On December 12, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the online publication of three posters with updates from three Phase 1 clinical trials to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 10-13, 2022 (Press release, Autolus, DEC 12, 2022, View Source [SID1234625274]).

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"With three years of median follow-up in our Phase 1 ALLCAR19 study we see 35% of adult relapsed/refractory B-ALL patients treated with obe-cel in sustained complete remissions between 24 and 47 months without any need for additional anti-leukemia therapy. Remarkably, these patients in long term remissions also have long-term persisting CAR T cells, a unique feature of obe-cel," said Dr. Christian Itin, Chief Executive Officer of Autolus. "With the initial data from the pivotal Phase 2 FELIX trial tracking the outcome of our previous ALLCAR19 trial, we are excited about the potential prospects of obe-cel in adult ALL patients and look forward to presenting the full data of the FELIX study in mid-2023. The potentially best-in-class profile of obe-cel is supported by the data we have observed in NHL, with continued high levels of clinical activity paired with an encouraging tolerability profile across DLBCL, MCL, FL and CLL."

"It’s great to be presenting clinical updates for AUTO1/22 in pediatric B-ALL and AUTO4 in peripheral T Cell Lymphoma. AUTO1/22 shows encouraging response rates in patients ineligible for commercial CAR T therapy, with 83% of patients achieving MRD negative complete responses. Importantly, we have not observed antigen negative relapse," said Dr. Martin Pule, Chief Scientific Officer at Autolus. "In the AUTO4 study, some patients have experienced durable metabolic CRs, including one patient up to the one-year mark. This is a notable finding given the poor prognosis of relapsed/refractory T cell lymphomas."

Conference Call

Management will host a conference call and webcast at 10:30 am ET/3:30 pm GMT to summarize the ASH (Free ASH Whitepaper) data. The webcast can be accessed at this link.

A simultaneous audio webcast and replay will be accessible on the events section of Autolus website.

Posters to be presented:

Title: Safety, Efficiency and Long-Term Follow-up of AUTO1, a Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia (B-ALL) and Other B-Cell Malignancies
LINK to poster
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
Session date and time: Sunday, December 11, 2022, 6:00 PM – 8:00 PM
Session room: Ernest N. Morial Convention Center, Hall D
Publication Number: 3318
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Consultant Haematologist and Honorary Senior Lecturer, Cancer Institute, University College London (UCL)
Summary: In the B-ALL cohort, 7 out of 20 (35%) patients were observed to be in ongoing Complete Remission (CR) at median follow up of 36 months (IQR 24-47) post-AUTO1 without the need for additional anti-leukemia therapy. Ongoing long-term remissions appear to be associated with CAR-T persistence, which was also observed in these 7 patients at their last follow-up. One patient with a subsequent stem cell transplant (SCT) also achieved long term remission but lost CAR T persistence after SCT. In the B-cell non-Hodgkin lymphoma/chronic lymphocytic leukemia (NHL/CLL) cohorts, AUTO1 continues to display a favorable tolerability profile with no immune effector cell-associated neurotoxicity syndrome (ICANS) or Grade ≥ 3 cytokine release syndrome (CRS) across different indications. Of 25 patients with NHL/CLL evaluable for efficacy, the best overall response rate (ORR) was 23/25 (92%). AUTO1 was observed to be well-tolerated and active in diffuse large B-cell lymphoma (DLBCL), with 7 of 8 patients in ongoing CR at last follow-up. In CLL, 4 of 5 treated patients achieved undetectable minimal residual disease (uMRD) in the bone marrow (BM), ongoing at last follow-up. While no relapses were seen in DLBCL patients, late CD19+ relapses were seen in follicular lymphoma (FL), and ongoing CAR-T persistence appears to be important.

Title: Dual Antigen Targeting with Co-Transduced CD19/22 CAR T Cells May Prevent Antigen-Negative Relapse after CAR T Cell Therapy for Relapsed/Refractory ALL (AUTO1/22)
LINK to poster
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III
Session date and time: Monday, December 12, 2022, 6:00 PM – 8:00 PM
Session room: Ernest N. Morial Convention Center, Hall D
Publication Number: 4650
Presenting Author: Dr. Sara Ghorashian, MD, PhD, Hon clinical senior lecturer, UCL Great Ormond Street Institute of Child Health
Summary: AUTO1/22 demonstrated a strong level of activity with 83% (10/12) MRD negative complete remissions and a favorable tolerability profile in a very challenging patient population (4 patients failed previous Kymriah treatment with three having CD19-negative disease, 3 had non-central nervous system (CNS) extra-medullary disease, which is associated with poor outcomes with CAR T therapy). AUTO1/22 showed excellent expansion, with a median 7.5 months duration of persistence of CD22 CAR. No antigen negative relapse was seen in responding patients. At a median follow up of 8.7 months, five of 10 responding patients were in MRD negative complete response (4-12 months) with two after further therapy for early loss of CAR T persistence.

Title: First in Human Study of AUTO4, a TRBC1-Targeting CAR T-Cell Therapy in Relapsed/Refractory TRBC1-Positive Peripheral T-Cell Lymphoma
LINK to poster
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III
Session date and time: Monday, December 12, 2022, 6:00 PM – 8:00 PM
Session room: Ernest N. Morial Convention Center, Hall D
Publication Number: 4634
Presenting Author: Dr Kate Cwynarski, Consultant Haematologist University College London Hospitals (UCLH)
Summary: Having shown proof of concept at EHA (Free EHA Whitepaper) in June 2022, AUTO4 treatment for peripheral T-cell Lymphoma continues to be observed to be well tolerated with no dose-limiting toxicities. Ongoing responses at 9- and 12-months post-dosing at the highest dose tested (450×106) are encouraging, and suggests a potential clinical benefit for patients. No CAR T cell expansion was observed in peripheral blood, but CAR T cells were detected in an on-treatment lymph node biopsy. Optimization of the AUTO4 manufacturing process has been performed, resulting in a product candidate with a more naive and central memory phenotype. The study is ongoing, with additional patients due to be treated to define the recommended Phase 2 dose.

On December 12, 2022 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported new preclinical data showing its DARPin T-cell engager MP0533 can induce preferential killing of cells expressing two or three tumor-associated antigens (TAAs) compared to cells expressing a single TAA (Press release, Molecular Partners, DEC 12, 2022, View Source [SID1234625238]). The data was disclosed in an oral presentation at the 64th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting in New Orleans.

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MP0533 engages CD3 on T cells while binding up to three tumor-associated antigens (CD33, CD70, and CD123) on AML cells. By modulating the affinity to each TAA, Molecular Partners designed MP0533 to induce T cell-mediated killing preferentially when the cancer cells express two or three of the TAAs. This avidity-driven T cell activation ensures preferential killing of AML cells, that consistently expresses two or three of the target antigens. At the same time, it reduces the damage to healthy cells, which tend to express only one of the target antigens. Such damages have been a recurrent issue with other T-cell engagers in AML.

"Our preclinical data provides a strong base for MP0533’s clinical entry. Its design strategy is to focus the proven power of CD3-mediated T-cell killing onto AML cells and eliminate the systemic toxicity that has been a challenge for CD3 T-cell engagers as a class in this disease. The ability of multi-specific DARPins to exploit the natural differentiation in antigen expression between healthy and cancerous cells supplies a powerful platform for highly targeted immuno-oncology solutions," said Nicolas Leupin, MD, Ph.D., CMO of Molecular Partners. "We look forward to the MP0533 PhI study which, on top of the recent encouraging Phase I data presented at SITC (Free SITC Whitepaper) (Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)) for MP0317 (targeting FAP and CD40, enabling tumor-localized immune activation), illustrates the strength and uniqueness of our DARPin portfolio."

As presented today, MP0533 was able to activate T-cells and destroy AML cells in samples from newly diagnosed and previously treated AML patients with different TAA expressions. Humanized mouse models confirmed MP0533’s ability to activate intra-tumoral T-cells and control tumor growth. The research also showed that MP0533 was able to directly target and kill LSCs while sparing a variety of healthy cells including hematopoietic stem cells. The unique safety profile of MP0533 was further supported by several other parameters including a lower level of cytokine release relative to benchmark mono-targeted T cell engagers, both in vitro in a whole blood assay and in vivo in the humanized mouse AML models.

These results have been disclosed at ASH (Free ASH Whitepaper) 2022 in a podium presentation, which will also be made available on Molecular Partners’ website.

Presentation: "A Multispecific DARPin CD3 Engager Targeting CD33, CD123, and CD70 for the Treatment of AML and MDS Designed to Selectively Target Leukemic Stem Cells"
Session: 604
Timing: December 12, 2022: 5:45PM Central Time
Presenter: Anne Goubier, DVM

A Phase I clinical trial to evaluate safety and dose of MP0533 has been authorized to proceed by Swiss regulatory authorities’ and ethics committees. Patient enrollment is planned to initiate in the near future.

On December 12, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported data from the completed phase 3 VITAL study demonstrating that in a post hoc analysis of patients with Mayo Stage IV AL amyloidosis, a statistically significant survival benefit was observed in those treated with birtamimab at 9 months (Press release, Prothena, DEC 12, 2022, View Source [SID1234625236]). The survival benefit of birtamimab in VITAL remained consistent across all key baseline variables in patients with Mayo Stage IV AL amyloidosis. The data were presented in an oral presentation at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in New Orleans, LA.

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Birtamimab is a potential best-in-class amyloid depleter treatment for AL amyloidosis. Based on the totality of the VITAL study data, Prothena has advanced birtamimab into the confirmatory Phase 3 AFFIRM-AL study in patients with Mayo Stage IV AL amyloidosis under a Special Protocol Assessment (SPA) agreement with the U.S. FDA with a primary endpoint of all-cause mortality at p≤0.10. Confirmatory Phase 3 AFFIRM-AL topline data is expected in 2024.

A post hoc analysis of patients with Mayo Stage IV AL amyloidosis showed a statistically significant survival benefit of 74 percent in patients treated with birtamimab versus a survival benefit of 49 percent in patients on placebo at 9 months (HR 0.413, p=0.021). The survival benefit of birtamimab in VITAL remained consistent across all key baseline variables in Mayo Stage IV patients, reinforcing the strength of the survival data in these patients at high risk of early mortality.

"AL amyloidosis is a rare and life-threatening disease without any treatment options that address resident amyloid deposits at the time of diagnosis," said Morie Gertz, MD, Hematologist, Chair emeritus Internal Medicine, Mayo Clinic. "The significant and consistent survival benefits of birtamimab in the VITAL study’s post hoc analysis of patients with Mayo Stage IV AL amyloidosis offers us hope that the removal of amyloid deposits leads to a survival benefit and affirms the potential of birtamimab as a safe, well-tolerated and meaningful therapy. We believe that the VITAL study results set the stage for the AFFIRM-AL trial which we hope will continue to show that birtamimab can help patients with Mayo Stage IV AL amyloidosis, who have the highest risk of early death."

The sensitivity analysis was performed as part of the post hoc analysis of patients with Mayo Stage IV AL amyloidosis. After adjusting for baseline demographic, clinical, and laboratory variables, the adjusted hazard ratios ranged from 0.336 to 0.465, with no upper bounds of the 90% confidence interval crossing 1, indicating a consistent survival benefit with birtamimab at 9 months.

Birtamimab also demonstrated statistically significant improvement over placebo in post hoc analyses of quality of life (assessed with the Short Form-36 version 2 physical component score, SF-36v2 PCS) and cardiac function (assessed with the 6-minute walk test). Patients treated with birtamimab showed a mean difference of 4.65 in the SF-36v2 PCS over placebo at 9 months (p=0.046). Mayo Stage IV patients treated with birtamimab after 9 months demonstrated an increase of 15.22 meters in the 6-minute walk test, whereas patients treated with placebo had a decrease of 21.15 meters (a difference of 36.37; p=0.022).

Birtamimab was generally safe and well tolerated in the overall patient population and in Mayo Stage IV patients. The rates of treatment emergent adverse events (TEAEs) were balanced between treatment arms. The rates of treatment-related TEAEs were similar or lower with birtamimab than in the placebo arm of both the overall population and in Mayo Stage IV patients. Consistent with AL amyloidosis, cardiac disorder was the most common class of fatal TEAEs. There were no fatal TEAEs that were considered treatment related.

Slides from today’s oral presentation at ASH (Free ASH Whitepaper) 2022 will be made available on www.prothena.com under the Investors tab in the Events and Presentations section.

About VITAL Phase 3 Study

VITAL was a phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial that evaluated the efficacy and safety of birtamimab plus standard of care versus placebo plus standard of care in newly diagnosed, treatment-naïve patients with AL amyloidosis. The study was terminated early based on a futility analysis. The primary endpoint in the full study population was the composite of time to all-cause mortality and cardiac hospitalization in patients with AL amyloidosis. The primary endpoint in the overall study population favored birtamimab over placebo, but the difference was not statistically significant at the time of early study termination. The primary study population included 260 patients with AL amyloidosis, of which patients who received birtamimab and placebo were evenly split. Approximately one-third of patients in the study had Mayo Stage IV AL amyloidosis (n=77). Patient demographics were generally balanced between the birtamimab and placebo groups in the study population and the Mayo Stage IV sub population.

About Birtamimab

Birtamimab is an investigational monoclonal antibody designed to specifically and selectively target and clear the amyloid that accumulates and causes organ dysfunction and failure in patients with AL amyloidosis. Birtamimab specifically binds to a defined epitope on kappa and lambda AL protein involved in the disease process. Birtamimab is the only investigational therapeutic that has shown a significant survival benefit in patients with Mayo Stage IV AL amyloidosis post-hoc in a placebo-controlled study. Birtamimab has been granted orphan drug designation for AL Amyloidosis by both the U.S. FDA and the European Medicines Agency and has been granted Fast Track designation by the FDA. A SPA was agreed to between Prothena and the FDA for the AFFIRM-AL trial which represents FDA’s agreement that the design and planned analysis for the primary endpoint of time to all-cause mortality adequately address the objectives necessary to support a regulatory submission. Results from the AFFIRM-AL trial are anticipated in 2024. Final marketing approval is predicated upon FDA’s complete review of the entire application.

About AL Amyloidosis

AL amyloidosis is a rare, progressive and fatal disease where clonal plasma cells overproduce light chain proteins that misfold, aggregate and deposit as amyloid in vital organs such as the heart. It is estimated that there are 60,000 – 120,000 patients worldwide living with Mayo Stage IV AL amyloidosis. Patients with AL amyloidosis can present with a wide range of general symptoms that are common to other conditions such as fatigue, shortness of breath or edema. Current treatment strategies target plasma cells to reduce production of new amyloid, but do not address the amyloid already deposited in organs. Mortality is driven primarily by cardiac failure. There is an urgent unmet medical need for therapies that improve survival in patients at risk for early mortality due to amyloid deposition.

On December 12, 2022 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, reported additional positive clinical data from its Phase 1 clinical trial of NX-2127 in two oral sessions by Anthony Mato, M.D., MSCE, former director of the Chronic Lymphocytic (CLL) Program at Memorial Sloan Kettering Cancer Center, and Omar Abdel-Wahab, M.D., Chair of Sloan Kettering Institute (SKI) Molecular Pharmacology Program at Memorial Sloan Kettering Cancer Center (Press release, Nurix Therapeutics, DEC 12, 2022, View Source [SID1234625219]). NX-2127 is a once daily, oral, investigational new drug that combines BTK degradation with immunomodulatory activity. The podium presentations took place at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition which is being held in New Orleans, Louisiana.

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"These early Phase 1 data demonstrate that NX-2127 effectively degrades BTK resulting in clinically meaningful responses independent of prior treatments or BTK mutational status and offering a potential new treatment modality for patients who have otherwise exhausted other approved and emerging treatment options," said Robert J. Brown, M.D., Nurix’s executive vice president of clinical development.

The data presented by Dr. Mato demonstrate that treatment with NX-2127 results in sustained BTK degradation and clinically meaningful responses in heavily pretreated patients with relapsed/refractory CLL independent of prior treatments or BTK mutational status. These presentations included preliminary data from 36 adults with relapsed/refractory B-cell malignancies enrolled in the Phase 1a/b study, including 23 patients with CLL who had undergone and failed a median of five prior therapies including a BTK inhibitor. Approximately 78% of this group had previously received both BTK and BCL2 inhibitors and 35% had been treated with the non-covalent BTK inhibitor pirtobrutinib. Of the CLL patients, 48% had one or more identified BTK resistance mutations prior to treatment with NX-2127. Following treatment with NX-2127 in this heavily pretreated CLL population, sustained BTK degradation and decreased B cell activation were observed regardless of prior treatment and baseline BTK mutation status with an overall response rate (ORR) of 33% (95% CI 12–62%). As of September 21, 2022, the data cut-off date, the median follow up was 5.6 months (0.3 to 15.7 months), and 14 of 23 patients remained on treatment. Importantly, the safety profile of NX-2127 was consistent with prior results from the Phase 1a portion of the trial and reports for BTK-targeted therapies in heavily pretreated patients with B cell malignancies.

"We are excited by the growing body of data generated in our Phase 1a/1b clinical trial of NX-2127 which highlights the significant differentiation and potential advantages of BTK degradation over BTK inhibition, especially in the setting of resistance to existing therapies," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We continue to explore the promise of this first-in-class targeted protein degrader of BTK as we enroll additional CLL patients in the ongoing expansion cohort and continue to enroll patients with non-Hodgkin lymphoma in the dose escalation. We look forward to additional clinical updates in 2023."

The presentation by Dr. Abdel-Wahab highlighted critical scientific findings underlying the emergence of new BTK inhibitor resistance mutations that lack BTK’s enzymatic function but still drive tumor growth. These so-call "kinase deficient" and "kinase dead" mutations underscore the importance of BTK’s scaffolding function, which is uniquely addressable by the BTK degrader modality. In the presentation, five different clinically emergent BTK resistance mutations were analyzed and categorized as kinase proficient, kinase deficient, or kinase dead, each conferring a different spectrum of resistance to available therapies. NX-2127 was found to be broadly active against all these mutations. These findings translated into clinically meaningful BTK degradation in the Phase clinical 1 trial and clinical activity independent of baseline BTK mutations.

Webcast details

The live KOL webcast event, which will begin at 8:30 pm CT (9:30 pm ET) on Monday, December 12, 2022, and the subsequent replay, will be available in the Investors section of the Nurix website under Events and Presentations.

About the Phase 1, Study of NX-2127

The multicenter Phase 1 study is designed to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary clinical activity of orally administered NX-2127 in adult patients with relapsed or refractory B-cell malignancies. The study is being conducted in two parts. The Phase 1a element is a dose-escalation study in which cohorts of patients will receive ascending oral doses of NX-2127 once daily to determine the maximum tolerated dose (MTD) and/or the optimal Phase 1b dose based on safety and tolerability. The second portion of the study, Phase 1b, is a dose expansion phase in which cohorts of patients with specific cancers will receive NX-2127 to further evaluate the safety and clinical activity of the recommended dose. The study is expected to enroll eligible patients with the following cancers: chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), Waldenstrom macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL), who have required and received prior systemic therapies. Additional information on the clinical trial can be accessed at ClinicalTrials.gov (NCT04830137).

About NX-2127

NX-2127 is a novel bifunctional molecule that degrades Bruton’s tyrosine kinase (BTK) and cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3). NX-2127 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies.

On December 12, 2022 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations who may benefit from treatment with KRAZATITM (adagrasib) (Press release, Agilent Technologies, DEC 12, 2022, View Source [SID1234625190]).

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This is the first liquid biopsy NGS assay approved by the FDA as a CDx for the newly approved KRAZATI in advanced NSCLC and was developed in collaboration with Mirati Therapeutics. ctDx FIRST has also been approved by the FDA for tumor profiling of the epidermal growth factor receptor (EGFR) gene for use by qualified health care professionals in accordance with professional guidelines in oncology patients with NSCLC.

As a professional service*, the ctDX FIRST test report includes broad genomic profiling on 109 genes across four types of alterations: single nucleotide variants (SNVs), insertions and deletions (indels), copy number amplifications (CNAs), and fusions.

Lung cancer is one of the most prevalent cancers among men and women in the U.S. and is the leading cause of cancer mortality, comprising 25% of all cancer-related deaths.1 Most patients with NSCLC are diagnosed at later disease stages due to undetected early symptoms.2 Approximately 14% of NSCLC patients harbor a KRAS G12C mutation, and approximately 32% of NSCLC patients have a mutation within their EGFR gene, making this new test an attractive solution to inform treatment decisions for these patients. 3,4 ctDx FIRST provides NSCLC patients and their oncologists with a new minimally invasive blood test to help clarify precision treatment options.

The ctDx FIRST assay uses novel propriety technology to detect genomic alterations in circulating tumor DNA (ctDNA) from plasma. This minimally invasive approach is preferred by 90% of cancer patients compared to more invasive tissue biopsy tests.5 In addition, liquid biopsy overcomes some limitations encountered with tissue-based methods providing a notably faster turn-around time to potentially accelerate treatment decisions.6

"Expanding access to accurate and fast genomic profiling is an essential step to unlocking important medicines for patients in desperate need," said Kenna Anderes, Mirati’s Vice President of Translational Medicine and Companion Diagnostics. "We appreciate the opportunity to partner with companies like Agilent who are committed to creating more opportunities for ‘decision medicine’ for people living with cancer."

"We are thrilled to partner with Agilent as they work to create greater access to efficient, effective and minimally-invasive tests to support clinicians with information that is critical to their patient care," said Alan Sandler, M.D., Mirati’s Chief Medical Officer. "At Mirati, we are focused on creating meaningful impacts on the lives of people with cancer. Tests like ctDx FIRST are important to realizing our commitment to patients."

"Commercializing the ctDx FIRST test enables us to support clinicians to positively impact the lives of patients with advanced NSCLC," said Sam Raha, Agilent’s President of the Diagnostics and Genomics Group. "Agilent values opportunities to partner with Mirati and other pharmaceutical companies in developing clinically relevant NGS-based diagnostics that enhance confidence in targeted cancer therapy."

To learn more about the test and order visit http://www.agilent.com/genomics/ctDxFIRST

* CLIA validated, not FDA approved