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Tagrisso Phase III ADAURA trial will be unblinded early after overwhelming efficacy in the adjuvant treatment of patients with EGFR-mutated lung cancer

On April 10, 2020 AstraZeneca reported the ADAURA Phase III trial for Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB, II and IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with complete tumour resection will be unblinded early following a recommendation from an Independent Data Monitoring Committee (IDMC) based on its determination of overwhelming efficacy (Press release, AstraZeneca, APR 10, 2020, View Source [SID1234556250]).

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José Baselga, Executive Vice President, Oncology R&D, said: "We are thrilled by the recommendation to unblind the Phase III ADAURA trial much earlier than expected and are incredibly excited with these unprecedented results in patients with early-stage EGFR-mutated non-small cell lung cancer. Lung cancer is a devastating diagnosis and for the first time an EGFR-targeted medicine can now provide the hope of cure."

The primary endpoint of the Phase III ADAURA trial is disease-free survival (DFS). Tagrisso was assessed against placebo for a treatment duration of up to three years. The trial will continue to assess the secondary endpoint of overall survival. In its communication to AstraZeneca, the IDMC did not raise any new safety concerns. The data will be presented at a forthcoming medical meeting.

Lung cancer

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined.1 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2 Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.3,4,5 These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors (TKIs) which block the cell-signalling pathways that drive the growth of tumour cells. Based on AstraZeneca estimates, just over 60% of NSCLC patients are diagnosed with early-stage (Stage I-III) disease.

ADAURA

ADAURA is a randomised, double-blinded, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC with complete tumour resection and optional, standard post-operative adjuvant chemotherapy. In the experimental arm, patients were treated with Tagrisso 80mg once-daily oral tablets for three years or until disease recurrence. The trial enrolled in more than 200 centres across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East. The primary endpoint is DFS; data readout was originally anticipated in 2022.

Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have now received approval in 80 countries, including the US, Japan, China and the EU, for 1st-line EGFRm advanced NSCLC, and in 87 countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being developed in the locally advanced unresectable setting (LAURA), in combination with chemotherapy (FLAURA2) in the metastatic setting, and with potential new medicines to address resistance to EGFR-TKIs (SAVANNAH, ORCHARD).

AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action. We aim to address the unmet needs of patients with EGFRm tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with the approved medicines Iressa (gefitinib) and Tagrisso, and its ongoing Phase III trials ADAURA, LAURA, and FLAURA2.3,6-7

We are also committed to addressing tumour mechanisms of resistance through the ongoing Phase II trials SAVANNAH and ORCHARD which test Tagrisso in combination with savolitinib, a selective inhibitor of c-MET receptor tyrosine kinase, along with other potential new medicines. Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate is in development for metastatic non-squamous HER2-overexpressing or HER2-mutated NSCLC including trials in combination with other anticancer treatments.

An extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a targetable genetic mutation which represents up to three-quarters of all patients with lung cancer.8 Imfinzi, an anti-PDL1 antibody, is in development for patients with advanced disease (Phase III trials POSEIDON and PEARL) and for patients in earlier stages of disease including potentially curative settings (Phase III trials AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) both as monotherapy and in combination with tremelimumab and/or chemotherapy. Imfinzi is also in development in the Phase II combination trials NeoCOAST, COAST and HUDSON in combination with potential new medicines from the early-stage pipeline.

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 six 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. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the 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.

Arena Pharmaceuticals to Present at the 19th Annual Needham Virtual Healthcare Conference on April 14

On April 10, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that Amit D. Munshi, the Company’s President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at the 19th Annual Needham Healthcare Conference on Tuesday, April 14, at 10:40 AM ET (7:40 AM PT) (Press release, Arena Pharmaceuticals, APR 10, 2020, View Source [SID1234556248]).

A live webcast of the presentation will be posted under the investor relations section of Arena’s website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event.

GRAIL Appoints Sir Harpal Kumar as President of GRAIL Europe

On April 10, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported the appointment of Sir Harpal Kumar as President of GRAIL Europe (Press release, Grail, APR 10, 2020, View Source [SID1234556247]). In this new role, Sir Harpal will be responsible for leading GRAIL’s entry and growth in Europe.

"I am delighted to welcome Harpal to the GRAIL team. He is a passionate advocate for better outcomes in cancer, with a widely recognized appreciation of the challenges health systems face in battling the increasing burden of this disease," said Hans Bishop, Chief Executive Officer at GRAIL. "With Harpal’s leadership, we can build partnerships that will bring the benefits of early cancer detection to patients and providers in Europe.’’

"I’m thrilled to be joining GRAIL and to have the opportunity to transform cancer care through early detection," said Sir Harpal. "I look forward to leading the company’s partnerships with European medical and healthcare services and the broader innovation community to support our goal of decreasing the burden of cancer."

Sir Harpal joins GRAIL from Johnson & Johnson where he most recently served as Senior Vice President and Head of Innovation EMEA. There, he oversaw a portfolio of co-investments and collaborations across the region to grow Johnson & Johnson’s networks within the EMEA innovation community. Before joining Johnson & Johnson Innovation, Sir Harpal spent 15 years with Cancer Research UK, and served as the organization’s Chief Executive Officer from April 2007 until June 2018. Prior to this, he was Chief Operating Officer & Executive Director of Development at CRUK and served as Chief Executive of Cancer Research Technology (a subsidiary of CRUK). Before CRUK, he worked with McKinsey & Co, The Papworth Trust, and Nexan Group. Sir Harpal received a Masters in Chemical Engineering from the University of Cambridge, and an MBA as a Baker Scholar from Harvard Business School. He has been awarded Honorary Doctorates from the Universities of Manchester, Newcastle, and Glasgow, and the Institute of Cancer Research, and he is a Fellow of The Academy of Medical Sciences. In 2016, he was knighted by Her Majesty Queen Elizabeth II for services to cancer research.

Genetron Health Appoints Former FDA Senior Officer Dr. Yun-Fu Hu as Chief Medical Officer

On April 10, 2020 Genetron Holdings Limited ("Genetron Health"), a China-based precision oncology company, reported the appointment of Dr. Yun-Fu Hu as Chief Medical Officer (Press release, Genetron Health Technologies, APR 10, 2020, View Source [SID1234556246]). A former deputy director with the US Food and Drug Administration (FDA), Dr. Hu will be tasked to steer the company forward in its in vitro diagnostic (IVD) devices registration and regulatory affairs as well as bio-pharmaceutical services business.

Dr. Hu has over two decades of experience in regulatory and managerial capacities related to medical devices and pharmaceutical industries. During his tenure at FDA, he has led a team of staff in premarket reviews and post-market compliance of IVD products and laboratory-developed tests (LDTs) for genetic testing, molecular cancer diagnostics, companion diagnostics, radiodosimetry, digital pathology and artificial intelligence devices. Some of his notable authorizations include: the first next generation sequencing (NGS)-based LDT as companion diagnostics (CDx) (Foundation Medicine FoundationFocus CDxBRCA); the first NGS-based CDx kit (ThermoFisher Oncomine Dx Target Test); the first NGS-based LDT for tumor profiling (MSK-IMPACT) and later on FoundationOne CDx); the first liquid biopsy test for NSCLC (Roche Cobas EGFR Mutation Test v2); and FDA’s only two approved cancer screening tests in the last decade (Exact Sciences’ Cologuard and Epigenomics’ Epi ProColon). Dr. Hu and his team have also won over 10 FDA-level group awards for outstanding contributions in FDA authorization of many such first-of-its-kind devices.

Prior to joining FDA, Dr. Hu has more than 10 years of product development experience in diagnostic and pharmaceutical industries, leading his teams to achieve outstanding results in biomarker discovery and diagnostic development.

Sizhen Wang, Genetron Health’s co-founder and CEO, said, "Dr. Hu’s caliber and depth of experience in molecular cancer diagnostics and pharmaceutical R&D is nothing short of exceptional. Hailed with outstanding regulatory background and solid industry experience, he is a perfect hybrid talent in the global biopharmaceutical field. With Dr. Hu joining our leadership team, he will value-add to our molecular diagnostic business with international best practices in technical R&D, product design, clinical approval and policy and regulatory matters. I believe he will be an asset to Genetron Health and the industry in driving high quality and high efficiency clinical adoption of more innovative technologies."

Dr. Hu said, "China has a unique advantage in precision oncology clinical data. We have witnessed the emergence of many outstanding companies, related technologies and products in recent years. I am truly impressed with the global vision shown by the leadership at Genetron Health. I believe Genetron has massive growth potential, driven by the company’s continuous innovation capabilities. I am delighted to be part of this team and I look forward to assisting the clinical adoption of Genetron’s innovative technologies and the establishment of a global one-stop bio-pharmaceutical service platform. It is our hope to bring high quality China biotechnology to the world."

Entry into a Material Definitive Agreement

On April 10, 2020 Pelican Therapeutics, Inc. ("Pelican"), reported that it was awarded $15.2 million to fund preclinical and certain clinical activities from Cancer Prevention Institute of Texas (CPRIT) grant (the "CPRIT Grant") (Filing, 8-K, Heat Biologics, APR 10, 2020, View Source [SID1234556244]). The CPRIT Grant is subject to customary CPRIT funding conditions.

The CPRIT Grant initially covered a three-year period from June 1, 2017 through May 31, 2019. On April 12, 2019, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from May 31, 2019 to November 30, 2019. On November 20, 2019, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from November 30, 2019 to May 30, 2020. On April 9, 2020, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from May 30, 2020 to November 30, 2020. All other terms and conditions of the CPRIT arrangement remained the same.