On September 28, 2019 GRAIL, Inc., a healthcare company focused on the early detection of cancer, reported that new data supporting its technology to detect cancer at early stages with a single blood test will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain (Press release, Grail, SEP 28 https, 2019, ://www.businesswire.com/news/home/20190927005539/en/GRAIL-Present-New-Data-Late-Breaking-Oral-Presentation [SID1234539889]).

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"Most cancers go undetected until too late, and cancer remains the second leading cause of death worldwide. To address this challenge, we embarked on one of the most ambitious clinical study programs in genomic medicine in support of a novel multi-cancer approach to early cancer detection," said Anne-Renee Hartman, MD, Vice President of Clinical Development at GRAIL. "We are pleased to be presenting new data from our large-scale, rigorous clinical study program that demonstrate the ability of our test to detect more than 20 cancer types across all stages from a single blood draw, and identify where the cancer is located in the body, while minimizing the rate of false positives."

The data are being presented by Geoffrey R. Oxnard, MD, Dana-Farber Cancer Institute. The presentation slides will be available online at View Source at time of presentation.

GRAIL will also present additional new data from its ongoing studies evaluating its multi-cancer early detection test at ASCO (Free ASCO Whitepaper) Breakthrough taking place October 11-13, 2019 in Bangkok, Thailand.

ESMO Oral Presentation Details
Abstract LBA77
Geoffrey R. Oxnard, et al. Simultaneous multi-cancer detection and tissue of origin (TOO) localization using targeted bisulfite sequencing of plasma cell-free DNA (cfDNA)
Proffered Paper Session – Translational Research: September 28, 2019: 8:30-10:00 AM CEST, Pamplona Auditorium (Hall 2)

About GRAIL’s Investigational Multi-Cancer Early Detection Test

GRAIL is developing a next-generation sequencing (NGS) blood test for the early detection of multiple deadly cancer types. GRAIL’s high efficiency methylation technology preferentially targets the most informative regions of the genome and is designed to use its proprietary database and machine-learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin. GRAIL’s sequencing database of cancer and non-cancer methylation signatures is believed to be the largest of its kind and covers approximately 30 million methylation sites across the genome. More than 20 cancer types across stages are represented within the database.

DNA methylation is a natural process used by cells to regulate gene expression. It is a chemical modification to DNA and a well-studied epigenomic feature of the genome. In cancer, abnormal methylation patterns and the resulting changes in gene expression can contribute to tumor growth. For example, hypermethylation can cause tumor-suppressor genes to be inactivated.

On September 28, 2019 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycles) product platform, reported the presentation of updated data from a Phase I/IIa trial conducted in collaboration with Cancer Research UK and evaluating BT1718 in an unselected group of patients with advanced solid tumors (Press release, Bicycle Therapeutics, SEP 28, 2019, View Source [SID1234539890]). The results are being presented by Natalie Cook, Ph.D., a study investigator and Senior Clinical Lecturer at the University of Manchester, today from 12:00-13:00 CET in a poster session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress in Barcelona, Spain. The poster is available on the Publications section of bicycletherapeutics.com.

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"The data being presented at ESMO (Free ESMO Whitepaper) demonstrate encouraging progress of the dose escalation portion of the Phase I/IIa trial evaluating BT1718," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We believe these early data underscore the potential of Bicycles as a novel therapeutic modality and plan to provide additional updates from across our pipeline at medical meetings through the rest of this year."

Patients in the Phase I dose escalation were assessed for anti-tumor activity, safety and pharmacokinetics up to the data cutoff of August 7, 2019. Based on data from patients in cohorts across dose levels tested, many of which are below the predicted therapeutic range, 13 of 24 evaluable patients (54%) had stable disease at the eight-week timepoint, including a patient who experienced a 45% reduction in a target lesion. With once-weekly dosing, which is the expected schedule for the Phase IIa portion of the study, BT1718 has appeared tolerable, with manageable adverse events. The Phase I once-weekly dose escalation portion of the trial is ongoing, with dosing at levels equivalent to those associated with preclinical responses.

Across all dose levels and schedules tested, the most common treatment-related adverse events (>15%, n=28) were anemia, diarrhea, nausea, vomiting, fatigue, alanine aminotransferase increase, aspartate aminotransferase increase, blood alkaline phosphatase increase, gamma-glutamyltransferase increase, decreased appetite, lethargy and peripheral neuropathy.

Evaluation of pharmacokinetics demonstrated that BT1718 area under the curve (AUC) was approximately dose proportional over the range 0.6-25 mg/m2, and cycle 2 values were consistent with cycle 1. Mean (±SD) plasma clearance (CLp) was 33.6 (±24.5) L/h, with mean (±SD) volume of distribution (Vss) of 12.5 (±7.3) L, resulting in a terminal half-life (t1/2) of 0.2 to 0.5 hours. Two tumor biopsies were obtained from patients dosed at levels above 15 mg/m2 and analysis showed delivery of DM1 to the tumor consistent with preclinical models. These findings suggest rapid tumor penetration by BT1718. Further plasma and tumor DM1 analysis is ongoing to assess the extent of DM1 retention.

"We are on track to achieve the primary objectives of the Phase I portion of the study," said Udai Banerji, M.D., Ph.D, chief investigator of the study and Deputy Director of the Drug Development Unit at The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust. "BT1718 represents an exciting potential first-in-class drug, which appears tolerable in Phase I evaluation. Importantly, in two patient biopsies, we observed presence of cytotoxic payload to tumors consistent with targeted delivery and in a manner predicted by our preclinical models."

Nigel Blackburn, Ph.D., Cancer Research UK’s Director of Drug Development, said: "Based on our experience, these early clinical data are very promising and a testament to our strong partnership with Bicycle Therapeutics. We are pleased to help accelerate potentially groundbreaking new therapeutics such as BT1718 into clinical trials. This is an excellent example of the innovative work our Centre of Drug Development can support and is an important step toward helping more people survive cancer."

The Phase I/IIa study of BT1718 is being sponsored by Cancer Research UK. The primary objectives of the Phase I dose escalation portion of the trial are to select the recommended Phase II dose (RP2D) by establishing the maximum tolerated dose and maximum administered dose, and to assess the safety and toxicity profile of BT1718 in patients with advanced solid tumors. Following selection of the once-weekly RP2D, the Phase IIa portion of the study, consisting of up to four cohorts in selected indications in which MT1-MMP is expressed, will be initiated.

About BT1718

BT1718 is a Bicycle Toxin Conjugate being developed by Bicycle Therapeutics that targets Membrane Type 1 Matrix Metalloproteinase (MT1-MMP), also known as MMP-14, which has an established role in cell invasion and metastasis, is linked to poor outcomes and is over-expressed in many solid tumors. BT1718 has demonstrated promising target-dependent efficacy in preclinical models, including both cell- and patient-derived xenografts that are resistant to treatment with standards of care. In addition, it shows only a subset of the toxicities typically associated with other highly potent cancer treatments.

On September 28, 2019 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported results from its non-clinical GLP toxicology program with first-in-class selective TGF-beta inhibitor AVID200 and evidence of TGF-beta target engagement in patients treated with this novel immuno-oncology agent at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress in Barcelona (Press release, Forbius, SEP 28, 2019, View Source [SID1234539891]).

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The presentation detailed for the first time that AVID200 administered at doses of ≥1 mg/kg sequestered its target TGF-beta in patient blood over the entire dosing period.

Key highlights of today’s presentation at ESMO (Free ESMO Whitepaper) (#504P):

AVID200 selectively neutralizes TGF-beta 1 & 3 with pM potency in vitro, and increases T-cell-mediated cytotoxicity as well as immune checkpoint inhibitor efficacy in syngeneic mouse tumor models
AVID200 was well tolerated in 1- and 6-month GLP toxicology studies in non-human primates
AVID200 in patient blood sequestered peripheral TGF-beta over the entire dosing period
A Phase 1a AVID200 monotherapy dose-escalation clinical trial is currently enrolling solid tumor patients (AVID200-03; NCT03834662)
About TGF-beta 1 & 3

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis, and resistance to anti-PD-(L)1 therapies such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

About AVID200 and the AVID200-03 Trial (NCT03834662)

AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3 undergoing Phase 1 clinical testing in solid tumors and fibrotic diseases. TGF-beta 1 & 3 are the principal disease-driving isoforms, while TGF-beta 2 is responsible for normal cardiac function and hematopoiesis.

AVID200’s selectivity for TGF-beta 1 & 3 was designed to achieve optimal efficacy while circumventing cardiac and other safety issues that have limited the applicability of older-generation, non-selective TGF-beta inhibitors. Therefore, AVID200 is positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings, including in combination with anti-PD-(L)1 therapy.

AVID200-03 (NCT03834662) is an open label, multicenter, dose-escalation study to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor effects of AVID200 in patients with advanced or metastatic solid tumor malignancies.

On September 28, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today reported preliminary overall survival (OS) data from the company’s randomized Phase 2 trial of trilaciclib in combination with chemotherapy for the treatment of metastatic triple-negative breast cancer (mTNBC) (Press release, G1 Therapeutics, SEP 28, 2019, View Source [SID1234539978]). In the trial, median overall survival for patients treated with trilaciclib in combination with a chemotherapy regimen of gemcitabine/carboplatin (GC) was 20.1 months, compared with 12.6 months for patients receiving chemotherapy alone. These data were reported as part of a late-breaking oral presentation (LBA22) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress and featured in a concurrent publication in The Lancet Oncology.

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Updated data from a separate randomized Phase 2 trial of trilaciclib in small cell lung cancer (SCLC) will be presented during a poster session (1742PD) on Sunday, September 29 at ESMO (Free ESMO Whitepaper) 2019 in Barcelona, Spain.

"Triple-negative breast cancer is the most aggressive form of breast cancer and tends to have a poorer prognosis than other breast cancers. We need new therapeutic approaches that improve outcomes for women diagnosed with triple-negative breast cancer," said Joyce A. O’Shaughnessy, M.D., Baylor University Medical Center, Texas Oncology, U.S. Oncology, and lead investigator for the trial. "As an oncologist specializing in triple-negative breast cancer, I am encouraged that trilaciclib has the potential to improve the survival of patients diagnosed with this disease."

"Trilaciclib is a first-in-class therapy that has improved outcomes for people with cancer being treated with chemotherapy in four randomized Phase 2 trials. The findings from these trials in small cell lung cancer and triple-negative breast cancer indicate that the clinical benefits of trilaciclib are meaningful and context-dependent," said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. "In metastatic triple-negative breast cancer, the benefit manifests as improved overall survival. In small cell lung cancer, patients experience myelopreservation benefits, including reduced rates of neutropenia, anemia and other chemotherapy-related side effects, and a corresponding decrease in the use of rescue therapies required to address those toxicities. Importantly, patient-reported outcome measures across all of our trials showed that trilaciclib improved the patient experience on chemotherapy."

Mark Velleca, M.D., Ph.D., Chief Executive Officer, added: "Based on feedback from our pre-NDA meeting with the FDA, we will begin a rolling NDA submission for small cell lung cancer in the fourth quarter of this year, which we expect to complete in the second quarter of 2020. We have also had initial discussions with the FDA regarding development of trilaciclib in triple-negative breast cancer, including the preliminary design of a Phase 3 trial. In 2020, we plan to initiate a Phase 3 trial in triple-negative breast cancer and a Phase 3 trial in colorectal cancer, with the goal of demonstrating the benefits of trilaciclib to patients receiving chemotherapy for multiple tumor types."

Overall survival benefit in mTNBC

The randomized, open-label Phase 2 study (NCT02978716) of trilaciclib in combination with GC, a current standard of care for TNBC, enrolled 102 patients who had received up to two prior chemotherapy regimens for locally recurrent or metastatic TNBC. In this three-arm trial, all three groups received a chemotherapy regimen of GC. Patients were randomized to receive GC only (Group 1) or GC plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy (Group 2) or trilaciclib administered the day prior to and the day of chemotherapy (Group 3). Primary endpoints for the trial included myelopreservation measures; secondary endpoints included additional myelopreservation measures and anti-tumor efficacy measures of overall response rate (ORR), progression-free survival (PFS) and OS. Myelopreservation and preliminary anti-tumor efficacy results from the trial were reported at the 2018 San Antonio Breast Cancer Symposium (press release here). Topline OS findings were announced in June 2019 (press release here); detailed OS results were reported for the first time at ESMO (Free ESMO Whitepaper) 2019.

Updated results from the trial showed:

The addition of trilaciclib to chemotherapy resulted in a significant increase in OS in both treatment groups compared to chemotherapy alone.

Compared to GC alone (Group 1), OS was improved for both trilaciclib arms (Groups 2 and 3) with median OS of 12.6 months, 20.1 months and 17.8 months, respectively (Group 2: HR=0.33, p=0.0283; Group 3: HR=0.34, p=0.0023). The median OS for Groups 2 and 3 combined was 20.1 months (HR=0.36, p=0.0015). The median OS for GC alone (Group 1, 12.6 months) was consistent with historical data.

PFS and ORR were consistent with previously reported data.

The safety and tolerability of trilaciclib were consistent with previously reported data.

There have been no serious adverse events attributed to treatment with trilaciclib in this trial.

Patient-reported outcome (PRO) measures related to anemia were improved in patients receiving trilaciclib versus patients receiving chemotherapy alone.

As previously reported, primary endpoints (myelopreservation measures) were not met.

Trilaciclib in SCLC

On Sunday, September 29, G1 Therapeutics will present updated results from its randomized, double-blind, placebo-controlled Phase 2 trial (NCT03041311) evaluating trilaciclib in extensive-stage SCLC patients receiving first-line chemotherapy and the checkpoint inhibitor Tecentriq (atezolizumab). The findings were consistent with previously reported data (press release here):

Trilaciclib demonstrated myelopreservation benefits, as shown by statistically significant and clinically meaningful improvement in reduction of myelosuppression endpoints, reduction of chemotherapy side effects and reduction of rescue interventions.

Trilaciclib was well tolerated, with fewer ³ Grade 3 adverse events (AEs) compared to placebo.

PRO measures related to anemia were improved in patients receiving trilaciclib versus patients receiving placebo.

Trilaciclib did not adversely impact chemotherapy anti-tumor efficacy as measured by ORR, PFS and OS.

Additionally, data from another randomized Phase 1b/2 trial of trilaciclib in patients with SCLC receiving first-line chemotherapy were recently published in Annals of Oncology, the official journal of ESMO (Free ESMO Whitepaper). Data in this trial demonstrated the myelopreservation benefits of trilaciclib as indicated by statistically significant reduction in clinically relevant consequences of myelosuppression compared to placebo, resulting in fewer supportive care interventions and dose reductions. Trilaciclib did not adversely impact the anti-tumor efficacy of chemotherapy.

Webcast and Conference Call Details

G1 Therapeutics will host a webcast and conference call of its investor and analyst event on Sunday, September 29, 2019, at 6:45 p.m. CEST (12:45 p.m. ET) to review the data being presented at ESMO (Free ESMO Whitepaper) 2019, as well as long-range development plans for all three of its clinical-stage therapies and commercial plans for trilaciclib. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 5878315. A live and archived webcast will be available on the Events & Presentations page of the company’s website at www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

About Trilaciclib

Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Based on results from three randomized trials in patients with small cell lung cancer, trilaciclib has received Breakthrough Therapy Designation, and G1 Therapeutics expects to submit marketing applications in the U.S. and Europe for myelopreservation in small cell lung cancer in 2020. In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. The company plans to initiate a Phase 3 clinical trial in triple-negative breast cancer and a Phase 3 clinical trial in colorectal cancer in 2020.

On September 27, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported updated, longer-term results from the pivotal Phase 3 SPARTAN study following a second interim analysis (Press release, Johnson & Johnson, SEP 27, 2019, View Source [SID1234539860]). Treatment with ERLEADA (apalutamide) plus androgen deprivation therapy (ADT) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high-risk of developing metastases, resulted in a 25 percent reduction in the risk of death compared with placebo plus ADT [HR=0.75; 95 percent CI, 0.59–0.96; p=0.0197 (to reach statistical significance, a p-value of p<0.0121 needed to be observed)].1,2

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The updated findings showed overall survival (OS) results supported the first interim analysis, despite a crossover of placebo patients to the apalutamide treatment group.1,2 Results were presented in an oral session at the 2019 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress (abstract #843O), and simultaneously published in Annals of Oncology.

At the second interim analysis, a longer median follow-up of 41 months, four-year OS rates were 72.1 percent for patients treated with apalutamide and 64.7 percent for patients treated with placebo.1,2 The OS benefit of apalutamide was consistent across baseline subgroups, such as race, prior treatments, baseline PSA and performance status.1,2

This interim analysis took place when 67 percent of the required OS events had been observed, compared with the original report when only 24 percent of required OS events had occurred (HR=0.70; 95 percent CI, 0.47–1.04; p=0.07).1,2 After unblinding the study, and prior to the second interim analysis, 76 non-progressing patients in the placebo group (19 percent of all placebo patients) crossed over to open-label apalutamide for an average of 15 months; the OS rates in the placebo group included those patients who were crossed over to apalutamide treatment, thereby underestimating the true treatment effect.1,2 The rates of treatment-emergent adverse events for apalutamide at the second interim analysis were consistent with rates previously reported.1,2 In the SPARTAN study, the most common adverse events (≥10 percent) were fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, falls, hot flush, decreased appetite, fracture and peripheral edema.3

"The data presented at ESMO (Free ESMO Whitepaper) 2019 add to the growing body of evidence demonstrating a trend for survival benefit achieved by apalutamide in patients with high-risk nmCRPC. This interim analysis for survival is in line with the initial data presented for all androgen signaling inhibitors in this disease setting. Hence all data presented to date reinforce the benefit of treating men with non-metastatic (by conventional imaging) castration-resistant prostate cancer," said Dr Eleni Efstathiou, MD, PhD, Associate Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, U.S. "For nmCRPC patients who remain at risk of their cancer spreading, and the clinicians that treat them, these data are very encouraging as they show the potential of this treatment in improving survival rates and slowing progression to a fatal stage of the disease – the ultimate goal when treating this population."

Initial results from the SPARTAN trial were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Annual Meeting Cancers Symposium (ASCO GU), and simultaneously published in The New England Journal of Medicine.4,5

"Despite many advances in the treatment of prostate cancer in recent years, there remains a high unmet need, particularly in the treatment of those patients who are at risk of their disease progressing to the most advanced form; the metastatic disease stage," said Dr Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A.. "We are very excited to share these new data from the SPARTAN trial, which reinforces the importance of apalutamide as a treatment option for patients with high-risk nmCRPC, for whom delaying the onset of metastases becomes a crucial objective in their disease journey. We will persist in our efforts to improve outcomes for patients through our robust research programme and remain committed to achieving our goal of making prostate cancer a manageable or even a curable disease."

-ENDS-

About the SPARTAN study

SPARTAN (NCT01946204) was a Phase 3, randomised, double-blind, placebo-controlled, multicentre study that evaluated ERLEADA (apalutamide) in combination with ADT in patients with high-risk nmCRPC with a rapidly rising PSA (PSA Doubling Time ≤10 months).4 The SPARTAN study enrolled 1,207 patients who were randomised 2:1 to receive either apalutamide orally at a dose of 240 mg once daily in combination with ADT (n=806) or placebo once daily in combination with ADT (n=401).4 Study results were initially reported at the 2018 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium and published in The New England Journal of Medicine.4,5

In the SPARTAN study, the most common adverse reactions (≥10 percent) were fatigue, hypertension, rash, diarrhea, nausea, decreased weight, arthralgia, falls, hot flushes, decreased appetite, bone fractures and peripheral edema.1

About non-metastatic castration-resistant prostate cancer

Non-metastatic castration-resistant prostate cancer (nmCRPC) refers to a disease stage when the cancer no longer responds to treatments that lower testosterone but has not yet been discovered in other parts of the body using a total body bone scan and CT/MRI scan.6 Features include: lack of detectable metastatic disease; rapidly rising prostate-specific antigen while on ADT with serum testosterone level below 50 ng/dL.7,8 Ninety percent of patients with nmCRPC will eventually develop metastases, which can lead to pain, fractures and other symptoms.9 The relative five-year survival rate for patients diagnosed at a distant-stage prostate cancer is 30 percent.10 It is critical to delay the development of metastasis in patients with nmCRPC.

About ERLEADA (apalutamide)

ERLEADA (apalutamide) is an androgen receptor (AR) inhibitor indicated for use in Europe for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.3 In the U.S. apalutamide is indicated for the treatment of nmCRPC and metastatic castration-sensitive prostate cancer.11 Apalutamide is currently under review by the European Medicines Agency (EMA) for the treatment of metastatic hormone-sensitive prostate cancer.12