On May 27, 2022 Exact Sciences Corp. (NASDAQ: EXAS), a leader in advanced cancer diagnostics, reported new data supporting its cancer tests and treatment guidance tools will be showcased in nine poster presentations and five e-abstracts at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 3-7 in Chicago, Illinois (Press release, Exact Sciences, MAY 27, 2022, View Source [SID1234615186]).

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"As the leading cause of death worldwide,1 cancer creates tremendous human suffering and staggering health care costs. Tests to help catch the disease earlier and guide more effective treatment are necessary to improve outcomes," said Kevin Conroy, chairman and CEO of Exact Sciences. "Together with our collaborators from leading medical institutions, Exact Sciences is proud to present extensive data at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting. These presentations highlight the breadth of our pipeline and portfolio of tests as part of our relentless efforts to advance the field of cancer diagnostics."

Studies supporting Exact Sciences’ screening and earlier detection efforts include a comparison of simulated outcomes between stool- and blood-based colorectal cancer screening tests. The modeled outcomes suggest blood-based tests result in detecting fewer colorectal cancer cases compared to stool-based tests due to differences in colorectal cancer sensitivity and specificity and lower advanced adenoma detection rates.2 A cost-effectiveness analysis that assumed adherence to stool-based screening and/or follow-up colonoscopy increased when coinsurance was waived showed improvement in outcomes including life years gained and CRC incidence and mortality reductions.3 Another study indicated a shorter time to diagnosis for screenable versus symptom-driven cancers, supporting an expanded use of multi-cancer testing.4

Also being presented are findings from Mayo Clinic as part of the academic center’s ongoing collaboration with Exact Sciences to advance the use of methylated DNA markers in detecting a range of cancer types, including cutaneous melanoma, prostate cancer, and lymphoma.5

Data highlighting Exact Sciences’ precision oncology portfolio of tests will also be presented. The analyses support use of Oncomap and Oncomap ExTra, comprehensive genomic profiling tests formerly known as the Oncotype Map Pan-Cancer Tissue and GEM ExTra tests, respectively, to inform targeted therapy selection and clinical trial options for patients with advanced solid tumors.6 Also being presented is an overview of the ongoing CORRECT-MRD II study, designed to generate clinical validation data for the company’s minimal residual disease assay in Stage II and III colorectal cancer patients.7

Following are details for the fourteen abstracts that have been accepted at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. All abstracts are now available in the ASCO (Free ASCO Whitepaper) Meeting Library.

Saturday, June 4

NSABP C-14: CORRECT-MRD II – Second colorectal cancer clinical validation study to predict recurrence using a circulating tumor DNA assay to detect minimal residual disease
Authors: Salem, M., et al.
Session: Gastrointestinal Cancer ‒ Colorectal and Anal
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: TPS3632

Methylated DNA markers in early detection of lymphoma: Discovery, validation, and clinical pilot
Authors: Witzig, T., et al.
Session: Hematologic Malignancies ‒ Lymphoma and Chronic Lymphocytic Leukemia
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 7562

Sunday, June 5

Comprehensive genomic profiling to identify gene alterations in DNA repair pathway across solid tumors
Authors: McDonnell, K., et al.
Session: Developmental Therapeutics ‒ Molecularly Targeted Agents and Tumor Biology
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 3124

Monday, June 6

Comprehensive whole-exome and transcriptome profiling to identify actionable alterations associated with response to PARP inhibitors in breast cancer
Authors: Dombrowski, S., et al.
Session: Breast Cancer ‒ Metastatic
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 1096

BRAF mutation classes and co-occurring mutations in NSCLC
Authors: Niu, J., et al.
Session: Lung Cancer ‒ Non-Small Cell Metastatic
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 9083

Characterization of time to diagnosis indicates shorter interval for screenable versus symptom-driven cancers
Authors: Gainullin, V., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Poster Discussion: 1:15-4:15 p.m. CT
Abstract Number: 10526

Comparison of simulated outcomes between stool- and blood-based colorectal cancer screening tests
Authors: Fendrick, A. M., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Poster Discussion: 1:15-4:15 p.m. CT
Abstract Number: 10529

Plasma methylated DNA markers of cutaneous melanoma: Association with PET/CT-positive disease
Authors: Meves, A., et al.
Session: Melanoma/Skin Cancers
Poster Discussion: 3:15-6:15 p.m. CT
Abstract Number: 9567

Methylated DNA markers in urine aid in the selective identification of patients with prostate cancer as well as clinically significant pathology
Authors: Shah, P., et al.
Session: Genitourinary Cancer ‒ Prostate, Testicular, and Penile
Poster Discussion: 3:15-6:15 p.m. CT
Abstract Number: 5091

Online Publications

Cost-effectiveness of mt-sDNA vs mailed FIT outreach for Medicare Advantage enrollees using the CRC-AIM microsimulation model
Authors: Bhatt, J., et al.
Abstract Number: e18827

Cost-effectiveness of waiving coinsurance for follow-up colonoscopy after a positive stool-based colorectal screening test in a Medicare population
Authors: Fendrick, A. M., et al.
Abstract Number: e13624

Modeling analysis of COVID 19-related delays in colorectal cancer screening on simulated clinical outcomes
Authors: Wilson, L., et al.
Abstract Number: e13631

Plasma methylated DNA markers detect recurrence and response to therapy in colorectal cancer
Authors: Zhu, M., et al.
Abstract Number: e15567

On May 27, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that management will participate in an upcoming investor conference (Press release, Zymeworks, MAY 27, 2022, View Source [SID1234615205]):

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Jefferies Healthcare Conference. Zymeworks will participate in one-on-one meetings on June 8th – 9th and will present on June 8th at 9:30 a.m. ET in New York, NY.
The presentation will be available on Zymeworks’ website at View Source

On May 27, 2022 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have a high unmet medical need, reported three poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3-7, 2022, in Chicago, Illinois (Press release, BeyondSpring Pharmaceuticals, MAY 27, 2022, View Source;utm_medium=rss&utm_campaign=beyondspring-presents-new-clinical-data-in-the-chemotherapy-induced-neutropenia-and-nsclc-programs-at-the-2022-asco-annual-meeting [SID1234615169]).

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Presentation highlights:

Chemotherapy-induced neutropenia (CIN): Real-world CMS data showed that week 1 after chemotherapy still presents unmet medical needs with febrile neutropenia (FN) risk, even with prophylactic G-CSF, among patients with breast cancer after high FN–risk chemo
DUBLIN-3 (non-small cell lung cancer, NSCLC): Improved quality of life (QoL) in plinabulin/docetaxel combination vs. docetaxel alone in 2nd/3rd line EGFR-wild type NSCLC patients using the validated EORTC QLQ C30 and QLQ LC13 questionnaires
DUBLIN-3 (NSCLC): Subgroup analysis in patients with non-squamous, EGFR-wild type, 2nd/3rd line NSCLC from the global Phase 3 trial showed a superior survival benefit of 2.6 months in median overall survival (OS) in the plinabulin/docetaxel combination (11.4 months) vs. docetaxel alone (8.8 months), HR=0.75, p=0.023
"We continue to develop plinabulin as a potential ‘pipeline in a drug,’ in both CIN prevention and in NSCLC. We now present ‘real-world’ data demonstrating an unmet medical need with standard of care (SoC) G-CSF for CIN, primarily due to G-CSF’s slow-onset mechanism of action (MoA) that leaves patients unprotected in Week 1 of the chemotherapy cycle. Plinabulin has a fast-onset MoA acting within 24 hours of administration and when combined with G-CSF provided superior CIN protection throughout the entire cycle," said Dr. Ramon Mohanlal, executive vice president, research and development, and chief medical officer, at BeyondSpring. "In terms of the DUBLIN-3 Phase 3 data, patient QoL is an important factor for treatment decisions in 2nd/3rd line NSCLC. The improvement in QoL seen when plinabulin is added to SoC docetaxel vs docetaxel alone could be an important point of product differentiation. Whereas the mOS data in the overall intention to treat (ITT) population was positive, but somewhat modest, we now demonstrate a more robust mOS benefit (of 2.6 months) in a large subgroup of non-squamous 2nd/3rd line NSCLC patients. We continue to work with health authorities on a path to approval in the U.S. and in China."

Dr. Lan Huang, co-founder, chairman and chief executive officer at BeyondSpring, added, "Since we’ve started studying plinabulin, it has continued to show a strong potential to make a difference in a number of oncology indications. We’ve been able to demonstrate repeatedly how it has a two-pronged ability to help prevent CIN and treat cancer directly. We are pleased with the ongoing discussions with China NMPA on the NDA review of the plinabulin and G-CSF combination for the prevention of CIN and plan to file an NDA application to the NMPA for the use of plinabulin in NSCLC by year-end. I’m grateful to our team and partners over the years who have continued to do all the hard work at the bench and in clinical trials to fully understand what plinabulin has to offer for cancer patients. We continue to stay strongly committed to this work in the hopes of bringing plinabulin to patients around the globe."

Title: Real-world effectiveness of prophylactic granulocyte colony-stimulating factor (G-CSF) early (week 1) and late (weeks 2-3) in the cycle for the prevention of febrile neutropenia (FN) among patients (pts) with breast cancer (BC) after high FN–risk chemotherapy (chemo)

Abstract #: 599

Poster Session: Breast Cancer—Local/Regional/Adjuvant
Date/Time: June 6, 2022, 9 AM EDT

Presenter: Douglas W. Blayney, M.D., FASCO, Stanford University

The relative FN risk in Week 1 vs. Weeks 2-3 of the cycle with G-CSF is unknown. It was analyzed compared with no G-CSF in the real-world setting with high FN risk chemotherapy.
Using a CMS database of administrative claims representing 100% of fee-for-service Medicare, an analysis of breast cancer patients who initiated docetaxel (T), doxorubicin (A) or cyclophosphamide (C) monotherapy or combination therapy between 01/01/2015 – 12/31/2019 was performed.
Prophylactic G-CSF was highly effective for the prevention of FN in weeks 2-3 (only 0.8% of patients had FN) but relatively ineffective in Week 1 of cycle 1 (3.2% of patients had FN, which was not different from patients without G-CSF (3.6%)) in the real-world setting. This represents an unmet medical need in Week 1 of the cycle with SoC G-CSF.

Title: DUBLIN-3 results on quality of life (QoL) in second/third-line EGFR-wild type NSCLC patients (pts) receiving docetaxel (Doc) with or without plinabulin (Plin) using the validated EORTC QLQ C30 and QLQ LC13 questionnaires

Abstract #: 9091

Session: Lung Cancer—Non-Small Cell Metastatic
Date/Time: June 6, 2022, 9 AM EDT

Presenter: Trevor Feinstein, M.D., Piedmont Cancer Institute

In the ITT population of the DUBLIN-3 Phase 3 trial, the plinabulin/docetaxel combination had better quality of life versus docetaxel alone in second/third-line EGFR-wild type NSCLC patients (QTWiST, p=0.026).
EORTC QLQ C30 and QLQ LC13 scores were collected at baseline, Day 1 and Day 8 of each cycle.
Mean (SEM) change from baseline in cumulative C30 and LC13 were overall in favor of plinabulin/docetaxel. LC13 items in favor of plinabulin/docetaxel vs docetaxel alone were items 31 (coughing; p<0.05), 36 (sore mouth; p<0.01) and 37 (dysphagia; p<0.01).

Title: Subgroup analysis in patients (pts) with non-squamous (N-Sq), EGFR-wild type (wt), second/third-line NSCLC from the global phase (Ph) 3 trial DUBLIN-3 with the plinabulin/docetaxel (Plin/Doc) combination versus Doc alone

Abstract #: 9090

Session: Lung Cancer—Non-Small Cell Metastatic
Date/Time: June 6, 2022, 9 AM EDT

Presenter: Baohui Han, M.D., Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University

With PD-1/PD-L1 inhibitors moving to first line in NSCLC, 2nd/3rd line NSCLC represents a severe unmet medical need, dominated by docetaxel-based therapies with >40% severe neutropenia and limited survival.
In the ITT population of the DUBLIN-3 Phase 3 trial, the plinabulin/docetaxel combination had superior efficacy, safety and quality of life versus docetaxel alone in EGFR-wild type, second/third-line NSCLC patients.
In this subgroup analysis of the non-squamous (N-Sq) subgroup, the addition of plinabulin to docetaxel was superior to docetaxel alone for efficacy (mOS 11.4 vs. 8.8 months, HR=0.75, p=0.023) and safety (Grade 4 neutropenia rate 13.9% vs 37.9%, p<0.001).

About DUBLIN-3

The DUBLIN-3 Phase 3 trial is a randomized, single blinded, active-controlled global trial that enrolled 559 patients with 2nd/3rd line NSCLC, EGFR wild type, with a measurable lung lesion. Patients were treated on a 21-day cycle with an infusion of docetaxel (75 mg/m2 on day 1) and plinabulin (30 mg/m2 on days 1 and 8) vs. docetaxel alone (75 mg/m2, day 1). The primary endpoint was overall survival. Secondary endpoints include ORR, PFS, grade 4 neutropenia, 2 year and 3 year OS rate and quality of life analysis. Plinabulin in combination with docetaxel (DP) showed statistically significant overall survival improvements compared to docetaxel alone (D) for the ITT population (DP: n=278; D: n=281).

On May 27, 2022 Modra Pharmaceuticals ("Modra") reported the final results of the lower dose cohort in the Company’s Phase 2b trial evaluating its oral taxane therapeutic, ModraDoc006/r, in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) compared to standard-of-care IV chemotherapy docetaxel at 75 mg/m2 Q3W. ModraDoc006/r is an oral tablet formulation of docetaxel co-administered with ritonavir, a boosting agent which enhances bioavailability (Press release, Modra Pharmaceuticals, MAY 27, 2022, View Source [SID1234615206]). The lower 20-20/200-100mg dose demonstrated a significantly improved safety profile compared to IV docetaxel while maintaining efficacy levels. Based on these encouraging results, this optimal dose has been selected for Modra’s planned Phase 3 pivotal trial in mCRPC patients. The Phase 2b data will be presented in a "poster discussion" presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting 2022, held from June 3 – 7.

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"The detailed analysis of the lower dose cohort has demonstrated that we can further improve the safety profile for ModraDoc006/r without compromising activity, making it a very attractive option to deliver chemotherapy. Now, with the optimal dosage of ModraDoc006/r selected, we are well-positioned to enter Phase 3 clinical testing and get one step closer to bringing a safer, effective and more convenient alternative to IV chemotherapy to patients living with mCRPC," said Colin Freund, CEO of Modra Pharmaceuticals.

Out of the 62 patients enrolled in the second cohort, 31 received IV docetaxel and 31 were administered ModraDoc006/r at 20mg ModraDoc006 combined with 200mg ritonavir in the morning, 20mg ModraDoc006 with 100mg ritonavir in the afternoon ("20-20/200-100") in a bi-daily weekly dosing (BIDW) regimen. Notably, neutropenia was eliminated with ModraDoc006/r 20-20; 0% vs. 26% on IV docetaxel. Neuropathy was significantly reduced at 10% G1 only on ModraDoc006/r vs. 29% total (10% G1, 19% G2) on IV docetaxel. Incidence of alopecia was 23% on ModraDoc006/r vs. 42% on IV docetaxel. ModraDoc006/r vs. IV docetaxel demonstrated an overall response rate (ORR) of 39% vs. 29% respectively. Prostate-Specific Antigen (PSA) responses were also comparable at 48% vs. 50%. Gastrointestinal toxicities with ModraDoc006/r 20-20 remained mild and similar to IV docetaxel.

"Not only did ModraDoc006/r 20-20 eliminate neutropenia, a significant hurdle in the oral taxane space, while maintaining equivalent efficacy to IV docetaxel, it also dramatically reduced neuropathy and alopecia, side-effects that frequently complicate the lives of mCRPC patients undergoing chemotherapy," said Ulka Vaishampayan, MD, Principal Investigator of the study and Professor of Internal Medicine, Division of Hematology/Oncology at the University of Michigan. "These encouraging data provide a compelling rationale for conducting further development in a pivotal study with ModraDoc006/r to further investigate its potential. ModraDoc006/r 20-20 will be applicable to a broader mCRPC patient population that may not have access to or tolerate more traditional IV chemotherapy regimens. The convenience of oral administration with maintained efficacy makes it an attractive option that is likely to improve prostate cancer outcomes."

The open label 1:1 randomized study compared ModraDoc006/r 20-20 in a BIDW schedule with IV docetaxel 75 mg/m2 administered in 21-day cycles. Participating patients had mCRPC with a performance status of 0-1 and had not received prior chemotherapy for mCRPC. All patients received 5 mg oral prednisone twice daily. The primary endpoint of the study was radiographic progression free survival (rPFS) per PCWG-3 criteria. Secondary objectives included ORR, PSA-PFS, time to skeletal related events, disease control rate, duration of response and safety assessments.

Presentation Details
Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Poster Title: A Phase 2 randomized study of oral docetaxel plus ritonavir (ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer (mCRPC)
Presenter: Ulka N. Vaishampayan, MD | University of Michigan
Location: In-Person & Live Stream | Arie Crown Theater
Session Date and Time: June 6, 2022 from 16:30 CDT – 18:00 CDT
Abstract Number: 5016
Poster Number: 200

About metastatic Castration-Resistant Prostate Cancer (mCRPC)
mCRPC is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is not amenable to surgical treatment and resistant to androgen deprivation therapy, a hormone therapy used as initial disease management to reduce growth of prostate cancer cells.

About ModraDoc006/r
ModraDoc006/r is a proprietary boosted taxane therapy based on docetaxel, an intravenously administered therapy, that is very broadly used in a variety of tumor types. ModraDoc006 – an oral docetaxel tablet – is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile, as compared to standard IV docetaxel.

On May 27, 2022 NEX-I reported that the company selected NXI-101, a new antibody treatment for non-small cell lung cancer that targets immunotherapy-refractory factors (Press release, NEX-I, MAY 27, 2022, View Source;mode=VIEW&num=15&category=&findType=&findWord=&sort1=&sort2=&page=3 [SID1234643432]).

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CEO Kyung-wan Yoon"NXI-101Not only does it improve the survival rate of patients who do not respond to existing immunotherapy treatments,,As an anticancer drug that guarantees the patient’s quality of life after treatment, it will bring a new paradigm to the cancer immunotherapy market."said.

The national new drug development project is a domestic pharmaceutical·To strengthen the global competitiveness of the bio industry and secure pharmaceutical sovereignty, which is an essential condition for public health, pharmaceutical companies and academia·kite·Based on bottle open innovation strategy,A pan-ministerial country that supports all stages of new drug developmentR&DStarting this year as a business10years2article2000Investing billions of won.

With the selection of this project, NexI plans to2yearsNXI-101You will receive support for the research costs necessary to derive the lead material.. NXI-101It targets immune evasion factors specifically secreted by cancer cells.First-in-classIt is a new antibody drug..Immune evasion factors are the cause of refractoriness to anticancer immunotherapy.,Controlling this can significantly improve the efficacy of anticancer immunotherapy..

The company said"New drugs under development are derived based on data from a number of immunotherapy-refractory animal models established in-house and from patients who are actually refractory to anti-cancer immunotherapy, so effective clinical efficacy can be expected."He said.

Meanwhile,Nexi this year4It is a new bio venture company established in February..Chief Scientific Officer of Genome & Company(CSO)·CEO Kyung-wan Yoon, who served as vice president,20Through more than a year of research on incurable cancer diseases, many anticancer drugs have been developed.·Professor Kim Tae-woo of Korea University College of Medicine, who has research achievements in immunotherapy, is the Chief Technology Officer.(CTO)I am in charge of.