidation Looms for Fast-Growing Customer Data Platform Industry: CDP Institute Report
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 3–7 Feb 2020
- Digi Communications N.V. hereby reports successful closing of the offering of senior secured notes by RCS & RDS S.A., its Romanian subsidiary
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 27 – 31 Jan 2020
- Digi Communications N.V.: Independent Limited Assurance Report issued by the external auditor on 30 Jan 2020 regarding the information included in the current reports under Law 24/2017 (Article 82) and FSA Regulation no. 5/2018
- Digi Communications N.V.: Rectification of the report published on 15 Jan 2020, regarding legal documents concluded by DIGI COMMUNICATIONS N.V. in other periods but effective in Dec 2019, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Digi Communications N.V. reports the upsize and successful pricing of the offering of senior secured notes by RCS & RDS S.A., its Romanian subsidiary
- RCH To Present New Smart ECR, Robust and Vintage POS Systems at EuroShop 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 20 – 24 Jan 2020
- Digi Communications N.V.: (i) launch of an offering by RCS & RDS S.A. of senior secured notes; (ii) issuance of a notice of conditional full redemption of all outstanding €550.0m 5.0% senior secured notes due 2023 issued by the Company and (iii) restatement by the Company of its unaudited interim condensed consolidated financial statements for the 9-month period ended 30 Sep 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 13 – 17 Jan 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in December 2019 or in other period but effective in December 2019, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 6 – 10 Jan 2020
- Berlin-based SuitePad named Best Places to Work in Hotel Tech 2020 category at HotelTechReport.com’s HotelTechAwards
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 30 Dec 2019 – 3 Jan 2020
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