NASDAQ OMX

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

Dela

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)
22.9-48.9
16 (11.8)
6.9-18.4
40 (18.8)
13.8-24.7
Duration of Response (DOR) 
Median, weeks
95% CI
 51.7
25.1-NE
NR
24.3-NE
51.7
40.3-NE
PFS
Median, months
95% CI
 7.1
3.4-9.2
 3.3
1.7-3.5
 3.5
1.8-4.0
OS
12-month OS, % 
95% CI
71.6
57.3-81.9
 47.3
38.2-55.9
 53.8
46.4-60.6
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%
(n=68)
PD-L1 less than 25%
(n=86)
PD-L1
unknown
(n=14)
Total
(N=168)
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) 
26.1
1.8 (1.8-1.9) 
22.6
4.9 (1.8-NE) 
38.5
1.9 (1.8-3.4) 
25.4
Median OS, months (95% CI) * 
OS 6-month rate
18.9 (8.1-NE) 
66.4
8.0 (4.8-10.0) 
51.9
16.4 (7.3-16.4) 
91.7
9.5 (8.1-18.9) 
60.9
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

NOTES TO EDITORS

For more information on AstraZeneca at AACR, please visit www.twitter.com/AstraZeneca.

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 www.medimmune.com.

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 www.astrazeneca.com 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.

CONTACTS

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

References

  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: https://www.astrazeneca.com/content/dam/az/PDF/2017/Full-Year/Full-Year%202017%20Results%20Clinical%20trials%20appendix.pdf. 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

Om

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

Immunicum AB (publ) Announces Appointment of Pawel Kalinski and Inge Marie Svane to Scientific Advisory Board17.9.2018 08:00Pressmeddelande

Press Release 17 September 2018 Immunicum AB (publ) Announces Appointment of Pawel Kalinski and Inge Marie Svane to Scientific Advisory Board Immunicum AB (publ; IMMU.ST) announced today the appointment of leading oncology experts to its Scientific Advisory Board with the addition of Pawel Kalinski, MD, PhD, Vice Chair for Translational Research within the Department of Medicine at Roswell Park Comprehensive Cancer Center, and Inge Marie Svane, MD, PhD, Professor, Head of the Clinical Cancer Research programme, Faculty of Health Sciences, University of Copenhagen, Director, Centre for Cancer Immunotherapy (CCIT), and consultant in Oncology, Herlev University Hospital. Both Scientific Advisory Board members will serve as a strategic resource to Immunicum as the company continues to advance the clinical development of its lead product, ilixadencel. "We are honored to have such highly specialized experts in the field of immuno-oncology and cell therapy join our Scientific Advisory Board a

Immunicum AB (publ) meddelar att Pawel Kalinski och Inge Marie Svane har valts in i det vetenskapliga rådet17.9.2018 08:00Pressmeddelande

Pressmeddelande 17 september 2018 Immunicum AB (publ) meddelar att Pawel Kalinski och Inge Marie Svane har valts in i det vetenskapliga rådet Immunicum AB (publ; IMMU.ST) meddelade i dag att två ledande immun-onkologiska experter har valts in i bolagets vetenskapliga råd för att fungera som strategiska resurser för Immunicum under bolagets fortsatta kliniska utveckling av sin ledande produkt, ilixadencel. Pawel Kalinski, MD, PhD, vice ordförande för translationell forskning vid den medicinska institutionen vid Roswell Park Comprehensive Cancer Center, och Inge Marie Svane, MD, PhD, professor, chef för det kliniska cancerforskningsprogrammet på medicinska fakulteten vid Köpenhamns universitet, chef för Center för cancerimmunterapi (CCIT) samt överläkare inom onkologi, Herlevs universitetssjukhus har valts in i rådet. - Vi är hedrade att ha experter med specialistkompetens inom området immunonkologi och cellterapi i vårt vetenskapliga råd, vilka kan erbjuda ytterligare vägledning när det

Hoylu AB: HOYLU HIRES NEW CTO, SATOSHI NAKAJIMA AND ANNOUNCES EXPANSION INTO JAPAN14.9.2018 08:30Pressmeddelande

Malmo, Sweden, September 14, 2018 - Hoylu, a leading enterprise collaboration company, announced today Satoshi Nakajima will join Hoylu in the newly created position, as Chief Technology Officer and President of Hoylu Japan. Nakajima will guide the strategic technology direction and innovation of Hoylu while also leading the new Hoylu office in Tokyo, Japan. "Satoshi is a visionary and world-class technologist who has substantial experience in delivering world class innovations. He is joining the Company as we are extending our reach and expanding into Japan," said Stein Revelsby, CEO. "Satoshi's extensive experience in strategy and delivering technology that support a great user experience will make an immediate impact on the company." Nakajima will serve as President of Hoylu Japan and will report to Stein Revelsby. His leadership will strengthen customer relations and help develop new business among emerging and established Japanese companies while strengthening the global position

Hoylu AB: HOYLU ANSTÄLLER SATOSHI NAKAJIMA SOM NY CTO OCH EXPANDERAR TILL JAPAN14.9.2018 08:30Pressmeddelande

Malmö, Sverige, 14 september 2018 - Hoylu, ett ledande företag inom samarbetsmjukvara för företagsmarknaden annonserar idag att Satoshi Nakajima tar anställning som CTO (Chief Technology Officer) och President för Hoylu Japan. Nakajima kommer styra den strategiska inriktningen för företagets produkter och leda innovationsarbetet. Han kommer också leda Hoylus nyöppnade kontor i Tokyo, Japan. Satoshi är en visionär teknologiexpert som har stor erfarenhet av att skapa innovativa lösningar. Han kommer till Hoylu samtidigt som vi utökar marknaden till att även täcka in Japan säger Stein Revelsby, VD. "Satoshis långa och gedigna erfarenhet i strategiska frågor och tekniska lösningar med fokus på användarupplevelse kommer få stor betydelse för oss." Nakajima kommer även att bli President för Hoylu Japan och kommer rapportera till Stein Revelsby. Hans ledarskap kommer stärka existerande kundrelationer och utveckla nya affärer på den japanska marknaden och samtidigt bidra till att flytta fram p

LeoVegas AB: LeoVentures invests in esports betting - Pixel.bet13.9.2018 08:45Pressmeddelande

The LeoVegas Group, through its wholly owned investment company LeoVentures Ltd, has acquired 51% of the shares in Pixel Holding Group Ltd, which runs the esports betting operator Pixel.bet. The investment amounts to EUR 1.5 million for 51 percent of the company and is made through a new issue. Pixel.bet's vision is to create the greatest gaming experience in betting on esports www.pixel.bet "Esports is an international and fast-growing area that engages millions of viewers and players every month. With this investment in Pixel.bet we as a Group will gain unique insight into a new and fast-growing segment," comments Gustaf Hagman, LeoVegas' Group CEO and co-founder of LeoVegas Mobile Gaming Group. "In Pixel.bet we have found a passionate team of entrepreneurs who come from the esports community. With its strong technology and mobile-first gaming experience, Pixel.bet is a perfect match for the LeoVegas Mobile Gaming Group. Together we will drive development for the absolute premier exp

LeoVegas AB: LeoVentures investerar i esport betting - Pixel.bet13.9.2018 08:45Pressmeddelande

LeoVegas-koncernen har, genom sitt helägda investmentbolag LeoVentures Ltd förvärvat Pixel Holding Group Ltd, som driver esport betting operatören pixel.bet. Investeringen uppgår till 1,5 miljoner euro för 51 procent av bolaget och görs genom en nyemission. Pixel.bets vision är att skapa den främsta spelupplevelsen inom betting på esport www.pixel.bet "Esport är ett internationellt och snabbt växande område som engagerar miljontals tittare och utövare varje månad. Med investeringen i Pixel.bet får vi som koncern en unik inblick i ett nytt och snabbt växande segment.", säger Gustaf Hagman, Group CEO och co-founder av LeoVegas Mobile Gaming Group. "I Pixel.bet fann vi ett passionerat entreprenörsteam som verkligen kommer inifrån esport communityn. Med en riktigt bra teknik och spelupplevelse utvecklad mobile-first är det en perfekt match med LeoVegas Mobile Gaming Group. Tillsammans ska vi driva utveckling för den absolut främsta upplevelsen inom esport betting.", säger Robin Ramm-Ericso

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

Besök vårt pressrum