On December 11, 2019 NanoString Technologies, Inc. (NASDAQ:NSTG), reported a leading provider of life science tools for translational research, reported the formation of the GeoMx Breast Cancer Consortium (GBCC) (Press release, NanoString Technologies, DEC 11, 2019, View Source [SID1234552269]).
s
The consortium is focused on using the GeoMx Digital Spatial Profiler to address some of the most challenging translational research questions in breast cancer by applying spatial analysis. Some of the initial projects that the GBCC is planning include studies that will explore the immune interactions in HER2+ breast cancer, responsiveness to immunotherapy in triple-negative breast cancer (TNBC), disease evolution in metastatic breast cancer, and role of the tumor microenvironment in molecular epidemiological studies.

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!

Through the work of the GBCC, NanoString intends to develop a GeoMx Atlas database combining spatial and clinical data to enable meta-analyses to identify and validate oncology biomarkers in the spatial domain.

"By evaluating breast cancer with a spatial approach, we hope to expand our ability to understand the impact of treatments on the tumor, immune infiltrate and microenvironment," said Sandra Swain, M.D., Associate Dean for Research Development and Professor of Medicine at Georgetown University Medical Center. "In forming this consortium, we are promoting the importance of engaging innovative approaches across multiple studies to ensure rapid progress in discovery of novel biomarkers which may lead to more effective means of treating breast cancer."

"While earlier diagnosis and new therapies have improved patient outcomes in breast cancer, there are subgroups of patients with aggressive disease where effective therapies remain elusive," said Brad Gray, president and CEO of NanoString. "We believe that by applying spatial analysis, the GeoMx Breast Cancer Consortium can help to address some of the most pressing needs in breast cancer research."

Founding member institutions and investigators of the GeoMx Breast Cancer Consortium include:

The Dana Farber Cancer Institute: Elizabeth Mittendorf, M.D., Ph.D.
The Mayo Clinic: Jodi Carter, M.D., Ph.D.; Aubrey Thompson, Ph.D.; Fergus Couch, Ph.D.
The Peter MacCallum Cancer Centre: Sherene Loi, Ph.D.
The University of North Carolina, Chapel Hill: Melissa Troester, M.P.H., Ph.D.
Georgetown University Medical Center: Sandra Swain, M.D.
The Institut d’Investigacions Biomèdiques: August Pi i Sunyer (IDIBAPS): Aleix Prat, M.D., Ph.D.
Researchers that are interested in joining the GeoMx Breast Cancer Consortium can find an application at: View Source

On December 11, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit (IJB-CTSU) and Frontier Science Foundation (FS) reported data from a second interim overall survival (OS) analysis of the phase III APHINITY study, evaluating the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) as an adjuvant (after surgery) treatment for patients with HER2-positive early breast cancer (eBC) (Press release, Hoffmann-La Roche, DEC 11, 2019, View Source [SID1234552253]). This latest interim OS analysis was conducted after a median follow-up of approximately 74 months, compared to approximately 45 months for the primary analysis in 2017, and includes updated descriptive iDFS and cardiac safety data.1

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!

"The goal of adjuvant treatment is to give each person with early breast cancer the best chance of a cure," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "These new data with longer follow-up show the continued effect of the Perjeta-based regimen and an increased invasive disease-free survival benefit."

Martine Piccart, M.D., Ph.D., BIG co-founder and Scientific Director at Institut Jules Bordet, added: "These results demonstrate the importance of longer follow-up of APHINITY and further confirm the Perjeta-based regimen as the standard of care for people with HER2-positive early breast cancer at high risk of recurrence, such as those with lymph node-positive disease."

At this latest planned analysis, in the overall study population, the Perjeta-based regimen reduced the risk of breast cancer recurrence or death by 24%, compared to Herceptin, chemotherapy and placebo (HR=0.76; 95% CI 0.64-0.91). At six years, 90.6% of patients in the Perjeta arm have not seen their breast cancer return, compared to 87.8% in the placebo arm, an absolute benefit of 2.8%.1

Consistent with the primary analysis, the greatest effect continues to be observed in patients at high risk of recurrence, such as those with lymph node (LN)-positive disease. In these patients there was a 28% reduction in the risk of recurrence or death with the Perjeta-based regimen compared to Herceptin, chemotherapy and placebo (HR=0.72; 95% CI 0.59-0.87). This corresponds to an absolute improvement in iDFS at six years of 4.5% (87.9% vs. 83.4%). With longer follow-up, the treatment effect of the Perjeta-based regimen is seen regardless of hormone receptor (HR) status. The iDFS hazard ratio for HR-positive patients is 0.73 (95% CI 0.59-0.92). The iDFS hazard ratio for HR-negative patients is 0.83 (95% CI 0.63–1.10).1

Fewer deaths have been observed in the Perjeta-based regimen arm (125 vs. 147 [HR=0.85; 95% CI: 0.67-1.07]); however, data remain immature at this time. The APHINITY study continues as planned with the third interim analysis of OS scheduled for 2022. Continued follow-up of these patients is very important to determine a possible OS benefit.1

No new cardiac safety concerns emerged. The safety profile of the Perjeta-based regimen was consistent with that seen at primary analysis and in previous studies, with a low incidence of cardiac events. The percentage of primary cardiac events recorded in the Perjeta-based regimen arm was 0.8% vs. 0.3% in the placebo arm.1,2

Based on the primary study analysis in 2017, the clinical value of the Perjeta-based regimen for patients with HER2-positive eBC has been recognised by regulatory bodies around the world. This regimen is now approved for the treatment of eBC for people at a high risk of recurrence in more than 86 countries, including the US and across the EU. To date, more than 150,000 patients have been treated with the Perjeta-based regimen in this setting.3 The regimen has also been recognised in multiple international treatment guidelines, including those from St Gallen International Breast Cancer Conference, NCCN, ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper), which recommend it as an adjuvant standard treatment for patients with HER2-positive eBC at high risk of recurrence.4,5,6,7

These results from APHINITY will be presented in an oral session on Wednesday 11 December at 09.30 CT at the 2019 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas, US, by Dr Martine Piccart (Abstract #GS1-04). The data will also be featured in SABCS’ official press programme.

About APHINITY
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy, compared to Herceptin and chemotherapy, as adjuvant therapy in 4,805 people with operable HER2-positive eBC. The primary efficacy endpoint of the APHINITY study is iDFS, which in this study is defined as the time a patient lives without return of invasive breast cancer at any site, or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, OS, disease-free survival and health-related quality of life. The study will continue to follow participants for ten years.2,8

About Perjeta
Perjeta is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Perjeta is designed specifically to prevent the HER2 receptor from pairing (or ‘dimerising’) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumour growth and survival.9 Binding of Perjeta to HER2 may also signal the body’s immune system to destroy the cancer cells. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different locations. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of HER signalling pathways, thus preventing tumour cell growth and survival.10

About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and metastatic HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients.11 Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test which identifies people who will likely benefit from these medicines at the onset of their disease.

On December 11, 2019 PierianDx, the leading clinical genomics informatics company, reported that Intermountain Healthcare has selected the PierianDx Clinical Genomics Workstation to advance their precision medicine program, Intermountain Precision Genomics (Press release, PierianDx, DEC 11, 2019, View Source [SID1234552270]). Intermountain Healthcare will leverage PierianDx for next-generation sequencing (NGS) variant analysis, classification, and reporting services to assist in the identification of targeted therapies and potential clinical trial opportunities for cancer patients.

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!

PierianDx provides a SaaS platform, Clinical Genomics Workspace (CGW), the industry-leading clinical software for informatics, interpretation, and reporting of NGS data. By joining the PierianDx customer network, Intermountain Healthcare can access the genomic data within CGW’s knowledgebase, the most clinically robust database comprised of millions of biomedical findings driven by public and highly curated sources. Intermountain Healthcare joins a long list of other leading diagnostic labs and health systems using PierianDx.

"We are thrilled that Intermountain Healthcare has joined our rapidly expanding partner network," says Michael L. Sanderson, CEO of PierianDx. "Intermountain Healthcare is widely known as a leader in precision medicine and we look forward to continued collaboration opportunities."

On December 11, 2019 MONALEESA-3 data reported that published in The New England Journal of Medicine (NEJM) shows Kisqali (ribociclib) plus fulvestrant demonstrated a statistically significant improvement in overall survival, with an almost 30% reduction in risk of death compared to fulvestrant alone, in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer1 (Press release, Novartis, DEC 11, 2019, View Source [SID1234552254]). MONALEESA-3 overall survival data were first presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2019 (see media release). The NEJM publication includes new analyses confirming overall survival benefit across all patient sub-groups treated with Kisqali plus fulvestrant.

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!

"These data show that treatment with Kisqali gives women with HR+/HER2- advanced breast cancer a chance for more life – whether they are treatment naïve or have had prior therapy," said Jeff Engelman, MD, PhD, Global Head of Oncology Research, Novartis Institutes for BioMedical Research. "Pre-clinical data show that Kisqali is distinct from other CDK4/6 inhibitors in its ability to more selectively target and inhibit CDK4."

The NEJM publication includes subgroup analyses according to line of therapy:

At 42 months, estimated survival rates among patients who received first-line therapy were 66.9% (95% CI, 58.7 to 73.9) with Kisqali plus fulvestrant vs. 56.3% (95% CI, 44.2 to 66.8) with fulvestrant alone (hazard ratio 0.70; 95% CI, 0.48 to 1.02)
Median overall survival among patients in the early-relapse and second-line subgroup was 40.2 months with Kisqali plus fulvestrant and 32.5 months with fulvestrant alone (hazard ratio, 0.73; 95% CI, 0.53 to 1.00)

A new post-hoc overall survival analysis based on prior endocrine therapy demonstrated that Kisqali plus fulvestrant had a:

36% reduction in risk of death in those who did not receive any previous endocrine therapy in any setting (HR= 0.64);
30% reduction in risk of death in those who were endocrine resistant, defined as progressive disease within the first 6 months of first-line endocrine therapy for advanced breast cancer while on endocrine therapy, or relapse within the first two years of (neo)adjuvant therapy (HR=0.70);
26% reduction in risk of death in those who were endocrine sensitive (HR=0.74).
No new safety signals were observed. The most common grade 3/4 adverse events of special interest observed in patients who received Kisqali plus fulvestrant compared to fulvestrant alone were neutropenia (57.1% vs 0.8%), hepatobiliary toxicity (13.7% vs 5.8%), QTc prolongation (3.1% vs 1.2%), respiratory disorders (2.3% vs 3.3%) and interstitial lung disease (0.2% vs 0%).

The publication of the full data results is available online.

About Kisqali (ribociclib)
Novartis is continuing to reimagine cancer by investigating Kisqali in early breast cancer. The NATALEE study is a Phase III clinical trial of Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer being conducted in collaboration with Translational Research In Oncology (TRIO)2.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

Kisqali (ribociclib) Important Safety Information
KISQALI (ribociclib) is a prescription medicine used in combination with an aromatase inhibitor as the first hormonal-based therapy to treat pre/perimenopausal and postmenopausal women and in combination with fulvestrant as the first hormonal-based therapy or following disease progression on hormonal therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. It is not known if KISQALI is safe and effective in children. KISQALI can cause severe or life-threatening inflammation of the lungs. Patients should tell their health care provider right away if they experience breathing problems or chest pains. KISQALI can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. KISQALI is not indicated for concomitant use with tamoxifen due to an increased risk of QT prolongation. Patients should tell their health care provider right away if they have a change in their heartbeat (a fast or irregular heartbeat), or if they feel dizzy or faint. KISQALI can cause serious liver problems. Patients should tell their health care provider right away if they get any of the following signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), dark or brown (tea-colored) urine, feeling very tired, loss of appetite, pain on the upper right side of the stomach area (abdomen), and bleeding or bruising more easily than normal. Low white blood cell counts are very common when taking KISQALI and may result in infections that may be severe. Patients should tell their health care provider right away if they have signs and symptoms of low white blood cell counts or infections such as fever and chills. Before taking KISQALI, patients should tell their health care provider if they are pregnant, or plan to become pregnant as KISQALI can harm an unborn baby. Females who are able to become pregnant and who take KISQALI should use effective birth control during treatment and for at least 3 weeks after the last dose of KISQALI. Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI. Patients should tell their health care provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements since they may interact with KISQALI. Patients should avoid grapefruit or grapefruit juice while taking KISQALI. The most common side effects (incidence ≥20%) include white blood cell count decreases, nausea, infections, tiredness, diarrhea, vomiting, hair loss, headache, constipation, rash, and cough. The most common grade 3/4 side effects (incidence >5%) were low neutrophils, low leukocytes, abnormal liver function tests, and low lymphocytes. Abnormalities were observed in hematology and clinical chemistry laboratory tests.

On December 11, 2019 Pyxis Oncology, an immuno-oncology company focused on developing a new family of antibody-based immunotherapies derived from novel insights into the biology of the tumor microenvironment, reported the appointment of Lara Sullivan, M.D. as Chief Executive Officer and Director (Press release, Pyxis Oncology, DEC 11, 2019, View Source [SID1234552271]). She succeeds Longwood General Partner and founding Chief Executive Officer, David Steinberg, who assumes the role of Chairman of the Board of Directors while John Flavin, the founding Chairman, will remain on the Board as an independent Director.

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!

"This is a very exciting time in immuno-oncology and Pyxis has a unique platform to understand the tumor microenvironment that will enable the company to make major contributions to the field," said Lara. "I am looking forward to working closely with our scientific co-founders and the Pyxis scientific team to unlock new avenues to restore the potency of dysfunctional immune cells. Building off this solid foundation with the support of our investors, I believe Pyxis will be able to make a real difference in the lives of cancer patients as we move our antibody programs into the clinic."

"We are excited to welcome Lara to Pyxis, and look forward to her leadership as we build and advance our pipeline. Lara brings a remarkable range of skills and experience spanning drug development, corporate strategy, finance and business development to the role of CEO at Pyxis," said David Steinberg, Chairman, Pyxis Oncology. "In addition, I would like to thank our co-founder and outgoing Chairman John Flavin for his exceptional early leadership and pivotal role in conceptualizing and establishing Pyxis. We look forward to his ongoing engagement and further contributions as an independent Director."

Prior to joining Pyxis, Lara was Founder and President of SpringWorks Therapeutics where she conceived of and executed the clinical stage spin-out from Pfizer and raised the Series A. In her executive roles at Pfizer, she led early stage R&D portfolio operations and strategy, and developed novel business models for early stage financing. Previously, Lara was an Associate Partner at McKinsey & Co. and a Principal at Paul Capital Partners, and earlier in her career worked in healthcare finance at CS First Boston. She is an independent Director of Rexahn Pharmaceuticals. Lara holds an M.D. from the University of Pennsylvania School of Medicine, an MBA from The Wharton School at the University of Pennsylvania, and a B.A. in Comparative Literature from Cornell University.