On May 28, 2020 Diaceutics reported new data insights into key areas of cancer testing (Press release, Diaceutics, MAY 28, 2020, View Source [SID1234558642]). In collaboration with the company’s network of industry advisors, the research has just been published in four abstracts and one poster at this year’s virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference. It exposes inefficiencies in precision medicine testing that are preventing patients from getting the treatment that they need, when they need it.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Diaceutics’ ASCO (Free ASCO Whitepaper) research provides a snapshot of the breadth of testing issues that can be addressed through collaboration on the DXRX network. The value of this can be seen in its FLT3 research, for example: using a standard health economic model1, Diaceutics calculated that failure to test for FLT3 could lead to an economic burden in the US of $148 million to $445 million where Midostaurin could have been prescribed, and $139 million to $417 million where Giltertinib would have been the appropriate treatment.

Research Highlights

FLT32: Diaceutics examined the economic cost of not testing for FLT3 to treat acute myeloid leukemia (AML), a cancer with poor five-year survival rates and high treatment costs. The FDA approved two FLT3 precision medicines for AML in the last four years. Diaceutics found that these therapies can provide hope for AML patients and every year, 2,164 FLT3 patients in the US could benefit from precision medicine interventions, generating up to 2,965 quality-adjusted life years.
NTRK3: On a global scale, using the world’s largest repository of diagnostic testing data, Diaceutics’ research shows the dramatic variation in levels of test availability for NTRK between the EU, US and Asia. NTRK is one of the first hyper-targeted pan-tumor biomarkers which is dependent on the testing ecosystem. Diaceutics found that 73% of the top 30 labs in the US are carrying out NTRK fusion testing, compared to just 22% of Japan’s top nine; 54% of China’s top 13; 60% of Italy’s top 20 and 65% of France’s top 20.
HRD4: Diaceutics’ research team examined HRD, an emerging predictive biomarker across multiple cancers, and a companion biomarker for two new drug approvals this month. Diaceutics found that a lack of standardized HRD panels and low testing rates are leading to poorer outcomes for ovarian cancer patients who may have been eligible for PARP inhibitor treatment. Research was based on a data set of 8,400 metastatic ovarian cancer patients.
KRAS G12C5: Insights from the DXRX diagnostic network also provides market readiness analysis for prospective therapies targeting KRAS-G12C – an aggressive, poor survival tumor genotype – in lung, colorectal and pancreatic cancers. Analysis of Diaceutics’ data found that following treatment with first-line therapies, primary tumor profile results can be less reliable. The team concluded that there is a need for improved reimbursement and repeated testing post-treatment for the continued efficacy in therapeutics – especially for patients with pancreatic cancer.
TP536: Diaceutics studied a cohort of 984 patients diagnosed with Acute Myeloid Leukemia (AML). The study found that where there was a TP53 mutation detected, patients had negative associations with 7 specific genes (ASXL1, CEBPA, FLT3, IDH1, NRAS, RUN1, TET2), meaning that a TP53 antagonist and targeted therapy may be a valuable treatment option in rare cases where co-mutation exists.
Chief Technical Officer, Jordan Clark, said: "Our data consistently reveals that testing inefficiencies due to a lack of collaboration among precision medicine stakeholders remains today’s most significant obstacle to getting every patient the treatment they deserve.

"To address this need for collaboration, we have spent the last 10 years building relationships with more than 2,500 laboratories and industry leading service providers in areas such as pathology training, health economics, reference standards, EQA and digital enablement.

"DXRX by Diaceutics will unlock the power of our data for all members of this network, delivering significantly more value for all stakeholders in precision medicine and, most of all, for patients.

"Several of the abstract authors are industry advisors in the DXRX network, and these studies demonstrate the power of being able to facilitate the collaboration required to advance our mission of getting every patient the treatment they deserve."

Diaceutics will launch DXRX, the world’s first diagnostic network in precision medicine, in Q4 2020 to help solve these issues through global stakeholder collaboration.

Through DXRX, Diaceutics will make these alliances and its real-world data repository available to its network of pharmaceutical, laboratory and diagnostic partners. Laboratory and diagnostic partners will join the DXRX network in Q3 2020, and pharmaceutical partners will gain access in Q4.

DXRX is industry shorthand for diagnostics (DX) and therapy (RX). For more information visit View Source

Diaceutics’ published research is available at View Sourcedata-insights.html

On May 28, 2020 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL) and Tavros Therapeutics, Inc., reported a strategic collaboration to apply Tavros’ functional genomic discovery platform to develop next generation targeted small molecule drug candidates, initially to expand Zentalis’ oncology pipeline (Press release, Zentalis Pharmaceuticals, MAY 28, 2020, View Source [SID1234578258]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to be collaborating with Zentalis, as this aligns with Tavros’ goal to improve cancer therapy by uncovering unique and druggable vulnerabilities within tumors," remarked Tavros CEO and co-founder Eoin McDonnell on behalf of Tavros co-founders Kris Wood and Greg Mossinghoff. "The Tavros functional genomic discovery platform employs proven technologies and proprietary know-how to significantly increase clinical success, as well as to improve the tolerability and toxicity profile of a new drug."

Tavros’ strategic approach allows for an unbiased analysis of intricate cellular signaling pathways to discover novel targets, synthetic lethality pairs, mechanisms to overcome cancer resistance, and unique genetic signatures for clinical trials.

Zentalis CEO Anthony Sun commented, "Tavros and Zentalis share a common goal: to utilize proprietary technologies to discover and develop drugs that are safer, more efficacious and tolerable for patients than existing therapies. Leveraging the unique insights provided by Tavros’ technologies coupled with Zentalis’ strong medicinal chemistry expertise, we believe this relationship could yield multiple novel drug candidates and combinations that may have the potential to address unmet needs for cancer patients."

The transaction terms were structured to build and expand the Tavros discovery platform, with each company given the rights to any new products generated from the platform.

On May 28, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, reported that it will hold virtual presentations at the following upcoming investor conferences (Press release, Ultragenyx Pharmaceutical, MAY 28, 2020, View Source [SID1234558609]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Shalini Sharp, the company’s Chief Financial Officer, will hold a virtual presentation at the Jefferies Healthcare Conference on Wednesday, June 3, 2020 at 2 PM ET.
Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will hold a virtual presentation at the Goldman Sachs 41ST Annual Global Healthcare Conference on Tuesday, June 9, 2020 at 3:50 PM ET.
The live and archived webcast of these presentations will be accessible from the company’s website at View Source Replays of the webcasts will be available for 90 days.

On May 28, 2020 ViewRay, Inc. (NASDAQ: VRAY) reported that the Company will present at the Jefferies 2020 Virtual Healthcare Conference (Press release, ViewRay, MAY 28, 2020, View Source [SID1234558644]). Scott Drake, President and CEO, will participate in a fireside chat at 2:30 p.m. Eastern Time on Tuesday, June 2, 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

An audio webcast of the Company’s presentation will be available on the investor relations section of ViewRay’s website at View Source A replay of the webcast will be available for 7 days after the date of the presentation.

On May 28, 2020 AstraZeneca reported that Detailed results from the Phase III ADAURA trial showed Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent (Press release, AstraZeneca, MAY 28, 2020, View Source [SID1234558612]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Results will be presented during the plenary session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program on 31 May (abstract #LBA5).

In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant treatment (after surgery) with Tagrisso reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12, 0.23; p<0.0001). DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).

At two years, 89% of patients in the trial treated with Tagrisso remained alive and disease free versus 53% on placebo. Consistent DFS results were seen across all subgroups, including patients who were treated with surgery followed by chemotherapy and those who received surgery only, as well as in Asian and non-Asian patients.

Roy S. Herbst, MD, Ph.D., chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT and principal investigator in the Phase III ADAURA trial, said: "These data are transformative for patients with early-stage EGFR-mutated non-small cell lung cancer who face high rates of recurrence even after successful surgery and subsequent treatment with adjuvant chemotherapy. Tagrisso will provide a much-needed new treatment option that has the potential to change the practice of medicine and improve outcomes for patients in this setting."

José Baselga, Executive Vice President, Oncology R&D, said: "The momentous results of the Phase III ADAURA trial for Tagrisso demonstrate for the first time in a global trial that an EGFR inhibitor can change the course of early-stage EGFR-mutated lung cancer and provide hope for a cure. We are discussing these outstanding data with regulatory authorities and look forward to bringing the benefits of Tagrisso to patients with early-stage disease."

In April 2020, an Independent Data Monitoring Committee recommended for the Phase III ADAURA trial to be unblinded two years early based on its determination of overwhelming efficacy. At the time of data cut-off, overall survival (OS) data favoured Tagrisso, but were not mature. The trial will continue to assess OS as a secondary endpoint.

Summary of ADAURA results

i The data cut-off date for DFS was 17 January 2020.

The safety and tolerability of Tagrisso in this trial was consistent with previous trials in the metastatic setting. Adverse events at Grade 3 or higher from all causes occurred in 10% of patients in the Tagrisso arm versus 3% in the placebo arm as assessed by the investigator.

Tagrisso is approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC in the US, Japan, China, the EU and many other countries around the world.

Several presentations featured during the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program will showcase AstraZeneca’s leadership in lung cancer across early and late-stage disease and reinforce the Company’s biomarker-driven approach.

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.1 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2 A significant portion of patients with resectable NSCLC eventually develop recurrence despite surgery (complete resection).3,4 Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.5-7 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.8 Approximately 25-30% of patients with NSCLC present with resectable disease at diagnosis.9-11

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 adjuvant chemotherapy as indicated. 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 in Stage II and IIIA patients and a key secondary endpoint is DFS in Stage IB, II and IIIA patients. The data readout was originally anticipated in 2022. The trial will continue to assess OS as a secondary endpoint.

Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have received approval in the US, Japan, China, the EU and many countries around the world for 1st-line EGFRm advanced NSCLC. Tagrisso is also being developed in the Stage III, unresectable setting (LAURA), in combination with chemotherapy (FLAURA2) and in combination 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. AstraZeneca aims 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 LAURA, and FLAURA2.5-7

AstraZeneca is 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.12 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 MERMAID-1, 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 trials NeoCOAST, COAST and HUDSON in combination with potential new medicines from the early-stage pipeline including Enhertu.

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.