On December 10, 2020 Boehringer Ingelheim reported the signing of a binding agreement for acquiring all shares of NBE-Therapeutics, a private, clinical-stage Swiss biotechnology company focused on antibody-drug conjugates and advancing targeted cancer therapies derived from its immune stimulatory iADC platform (Press release, Boehringer Ingelheim, DEC 10, 2020, View Source [SID1234572604]). NBE-Therapeutics’ lead compound NBE-002 is currently in phase I clinical studies for triple negative breast cancer and other solid tumors. Importantly, Boehringer Ingelheim gains access to an innovative and unique platform that it will use to build a leading ADC portfolio and develop potential combinations with other assets from its cancer immunology portfolio.

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"NBE-Therapeutics’ iADC platform adds exceptional tumor targeting capabilities to our oncology portfolio. Together with our immune cell-targeting assets, this could enable new powerful combinations that will allow for efficacious and durable treatments for patients," said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. "This acquisition is a further example of Boehringer Ingelheim’s long-term strategy to enhance our position as an innovator of novel cancer therapies for patients in need. We welcome NBE-Therapeutics’ richly talented team to Boehringer Ingelheim and we look forward to collaborating with them on this important work."

The total transaction value is 1.18 billion euros and also includes contingent clinical and regulatory milestones.

"I am extremely proud of the NBE-Therapeutics’ team and delighted that our world class ADC expertise is being recognized by Boehringer Ingelheim. This transaction is a validation of our platform and its potential for the next generation cancer therapies," said Bertrand Damour, Chief Executive Officer of NBE-Therapeutics. "We look forward to progressing NBE-002, our lead program and best-in-class anti ROR1 ADC, and to continuing the fight against cancer alongside Boehringer Ingelheim with its strong clinical development capabilities."

Boehringer Ingelheim’s cancer cell directed research is focused on the development of targeted therapies for the treatment of difficult-to-treat solid tumors. Inducing tumor cell death is a key component, and ADC based approaches have emerged as a powerful targeted therapy with potential for induction of immunogenic cell death at reduced systemic exposure and toxicity.

The NBE-Therapeutics’ acquisition will significantly strengthen Boehringer Ingelheim’s strategic focus on targeted cancer cell-directed therapies and complements existing capabilities in antigen discovery as well as antibody and T-cell engager technologies. By combining its world-class, in-house research and development with that of highly innovative biotechnology companies, Boehringer Ingelheim is developing innovative therapies and accelerating the delivery of the next generation of cancer treatments. This builds on recent strategic acquisitions and collaborations, including the acquisition of ViraTherapeutics and AMAL Therapeutics, which are also contributing assets.

NBE-Therapeutics is headquartered in Basel, Switzerland, where it was founded with financial backing from a syndicate of both corporate and institutional investors, including the Boehringer Ingelheim Venture Fund, and PPF Group, as their largest shareholders, and Denmark’s Novo Holdings. NBE-Therapeutics’ technology platform and derived assets are protected by a broad portfolio of patents and licenses.

The consummation of the transaction is subject to customary closing conditions and is expected during the course of Q1 2021.

About the ADC Platform
Antibody-drug conjugates (ADC’s) are a class of drugs that consist of an antibody that specifically binds to a target on tumor cells. The antibody is also linked to a cytotoxic drug to kill these cells. If the drug was given systemically, it would cause an unacceptable level of toxicity. However, due to the ability to now localize the drug to the tumor microenvironment using an antibody, the safety profile of the drug becomes acceptable.

NBE-Therapeutics’ proprietary technology platform creates highly potent immune stimulatory antibody-drug conjugates with an anthracycline payload, directly targeting tumor cells and inducing a long-lasting immunological anti-tumor effect. Its technology also incorporates a proprietary enzymatic conjugation step allowing for the site-specific conjugation of small molecule drugs to monoclonal antibodies overcoming liabilities related to limited serum stability and heterogeneous linkage.

About NBE-002
NBE-Therapeutics’ lead candidate, NBE-002, is an anti-ROR1 ADC. ROR1 is a receptor tyrosine kinase expressed in various hematologic and solid malignancies, including triple negative breast cancers and lung adenocarcinoma. The compound is currently in phase I clinical studies.

On December 10, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported that it has entered into a securities purchase agreement with several institutional and accredited investors providing for the purchase and sale of 2,448,980 shares of the Company’s common stock at a purchase price of $2.45 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Xenetic Biosciences, DEC 10, 2020, View Source [SID1234572584]). The offering is expected to result in gross proceeds to Xenetic of approximately $6.0 million before deducting placement agent fees and other offering expenses payable by Xenetic.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The Company intends to use the net proceeds of this offering for general corporate purposes, working capital, and for the advancement of the XCART platform, the Company’s differentiated, proprietary approach to personalized CAR T therapy in development for the treatment of multiple tumor types of B-cell Non-Hodgkin lymphomas.

The registered direct offering is expected to close on or about December 14, 2020, subject to the satisfaction of customary closing conditions.

The shares described above are being offered by Xenetic pursuant to a "shelf" registration statement on Form S-3 (File No. 333-227572) previously filed with the U.S. Securities and Exchange Commission ("SEC") on September 27, 2018 and declared effective by the SEC on October 12, 2018. Such shares may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Alternatively, when available, electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by email at [email protected] or by phone at (646) 975-6996.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 10, 2020 Targovax ASA, reported that Øystein Soug, CEO of Targovax, will present the company at DNB’s 11th Annual Nordic Healthcare Conference, Tuesday 15 December (Press release, Targovax, DEC 10, 2020, View Source [SID1234572583]).

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DNB’s 11th Annual Nordic Healthcare Conference
Date: 15 December 2020
Presenter: Øystein Soug, CEO
Presentation time: 12:30 CET
The presentation will be available to download at www.targovax.com after the event.

On December 10, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported an exploratory analysis from the Phase III IMvigor010 study evaluating Tecentriq (atezolizumab), compared with observation, as an adjuvant (after surgery) monotherapy treatment for people with muscle-invasive urothelial cancer (MIUC) at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Virtual Congress, 9–12 December 2020 (Press release, Hoffmann-La Roche, DEC 10, 2020, View Source [SID1234572580]).

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Data from IMvigor010 show that in people with circulating tumour DNA (ctDNA), a benefit in disease-free survival (DFS) was seen in those receiving Tecentriq when compared with observation (median 5.9 months versus median 4.4 months, hazard ratio [HR]=0.58; 95% CI: 0.43–0.79). Overall survival (OS) at an interim analysis also favoured treatment with Tecentriq in the ctDNA-positive population, with a median of 25.8 months with Tecentriq, compared with 15.8 months for observation (HR=0.59; 95% CI: 0.41–0.86). Although these pre-specified analyses are exploratory and could not be formally tested per the statistical plan in the IMvigor010 study, the data further our understanding of the disease and will inform a new Phase III study in people with ctDNA-positive muscle-invasive bladder cancer.

"Bladder cancer is a complex and often difficult disease to treat, but as we continue to understand its biology, we are gaining greater clarity around new therapeutic avenues," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "By using ctDNA and other biomarkers, we hope to gain insights that enable a more personalised approach to treatment. We are applying these findings to our clinical development programme."

As presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Congress, IMvigor010 did not meet its primary endpoint of DFS compared with observation in people with high-risk MIUC in the intention-to-treat population (19.4 months with Tecentriq versus 16.6 months with observation [HR=0.89; 95% CI: 0.74–1.08; p=0.2446]). In an interim analysis of OS, the median was not reached in either treatment arm (HR=0.85). Safety data for Tecentriq were consistent with the known monotherapy safety profile, and no new safety concerns were identified.

The goal of current treatment in people with MIUC is to provide early intervention to reduce the risk of the disease recurring or spreading to other parts of the body. As tumours grow, dying cells are replaced by new ones, releasing tumour DNA into the bloodstream. This DNA, known as ctDNA, can be utilised in different ways, including identifying people with minimal residual disease who may benefit the most from adjuvant therapy as well as those for whom adjuvant therapy may not provide benefit. In MIUC, ctDNA is a strong prognostic marker of disease recurrence.1 More treatment options following surgery are needed because approximately half of people with MIUC will develop a recurrence of their disease within 2 years of surgery,2 and with no predictive or prognostic biomarkers used in current clinical practice for MIUC,1,3 there is a need for more personalised treatments for this disease.1

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

These data were presented at the ESMO (Free ESMO Whitepaper) IO Virtual Congress in the Proffered paper oral session on 10 December 2020, 13:50-14:02 CET.

About the IMvigor010 study
IMvigor010 is a global Phase III, open-label, randomised, controlled study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq compared with observation in 809 people with MIUC, who are at high risk of recurrence following resection. The primary endpoint is DFS as assessed by investigator, which is defined as the time from randomisation to invasive urothelial cancer recurrence or death.

Key efficacy results from the exploratory analysis are below:

ctDNA-positive population
(n=214, 37% of biomarker evaluable population, n=581)
Tecentriq (n=116) Observation (n=98)
Median DFS (months)
(95% CI) 5.9
(5.6–11.2) 4.4
(2.9–5.6)
DFS, HR
(95% CI) 0.58
(0.43–0.79)
p=0.0005
Median OS at interim analysis (months) 25.8
(20.5–NR) 15.8
(10.5–19.7)
OS, HR
(95% CI) 0.59
(0.41–0.86)
p=0.0059
ctDNA-negative population
(n=367, 63% of biomarker evaluable population, n=581)
DFS, HR
(95% CI) 1.14
(0.81–1.62)
p=0.45
OS at interim analysis, HR
(95% CI) 1.31
(0.77–2.23)
p=0.32
ctDNA-positive and PD-L1-positive population
(n=102)
DFS, HR
(95% CI) 0.52
(0.33–0.82)
ctDNA-positive and TMB-high population
(n=69)
DFS, HR
(95% CI) 0.34
(0.19–0.60)
Note: p-values from exploratory analyses are provided for descriptive purposes. NR=not reached. TMB=tumour-mutational burden.

About bladder cancer and muscle-invasive urothelial cancer
In 2018, there were over half a million new cases of bladder cancer diagnosed globally, with approximately 200,000 deaths from the disease.4 Urothelial cancer is the most common type of bladder cancer, accounting for about 90–95% of all cases.5 MIUC is a type of urothelial cancer that has spread into the muscle of the bladder, ureter or renal pelvis.6 Approximately 25% of new cases of bladder cancer are diagnosed with muscle-invasive disease,7 which is associated with a poorer prognosis than non-MIUC.6

Roche will run a new Phase III study in people with ctDNA-positive muscle-invasive bladder cancer. More information is available here.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer, small cell lung cancer, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:
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On December 10, 2020 AstraZeneca and Daiichi Sankyo Company reported that Updated results from the positive DESTINY-Breast01 Phase II trial showed (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) continued to demonstrate impressive efficacy and durable responses in patients with HER2-positive metastatic breast cancer following two or more prior HER2-based regimens (Press release, AstraZeneca, DEC 10, 2020, View Source [SID1234572577]).

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The updated data were presented in a Spotlight Poster Discussion at the 2020 San Antonio Breast Cancer Symposium (SABCS).

With a median duration of follow-up of 20.5 months, patients treated with Enhertu (5.4 mg/kg) achieved an objective response rate (ORR) of 61.4% and a median duration of response (DoR) of 20.8 months. The median progression-free survival (PFS) was 19.4 months. In an exploratory landmark analysis of overall survival (OS), evaluated at 35% maturity, an estimated 74% of patients remained alive at 18 months.
In the previous analysis at 11.1 months of follow-up, an ORR of 60.9% was seen with a median DoR of 14.8 months and median PFS of 16.4 months. Additional trials are ongoing to confirm the results seen in DESTINY-Breast01.
Approximately one in five patients with breast cancer are considered HER2 positive, which is associated with aggressive disease, high recurrence rate, and increased mortality.1,2
Shanu Modi, MD, Breast Medical Oncologist, Memorial Sloan Kettering Cancer Center and principal investigator in the DESTINY-Breast01 trial, said: "These longer-term data from the DESTINY-Breast01 trial further highlight the role that this treatment option may have in changing clinical outcomes for patients with previously treated HER2-positive metastatic breast cancer. It is important that we are able to offer patients therapy like this which provides a meaningful clinical benefit, as historically there have been few therapies that were able to do that in this patient population."
José Baselga, Executive Vice President, Oncology R&D, said: "These results reinforce the transformational potential of Enhertu in patients with previously treated HER2-positive metastatic breast cancer. With a median duration of response of greater than twenty months, the updated results of DESTINY-Breast01 are unprecedented. We look forward to further confirming the DESTINY-Breast01 findings with results from our Phase III development programme for Enhertu."
Antoine Yver, Executive Vice President and Global Head, Oncology R&D, Daiichi Sankyo, said: "The updated findings illustrate the practice-changing potential for Enhertu to become a long-term treatment option for patients with previously treated HER2-positive metastatic breast cancer. The duration of response and long-term safety profile further validate that our proprietary DXd antibody drug conjugate technology delivers effective and durable treatment."

Summary of updated efficacy results from DESTINY-Breast01

Summary of updated efficacy results from DESTINY-Breast01
i Data from the 1 August 2019 cut-off were presented at the 2019 SABCS and published in The New England Journal of Medicine
ii As of data cut-off, 20.1% of patients remained on treatment with Enhertu
iii ICR, independent central review
iv CI, confidence interval
v NE, not estimable
vi 114 patients (62.0%) were censored at time of analysis
vii OS was estimated at 35% maturity, with 119 patients (64.7%) censored and only 17 patients at risk at 24 months; additional follow-up is required for more mature OS data
The overall safety and tolerability profiles of Enhertu were consistent with what has been previously reported, with few additional treatment discontinuations due to adverse events with longer treatment duration. In the updated analysis, 18.5% of patients discontinued treatment due to adverse events compared to 15.2% in the previous analysis. Most cases of interstitial lung disease (ILD) or pneumonitis occurred during the first 12 months of treatment and the results suggest the risk of developing ILD or pneumonitis toxicity is not related to cumulative treatment with Enhertu. There were three new cases of treatment-related ILD reported, as determined by an independent adjudication committee, including one Grade 1, one Grade 2 and one death (Grade 5). Two potential cases were pending adjudication at data cut-off. Continued attention to monitoring to identify pulmonary symptoms and ensure early intervention is warranted.
Enhertu was approved in the US and Japan for the treatment of HER2-positive, unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens in the metastatic setting based on the earlier results from the DESTINY-Breast01 trial. In the US, Enhertu was approved under FDA Accelerated Approval and confirmatory trials are underway.
Several ongoing randomised Phase III trials are further testing Enhertu in patients with HER2-expressing metastatic breast cancer. These include DESTINY-Breast02, which is evaluating Enhertu as a 3rd-line treatment for patients with HER2-positive metastatic breast cancer and DESTINY-Breast03, which is testing Enhertu as a 2nd-line treatment for these patients. DESTINY-Breast04 is investigating Enhertu in patients with metastatic breast cancer and low expression of HER2.
HER2-positive breast cancer
In women, breast cancer is the most common cancer and one of the most common causes of cancer mortality worldwide; there were an estimated 2.1 million new cases of female breast cancer diagnosed in 2018.3,4 Breast cancer occurs mainly in women, but in rare cases it occurs in men too.5

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including gastric, breast and lung cancers. HER2 overexpression is associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and poorer prognosis.6 Approximately one in five patients with breast cancer are considered HER2 positive.2

DESTINY-Breast01
DESTINY-Breast01 is a pivotal Phase II, single-arm, open-label, global, multicentre, two-part trial evaluating the safety and efficacy of Enhertu in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine. The primary endpoint of the trial is ORR, as determined by ICR. Secondary objectives include DoR, disease control rate, clinical benefit rate, PFS and OS.

Enhertu

Enhertu is a HER2-directed antibody drug conjugate (ADC). Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (‘payload’) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Enhertu is comprised of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker.
Enhertu (5.4mg/kg) is approved in the US and Japan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting based on the DESTINY-Breast01 trial. Enhertu (6.4mg/kg) is approved in Japan for patients with HER2-positive unresectable advanced or recurrent gastric cancer that progressed after chemotherapy.
Enhertu clinical development

A comprehensive development program is underway globally, with nine registrational trials evaluating the efficacy and safety of trastuzumab deruxtecan monotherapy across multiple HER2 cancers, including breast, gastric and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

In October 2020, Enhertu was granted Priority Review from the US Food and Drug Administration for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. In May 2020, Enhertu received a Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) for gastric cancer, including GEJ adenocarcinoma.

In July 2020, The European Medicines Agency’s Committee for Medicinal Products for Human Use granted accelerated assessment for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens.
In May 2020, Enhertu also received a BTD for the treatment of patients with metastatic non-small cell lung cancer whose tumours have a HER2 mutation and with disease progression on or after platinum-based therapy.
Collaboration between AstraZeneca and Daiichi Sankyo
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialise trastuzumab deruxtecan (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and the next-generation SERD and potential new medicine AZD9833. PARP inhibitor, Lynparza (olaparib) is a targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease state. Building on the first approval of Enhertu, a HER2-directed antibody-drug conjugate, in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings. To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy durvalumab in combination with other oncology medicines, including Lynparza and Enhertu, investigating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan (DS-1062).
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 seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies – 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.