On October 5, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that efficacy results of neratinib in HER2-positive, hormone receptor-positive (HR+), early stage breast cancer (eBC) from the Phase III ExteNET trial were published in Clinical Breast Cancer (Press release, Puma Biotechnology, OCT 5, 2020, View Source [SID1234568118]). The manuscript appears in the October 5, 2020 online issue accessible at View Source(20)30258-5/fulltext.

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ExteNET was a multicenter, randomized, double-blind, Phase III trial of 2,840 HER2-positive eBC patients who received neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab. Patients were stratified by hormone receptor status and randomly assigned to one year of treatment with either oral neratinib 240 mg/day or placebo. The primary endpoint of the trial was invasive disease-free survival (iDFS) with overall survival as a key secondary endpoint. Within the European Union, neratinib is approved in patients with HR+ breast cancer who initiated treatment within one year of completing an adjuvant trastuzumab containing regimen.

The manuscript presents data focusing on HR+ patients who initiated treatment within a year of completing an adjuvant trastuzumab containing treatment (HR+ /< 1 yr) and subgroups of clinical interest including patients who did not achieve a pathological complete response (no pCR) after neoadjuvant treatment and therefore were at a high risk of disease recurrence. (HR+/ <1 yr, no pCR)

In the HR+ /< 1 yr patient population, the absolute 5-year invasive disease-free survival benefit versus placebo was 5.1% (HR=0.58, 95% CI 0.41‒0.82) and absolute 8-year overall survival benefit was 2.1%. (HR=0.79, 95% CI 0.55‒1.13). The 5-year cumulative incidence of CNS metastases was 0.7% in the neratinib arm and 2.1% in the placebo arm.

In the HR+/ <1 yr, no pCR subgroup of patients that were at a high risk of disease recurrence the absolute 5-year iDFS benefit in the neratinib arm versus placebo was 7.4% (HR=0.60; 95% CI 0.33‒1.07) and the 8-year overall survival benefit was 9.1% (HR=0.47; 95% CI 0.23–0.92).

Most common grade 3 adverse events were diarrhea (39% vs placebo, 1%; without mandatory anti-diarrheal prophylaxis), vomiting (4% vs <1%), and fatigue (2% vs <1%).

Professor Arlene Chan, Vice Chair Breast Cancer Research Centre – WA, said, "Deciding on which patients benefit most from a given therapy is an important goal for clinicians. This newly published study provides consistent and durable benefits of neratinib in a subset of HER2-positive early stage breast cancer patients who are considered to be at greater risk of relapse: namely patients with HR+ tumors that did not achieve a pCR after neoadjuvant treatment (no pCR). The benefits demonstrated are meaningful in all endpoints evaluated, including iDFS, OS and CNS recurrence, and thus should help guide future clinical decisions."

Hope S. Rugo, MD, Professor of Medicine, University of California San Francisco Comprehensive Cancer Center, said, "HER2-positive HR+ patients who do not achieve a pCR are at increased risk of recurrence, even after receiving current standard of care treatment. In a descriptive subset analysis, extended adjuvant therapy with neratinib demonstrated a positive benefit in these patients not only in iDFS, but also in OS. In addition, the trend toward lower CNS involvement is a very important consideration, given the profound impact of CNS metastasis on future prognosis. These data coupled with the recently published data from the CONTROL study, which shows improved tolerability with dose escalation, should allow more patients to benefit from this important therapy."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "Although there have been many new treatment options for patients with early stage HER2-positive breast cancer, the risk of disease recurrence remains significant and more must be done. These newly published data demonstrate that neratinib provides a clinically meaningful reduction in the risk of recurrence and provides a very important option for these high risk patients."

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

On October 5, 2020 McKesson Corporation (NYSE:MCK) reported that it will release its second quarter fiscal 2021 financial results before market open on Tuesday, November 3, 2020 (Press release, McKesson, OCT 5, 2020, View Source [SID1234568117]). The company will host a live webcast of the earnings conference call for investors at 8:00 AM Eastern Time to review its financial results.

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The live webcast will be available on McKesson’s Investor Relations website at View Source, along with the company’s earnings press release, financial tables and slide presentation.

On October 5, 2020 Guardant Health, Inc. (Nasdaq: GH). Despite advances in precision oncology, reported that progress is slowed by the limitations of tissue genotyping, which is traditionally used to enroll patients in clinical trials (Press release, Guardant Health, OCT 5, 2020, View Source [SID1234568116]). A new study published in Nature Medicine,1 led by the National Cancer Center Hospital East (NCCHE) in Japan, demonstrates that the Guardant360 liquid biopsy is not only concordant to tissue genotyping, but also accelerates clinical trial enrollment, detects more actionable alterations, and achieves similar treatment response rates and progression-free survival in patients with advanced gastrointestinal cancer. Publication link here.

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The study, SCRUM-Japan GOZILA, compares comprehensive genomic profiling using the Guardant360 liquid biopsy, versus tissue genotyping for trial enrollment into the SCRUM-Japan study network. Patients with advanced gastrointestinal cancer, including gastric and colorectal cancer, were matched to novel therapies that target the specific biomarkers identified. Compared to tissue genotyping (n=5,621) used in GI-SCREEN, the Guardant360 liquid biopsy (n=1,687) shortened screening duration by 67 percent (median 11 vs. 33 days) and improved trial enrollment rate by 132 percent (9.5 vs. 4.1 percent).

Additionally, the Guardant360 liquid biopsy revealed more actionable alterations because of its high success rate and ability to detect heterogeneously-distributed mutations which are often missed by single-locus tissue analysis. Most importantly, similar objective response rates and progression-free survival were seen in both studies, which included patients who were matched to interventional biomarker-targeted therapies when their cancer had progressed, after receiving first-line treatment.

"The data demonstrate that genomic profiling by ctDNA (circulating tumor DNA) analysis using the Guardant360 liquid biopsy has the advantage of shorter turnaround times and improved patient enrollment compared to tissue biopsy for clinical trials, without compromising treatment efficacy. The paradigm of precision oncology should be shifted toward greater use of liquid biopsies." said the Principal Investigator of this study Dr. Yoshiaki Nakamura, Attending Physician, Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East.

AmirAli Talasaz, Ph.D., Guardant Health President added, "These data complement other studies supporting the routine use of the Guardant360 test in personalized treatment decisions for patients with advanced cancer, and its potential to significantly accelerate the development and delivery of innovation in precision medicine to patients."

The Guardant360 test is increasingly being used by pharmaceutical companies and academic researchers in clinical trials to accelerate precision medicine drug development, and by oncologists to guide treatment across solid cancers as the number of treatment-relevant genomic alterations continues to grow. Using next-generation sequencing, the Guardant360 test analyzes 74 genes using cell-free tumor DNA from blood samples and is broadly covered by Medicare for use across the vast majority of advanced solid tumors and many private payers. The Guardant360 CDx was recently approved by the FDA for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor). The Guardant360 CDx is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib).

On October 5, 2020 Diaceutics PLC, (AIM: DXRX) reported new research which predicts that the Non-Small Cell Lung Cancer (NSCLC) testing market will expand to $3.6 billion in the United States by 2025 – up considerably from just $125 million today (Press release, Diaceutics, OCT 5, 2020, View Source [SID1234568115]). The findings are published in the 2020 Diaceutics PM Readiness Report.

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Driven by the increased utility of NSCLC testing and testing services, as well as new single and combination treatments – Diaceutics’ research found that currently, there are 714 new precision medicine treatments focused on NSCLC in late-stage clinical trials – this exponential growth represents 40% of the total value for the NSCLC treatment market. The growing market demonstrates the mounting dependence on precision medicine therapies for cancer treatment; and the pharmaceutical sector’s increasing investment in testing to ensure that their new treatments reach the eligible patient population. In doing so, they are closing the gap on the $2-3 billion in potential NSCLC revenues that is currently lost every year due to inefficient testing.

Currently, only half of patients with advanced NSCLC are receiving the right drug
As pharma revenues continue to be lost due to hurdles inherent with current NSCLC testing pathways, analysis in Diaceutics’ PM Readiness Report shows that this has a significant impact on patient treatment. Currently, only half of NSCLC patients who are eligible for precision medicine therapies receive them, with not enough emphasis being placed on the economic value of diagnostic testing. Pharma investment therefore often does not reflect the true value of efficient testing, or the investment is spread too thinly across multiple players. This disincentivises stakeholders within the testing ecosystem from addressing the entire patient journey from cough to precision treatment, leading to a fragmented approach to testing.

Diaceutics’ research found that by investing heavily in the PD-L1 22C3 antibody, Merck has shown how education and investment drives biomarker adoption, with 83% of all PD-L1 testing today using Merck’s associated antibody.

Furthermore, 10% of patients receive NSCLC treatment without relevant testing
Diaceutics’ research shows that even when patients do receive a precision medicine drug, one-in-10 will receive the wrong one. The PM Readiness Report found that 10% of NSCLC patients are receiving precision medicine treatments without having had the relevant biomarker tests, signifying a knowledge gap amongst oncologists around biomarkers and their associated treatments.

Progress is being made with PD-L1
Recent guidance from the FDA states that it is continually approving multiple drugs that are dependent on the same biomarkers, and pharmaceutical companies should therefore focus on promoting multiple tests that lead patients to their specific therapies, rather than focusing on one proprietary test.

Diaceutics analysed the value in multiple pharma competitors simultaneously promoting companion diagnostic tests for specific groups of therapies and found significant revenue benefits for pharma. In the case of PD-L1 testing, this approach has reduced the post-launch time it takes for a new biomarker test to reach 80% of the eligible patient population from seven years to three. In the case of EGFR and ALK, however, the average delay remains high at six years due to poor pre-launch preparation.

The impact of COVID-19
The fragility of the testing ecosystem has been highlighted by the emergence of COVID-19 and Diaceutics has observed the pandemic’s highly disruptive impact on cancer testing. It found that cancer testing in China decreased by as much as 50% in Q2 2020 versus the Q2 2019. The company’s tracker in the US also revealed that there was a 31% drop in newly diagnosed cases of lung cancer between February and March 2020. The research revealed that while patients already diagnosed with cancer and receiving treatment were continuing to be supported, the decrease in testing over this period will result in a backlog of undiagnosed patients. The ramifications of this backlog will be felt in 2021 and beyond. Furthermore, the increased pressure on testing laboratories caused by the demand for COVID testing has seen a decentralisation of cancer testing observed across China with regional laboratories having to manage the fallout. As a result, Diaceutics observed that enhanced planning and investment will be critical to absorb what will be a significant increase in testing needs following COVID-19.

Speaking about the findings of the report, Peter Keeling, CEO and Founder of Diaceutics, said: "Patients simply cannot get the right treatment without efficient testing – COVID-19 has unequivocally proven that model to be true and has presented us with an opportunity to get out in front of a global testing crisis which has this year, been put in the spotlight.

"The era of launching a therapy with a single companion diagnostic partner is definitely behind us. We need to consider the global needs of our patients and the regional restrictions which have been further exacerbated by the pandemic. This calls for pharma to think beyond a one-size-fits-all approach and to embrace the democratisation of testing.

"The time has come to eradicate the hurdles that stand in the way of getting patients the treatment they deserve. Our evidence, our partners and our experience tell us that there is a better way and that the time for that better way is now. We believe that a global platform will enable the collaboration required between stakeholders to overcome the hurdles in today’s testing ecosystem.

"Research from the Report shows that a platform like DXRX has the potential to reduce the time to achieve 50% test adoption in NSCLC from the current average of 4.5 years to just months. That would be transformative for patients and could make the promise of precision medicine a reality for more people."

On October 5, 2020 The Pershing Square Sohn Cancer Research Alliance (PSSCRA) reported the opening of applications for its 2021 Prize for Young Investigators in Cancer Research (Press release, The Pershing Square Sohn Cancer Research Alliance, OCT 5, 2020, View Source [SID1234568114]). The prize of $200,000 per year for up to three years is awarded annually to at least six New York City area-based scientists. The prize empowers researchers to pursue innovative, high-risk/high-reward cancer research at a stage when traditional funding is lacking.

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"Science, social justice and the collective environmental conscience have never been as intertwined. Symbolizing the notion of infinity, our eighth year promises to reveal new insights and innovation in cancer research at a scale that is as broad as it is entangled: spanning the micro and the macro, the individual and the societal; the biologic and the synthetic," said Pershing Square Foundation Trustee Neri Oxman. "We look forward to reviewing radically innovative applications as we continue to grow our PSSCRA community."

Applicants must have between two and eight years of experience running their own laboratories by the award start date (July 2021), hold a PhD, MD or MD-PhD (or degree equivalent), and be affiliated with a research institution in the greater New York City area. The greater New York City area includes New York City’s five boroughs, Long Island, Westchester County, New Jersey, and Western Connecticut (Fairfield and New Haven Counties). The deadline to submit a Letter of Intent is November 9, 2020. For more details on PSSCRA and the application process, including the full eligibility criteria, please visit: View Source

Now providing funding and support for 46 investigators at eleven academic research institutions, the highly competitive Prize underwrites the bold research of cancer scientists at a formative stage in their careers. In order to facilitate collaboration and innovation, each Prize winner is given access to leaders in the pharmaceutical and biotech industries and the opportunity to present his or her work to scientific, business, and philanthropic audiences.

"As we embark on the eighth year of the Prize, we remain extremely impressed by the remarkable scientific talent in the NYC area. It is our goal to build a community of innovative and skilled individuals and to support their exploration of the most exciting and revolutionary ideas, especially during a time when scientific research is more pressing and vital than ever," said Olivia Tournay Flatto, PhD, President of The Pershing Square Foundation and Co-Founder and Executive Director of the Pershing Square Sohn Cancer Research Alliance. "The future of the New York area’s life science research and industry relies on our ability to discover and support such new talent."

"The Pershing Square Sohn Prize is an immense honor for me and my team," said Britta Will, PhD, a 2020 Prize winner who is an Assistant Professor of Medicine at Albert Einstein College of Medicine. "It provides us with a truly unique opportunity to comprehensively explore a wholly new research direction which would have otherwise taken years to realize."

"The Pershing Square Sohn Prize will open the gateway for my laboratory to tackle high-risk and bold questions. This award will also provide the means to establish communication and collaboration with other outstanding scientists by virtue of participation in networking events. It will, therefore, undoubtedly support the development of my scientific career," said Camila dos Santos, PhD, a recipient of the 2018 Prize and Assistant Professor at Cold Spring Harbor Laboratory. "I am incredibly honored to be a recipient of this prestigious award and become a part of such an extraordinary effort and community."

"This is a highly impactful and prestigious award which has made a major impact on my career," remarked 2014 Prize winner Ross Levine, MD, the Laurence Joseph Dineen Chair in Leukemia Research and Director of the MSK Center for Hematologic Malignancies at Memorial Sloan Kettering Cancer Center. Dr. Levine concluded his project in 2017 and has participated in PSSCRA’s application process as a guest reviewer for the past three years.