On May 19, 2021 AVEO Oncology (Nasdaq: AVEO), a commercial and clinical development stage biopharmaceutical company, reported results from a randomized confirmatory Phase 2 study of ficlatuzumab as a single agent or in combination with cetuximab (ERBITUX), an EGFR-targeted antibody, in patients who relapsed or were refractory to prior immunotherapy, chemotherapy, and cetuximab (pan-refractory) with metastatic head and neck squamous cell carcinoma (HNSCC) (Press release, AVEO, MAY 19, 2021, View Source [SID1234580271]). Ficlatuzumab is AVEO’s potent humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets hepatocyte growth factor (HGF). The results will be presented by lead investigator Julie E. Bauman, M.D., MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Deputy Director, University of Arizona Cancer Center, at a poster discussion session of the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 4-8 in a virtual setting.

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"Human papillomavirus (HPV) negative HNSCC is associated with poorer outcomes compared to HPV positive disease, particularly in pan-refractory disease, where there are currently no effective treatment options," said Professor Bauman. "Crosstalk between EGFR and HGF/cMet pathways is a known tumor intrinsic resistance mechanism, and HGF expression is known to be high in HPV negative disease, suggesting that the simultaneous inhibition of these pathways with cetuximab and ficlatuzumab could enhance anti-cancer response in this population. Results from this study are highly encouraging, with notable activity in pan-refractory, HPV negative disease warranting Phase 3 investigation."

"Results in patients with HPV negative disease who received ficlatuzumab and cetuximab produced prolonged progression free survival (PFS) and a response rate of 38%, which included two (18%) complete responses (CRs). These results suggest the combination has the potential to play a meaningful role in the treatment and the ultimate quality of life of patients with relapsed/metastatic HNSCC," said Michael Bailey, president and chief executive officer of AVEO. "The results compare favorably to historical controls of cetuximab in earlier lines of treatment. After receiving FDA feedback, we look forward to making a go/no-go decision by mid-year on the initiation of a Phase 3 study in an HPV negative HNSCC patient population, which we would expect to initiate in the first half of 2022, upon the availability of clinical drug supply."

In the Phase 2 study, a total of 60 patients with metastatic HNSCC who relapsed or were refractory to prior immunotherapy, chemotherapy, and cetuximab were randomized 1:1 to receive either ficlatuzumab alone (20 mg/kg IV) or ficlatuzumab in combination with cetuximab (500 mg/m2 IV) every two weeks. The ficlatuzumab/cetuximab combination arm met the study’s primary endpoint of median PFS, with the 32 evaluable patients in the arm demonstrating a median PFS of 3.6 months (lower bound 90% confidence interval [CI] 2.3 months; p=0.04), and 1.8 months (lower bound 90% CI: 1.7 months) for the 26 evaluable patients receiving ficlatuzumab alone. For the key secondary endpoint of overall response rate (ORR), the combination arm demonstrated an ORR of 19%, and 4% for ficlatuzumab alone.

Enrolled patients were stratified by HPV status, as HPV negative patients are known to have poorer outcomes. In an exploratory comparison of the HPV positive (n=16) and HPV negative (n=16) subgroups of the combination arm, HPV negative patients demonstrated both a superior ORR of 38% (versus 0% for HPV positive, p=0.02), with two CRs and four partial responses, and a median PFS of 4.1 months (versus 2.3 months for HPV positive, p=0.03). These results reflect updated data from those available at the time of abstract submission.

The combination of ficlatuzumab and cetuximab was generally well-tolerated with expected class toxicities from HGF/cMet inhibitors observed, including common adverse events of edema and hypoalbuminemia, and an uncommon adverse event of pneumonitis. Two treatment related deaths occurred, including pneumonitis (ficlatuzumab arm) and cardiopulmonary arrest (combination arm).

A copy of the poster will be available at www.aveooncology.com after its presentation at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.

ASCO Presentation Details

Title: Randomized Phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC).
Presenter: Julie E. Bauman, M.D., MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center
Abstract: 6015
Track: Head and Neck Cancer
Date and Time: June 4, 2021 at 9:00 a.m. Eastern Time
About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) immunoglobulin G1 (IgG1) inhibitory antibody that binds to the HGF ligand with high affinity and specificity. HGF is the natural ligand of c-Met and blocking HGF inhibits signaling through the HGF/c-Met signaling pathway. Ficlatuzumab is currently being evaluated in squamous cell carcinoma of the head and neck (HNSCC) and metastatic pancreatic ductal cancer (PDAC).

On May 19, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that four abstracts featuring data from clinical studies evaluating Rubraca and/or lucitanib and one abstract on real world data of PARP inhibitor usage, will be presented during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held virtually, June 4-8, 2021 (Press release, Clovis Oncology, MAY 19, 2021, View Source [SID1234580287]).

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"We remain committed to understanding how Rubraca and lucitanib may benefit patients with cancer, and the data presented at ASCO (Free ASCO Whitepaper) further enhance our understanding of their potential benefit in different patient populations and solid tumor types," said Patrick J. Mahaffy, President and CEO of Clovis Oncology.

The following Clovis-sponsored full abstracts are available as of May 19 at 5:00 pm ET on ASCO (Free ASCO Whitepaper)’s Meeting Library. Clovis-sponsored posters and supplemental information will be available as of June 3at 5:00 pm ET at View Source

Rubraca

Abstract #5517: Subgroup Analysis of Rucaparib Versus Chemotherapy as Treatment for BRCA-mutated, Advanced, Relapsed Ovarian Carcinoma: Effect of Platinum Sensitivity in the Randomized, Phase 3 Study ARIEL4

Lead Author: Amit M. Oza, MD, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada
Poster Discussion Session: Gynecologic Cancer
Date/Time: June 4 at 9:00 am ET
Key Takeaways: Results from this exploratory subgroup analysis of the Phase 3 ARIEL4 trial demonstrate that patients treated with Rubraca had comparable or longer PFS vs. standard-of-care platinum-chemotherapy across all platinum status subgroups. Safety profiles for Rubraca and chemotherapy across the subgroups were consistent with known safety profiles of these agents. These results suggest that Rubraca is an effective treatment option for heavily pretreated patients with BRCA-mutated, advanced, relapsed ovarian cancer as compared to chemotherapy, regardless of their sensitivity to platinum-based therapy.
Abstract #5537: Clinical and Molecular Characteristics of ARIEL3 Patients Who Derived Exceptional Benefit from Rucaparib Maintenance Treatment for High-grade Ovarian Cancer (HGOC)

Lead Author: Tanya Kwan, PhD, Clovis Oncology, Inc., Boulder, Colorado, USA
Poster Session: Gynecologic Cancer
Date/Time: June 4 at 9:00 am ET
Key Takeaways: In the Phase 3 ARIEL3 trial, exceptional benefit (progression-free survival ≥2 years) was more common in, but not exclusive to, patients with favorable clinical characteristics and known mechanisms of PARP inhibitor sensitivity, including mutations of
BRCA1/2
and
RAD51C/D
. These results suggest that rucaparib can deliver exceptional benefit to a diverse set of patients with high-grade ovarian cancer. In all, 21% (79/375) of patients in the rucaparib arm derived exceptional benefit versus only 2% (4/189) in the placebo arm of the trial. Among rucaparib-treated patients, incidence rates of the most common TEAEs were generally consistent between the exceptional benefit subgroup and the overall ARIEL3 patient population.
Rubraca in Combination with Lucitanib

Abstract #3102: Phase 1b/2 SEASTAR Trial: Safety, Pharmacokinetics, and Preliminary Efficacy of the Poly(ADP-ribose) Polymerase (PARP) Inhibitor Rucaparib and Angiogenesis Inhibitor Lucitanib in Patients with Advanced Solid Tumors

Lead Author: Ecaterina E. Dumbrava, MD, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
Poster Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date/Time: June 4 at 9:00 am ET
Key Takeaways: Initial findings suggest that rucaparib plus lucitanib has an acceptable safety profile, and there was some evidence of effect on tumor and disease stabilization among patients with measurable disease, with a 23.5% disease control rate. A maximum tolerated dose for the combination was not established, and no drug-drug interactions were observed. These data suggest the combination of a PARP inhibitor and an angiogenesis inhibitor is feasible and may merit further evaluation.
Lucitanib in Combination with Nivolumab

Abstract #5538: LIO-1: Lucitanib + Nivolumab in Patients with Advanced Solid Tumors—Updated Phase 1b Results and Initial Experience in Phase 2 Ovarian Cancer Cohort

Lead Author: Erika Hamilton, MD, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee, USA
Poster Session: Gynecologic Cancer
Date/Time: June 4 at 9:00 am ET
Key Takeaways: Data from the Phase 1b LIO-1 trial identified the Phase 2 starting dose of the combination and updated Phase 1b efficacy data suggest that lucitanib plus nivolumab has promising antitumor activity (47.1% disease control rate) with a manageable safety profile in patients with advanced solid tumors with no satisfactory treatment options. The Phase 2 study is currently assessing four cohorts of patients with advanced gynecologic malignancies. Interim results from one of these, non-clear cell ovarian cancer (OC) are reported here. 70.8% of patients had received at least 3 previous therapy lines, and 29.2% had primary platinum resistant disease. In 22 evaluable patients, the disease control rate was 31.8% including one confirmed PR. The safety profile of the combination was consistent with that reported in the Phase 1b portion of the study. In addition, the data support the individualized lucitanib dose-titration strategy. While evidence of clinical activity has been observed, Clovis does not believe that the interim efficacy data support further development in non-clear cell OC. Enrollment to the other cohorts continues.
HEOR

Abstract #e18702: Real-world Data Analysis of the Utilization of Second-Line Maintenance Therapy for Patients with Advanced Ovarian Cancer

Lead Author: Robert Reid, MD, FACP, US Oncology, Virginia Cancer Specialists, Fairfax, Virginia, USA
Accessible as e-publication only
Key Takeaways: Real world data from the iKnowMed electronic database of the US Oncology Network (including >470 sites) found that fewer than half of eligible ovarian cancer patients receive second-line maintenance treatment, despite treatment guidelines recommending its usage. In addition, the proportion of patients receiving 2L PARPi maintenance increased from 17% in 2018 to 34% in 2019 but decreased to 22% in 2020.
About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

Rubraca Ovarian Cancer U.S. FDA Approved Indications

Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated for the treatment of adult women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) have occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.

Please Click here for full Prescribing Information for Rubraca.

You may also report side effects to Clovis Oncology, Inc. at 1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US toll-free).

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy.

Lucitanib is an unlicensed medical product.

On May 19, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported mature data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate (Press release, ImmunoGen, MAY 19, 2021, View Source [SID1234580303]). These findings will be highlighted in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting, which is being held June 4-8, 2021. Two posters highlighting mirvetuximab combination regimens will also be presented by ImmunoGen’s collaborators during the meeting.

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"Due to the introduction of effective maintenance therapies, patients with recurrent ovarian cancer are living longer and comprise an increasing population in need of effective, well-tolerated non-platinum based regimens," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "With a 64% ORR, 11.8 month mDOR, and 10.6 month mPFS, the combination of mirvetuximab plus bevacizumab shows compelling activity in patients with high FRα recurrent ovarian cancer. We are extremely pleased to present these data during an oral presentation at ASCO (Free ASCO Whitepaper), as they build on previous findings and provide us with further evidence of mirvetuximab’s potential to become the combination agent of choice for ovarian cancer patients."

MATURE DATA FROM FORWARD II DOUBLET COHORT WITH BEVACIZUMAB

The cohort enrolled 60 patients with a median age of 60 and a median number of 2 prior lines of therapy (range 1-4). 53% had platinum-resistant disease with a platinum-free interval (PFI) of less than or equal to 6 months; 33% had partially platinum-sensitive disease with a PFI greater than 6 months and less than or equal to 12 months; and 13% had a PFI greater than 12 months. 40% of patients in the cohort were previously treated with bevacizumab and 35% of patients in the cohort were previously treated with a PARP inhibitor. The combination of mirvetuximab with bevacizumab in this cohort demonstrates promising anti-tumor activity with a favorable tolerability profile, particularly among patients with high levels of FRα expression, and is encouraging relative to outcomes with available therapies reported in similar populations. In the oral presentation, key updated data include:

In the overall patient population, objective responses were seen in 30 patients and the confirmed overall response rate (ORR) was 50% (95% CI, 34, 60), with a median duration of response (mDOR) of 9.7 months (95% CI 6.7, 12.9) and median progression-free survival (mPFS) of 8.3 months (95% CI 5.6, 10.1).
In patients with high FRα expression (n=33), the confirmed ORR was 64% (95% CI, 45, 80), mDOR was 11.8 months (95% CI 6.7, 13.7), and mPFS was 10.6 months (95% CI 8.3, 13.3).
In high FRα platinum-sensitive patients, who represent a growing population, the combination of mirvetuximab plus bevacizumab achieved a 69% ORR, 12.7 month mDOR, and a 13.3 month mPFS.
In high FRα platinum-resistant patients, the combination of mirvetuximab plus bevacizumab achieved a 59% ORR, 9.4 month mDOR, and a 9.7 month mPFS.
The adverse events (AEs) observed with the doublet were manageable and consistent with the side effect profiles of each agent. Treatment-related AEs were generally low grade, with diarrhea (62%), blurred vision (60%), fatigue (60%), and nausea (57%) being the most common. The most common grade 3+ events were hypertension (17%) and neutropenia (13%).
"Despite advances in the maintenance setting of ovarian cancer, a high unmet need for novel, well-tolerated, targeted treatments exists in those patients with recurrent high-grade epithelial ovarian cancer," said David O’Malley, MD, Professor, Director of Gynecologic Oncology and Co-Director, Gynecologic Oncology Phase 1 Program at The Ohio State University and the James Cancer Center, and FORWARD II Principal Investigator. "The data we continue to see when mirvetuximab is combined with bevacizumab in recurrent disease are extremely encouraging, particularly in light of outcomes reported with available therapies in even less heavily pre-treated populations. The strength of these mature data warrant further development of this novel, targeted combination and I look forward to evaluating this regimen in earlier lines of therapy."

ORAL PRESENTATION SESSION

Title: "Mirvetuximab Soravtansine, a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, in Combination with Bevacizumab in Patients with Platinum-Agnostic Ovarian Cancer – Final Analysis"
Day/Time: Monday, June 7 from 8:00 a.m. to 11:00 a.m. ET
Lead Author: David M. O’Malley, MD, The Ohio State University College of Medicine
Abstract: 5504
POSTER SESSIONS

The following posters will be available on Friday, June 4 at 9:00 a.m. ET in the ASCO (Free ASCO Whitepaper) Meeting Library:

Title: "A Phase I Study of Mirvetuximab Soravtansine and Gemcitabine in Patients with FRα-Positive Solid Tumors: Results from the Ovarian Cancer Cohort"
Lead Author: Mihaela C. Cristea, MD, City of Hope National Medical Center
Abstract: 5542
Title: "A Phase 2, Two-Stage Study of Mirvetuximab Soravtansine in Combination with Pembrolizumab in Patients with Microsatellite Stable Endometrial Cancer"
Lead Author: Rebecca L. Porter, MD, PhD, Dana-Farber Cancer Institute
Abstract: TPS5611
Additional information can be found at www.asco.org.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.

ABOUT FORWARD II

FORWARD II is a Phase 1b/2 study of mirvetuximab soravtansine in combination with Avastin (bevacizumab), carboplatin, or Keytruda (pembrolizumab) in patients with FRα-positive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers, as well as a triplet combination of mirvetuximab plus carboplatin and bevacizumab in patients with FRα-positive platinum-sensitive ovarian cancer.

On May 19, 2021 Guardant Health, Inc. (Nasdaq: GH), reported to present data demonstrating the use of the company’s proprietary blood tests to advance precision oncology, including cancer screening, detecting residual or recurrent disease in early-stage cancer, and treatment selection and treatment response monitoring in advanced cancer (Press release, Guardant Health, MAY 19, 2021, View Source;and-Late-Stage-Cancers [SID1234580319]). Data, from 20 abstracts, will be presented along with other leading medical institutions and pharmaceutical companies, during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held from June 4-8, 2021.

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"The data at ASCO (Free ASCO Whitepaper) not only demonstrate the advantages of blood-based comprehensive genomic profiling in advanced cancer, but also the growing body of evidence showing the power of our blood tests across the continuum of care. We are pleased to share data that not only informs treatment decisions, but that also shows value in assessing treatment response, screening for early-stage colorectal cancer in asymptomatic patients, and detecting residual or recurrent disease in early-stage cancers, including colorectal, non-small cell lung, and bladder," said Helmy Eltoukhy, Guardant Health CEO. "The data also illustrates the value of our liquid biopsy tests and our real-world clinical-genomic platform to gain new insights which help accelerate research and development of the next generation of cancer therapeutics."

LUNAR-2 Blood Test Detects Early-Stage Colorectal Cancer (CRC) with High Accuracy in Largest Cohort to Date

The data (N=705) show that the LUNAR-2 assay achieved overall sensitivity of 91% in early-stage CRC (stage I, II, and III), and specificity of 94%. The performance in this new large cohort of CRC cases, and cancer-free controls, is consistent with previously reported data.1-2 Notably no differences in sensitivity for CRC detection were observed in patients presenting with asymptomatic disease, compared to those patients who were symptomatic, despite the lower cell-free DNA (cfDNA) tumor fractions observed in asymptomatic patients, suggesting the test will have clinically meaningful performance in an average-risk screening population (Abstract 3536).

Guardant Reveal Blood Test Detects ctDNA in Early-Stage Non-Small Cell Lung and Bladder Cancers, and Predicts Recurrence in Oligometastatic CRC in Post-Surgical Setting

The data show that Guardant Reveal, a first of its kind, blood-only minimal residual disease (MRD) test for solid tumors, detects circulating tumor DNA (ctDNA) in pre-treatment, early-stage non-small cell lung cancer and bladder cancer, without the need for tumor tissue, and with comparable sensitivity to tissue-dependent approaches (Abstract 3045).

Additionally, in a study (Abstract 3565) with the University of California San Francisco (UCSF) and Massachusetts General Hospital, the Guardant Reveal test detected MRD in patients with oligometastatic colorectal cancer undergoing curative intent surgery or radiotherapy. Detection of ctDNA post-procedure had a high positive predictive value (PPV) for cancer recurrence, with a median lead time of six months compared to surveillance imaging.

Guardant Health will also provide an update on the COBRA interventional trial (NRG-G1005: Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Stage II Colon Cancer) (Abstracts TPS3622, TPS148).

The Guardant Reveal test is commercially available for the detection of residual and recurrent disease in early-stage colorectal cancer. The test identifies patients with residual disease who may benefit most from adjuvant therapy, and has been shown to detect recurrence months earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging.3-8 The Guardant Reveal test achieves industry-leading sensitivity (91%)9 for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. Test results are obtained from a simple blood draw and returned in as little as seven days without the need for a tissue biopsy.

Guardant360 Blood Tests Demonstrate Clinical Utility in the Treatment and Management of Locally Advanced and Metastatic Cancers

Fifteen abstracts, now online, highlight the use of the Guardant360 test to detect clinically actionable mutations and to inform treatment options for patients. Key findings include data showing the ability of Guardant360 liquid biopsy to robustly detect tumor mutational burden across a wide range of solid tumors (Abstract 3040) and to predict clinical outcomes in a prospectively collected cohort of non-small cell lung cancer patients treated with targeted therapy (Abstract 9027). In addition, several abstracts highlight the ability of the Guardant360 test to predict molecular response in patients across a variety of cancer types and therapy classes (Abstract 4130, Abstract 9011).

GuardantINFORM Real-World Evidence Platform Used to Identify Unmet Need for Patients with Lung Adenocarcinomas Harboring STK11 and KRAS G12C Mutations Treated with Checkpoint Inhibitors

A study in collaboration with faculty from Massachusetts General Hospital and Mirati Therapeutics, Inc. (NASDAQ: MRTX) using clinical-genomic information from the GuardantINFORM platform demonstrated that patients with metastatic lung adenocarcinoma and co-occurring STK11 and KRAS G12C mutations had significantly worse outcomes to treatment with first-line checkpoint inhibitor-based treatment regimens (including combination with platinum-based chemotherapy), highlighting the need for effective targeted and/or combination therapies to address this patient population (Abstract 9106).

The GuardantINFORM clinical-genomic platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test. With data from more than 160,000 patients diagnosed with locally advanced and metastatic cancers, this robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers, including non-small cell lung, breast, colon, and prostate.

Data at ASCO (Free ASCO Whitepaper)

Abstract#

Title

LUNAR-2

Abstract No. 3536

Multimodal circulating tumor DNA (ctDNA) colorectal neoplasia detection assay for asymptomatic and early-stage colorectal cancer (CRC)

Guardant Reveal

Abstract No. 3045

Multiomic, plasma-only ctDNA NGS assay for minimal residual disease (MRD) detection in solid tumors.

Abstract No. 3565

Circulating tumor derived cell-free DNA (ctDNA) to predict recurrence of metastatic colorectal cancer (mCRC) following curative intent surgery or radiation.

Abstract No. TPS3622, TPS148

Phase II/III study of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-G1005 (COBRA).

Guardant 360

Abstract No. 3040

Blood-based tumor mutational burden from circulating tumor DNA (ctDNA) across advanced solid malignancies using a commercially available liquid biopsy assay.

Abstract No. 9027

Clinical outcomes for plasma-based comprehensive genomic profiling versus tissue testing in advanced lung adenocarcinoma.

Abstract No. 4130

Circulating cell free tumor DNA detection as a prognostic tool in advanced pancreatic cancer.

Abstract No. 9011

Early circulating tumor DNA dynamics and efficacy of lorlatinib: Analysis from the CROWN study.

Abstract No. 1028

Identification of pathogenic CDK12 alterations in cell-free DNA (cfDNA) from patients with breast cancer.

Abstract No. 8577

Cell-free circulating tumor DNA (cfDNA) analysis of advanced thymic epithelial tumors (TETs).

Abstract No. 4585

Circulating tumor DNA (ctDNA) in patients with advanced adrenocortical carcinoma.

Abstract No. 9108

Genomic landscape differences in patients with advanced non-small cell lung cancer by sex and age.

Abstract No. 3523

Circulating tumor DNA-based genomic profiling of small bowel

adenocarcinoma.

Abstract No. e17018

Serial ctDNA profiling in patients with metastatic prostate cancer undergoing treatment with Radium-223.

Abstract No.

3572

Serial circulating tumor DNA (ctDNA) monitoring in metastatic colorectal cancer (mCRC) reveals dynamic profile of actionable alterations.

Abstract No. 5038

Complementary detection of genomic alterations in metastatic castration‑resistant prostate cancer (mCRPC) from CheckMate 9KD through analyses of tumor tissue and plasma DNA.

Abstract No. 3589

Assessment of HER2 (ERBB2) amplification (HER2amp) using blood-based circulating tumor DNA (ctDNA) next generation sequencing (NGS) and correlation with tissue-based testing in metastatic colorectal cancer (mCRC)

Abstract No. 4058

Early predictors of benefit to dual anti-PD1/HER2 inhibition: Biomarker analysis from phase 2 trial of pembrolizumab/trastuzumab in HER2-positive metastatic esophagogastric (mEG) cancer.

Abstract No. 3555

Pertuzumab plus trastuzumab and real-world standard of care (SOC) for patients (pts) with treatment refractory metastatic colorectal cancer (mCRC) with HER2 (ERBB2) amplification (amp) confirmed by tumor tissue or ctDNA analysis.

GuardantINFORM

Abstract No. 9106

Impact of STK11 mutation on first-line immune checkpoint inhibitor outcomes in a real-world KRAS G12C mutant lung adenocarcinoma cohort.

On May 19, 2021 Amgen (NASDAQ: AMGN) reported that it will present at the Cowen 2nd Annual Virtual Oncology Innovation Summit at 11:20 a.m. ET on Friday, May 21, 2021 (Press release, Amgen, MAY 19, 2021, https://investors.amgen.com/news-releases/news-release-details/amgen-present-cowen-2nd-annual-virtual-oncology-innovation [SID1234580335]). David M. Reese, M.D., executive vice president of Research and Development at Amgen, will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.