On May 31, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported a collaboration with the U.S. Department of Veterans Affairs (VA) Veterans Health Administration, America’s largest integrated health care system, and the Veterans Health Foundation to provide Galleri, GRAIL’s groundbreaking multi-cancer early detection (MCED) blood test, to 10,000 veterans across approximately 10 participating VA sites over the next three years (Press release, Grail, MAY 31, 2022, View Source [SID1234615289]). The VA Pittsburgh Healthcare System is the first VA site that will be participating.

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Through the collaboration, eligible U.S. military veterans will be able to receive the Galleri test and can enroll in GRAIL’s REFLECTION registry, an observational, multi-center, real-world evidence study. REFLECTION will assess Galleri’s performance, when combined with recommended cancer screenings, to find earlier cancer in the population, when there is a higher chance of successful and potentially curative treatment. REFLECTION will enroll 35,000 healthy volunteers and evaluate the performance of Galleri in diverse clinical settings as part of routine medical care.

"Cancer is a significant issue for U.S. veterans, many of whom are at high risk," said Dr. Charles Atwood, pulmonologist and lead researcher on the REFLECTION study at VA Pittsburgh. "GRAIL’s multi-cancer early detection test will be provided to veterans, in addition to current recommended screenings, with the aim of improving early diagnoses and outcomes."

The Galleri test is a first-of-its-kind MCED blood test. In a clinical study, the Galleri test demonstrated the ability to detect signals across more than 50 types of cancers, over 45 of which lack recommended screening tests today. Using advanced genomics and machine learning, the test also determines the origin of the cancer signal, which can then guide diagnostic workup. Early detection of cancer is known to improve cancer outcomes, yet today, the majority of cancers are detected in late stages because only five cancer types have recommended screenings – breast, cervical, colon, lung and prostate cancers.

"As the largest national integrated health system in the U.S., the VA delivers unparalleled care to our veterans, many of whom are at elevated risk of developing cancer. We are thrilled to collaborate with the VA, the Veterans Health Foundation and U.S. veterans for this important real-world evaluation of the Galleri test and its potential to transform early cancer detection," said Bob Ragusa, chief executive officer at GRAIL. "Together, we hope participation in the REFLECTION registry study and receiving a Galleri test will lead to more cancer diagnoses at an earlier stage, when treatment is more likely to be successful."

Nationwide, 1.2 million veterans who have used VA health care since the beginning of fiscal year 2021 have received a cancer diagnosis. That number includes 14 percent of veterans treated at VA Pittsburgh in the same time frame.

About VA Pittsburgh Healthcare System

VA Pittsburgh Healthcare System (VAPHS) is one of the largest and most progressive VA health care systems in the nation. More than 4,000 employees serve nearly 80,000 veterans every year, providing a range of services from complex transplant medicine to routine primary care. VAPHS is a leader in virtual care delivery through telehealth technology; a center of research and learning with 130 research investigators and $14.8 million in funding in fiscal year 2021; and a provider of state-of-the-art healthcare training to some 1,500 student trainees annually. VAPHS provides care at medical centers in Pittsburgh’s Oakland neighborhood and nearby O’Hara Township, both in Pennsylvania, and five outpatient clinics in Belmont County, Ohio, and Beaver, Fayette, Washington and Westmoreland counties in Pennsylvania. An additional site of care is expected to open in Monroeville, Pennsylvania, in 2023. Veterans can call 412-360-6162 to check eligibility or enrollment. Stay up to date at pittsburgh.va.gov, Facebook and Twitter.

On May 31, 2022 Lucence, the precision oncology company pioneering ultrasensitive liquid biopsy tests using circulating tumor DNA (ctDNA) and circulating tumor RNA (ctRNA), reported that it will present promising new data on the extension of its amplicon-based next generation sequencing (NGS) assays to new applications at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in-person in Chicago, from June 3rd to June 7th, 2022 (Press release, Lucence, MAY 31, 2022, View Source [SID1234615288]).

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"Lucence strives to provide clinicians with the most clinically actionable information to impact patient care using liquid biopsy. The data we are presenting at 2022 ASCO (Free ASCO Whitepaper) shows how a total nucleic acid approach combining ctDNA and ctRNA in one liquid biopsy assay could dramatically increase actionable molecular information in lung cancer patients," said Min-Han Tan, PhD, MBBS, Founding CEO of Lucence.

In an abstract to be presented (#3040) as part of the conference poster sessions, Lucence CTO Yukti Choudhury and collaborators examined combining an amplicon-based NGS ctRNA assay with a ctDNA assay for enhanced detection of clinically actionable gene fusions in lung cancer when compared with ctDNA alone. In plasma samples from non-small cell lung cancer (NSCLC) patients that were either baseline driver-negative (by ctDNA) or treated with tyrosine kinase-inhibitors, the combined assay found 8.7% (9/103) more actionable fusions than ctDNA alone. Together ctRNA and ctDNA resulted in detection of 30 fusions compared to 21 when only ctDNA was tested, representing a 42.8% (9/21) increase in fusion-specific detection of the combined assay; additional fusions detected included BRAF, MET and NRG1 fusions. The data support combining ctRNA with ctDNA in liquid biopsy to increase the total actionable diagnostic information in NSCLC patients where tissue samples are lacking, especially for gene fusions not amenable to detection in ctDNA.

Lucence Research Scientist Jonathan Poh and collaborators will present data (#3042) showing that ctDNA can be utilized to non-invasively assess loss of heterozygosity (LOH) in multiple cancer types. LOH is a key biomarker to identify homologous recombination deficiency (HRD) status and predict response to PARP inhibitors. Using this approach, Poh et al. showed concordance of HRD status with an orthogonal test at 91.3%. Even in the absence of pathogenic HR gene alterations, LOH detection in ctDNA provided additional diagnostic yield of HRD+ status in multiple cancer types.

In another abstract authored by Choudhury and collaborators (#3041), analysis showed that it was possible to derive meaningful ctDNA fragment size information from a multiplexed amplicon-based assay. Several groups have shown analyzing ctDNA fragment size and ratios might be used to identify and characterize early stage cancers. Choudhury hopes to extend these so-called "fragmentomics" signatures to LiquidHALLMARK.

Lucence will be exhibiting at booth 16112 at the ASCO (Free ASCO Whitepaper) Annual Meeting. For the latest information on Lucence at 2022 ASCO (Free ASCO Whitepaper), please visit View Source

Poster Presentation Details

Yukti Choudhury, et al. A cell-free RNA-based next-generation sequencing (NGS) assay for the detection of actionable gene fusions in non-small cell lung cancer (NSCLC) patients
Poster Session: Sunday, June 5th from 8am-11am CDT

Jonathan Poh, et al. Detection of homologous recombination deficiency (HRD) in cell-free DNA (cfDNA) using an amplicon-based next-generation sequencing (NGS) assay
Poster Session: Sunday, June 5th from 8am-11am CDT

Yukti Choudhury, et al. Early detection of cancer using cell-free DNA (cfDNA) size analysis on a multiplexed amplicon-based next-generation sequencing (NGS) platform
Poster Session: Sunday, June 5th from 8am-11am CDT

On May 31, 2022 Oncomatryx reported that the FDA and the Spanish Drug Agency (AEMPS) have cleared its investigational new drug (IND) application for OMTX705, a First-in-Class antibody-drug conjugate (ADC) targeting the tumor microenvironment (Press release, Oncomatryx, MAY 31, 2022, View Source [SID1234615287]).

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OMTX705 is a pioneering ADC that targets, with a novel, dual mechanism of action, the Cancer-Associated Fibroblasts that enable tumor metastasis, drug resistance and immunosuppression.

OMTX705 has already shown unbeatable safety in non-human primates and tumor regression in murine models of pancreatic, breast, lung and gastric cancer.

Oncomatryx will run a multicenter, dose escalation trial in patients suffering metastatic solid tumors. OMTX705 will be administered as single agent and in combination with immunotherapy.

OMTX705 phase I clinical trial will be run in seven hospitals in USA and Spain.

On May 31, 2022 Fresenius Kabi reported the immediate availability in the U.S. of PEMEtrexed for Injection, USP, a new generic equivalent to Alimta (Press release, Fresenius Kabi Oncology, MAY 31, 2022, View Source [SID1234615286]). Fresenius Kabi produces its PEMEtrexed for Injection, USP in the United States, where the company offers the most comprehensive injectable oncology portfolio of any pharmaceutical manufacturer.

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Fresenius Kabi PEMEtrexed for Injection, USP is an affordable treatment option for adult patients with non-squamous non-small cell lung cancer and malignant pleural mesothelioma.

Available in four presentations for intravenous (IV) use, Fresenius Kabi now has the broadest portfolio of PEMEtrexed for Injection, USP products available from any manufacturer in the U.S., including two new strengths designed to help streamline pharmacy operations and reduce drug waste:

PEMEtrexed for Injection, USP 100 mg per single-dose vial
PEMEtrexed for Injection, USP 500 mg per single-dose vial
New strength: PEMEtrexed for Injection, USP 750 mg per single-dose vial
New strength: PEMEtrexed for Injection, USP 1 gram per single-dose vial
"We are pleased to introduce another generic chemotherapy medication to help make cancer treatments more accessible and affordable for patients," said John Ducker, president and CEO of Fresenius Kabi USA. "And we’re proudly producing our PEMEtrexed for Injection here in the U.S."

Fresenius Kabi offers more than 30 different oncology drugs in the U.S., and nearly 90 percent are formulated, filled and finished in the U.S. PEMEtrexed for Injection, USP is the newest example of the company’s commitment to investing "More in America." This effort is focused on providing more supply, more science, more support and more care to its customers and the patients they serve in the U.S. Fresenius Kabi has invested nearly $1 billion to modernize and expand advanced U.S. pharmaceutical production and distribution facilities.

PEMEtrexed for Injection, USP, along with other oncology medicines, is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program that offers copay assistance to eligible U.S. patients. The program can lower out-of-pocket costs to as little as $0 per month for eligible patients. To determine eligibility, patients should speak to their physician. Enrollment is a simple online process. Details can be found on the KabiCare website at kabicare.us.

Important Safety Information

INDICATIONS AND USAGE

Pemetrexed for Injection is a folate analog metabolic inhibitor indicated:

in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.
initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
IMPORTANT SAFETY INFORMATION

Pemetrexed for Injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed.

Myelosuppression: Can cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer pemetrexed for injection when the absolute neutrophil count is less than 1500 cells/mm3 and platelets are less than 100,000 cells/mm3. Initiate supplementation with oral folic acid and intramuscular vitamin B12 to reduce the severity of hematologic and gastrointestinal toxicity of pemetrexed for injection.

Renal Failure: Can cause severe, and sometimes fatal, renal failure. Do not administer when creatinine clearance is less than 45 mL/min.

Bullous and Exfoliative Skin Toxicity: Permanently discontinue for severe and life-threatening bullous, blistering or exfoliating skin toxicity.

Interstitial Pneumonitis: Withhold for acute onset of new or progressive unexplained pulmonary symptoms. Permanently discontinue if pneumonitis is confirmed.

Radiation Recall: Can occur in patients who received radiation weeks to years previously; permanently discontinue for signs of radiation recall.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

The most common adverse reactions (incidence ≥ 20%) of pemetrexed for injection, when administered as a single agent are fatigue, nausea, and anorexia.

The most common adverse reactions (incidence ≥ 20%) of pemetrexed for injection when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation.

The most common adverse reactions (incidence ≥ 20%) of pemetrexed for injection when administered in combination with pembrolizumab and platinum chemotherapy are fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Ibuprofen increased risk of pemetrexed for injection toxicity in patients with mild to moderate renal impairment. Modify the ibuprofen dosage as recommended for patients with a creatinine clearance between 45 mL/min and 79 mL/min.

On May 31, 2022 Median Technologies (Paris:ALMDT) reported that the company is expanding its portfolio of services with Imaging Lab, a new entity whose mission is to leverage AI, data mining, and radiomics technologies to exploit imaging data from clinical trials in oncology (Press release, MEDIAN Technologies, MAY 31, 2022, View Source [SID1234615284]).

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The creation of Imaging Lab materializes the convergence of iCRO’s activities for image management in the development of new oncologic drugs and iBiopsy’s activities for the development of software as medical device targeting early diagnosis of cancers, especially lung cancer.

"We are seeing a paradigm shift of pharmaceutical companies towards new drug candidates targeting patients with early-stage cancers," said Fredrik Brag, CEO and founder of Median Technologies. "The synergy between our iCRO and iBiopsy businesses is perfect to respond to this change: iBiopsy develops software as medical device, integrating AI technologies, which allow the diagnosis of diseases at a very early stage, when patients are still asymptomatic. At the same time, iCRO has extensive knowledge of image processing and its management in clinical trials. The cross-fertilization of our two businesses will enable us to leverage imaging data in conjunction with other clinical information in an unparalleled way and provide biopharmaceutical companies with tools for Go/No-Go decisions in trials," adds Fredrik Brag.

Imaging Lab will provide new answers in four areas that determine the success of clinical trials: selection of patients included in trials, especially inclusion of patients diagnosed at early stages of disease thanks to AI technologies, prediction of response to therapy, measurement of disease progression, and evaluation of the safety of drug candidates. The goal is to optimize development plans, including facilitating Go/No-Go decisions to increase the success rate of clinical trials. This rate is especially low in oncology, generating an average development cost of $2.8 billion to take a new molecule to market, compared with an average of $1 billion per new molecule brought to market for other therapeutic areas1.

"Our experience of image management in clinical trials has shown that trial data is vastly underutilized. We can extract much more information from images through the widescale use of data mining, AI, and radiomics and use these technologies to better support our customers and biopharmaceutical partners in their clinical developments," says Nicolas Dano, COO iCRO of Median Technologies.

The Imaging Lab team will be present from June 4-6 (exhibition dates) at the ASCO (Free ASCO Whitepaper) Annual Conference in Chicago , Median’s booth #2098, Exhibit Hall A, to meet the pharmaceutical community.