AstraZeneca Presents Imfinzi (durvalumab) Plus tremelimumab Combination Data at AACR Annual Meeting


Phase Ib Study 006 long-term follow-up shows clinical activity in PD-L1 greater than or equal to 25% and less than 25% groups in 2nd-line non-small cell lung cancer

Phase I Study 10 data shows clinical activity with combination treatment in 2nd-line metastatic urothelial carcinoma

CAMBRIDGE, United Kingdom, April 16, 2018 (GLOBE NEWSWIRE) -- AstraZeneca and MedImmune, its global biologics research and development arm, today presented efficacy and safety data from two Phase I trials evaluating Imfinzi (durvalumab) in combination with tremelimumab in 2nd-line immunotherapy-naïve patients with either non-squamous advanced non-small cell lung cancer (NSCLC) (Study 006) or metastatic urothelial carcinoma (mUC) (Study 10).1,2 The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2018.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The mature data sets from these Phase I trials help further characterise the overall survival of durvalumab plus tremelimumab combination in 2nd-line non-squamous non-small cell lung cancer and 2nd-line metastatic urothelial carcinoma. We look forward to exploring whether OS is distinguished from durvalumab monotherapy in our Phase III MYSTIC and DANUBE trials, expected to read out later this year and next year, respectively."

Study 006: Safety and activity of 2nd-line  durvalumab   + tremelimumab in non-squamous advanced NSCLC
The Study 006 long-term follow-up results showed clinical activity in both PD-L1 greater than or equal to 25% and less than 25% groups.1 Tumour PD-L1 expression was assessed with the Ventana PD-L1 (SP263) assay, PD-L1 cut-off: greater than or equal to 25% of tumour cells with membrane staining.1 The table below shows anti-tumour activity and survival by PD-L1 status.1

Response and survival PD-L1 greater than or equal to 25%
N = 57
PD-L1 less than 25%
N = 136
Total a
N = 213
Complete Response (CR) 1 (1.8) 0 1 (0.5)
Partial Response (PR) 19 (33.3) 16 (11.8) 39 (18.3)
Stable Disease (SD) 17 (29.8) 55 (40.4) 77 (36.2)
Progressive Disease (PD) 16 (28.1) 52 (38.2) 77 (36.2)
Confirmed  Objective Response Rate (ORR) 
(CR + PR)

n (%)
95% CI
 20 (35.1)
16 (11.8)
40 (18.8)
Duration of Response (DOR) 
Median, weeks
95% CI
Median, months
95% CI
12-month OS, % 
95% CI
Note: Investigator-assessed anti-tumour activity according to RECIST v1.1. NE, not estimable.
a20 patients had unknown PD-L1 expression

The combination of durvalumab and tremelimumab demonstrated a manageable safety profile in patients with advanced NSCLC.1 The most common treatment-related adverse events (AEs) were fatigue (19%), pruritus (17%), diarrhoea (15%), reduced appetite (14%) and rash (14%).1 14 patients (7%) experienced a treatment-related AE that led to treatment discontinuation, and 23% experienced a Grade 3/4 treatment-related AE.1 There was one treatment-related death (multifactorial hypoxia).1

Study 10:  durvalumab   + tremelimumab in patients with metastatic urothelial cancer
The combination of durvalumab plus tremelimumab showed clinical activity in previously treated mUC, regardless of PD-L1 status.3 Tumour and immune-cell PD-L1 expression was assessed with the Ventana PD-L1 (SP263) assay, PD-L1 cut-off: greater than or equal to 25% of tumour and immune cells with membrane staining.2 The table below shows anti-tumour activity and survival by PD-L1 status.3

Response and survival PD-L1 greater than or equal to 25%
PD-L1 less than 25%
Confirmed Objective Response Rate (ORR)
(CR+PR) (95% CI), %
29.4 (19.0-41.7) 15.1 (8.3-24.5) 14.3 (1.8-42.8) 20.8 (15.0-27.8)
Ongoing ORR, % 60.0 92.3 100 74.3
Disease Control Rate (DCR)
(CR+PR+SD greater than or equal to 24 weeks) (95% CI), %
32.4 (21.5-44.8) 24.4 (15.8-34.9) 42.9 (17.7-71.1) 29.2 (22.4-36.7)
Median PFS, months (95% CI) 
PFS 6-month rate
3.5 (1.9-3.7) 
1.8 (1.8-1.9) 
4.9 (1.8-NE) 
1.9 (1.8-3.4) 
Median OS, months (95% CI) * 
OS 6-month rate
18.9 (8.1-NE) 
8.0 (4.8-10.0) 
16.4 (7.3-16.4) 
9.5 (8.1-18.9) 
NE = not estimable
*Should be interpreted with caution due to limited follow-up at data cut-off

The combination of durvalumab and tremelimumab demonstrated a manageable safety profile in patients with mUC.2 Treatment-related AEs occurred in 76% of patients and were Grade 3-4 in 29%.2 The most common treatment-related AEs were pruritus (26%), fatigue (24%), diarrhoea (20%), rash (14%) and increased lipase (12%). Treatment-related AEs led to discontinuation of therapy in 12% of patients.2 There was one treatment-related death (pulmonary haemorrhage).2


For more information on AstraZeneca at AACR, please visit

About Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.4-7

In February 2018, durvalumab received US FDA approval for the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Durvalumab also received accelerated approval in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma, 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.8

As part of a broad development programme, durvalumab is also being investigated as a monotherapy and/or in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody, as a first line treatment for patients with NSCLC, small cell lung cancer, locally advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumours.9

About tremelimumab
Tremelimumab is an investigational human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer.10-12 Tremelimumab is being investigated in an extensive clinical trial programme in combination with durvalumab, in NSCLC, locally-advanced or metastatic urothelial carcinoma, head and neck cancer, liver cancer and blood cancers.9

About AstraZeneca's Approach to Immuno-Oncology
Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body's immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the clear majority of patients.

We are pursuing a comprehensive clinical-trial programme that includes durvalumab (anti-PD-L1) as monotherapy and in combination with tremelimumab (anti-CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our Oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.

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 growth platform 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.

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 commercialisation of small-molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory; Cardiovascular, Renal & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca's three global R&D centres, with additional sites in Cambridge, UK, and Mountain View, CA. For more information, please visit

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company is also 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 and follow us on Twitter @AstraZeneca.

Intended audiences
This press release is issued from AstraZeneca Corporate Headquarters in Cambridge, UK and is intended to provide information about our global business for health specialist or medical media. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where AstraZeneca conducts business.


Karen Birmingham   +44 203 749 5634
Eleanor Duff   +1 301 398 0967
Hugues Joublin   +1 301 398 3041


  1. Chaft, J et al. Safety and activity of second-line durvalumab + tremelimumab in non-squamous advanced NSCLC. To be presented at AACR 2018, April 14-18, 2018. Chicago, IL.
  2. Balar, A et al. Durvalumab + tremelimumab in patients with metastatic urothelial cancer. To be presented at AACR 2018, April 14-18, 2018. Chicago, IL.
  3. Balar, A et al. "Durvalumab + tremelimumab in patients with metastatic urothelial cancer." Abstract. To be presented at AACR 2018, April 14-18, 2018. Chicago, IL.
  4. Stewart R, et al. Identification and Characterization of MEDI4736, an Antagonistic Anti-PD-L1 Monoclonal Antibody. Cancer Immunol Res; 2015. Published OnlineFirst May 5, 2015; doi: 10.1158/2326-606.
  5. Patel S P and Kurzrock R. PD-L1 Expression as a Predictive Biomarker in Cancer Immunotherapy. Mol Cancer Ther; 14(4) April 2015:847-856.
  6. Haile S et al. Tumor Cell Programmed Death Ligand 1-Mediated T Cell Suppression Is Overcome by Coexpression of CD80. J Immunol 2011; 186: 6822-6829.
  7. Haile S et al. Soluble CD80 Restores T Cell Activation and Overcomes Tumor Cell Programmed Death Ligand 1-Mediated Immune Suppression. J Immunol 2013; 191: 2829-2836.
  8. US FDA. US Imfinzi (durvalumab) prescribing information. February 2018.
  9. AstraZeneca. Clinical Trials Appendix Full-year and Q4 2017 Results Update. Available at: Accessed Apr. 2018
  10. Bograd AJ, et al. Immune responses and immunotherapeutic interventions in malignant pleural mesothelioma. Cancer Immunol Immunother. 2011;60(11):1509-27.
  11. Lee et al. Novel antibodies targeting immune regulatory checkpoints for cancer therapy. Br J Clin Pharmacol. 2013;76(2):233-47.
  12. Eroglu, et al. Long term survival with cytotoxic T lymphocyte-associated antigen 4 blockade using tremelimumab. Eur J Cancer. 2015;51(17):2689-97

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: AstraZeneca via Globenewswire




Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

eGain Enables Conversational Customer Service Through Apple Business Chat20.7.2018 12:30Pressmeddelande

SUNNYVALE, Calif. and NEWBURY, United Kingdom, July 20, 2018 (GLOBE NEWSWIRE) -- eGain (NASDAQ:EGAN), the leading provider of cloud-based customer engagement solutions, today announced its integration with Apple Business Chat. According to Gartner, requests for customer support through consumer mobile messaging apps will exceed requests for customer support through traditional social media by 2019*. Moreover, 56% of consumers surveyed in a Nielsen study would rather message a business than call customer service, and 67% expect to message businesses even more over the next two years. Key capabilities Among key capabilities of the integrated solution are: Enabling hundreds of millions of consumers on iPhone and iPad to interact with businesses through the Messages app Leverage eGain AI to infer customer intent, power bot conversations through messaging, route escalations to contact center agents, and guide agents through messaging conversations Provide immersive customer experiences with

Marcus Hiles - Texas Takes #1 Four Years in a Row in America's Top States for Business19.7.2018 23:39Pressmeddelande

DALLAS, July 19, 2018 (GLOBE NEWSWIRE) -- The future business scene in Texas is looking brighter than ever as the state continues to hold its place as a national leader. Growth is spreading across areas such as North Texas, Houston and San Antonio with businesses quickly expanding their operations in the state that offers some of the best in business-friendly climates and overall growth potential. Tapping into the market recently are global leaders such as Toyota, Liberty Mutual and JP Morgan who have taken advantage of the state's increasing network of commercial properties, workforce and business resources. Named by CNBC for the fourth consecutive year as America's Top State for Business, Texas scored above all 50 states on overall business competitiveness. With the business hub building on its role as a national leader for the past decade, this top rank title reflects the progress Texas has made in cementing its place in the global economy. "This national recognition comes without s

Second Quarter 2018 Results Conference Call19.7.2018 21:34Pressmeddelande

AURORA, Ontario, July 19, 2018 (GLOBE NEWSWIRE) -- Magna International Inc. (TSX:MG) (NYSE:MGA) SECOND QUARTER 2018 RESULTS CONFERENCE CALL WEDNESDAY - AUGUST 8th, 2018 7:30 AM ET DIAL IN NUMBERS North America Toll Free: International Toll: Webcast: 1-888-223-4641 1-416-981-9080 Slide presentation will be available on our website prior to the call. REBROADCAST INFORMATION Replay available 2 hours after the call until August 15, 2018 North America Toll Free: International Toll: Reservation No.: 1-800-558-5253 1-416-626-4100 21892829 INVESTOR CONTACT Louis Tonelli, Vice-President, Investor Relations, 905-726-7035 TELECONFERENCE CONTACT Nancy Hansford, Executive Assistant, Investor Relations, 905-726-7108 This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients. The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originali

Uganda National Airlines Company Limited Signs Firm Order for Four Bombardier CRJ900 Aircraft19.7.2018 18:36Pressmeddelande

First operator of the new CRJ Series ATMOSPHÈRE cabin in Africa MONTREAL, July 18, 2018 (GLOBE NEWSWIRE) -- Bombardier Commercial Aircraft announced today that it has signed a firm order for four new CRJ900 regional jets with Uganda National Airlines Company. Based on the list price for the CRJ900 aircraft, the firm order is valued at approximately US$190 million. "We congratulate the Government of Uganda for the revival of its national flag carrier, and are thrilled that the new airline has selected Bombardier and the CRJ900 regional jets for its upcoming debut," said Jean-Paul Boutibou, Vice President, Sales, Middle-East and Africa, Bombardier Commercial Aircraft. "Recognized for its superior economics and efficiency, the CRJ Series aircraft have enabled airlines worldwide to serve communities with better connectivity, and we look forward to supporting the development of Uganda's regional air travel with these CRJ900 regional jets." Uganda Airlines will operate the CRJ900 in dual-cla

CrownBio Supports Excellence in Translational Research with Grant Award that Funds Innovative PDX Model Development in Immuno-Oncology19.7.2018 15:03Pressmeddelande

"Cancer Research Center of Lyon iPS novel PDX models formulate new immune cell focused strategies" SAN DIEGO, July 19, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, is proud to announce the award of its Patient-Derived Xenograft (PDX) grant program to doctors Fabrice Lavial, Christophe Caux and Bertrand Dubois from the Cancer Research Center of Lyon (CRCL). The grant program was established to support oncology researchers pursuing scientific advancements in cancer using PDX technology. Following an extensive review, CrownBio's Scientific Steering Committee selected Dr. Lavial and his colleagues at the CRCL due to their project's potential to create breakthroughs in preclinical oncology strategies. Their research combines PDX and iPS cell technologies to create patient-specific, humanized models. These unique models wil

Jumio Introduces Liveness Detection for Web to Better Deter Fraud During Account Onboarding19.7.2018 14:00Pressmeddelande

New identity proofing functionality ensures that the person behind a Web upload verification is present and the person actually creating a new online account PALO ALTO, Calif., July 19, 2018 (GLOBE NEWSWIRE) -- Jumio, the creator of Netverify(TM) Trusted Identity as a Service (TIaaS), today announced the addition of Liveness Detection for Web to better thwart fraudsters' evolving and sophisticated attempts to assume another individual's identity. With identity verification, Jumio's approach is to first verify the government-issued ID (e.g., driver's license, passport or ID card) and ensure that it is authentic and has not been doctored. For mobile SDK customers, Jumio then requires the user to take a selfie which enables the company to compare the person in the selfie to the person pictured in the ID document. Since Netverify is an omnichannel solution, Jumio also supports identity verification via desktop webcams. This channel enables our customers to reach large market segments who a

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum