On May 28, 2021 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the launch of an expanded scope of companion diagnostic (CDx) claims for the therascreen KRAS RGQ PCR Kit (therascreen KRAS Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients that may be eligible for treatment with LUMAKRASTM (sotorasib), a newly approved therapy developed and marketed by Amgen Inc. (AMGN) (Press release, Qiagen, MAY 28, 2021, View Source [SID1234583280]).

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The therascreen KRAS Kit is the first companion diagnostic test to obtain premarket approval from the U.S. Food and Drug Administration (FDA) for use to identify the KRAS G12C mutation in samples of NSCLC tumour tissue. KRAS is one of the most frequently occurring mutation in this form of cancer, and is estimated to be present in up to 13% of cases of the disease. Until now KRAS G12C has not been actionable, and in fact had only previously been linked with resistance to therapies. The real-time qualitative PCR kit is used with the Rotor-Gene Q MDx instrument, a member of the modular QIAsymphony family of automation solutions, and builds upon QIAGEN’s nine years of experience in KRAS CDx test development and commercialization.

"We are pleased to announce this significant expansion in the scope of FDA-approved CDx claims for the therascreen KRAS Kit" said Jean-Pascal Viola, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. "This new approval further expands our market-leading therascreen portfolio of companion diagnostic tests, and illustrates our determination to support the delivery of the latest innovations in precision healthcare to patients with NSCLC, for whom every new treatment option is extremely welcome."

"With advances in precision medicine, biomarker testing is critical for patients with non-small cell lung cancer because it informs treatment options during the course of their disease. It is important that patients and their healthcare providers know that KRAS G12C is now an actionable mutation and start testing for it," said Darryl Sleep, M.D., chief medical officer and senior vice president of Global Medical at Amgen. "With the approval of QIAGEN’s companion diagnostic for LUMAKRAS, patients and clinicians will have more options and flexibility for biomarker testing."

Up to 13% of NSCLC-patients may have KRAS G12C positive tumours and hence be potentially eligible for treatment with LUMAKRASTM. To accelerate identification of these patients, following the FDA approval of this test QIAGEN is making testing of NSCLC tumour tissue samples with the therascreen KRAS Kit available immediately at leading laboratories across the U.S, through QIAGEN’s Day-One Lab Readiness program for Precision Medicine.

QIAGEN’s therascreen KRAS Kit was used to support the CodeBreaK 100 clinical trial of sotorasib and the expansion of the Kit’s CDx claims to include identification of the KRAS G12C mutation in NSCLC samples has been co-approved with LUMAKRAS by the FDA. The Amgen drug is a new inhibitor of the G12C-mutated form of the KRAS (Kirsten rat sarcoma) protein, and is the first-in-class drug approved for treatment of this form of cancer. Further details about the Kit are available at www.qiagen.com/KRAS.

QIAGEN’s Day-One Lab Readiness program builds on the FDA’s modernized regulatory approach to benefit patients by accelerating the launch of advanced diagnostics. An updated list of U.S. laboratories offering testing of NSCLC samples for the KRAS G12C mutation using the therascreen KRAS test is available at www.qiagen.com/KRAS-lab-finder.

QIAGEN is a pioneer in Precision Medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) for companion diagnostic development. QIAGEN now has ten PCR based companion diagnostic indications that are FDA approved, including therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer, therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer.

Currently, QIAGEN is working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates – a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients. The therascreen KRAS Kit co-approval with LUMAKRASTM marks the tenth FDA approval of a therapy partnered with a QIAGEN companion diagnostic assay.

On May 28, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that the U.S. Food and Drug Administration (FDA) has approved the Guardant360 CDx test as the first and only liquid biopsy companion diagnostic for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the KRAS G12C mutation and may benefit from LUMAKRAS (sotorasib), an FDA-approved KRASG12C inhibitor developed and manufactured by Amgen (Press release, Guardant Health, MAY 28, 2021, View Source [SID1234583279]).

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The Guardant360 CDx FDA approval was based on clinical validation data from the CodeBreaK 100 trial evaluating sotorasib in patients with locally advanced or metastatic NSCLC. Patients identified with the KRAS G12C mutation using the Guardant360 CDx demonstrated an objective response rate consistent with those identified using traditional tissue-based biomarker testing.

Lung cancer is the leading cause of cancer death in the U.S.1 and NSCLC accounts for approximately 84 percent of all lung cancers.2 It is estimated that 66 percent of patients with NSCLC have advanced or metastatic disease at initial diagnosis,3 and two out of three with lung adenocarcinoma harbor a driver mutation.4 Clinical guidelines recommend comprehensive genomic profiling at diagnosis, for all patients with advanced NSCLC, to evaluate whether they have one of the growing list of actionable and emerging biomarkers with associated treatment options.5-7 KRAS G12C is one of the most common driver mutations in NSCLC, occurring in 13 percent of patients, and until now, FDA-approved targeted therapy options did not exist.4,8

"The approval of LUMAKRAS represents a significant medical advancement for patients with advanced non-small cell lung cancer who harbor the KRAS G12C mutation because it is the first and only targeted therapy now available to them," said Darryl Sleep, M.D., Amgen chief medical officer and senior vice president of Medical Affairs "However, patients can only benefit from targeted therapies, or personalized treatments, if they are tested for biomarkers. Today’s FDA approval of Guardant360 CDx, offers an important development in biomarker testing by providing a high-quality, blood-based testing option for patients."

"In the CodeBreaK 100 phase 2 clinical trial, which was the basis for the FDA approval, sotorasib demonstrated compelling efficacy and tolerability in patients with KRAS G12C-mutated non-small cell lung cancer. This approval represents a historic milestone for patients with this mutation," said Vamsidhar Velcheti, M.D., director of thoracic oncology at NYU Langone Health Perlmutter Cancer Center. "This new targeted therapy, reinforces once again why comprehensive biomarker testing at diagnosis is critical. Having additional options, including the availability of a blood-based testing option, such as the Guardant360 CDx, will help to more quickly identify the patients who may benefit and help guide treatment decisions."

"This groundbreaking new therapy from Amgen, LUMAKRAS, underscores the importance of incorporating comprehensive genomic profiling in routine clinical practice to ensure all patients are evaluated for KRAS G12C and the growing list of other actionable mutations that can be treated with targeted therapies shown to significantly improve clinical outcomes," said Helmy Eltoukhy, Guardant Health CEO. "By offering an FDA-approved companion diagnostic that can quickly deliver comprehensive results from a simple blood test, clinicians can have greater confidence using the test, and patients benefit from less invasive testing and shorter wait times to see whether they are eligible for a targeted therapy such as LUMAKRAS."

For oncologists, the FDA-approved Guardant360 CDx provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.

Since being introduced, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling with more than 200 peer-reviewed publications. It has been trusted by more than 9,000 oncologists, with more than 150,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 200 million lives.

On May 28, 2021 EQRx, a company committed to developing and delivering important new medicines at lower prices, along with its partner CStone Pharmaceuticals, reported that the Phase 3 study evaluating sugemalimab, an anti-PD-L1 antibody, in Stage III NSCLC met its primary endpoint of prolonged progression-free survival (Press release, EQRx, MAY 28, 2021, View Source [SID1234583278]). These results were disclosed after a planned interim analysis of GEMSTONE-301, a study investigating sugemalimab as consolidation therapy in patients with locally advanced, unresectable Stage III NSCLC without disease progression after either concurrent or sequential chemoradiotherapy. These findings, which were statistically significant and clinically meaningful, were determined by Blinded Independent Central Review (BICR) based on RECIST v1.1. Sugemalimab was well-tolerated and no new safety signals were observed. In stratified subgroup analyses, sugemalimab was associated with clinical benefit regardless of whether patients received concurrent or sequential chemoradiotherapy prior to sugemalimab.

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"Stage III NSCLC represents a heterogeneous group of patients with a wide range of therapeutic outcomes. Around the world, both sequential and concurrent chemotherapy are commonly used treatment approaches for this stage of disease"

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Positive results were previously reported on the use of sugemalimab in Stage IV NSCLC at ESMO (Free ESMO Whitepaper) Asia 2020, demonstrating that sugemalimab plus standard-of-care chemotherapy prolonged PFS and was well-tolerated compared to chemotherapy regardless of PD-L1 expression level or histology. Together, these two positive Phase 3 studies position sugemalimab as a potential treatment option to address both Stage III and IV NSCLC.

"Stage III NSCLC represents a heterogeneous group of patients with a wide range of therapeutic outcomes. Around the world, both sequential and concurrent chemotherapy are commonly used treatment approaches for this stage of disease," said Vincent Miller, M.D., physician-in-chief at EQRx. "These encouraging results from both the Stage III and Stage IV studies suggest sugemalimab is a promising potential treatment option in a broad range of patient populations."

"The PD(L)1 market is becoming more crowded, but the constant debate around pricing without action is to the detriment of patients. EQRx was created to address this challenge head-on by bringing high-quality medicines to patients at much lower prices," commented Alexis Borisy, chief executive officer of EQRx. "PD(L)1 therapies are the backbone of cancer treatment, and we see tremendous opportunity for sugemalimab as a monotherapy or in combination regimens, lowering the overall costs of immunotherapy options."

Specific study data will be presented at an upcoming medical conference.

EQRx and CStone Pharmaceuticals have partnered to expand global access to sugemalimab. The Companies plan to pursue regulatory discussions in multiple countries.

ABOUT LUNG CANCER

Every 15 seconds, a person across the world is diagnosed with lung cancer, and every 18 seconds, a person dies of the disease, making it the most commonly diagnosed cancer and the leading cause of cancer death worldwide. Lung cancer is the second most commonly diagnosed cancer worldwide. In 2020, an estimated 2.2 million people were diagnosed with lung cancer.1 NSCLC is the most common type of lung cancer, accounting for 84% of all lung cancer diagnoses.

GEMSTONE-301 STUDY

GEMSTONE-301 study is a multicenter, randomized, double-blind Phase 3 clinical trial (clinicaltrials.gov registration number: NCT03728556; drug clinical trial registration number: CTR20181429), being conducted in China to evaluate the efficacy and safety of sugemalimab as consolidation therapy in patients with locally advanced/unresectable Stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. The study’s primary endpoint was PFS as assessed by BICR according to RECIST v1.1; the secondary endpoints included overall survival, PFS as assessed by the investigators and safety.

GEMSTONE-302 STUDY

GEMSTONE-302 (clinicaltrials.gov registration number: NCT03789604; drug clinical trial registration number: CTR20181452) is a randomized, double-blind, Phase 3 study of anti-PD-L1 monoclonal antibody sugemalimab plus platinum-based chemotherapy as first-line treatment for Stage IV squamous or non-squamous NSCLC to evaluate the efficacy and safety of sugemalimab combined with chemotherapy vs. placebo combined with chemotherapy in first-line treatment naïve patients with Stage IV NSCLC. The study was conducted in China and the primary endpoint was investigator-assessed PFS. Secondary endpoints included overall survival, BICR-assessed PFS and safety.

In August 2020, the GEMSTONE-302 study met its primary endpoint and data was presented at ESMO (Free ESMO Whitepaper) Asia 20202, demonstrating that sugemalimab in combination with chemotherapy significantly prolonged PFS and reduced the risk of disease progression or death by 50% compared to placebo in combination with chemotherapy, as assessed by iDMC at the planned interim analysis. Subgroup analysis showed clinical benefit regardless of PD-L1 expression level or pathologic subtype in patients with Stage IV NSCLC. Sugemalimab in combination with chemotherapy was well tolerated, no new safety signals were identified. In November 2020, the National Medical Products Administration (NMPA) of China accepted the New Drug Application for sugemalimab combined with chemotherapy for the first-line treatment of advanced squamous and non-squamous non-small cell lung cancer patients.

ABOUT SUGEMALIMAB

Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which reduce the risk of immunogenicity and potential toxicities in patients, a potential advantage during treatment.

Currently, sugemalimab is being investigated in a number of ongoing clinical trials. In addition to a Phase 1 study in the U.S., the clinical program in China includes one Phase 2 registration study for lymphoma (CS1001-201) and four Phase 3 registration studies in Stage III NSCLC, Stage IV NSCLC, gastric cancer, and esophageal cancer.

CS1001-201 is a single-arm, multicenter, Phase 2 pivotal study designed to evaluate the efficacy and safety of sugemalimab as monotherapy for the treatment of adult patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL). Based on the encouraging preliminary efficacy results, sugemalimab was granted Orphan Drug Designation for the treatment of T-cell lymphoma and Breakthrough Therapy Designation for the treatment of R/R ENKTL by the U.S. Food and Drug Administration. It has also been granted Breakthrough Therapy Designation by the NMPA of China. The proposed indication is R/R ENKTL.

EQRx holds the development and commercialization rights to sugemalimab outside of Greater China.

On May 28, 2021 NEC Corporation (NEC; TOKYO: 6701) reported the development of an AI technology for supporting doctors to detect neoplasia in Barrett’s esophagus during endoscopic procedures (Press release, NEC, MAY 28, 2021, View Source [SID1234583277]). This is the world’s first technology of its kind to comply with the requirements for CE mark labeling, a European safety, health and environmental protection standard (*1), and is being released as WISE VISION Endoscopy, where it will soon be available in Europe to help doctors in the detection of Barrett’s neoplasia (*2).

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This software is connected to endoscopy processors and automatically notifies users of potential Barrett’s neoplasia from images captured during endoscopic procedures.

Barrett’s esophagus is a pre-cancerous condition in which the inner lining of the esophagus is replaced by a lining that resembles that of the stomach. Patients with Barrett’s esophagus have 30-40 fold higher risk of developing cancer of the esophagus as compared to the normal population (*3).

However, if this cancer can be detected at an early stage, then it can be removed through the endoscope and a patient can be cured.

To help resolve this issue, NEC collaborated with Professor Pradeep Bhandari (Portsmouth, UK), Chair of the European Society of Gastrointestinal Endoscopy (ESGE) Research Committee, in development of this new technology to support doctors to detect Barrett’s neoplasia during examination. In developing this solution, NEC applied its face recognition technology that has been highly evaluated (*4) by the National Institute of Standards and Technology (NIST) in the United States, and belongs to NEC’s portfolio of cutting-edge AI technologies, "NEC the WISE."

"I am delighted that NEC, as one of the world’s leaders in AI technology, has entered the field of endoscopy and developed WISE VISION Endoscopy to detect and help manage Gastrointestinal neoplasia," said Professor Pradeep Bhandari, Chair of the ESGE Research Committee.

On May 28, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company,reported that filed a lawsuit against Natera, Inc. for false advertising, unfair competition, and unlawful trade practices, relating to misleading statements Natera has made about its own products and the performance of Guardant Health’s new oncology test, Guardant Reveal (Press release, Guardant Health, MAY 28, 2021, View Source [SID1234583276]).

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Guardant Health asked the federal court in San Francisco, California for an injunction preventing Natera from continuing to make these false or misleading statements and requiring Natera to take corrective actions.

Guardant Health’s recent introduction of Guardant Reveal, the first blood-only liquid biopsy test to detect residual and recurrent disease in early-stage cancer survivors, represents an important medical breakthrough for the 1.5 million early-stage colorectal cancer survivors in the U.S.1 Colorectal cancer is the second leading cause of cancer death in the U.S.2 The Guardant Reveal test detects circulating tumor DNA (ctDNA) from a simple blood draw and is performed after surgery to identify patients with residual disease who may benefit most from adjuvant therapy and surveillance. The test can also detect recurrence months earlier than current standard-of-care methods, such as carcinoembryonic antigen tests or imaging.3-8 Guardant Health’s method for ctDNA detection is vastly different from Natera’s Signatera assay, which requires a tissue-biopsy.9

The complaint alleges that Natera is misleading healthcare providers about the performance of the Guardant Reveal test by suggesting the test is inaccurate and/or insensitive, and inferior to Signatera. As a direct result, colorectal cancer patients are missing opportunities for minimal residual disease (MRD) detection and recurrence monitoring, and the attendant benefits of guided treatment decisions.

"Guardant Health believes it is vital that clinicians receive accurate and truthful information, as this impacts potentially life-saving patient treatment decisions. We also believe that companies in the cancer diagnostics business must have patient care as their central mission and should not misrepresent medical science. When they do, we believe that immediate corrective action is required," said John Saia, Senior Vice President, General Counsel and Corporate Secretary at Guardant Health.