On August 24, 2022 Ranok Therapeutics, a clinical-stage biopharmaceutical company that is developing a novel approach to targeted protein degradation for the treatment of cancer and other serious diseases, reported the initiation of patient dosing in the U.S. for a Phase 1/2 study of RNK05047 (Press release, Ranok Therapeutics, AUG 24, 2022, View Source [SID1234618616]). The trial, entitled CHAMP-1, will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RNK05047 in patients with advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Ranok anticipates preliminary data from the study in the second half of 2023.

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"RNK05047 is Ranok’s first therapy based on our proprietary CHAMP technology, as well as the first BRD4 protein degrader in the pharmaceutical industry to enter clinical testing," said Weiwen Ying, Ph.D., Founder and Chief Executive Officer of Ranok. "RNK05047 is designed to selectively degrade BRD4 protein preferentially in tumors, thereby improving safety and efficacy, which differentiates it from other investigational therapies such as non-selective BET inhibitors."

"The BET bromodomain transcription factor BRD4 is a master regulator of oncogenes involved in diverse cancer types," said Manuel Hidalgo Medina, M.D., Ph.D., Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center, Associate Director of Clinical Services at the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and a site Principal Investigator in the trial. "We are pleased to be participating in this trial and are hopeful that RNK05047 will provide a beneficial new therapeutic option for patients."

Additional information on this clinical trial (NCT05487170) can be found at www.clinicaltrials.gov.

About Ranok’s CHAMP platform

Ranok’s proprietary Chaperone-mediated Protein Degradation/Degrader (CHAMP) platform and Chaperone-Tether Library are based on our founders’ extensive backgrounds researching protein homeostasis. CHAMP technology takes advantage of the cellular chaperone network, which regulates the folding and stability of proteins, distinguishing it from other targeted protein degradation approaches. CHAMP has a number of unique advantages, such as the evasion of mechanisms of drug resistance, and is designed to improved safety and efficacy due to the selective targeting of disease tissues.

About RNK05047

RNK05047 is a first-in-class, small-molecule, tumor- and BRD4-selective protein degrader that was discovered and developed using Ranok’s proprietary approach to targeted protein degradation, CHAMP. The bromodomain transcription factor BRD4 is a key regulator of oncogenes such as MYC and BCL2 and is involved in diverse cancer types. CHAMP-1 is a Phase 1/2 trial of RNK05047 currently underway in the U.S. that will assess its safety, tolerability and pharmacokinetics, and also includes measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints. Preliminary data is expected from the trial in the second half of 2023.

On August 24, 2022 Tachyon Therapeutics, Inc. ("Tachyon" or "the Company"), a private biotechnology company developing transformative cancer therapies against novel targets, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to develop TACH101 for the treatment of advanced solid tumors (Press release, Tachyon Therapeutics, AUG 24, 2022, View Source [SID1234618615]).

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"The approval of this IND marks a significant milestone for the Company, as TACH101 will be the first KDM4 inhibitor to enter clinical stage," said Dr. Frank Perabo, CEO of Tachyon. "Based on encouraging preclinical data, we believe that this novel epigenetic drug candidate holds promise to become a safe and effective treatment option for patients with advanced solid tumors, and we look forward to starting a clinical trial later this year."

The first-in-human clinical study of TACH101 is expected to commence in Q4 2022 and will include a Phase 1a open-label, single-arm, dose escalation portion to evaluate the safety and tolerability of orally administered TACH101 in subjects with advanced and metastatic solid tumors. Once the recommended Phase 2 dose (RP2D) is determined, the Phase 1b dose expansion portion is planned to commence in select tumor types including gastrointestinal and colorectal cancers.

On August 24, 2022 Provectus (OTCQB: PVCT) reported that the Company has expanded its sponsored research program with Michio Kurosu, PhD, Professor, Department of Pharmaceutical Sciences at the College of Pharmacy of the University of Tennessee Health Science Center (UTHSC) in Memphis, Tennessee to investigate Provectus’ pharmaceutical-grade rose bengal for the treatment of anti-fungal and anti-oral bacterial infections (Press release, Provectus Biopharmaceuticals, AUG 24, 2022, View Source [SID1234618614]). Provectus’ innovatively-assembled and proprietary rose bengal is the lead member of a class of the Company’s small molecules called halogenated xanthenes.

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As part of this new sponsored research, the Kurosu team plans to evaluate the in vitro activity of Provectus’ rose bengal against different fungal strains and to conduct susceptibility tests against fungal and bacterial mouth microbes.

The Kurosu team has previously shown the favorable tolerability of the Company’s rose bengal as a topical application under different types of normal light, and the molecule’s in vitro activity against a range of different Gram-positive bacteria and against biofilms. These data and conclusions were noted in Kurosu et al.’s 2022 Molecules article entitled "Antibacterial Activity of Pharmaceutical-Grade Rose Bengal: An Application of a Synthetic Dye in Antibacterial Therapies." The Kurosu team is currently developing a journal manuscript of their prior study of the molecule’s in vitro activity against Gram-negative bacteria.

On August 24, 2022 Bavarian Nordic A/S (OMX: BAVA) reported an agreement with the Pan American Health Organization (PAHO) to facilitate equitable access to the Company’s monkeypox vaccine for countries in Latin America and the Caribbean (Press release, Bavarian Nordic, AUG 24, 2022, View Source,Latin%20America%20and%20the%20Caribbean. [SID1234618613]). Deliveries of the vaccines are expected to begin in September .

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The vaccines will be made available to those countries that participate in PAHO’s Revolving Fund for Access to Vaccines – a technical cooperation mechanism established more than 40 years ago to support national immunization programs, pooling resources from participating PAHO member countries across the Americas to procure vaccines and related supplies.

Paul Chaplin, President and CEO of Bavarian Nordic said: "Monkeypox is a global health challenge that has prompted health authorities worldwide to respond, and we are pleased to work with PAHO to ensure access to vaccines for its member states in the Americas. With the agreement, we have now helped to secure access to our vaccine in more than 70 countries globally, representing the vast majority of affected regions outside endemic areas. While the global supply is currently limited, we are working diligently to increase our manufacturing capacity and have taken steps to partner with other companies to rapidly produce more vaccines to help combat the outbreak."

Bavarian Nordic maintains its guidance for 2022 as this order has already been included in the upgraded financial expectations, as communicated on July 18, 2022.

On August 24, 2022 AstraZeneca reported that it will present new data supporting its ambition to redefine cancer care at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, 9 to 13 September 2022 (Press release, AstraZeneca, AUG 24, 2022, View Source [SID1234618612]).

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A total of 15 approved and potential new medicines from AstraZeneca will be featured across more than 75 abstracts in 13 tumour types.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "At ESMO (Free ESMO Whitepaper) this year, new evidence will demonstrate how our medicines are prolonging patient survival across several cancers. Data from the SOLO-1 and PAOLA-1 Phase III trials will reinforce the long-term survival benefits of PARP inhibition with Lynparza in advanced ovarian cancer, and new data for Imfinzi combinations in liver, biliary tract and lung cancers will show the potential to improve outcomes for patients in these areas of high unmet need."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The momentum will continue for Enhertu at ESMO (Free ESMO Whitepaper) with new data across tumour types, including results from the DESTINY-Lung02 Phase II trial in HER2-mutant metastatic non-small cell lung cancer which formed the basis for the recent FDA approval. Additionally, we’re excited to advance the science of CTLA-4 inhibition with new analyses presented from two Phase III trials of Imfinzi plus tremelimumab, HIMALAYA in liver cancer and POSEIDON in lung cancer, and for MEDI5752, our bispecific antibody targeting both PD-1 and CTLA-4 in lung cancer."

Transforming outcomes across tumours over time
Mature disease-free survival (DFS) data from the ADAURA Phase III trial will be featured in a late-breaking presentation detailing two years of additional follow-up in patients with early-stage (Stage IB-IIIA) EGFR-mutated non-small cell lung cancer (NSCLC) treated with adjuvant Tagrisso (osimertinib). Tagrisso is the only targeted treatment option approved in this setting. The presentation will also report updated results for patterns of recurrence and central nervous system DFS.

A late-breaking presentation will feature landmark five-year overall survival (OS) data from the externally sponsored PAOLA-1 Phase III trial of Lynparza (olaparib) in combination with bevacizumab in 1st-line advanced ovarian cancer, including patients with homologous recombination deficiency (HRD) positive disease. This is the longest follow up for a PARP inhibitor in combination with standard of care in this setting.

In addition, seven-year OS data from the SOLO1 Phase III trial of Lynparza for 1st-line maintenance therapy in BRCA-mutated (BRCAm) advanced ovarian cancer will be presented. This is the longest follow-up for any PARP inhibitor in newly diagnosed advanced ovarian cancer.

Data will also include updated OS results at two years from the TOPAZ-1 Phase III trial of Imfinzi (durvalumab) plus standard-of-care chemotherapy (gemcitabine plus cisplatin) in 1st-line unresectable or advanced biliary tract cancer, as well as an analysis of immune-mediated adverse events. TOPAZ-1 is the first Phase III trial to show improved OS with an immunotherapy combination versus chemotherapy alone in this setting.

Extending the benefit of antibody drug conjugates (ADCs) to more patients
Several presentations will demonstrate the clinical potential of Enhertu (trastuzumab deruxtecan) treatment across HER2-targetable lung, gastric and breast cancers.

A late-breaking presentation will feature interim results from the DESTINY-Lung02 Phase II trial investigating Enhertu in patients with HER2-mutant (HER2m) metastatic NSCLC (mNSCLC) who have progressed following one or more systemic therapies. Enhertu was recently approved in the US in this setting as the first HER2-directed treatment for these patients. Detailed data will also be shared from the DESTINY-Lung01 Phase II trial, both in this setting and in patients with HER2-overexpressing mNSCLC.

Another presentation will feature updated data from the DESTINY-Gastric02 Phase II trial in HER2-positive metastatic gastric cancer, the first Enhertu trial in Western patients with gastric cancer.

Data will also include a subgroup analysis of the DESTINY-Breast03 Phase III trial of Enhertu by disease history and prior treatments in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. Patient-reported outcomes from the DESTINY-Breast04 Phase III trial will also highlight quality of life data for patients treated with Enhertu in HER2-low unresectable and/or metastatic breast cancer. Enhertu was recently approved in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer based on this trial.

Additional posters will describe trials evaluating the TROP2-directed ADC datopotamab deruxtecan in patients with hormone-receptor positive, HER2-negative breast cancer (TROPION-Breast01 Phase III trial) and in a platform trial in combination with Tagrisso in patients with advanced NSCLC who have experienced disease progression (ORCHARD Phase II trial). There are currently no approved TROP2-directed therapies for patients in these settings.

Advancing the science of CTLA-4 inhibition
A new analysis from the positive HIMALAYA Phase III trial will show the impact of viral aetiology on outcomes in unresectable liver cancer for patients treated with a single priming dose of tremelimumab, an anti-CTLA-4 antibody, added to Imfinzi (STRIDE regimen).

In addition, a poster will describe the EMERALD-3 Phase III trial evaluating tremelimumab added to Imfinzi and transarterial chemoembolisation with or without lenvatinib in unresectable liver cancer patients eligible for embolisation.

A late-breaking presentation of the positive POSEIDON Phase III trial in mNSCLC will feature four-year OS outcomes in patients treated with a limited course of tremelimumab added to Imfinzi plus chemotherapy.

Another late-breaking presentation will share initial data for MEDI5752 plus chemotherapy in patients with treatment-naïve Stage IIIB-IV non-squamous NSCLC. MEDI5752 is a novel bispecific antibody that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4. Bispecific antibodies are a promising approach in immuno-oncology that combines the potential benefits of two medicines into one antibody without the increased toxicity seen with administration of two separate medicines.

Reinforcing the robust benefits of PARP inhibitors across a broad range of tumour types
In addition to data from PAOLA-1 and SOLO1, an oral presentation will share updated efficacy analyses across biomarker subgroups from the PROpel Phase III trial of Lynparza plus abiraterone in patients with newly diagnosed metastatic castration-resistant prostate cancer (mCRPC) treated with the combination with or without homologous recombination repair (HRR) gene mutations. Lynparza is the first PARP inhibitor to demonstrate a significant improvement in radiographic progression-free survival in combination with abiraterone versus abiraterone alone in 1st-line mCRPC irrespective of biomarker status.

Additionally, final OS data will be presented from the MEDIOLA Phase II trial of Lynparza and Imfinzi in germline BRCAm platinum-sensitive relapsed ovarian cancer and from the OPINION Phase IIIB trial of Lynparza maintenance monotherapy in patients with platinum-sensitive relapsed ovarian cancer without a germline BRCA1/BRCA2 mutation.

Data will also include an extended OS analysis from the POLO Phase III trial of Lynparza in germline BRCA-mutated metastatic pancreatic cancer, a disease in which no other PARP inhibitor is approved.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and datopotamab deruxtecan, and with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza.

Key AstraZeneca presentations during ESMO (Free ESMO Whitepaper) 2022

Lead author

Abstract title

Presentation details

Antibody drug conjugates
Goto, K

Trastuzumab Deruxtecan (T-DXd) in Patients (Pts) With HER2-Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC): Interim Results From the Phase 2 DESTINY-Lung02 Trial

Presentation #LBA55

Mini Oral Session

11 September 2022

10:15am (CEST)

Ueno, NT

Patient-Reported Outcomes (PROs) From DESTINY-Breast04, a Randomized Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) vs Treatment of Physician’s Choice (TPC) in Patients (pts) With HER2-Low Metastatic Breast Cancer (MBC)

Presentation #217O

Proffered Paper Session

11 September 2022

9:30am (CEST)

Ku, GY

Updated Analysis of DESTINY-Gastric02: a Phase 2 Single-Arm Trial of Trastuzumab Deruxtecan (T-DXd) in Western Patients (Pts) With HER2-Positive (HER2+) Unresectable/Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer Who Progressed on or After Trastuzumab-Containing Regimen

Presentation #1205MO

Mini Oral Session

10 September 2022

3:45pm (CEST)

Cortés, J

Subgroup Analysis by Disease History and Prior Treatments of Patients (pts) With HER2-Positive (HER2+) Metastatic Breast Cancer (MBC) From DESTINY-Breast03, a Randomized Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) vs Trastuzumab Emtansine (T-DM1)

Presentation #236P

e-Poster

10 September 2022

Li, BT

Phase 2 Trial of Trastuzumab Deruxtecan (T-DXd) in Patients (Pts) With HER2-Mutated (HER2m) Metastatic Non-Small Cell Lung Cancer (NSCLC): Registrational Data From DESTINY-Lung01

Presentation #976P

e-Poster

12 September 2022

Bardia, A

Datopotamab deruxtecan (Dato-DXd), a TROP2 antibody-drug conjugate, vs investigators’ choice of chemotherapy (ICC) in previously-treated, inoperable or metastatic hormone-receptor (HR) positive, HER2-negative (HR+/HER2–) breast cancer: TROPION-Breast01

Presentation #274TiP

Trial in Progress

10 September 2022

De Langen, J

ORCHARD platform study: osimertinib + datopotamab deruxtecan (Dato-DXd) cohort in patients (pts) with advanced NSCLC (aNSCLC) who have progressed on first-line (1L) osimertinib

Presentation #1188TiP

Trial in Progress

12 September 2022

Immuno-oncology
Johnson, ML.

Durvalumab (D) ± tremelimumab (T) + chemotherapy (CT) in 1L metastatic (m) NSCLC: overall survival (OS) update from POSEIDON after median follow-up (mFU) of approximately 4 years (y)

Presentation #LBA59

Mini Oral Session

11 September 2022

11:05am (CEST)

Ahn, MJ

MEDI5752 or pembrolizumab (P) plus carboplatin/pemetrexed (CP) in treatment-naïve (1L) non-small cell lung cancer (NSCLC): a Phase 1b/2 trial

Presentation #LBA56

Mini Oral Session

11 September 2022

10:20am (CEST)

Spicer, J

Platform study of neoadjuvant durvalumab (D) alone or combined with novel agents in patients (pts) with resectable, early-stage non-small-cell lung cancer (NSCLC): pharmacodynamic correlates and circulating tumor DNA (ctDNA) dynamics in the NeoCOAST study

Presentation #929MO

Mini Oral Session

12 September 2022

3:15pm (CEST)

Oh, DY

Updated overall survival (OS) from the Phase 3 TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+ GC) in patients (pts) with advanced biliary tract cancer (BTC)

Presentation #56P

e-Poster

12 September 2022

Antonuzzo, L

Immune-mediated adverse event (imAE) incidence, timing and association with efficacy in the Phase 3 TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+ GC) in advanced biliary tract cancer (BTC)

Presentation #57P

e-Poster

12 September 2022

Chan, LS

Impact of viral aetiology in the Phase 3 HIMALAYA study of tremelimumab (T) plus durvalumab (D) in unresectable hepatocellular carcinoma (uHCC)

Presentation #714P

e-Poster

12 September 2022

Özgüroğlu, M

Phase 3 trial of durvalumab combined with domvanalimab following concurrent chemoradiotherapy (cCRT) in patients with unresectable stage III NSCLC (PACIFIC-8)

Presentation #971TiP

Trial in Progress

10 September 2022

Abou-Alfa, GK

A randomised Phase 3 study of tremelimumab (T) plus durvalumab (D) with or without lenvatinib combined with concurrent transarterial chemoembolisation (TACE) versus TACE alone in patients (pts) with locoregional hepatocellular carcinoma (HCC): EMERALD-3

Presentation #727TiP

Trial in Progress

12 September 2022

DNA damage response
Ray-Coquard, IL

Final overall survival (OS) results from the Phase III PAOLA-1/ENGOT-ov25 trial evaluating maintenance olaparib (ola) plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC)

Presentation #LBA29

Proffered Paper Session

9 September 2022

2:00pm (CEST)

DiSilvestro, P

Overall survival (OS) at 7-year (y) follow-up (f/u) in patients (pts) with newly diagnosed advanced ovarian cancer (OC) and a BRCA mutation (BRCAm) who received maintenance olaparib in the SOLO1/GOG-3004 trial

Presentation #517O

Proffered Paper Session

9 September 2022

2:10pm (CEST)

Guo, C

A Phase (Ph) I/II trial of the CXCR2 antagonist AZD5069 in combination with enzalutamide (ENZA) in patients (pts) with metastatic castration resistant prostate cancer (mCRPC)

Presentation #454O

Proffered Paper Session

10 September 2022

11:15am (CEST)

Saad, F

Biomarker analysis and updated results from the Phase III PROpel trial of abiraterone (abi) and olaparib (ola) vs abi and placebo (pbo) as first-line (1L) therapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)

Presentation #1357O

Proffered Paper Session

11 September 2022

9:30am (CEST)

Banerjee, S

Phase II study of olaparib plus durvalumab with or without bevacizumab (MEDIOLA): final analysis of overall survival in patients with non-germline BRCA-mutated platinum-sensitive relapsed ovarian cancer

Presentation #529MO

Mini Oral Session

11 September 2022

5:00pm (CEST)

Poveda Velasco, AM

Maintenance olaparib monotherapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC) without a germline BRCA1/BRCA2 mutation (non-gBRCAm): final overall survival (OS) results from the OPINION trial

Presentation #531P

e-Poster

11 September 2022

Hammel, P

Extended overall survival results from the POLO study of active maintenance olaparib in patients with metastatic pancreatic cancer and a germline BRCA mutation

Presentation #1298P

e-Poster

12 September 2022

Tumour drivers and resistance
Tsuboi, M

Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC): updated results from ADAURA

Presentation #LBA47

Proffered Paper Session

11 September 2022

8:30am (CEST)

Piotrowska, Z

ELIOS: A multicentre, molecular profiling study of patients (pts) with epidermal growth factor receptor-mutated (EGFRm) advanced NSCLC treated with first-line (1L) osimertinib

Presentation #LBA53

Proffered Paper Session

11 September 2022

3:05pm (CEST)

Nakamura, A

Final results and biomarker analysis of a randomized phase II study of osimertinib plus bevacizumab versus osimertinib monotherapy for untreated patients with non-squamous non-small-cell lung cancer harboring EGFR mutations; WJOG9717L study

Presentation #982P

e-Poster

12 September 2022

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.