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.

On May 28, 2021 Alkermes plc (Nasdaq: ALKS) reported that it will host a webcast and conference call at 4:00 p.m. ET (9:00 p.m. BST) on Friday, June 4, 2021 to review data updates presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from the company’s ARTISTRY-1 and ARTISTRY-2 clinical trials evaluating immuno-oncology candidate nemvaleukin alfa (nemvaleukin) (Press release, Alkermes, MAY 28, 2021, View Source [SID1234583275]). The company will provide an overview of the data being presented followed by a roundtable discussion with expert oncologists and ARTISTRY clinical program investigators, Valentina Boni, M.D., Ph.D., Medical Oncologist and Principal Investigator, START Madrid at Centro Integral Oncológico Clara Campal; and Omid Hamid, M.D., Chief of Research and Immunotherapy, The Angeles Clinic and Research Institute.

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Investor and Analyst Webcast with Expert Oncologists
Date and Time: Friday, June 4, 2021, at 4:00 p.m. ET (9:00 p.m. BST)
Dial-in: +1 877-407-2988 for U.S. callers and +1 201-389-0923 for international callers.
Investors and analysts can also view slides and listen to the live audio webcast of the presentation on the Investors section of Alkermes’ website at www.alkermes.com. A replay of the webcast will be archived on the company’s website for 30 days following the presentation.

Nemvaleukin Poster Presentations at ASCO (Free ASCO Whitepaper)

Abstract: 2513
Title: ARTISTRY-1: Nemvaleukin Alfa Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Presenter: Valentina Boni, M.D., Ph.D., Medical Oncologist and Principal Investigator, START Madrid at Centro Integral Oncológico Clara Campal, Madrid, Spain
Presentation Date/Time: The on-demand poster discussion session will take place on June 4, 2021 at 9:00 a.m. ET.

Abstract: 2552
Title: Selection of the Recommended Phase 2 Dose (RP2D) for Subcutaneous Nemvaleukin Alfa: ARTISTRY-2
Presenter: Omid Hamid, M.D., Chief of Research and Immuno-Oncology, The Angeles Clinic and Research Institute
Presentation Date: The poster presentation will be available on-demand to attendees beginning June 4, 2021.

About Nemvaleukin alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin alfa as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3 and ARTISTRY-6.