On December 10, 2020 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, reported that the National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for ATG-010 (selinexor), an oral Selective Inhibitor of Nuclear Export (SINE) compound, in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (rrMM) in China (Press release, Antengene, DEC 10, 2020, View Source [SID1234572630]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The trial is a randomized, controlled, open-label, multicenter, Phase 3 trial, aiming to evaluate the efficacy and safety of ATG-010, bortezomib and dexamethasone (SVd) regimen against bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with rrMM who have received one to three prior lines of therapy. A total of 150 patients will be randomized in a 2:1 ratio to receive SVd or Vd treatment.

ATG-010 is a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) and it is now the first and only drug approved by the Food and Drug Administration (FDA) for use in both multiple myeloma and diffuse large B-cell lymphoma. In China, Antengene is conducting a registrational Phase 2 clinical trial of ATG-010 for rrMM (MARCH). The trial is expected to complete enrollment by the end of 2020.

"The result of the BOSTON study has demonstrated that the SVd regimen reduced the risk of disease progression or death with lower doses of bortezomib and dexamethasone in the triplet combination when compared to the standard Vd regimen. Addition of ATG-010 to Vd may be more convenient and provides a more significant therapeutic effect in patients with rrMM." said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "This planned Phase 3 trial, which is the registrational study based on BOSTON, is going to validate the SVd regimen’s efficacy and safety in Chinese population."

About ATG-010 (selinexor, XPOVIO)

ATG-010 (selinexor, XPOVIO) is a first-in-class and only-in-class oral selective inhibitor of nuclear export compound, developed by Antengene and Karyopharm Therapeutics Inc. (NASDAQ: KPTI). In July 2019, the US Food and Drug Administration (FDA) approved ATG-010 in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved ATG-010 as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). ATG-010 is so far the first and only oral SINE compound approved by the FDA. ATG-010 is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm Therapeutics, presented positive results from the Phase 3 randomized, double blind, placebo controlled, cross-over SEAL study evaluating single agent, oral ATG-010 versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the ongoing Phase 3 SIENDO study of ATG-010 in patients with endometrial cancer passed planned interim futility analysis and that Data and Safety Monitoring Board (DSMB) recommended the study should proceed as planned without any modifications. Top-line SIENDO study results are expected in the second half of 2021.

Antengene is conducting two registrational Phase 2 clinical trials of ATG-010 in China for relapsed refractory multiple myeloma (MARCH) and for relapsed refractory diffuse large B-cell lymphoma (SEARCH), and has initiated clinical trials for high prevalence cancer types in the Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma (TOUCH) and KRAS-mutant non-small cell lung cancer (TRUMP).

On December 10, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the first patient has been successfully enrolled and dosed in the randomized, double-blind, phase 2 multi-center clinical trial (NCT04590599) evaluating its IBI310 (anti CTLA-4 monoclonal antibody) in combination with TYVYT (sintilimab injection) for the treatment of patients with second-line or above advanced cervical cancer (Press release, Innovent Biologics, DEC 10, 2020, View Source [SID1234572629]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The trial is a randomized, double-blind, controlled, parallel cohort phase 2 clinical trial evaluating the efficacy and safety of IBI310 versus placebo, in combination with TYVYT (sintilimab injection), for advanced cervical cancer patients who have failed first and later line or intolerant of platinum-based chemotherapy. This clinical trial plans to enroll 174 patients with advanced cervical cancer.

Primary Investigator of the study, Professor Ding Ma of Tongji Hospital affiliated to Huazhong University of Science and Technology, stated:" Cervical cancer is the 4th most common malignant tumor among women in the world. in China, it ranks the 6th highest incidence rate (154/100,000) and 8th highest mortality rate (69/100,000) across tumor types. Treatment option of advanced cervical cancer is limited. The five-year survival rate of Stage IVb cervical cancer is still at a low level of less than 17%. Currently there is no standard treatment for patients with advanced cervical cancer who have failed platinum-based chemotherapy, representing a huge unmet clinical need. In recent years, immune checkpoint inhibitors have brought new hope to such patient population. We hope to explore the therapeutic value of the regimen of IBI310 in combination with TYVYT (sintilimab injection) as second-line or above treatment for patients with advanced cervical cancer."

Dr. Hui Zhou, Vice President and Head of Medical Sciences and Oncology Strategy of Innovent, stated: "CTLA-4 is an important immunosuppressive receptor. Currently, only one antibody drug targeting CTLA-4 has been approved and marketed globally, though lots of clinical trials on CTLA-4 targeted drugs have been conducted. So far there is no CTLA-4 targeted drug approved in China. With the most advanced progress in clinical development in China, IBI310 in combination with TYVYT (sintilimab injection) has shown promising preliminary anti-tumor potential value. We will evaluate the efficacy of IBI310 combined with TYVYT (sintilimab injection) in the phase II trial and we hope to provide more effective treatment to benefit patients and their families."

About IBI310

IBI310 is a recombinant fully-human monoclonal antibody against cytotoxic T lymphocytic associated antigen 4 (CTLA-4). IBI310 can interfere with the binding of CTLA-4 and CD80/CD86 on antigen presenting cells, thereby blocking the inhibitory effect on T cell activation. IBI310 can promote the activation and amplification of T cells, and enhance the anti-tumor ability of the immune system.

CTLA-4 provides a new approach for immunotherapy in many diseases, including tumors. Innovent has announced the preliminary results of the Phase 1 clinical trial about anti-CTLA-4 monoclonal antibody (NCT03545971) at the 56th Annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Online Publication, Abstract No. 302489). Phase II/III clinical studies of IBI310 combined with TYVYT (sintilimab injection) for multiple tumors are ongoing.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor included in the new Catalogue of the National Reimbursement Drug List (NRDL). In April 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with nonsquamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study.

TYVYT (sintilimab injection) is a fully human immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. This includes global clinical research studies on TYVYT (sintilimab injection).

On December 10, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) reported that new data from the Phase 3 ASCENT trial of Trodelvy (sacituzumab govitecan-hziy) in metastatic triple-negative breast cancer (mTNBC) at the 2020 San Antonio Breast Cancer Symposium being held virtually December 8-11, 2020 (Press release, Gilead Sciences, DEC 10, 2020, View Source [SID1234572628]). The new data and analyses from the ASCENT trial continue to demonstrate the high clinical activity of Trodelvy in this patient population with traditionally poor outcomes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate that is indicated in the U.S. for the treatment of adult patients with mTNBC who have received at least two prior therapies for metastatic disease. Trodelvy received accelerated approval for this patient population in April 2020, based on objective response rate and duration of response results observed in a single-arm, multicenter Phase 2 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe neutropenia and severe diarrhea; see below for Important Safety Information.

Based on the overall efficacy and safety results with Trodelvy in the Phase 3 ASCENT trial, Gilead has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for full approval as a treatment for adult patients with mTNBC who have received at least two prior therapies.

"These new data and analyses from the ASCENT trial continue to demonstrate the benefits of Trodelvy in a difficult-to-treat patient population and reinforce the role of Trodelvy as an important treatment option for mTNBC patients," said Loretta M. Itri, Chief Medical Officer of Immunomedics, a wholly owned subsidiary of Gilead.

"We look forward to working with the FDA in their review of the sBLA submission for Trodelvy in mTNBC, and partnering with the agency, clinical trial investigators and participants as we build on the work of Immunomedics and continue to study Trodelvy in other cancers with unmet medical need," said Daejin Abidoye, Senior Vice President, Head of Oncology, Gilead Sciences.

Data and analyses from the Phase 3 ASCENT trial being presented at SABCS 2020 include:

An exploratory analysis demonstrating overall survival, objective response rate and progression-free survival with Trodelvy versus chemotherapy in brain metastases-negative mTNBC patients irrespective of Trop-2 expression levels. Trop-2 receptors are expressed on the surface of many epithelial tumor cells and linked to poor prognosis, including decreased survival. (Abstract #GS3-06)
An exploratory analysis demonstrating tumor response, progression-free survival and overall survival with Trodelvy versus chemotherapy in a subset of mTNBC patients with stable brain metastases of limited sample size (Trodelvy, N=32; TPC, N=29). (Abstract #PD13-07)
Additional safety data on Trodelvy in mTNBC patients with reduced uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) activity. Patients who are homozygous for the UGT1A1*28 allele are at increased risk for neutropenia following initiation of treatment with Trodelvy. (Abstract #PS11-09)
About Triple-Negative Breast Cancer (TNBC)

TNBC is an aggressive type of breast cancer, accounting for up to 20% of all breast cancers. The disease is diagnosed more frequently in younger and premenopausal women and is highly prevalent in African American and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Medicines targeting these receptors therefore are not typically effective in treating TNBC. There is currently no approved standard of care for people with previously treated metastatic TNBC.

About the ASCENT Trial

The Phase 3, international, multi-center, randomized confirmatory trial enrolled more than 500 patients with relapsed/refractory, metastatic triple-negative breast cancer who had received at least two prior therapies for metastatic disease. Patients were randomized to receive either Trodelvy or a chemotherapy chosen by the patients’ treating physicians. The primary endpoint of the study was progression-free survival. Secondary endpoints include overall survival, objective response rate, duration of response, time to onset of response, and other measures of safety and tolerability. More information about ASCENT is available at View Source

About Trodelvy

Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated in the U.S. for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Trodelvy binds to the cell-surface protein Trop-2 and delivers the anti-cancer drug SN-38 to kill cancer cells.

Trodelvy received accelerated approval as a treatment for adult patients with mTNBC who have received at least two prior therapies, based on results of a single-arm, multicenter Phase 2 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In addition to multiple ongoing studies of Trodelvy in triple-negative breast cancer, Trodelvy is being developed as an investigational treatment for metastatic urothelial cancer, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer, and metastatic non-small cell lung cancer, either as a monotherapy or in combination with other agents.

Important Safety Information for Trodelvy

WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe or life-threatening neutropenia. Withhold TRODELVY for absolute neutrophil count (ANC) below 1500/mm3 on Day 1 of any cycle or ANC below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever.

Monitor blood cell counts periodically during treatment. Consider Granulocyte Colony-Stimulating Factor (G-CSF) for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia without delay.

Dose modifications may be required due to neutropenia. Febrile neutropenia occurred in 6% (24/408) of patients treated with TRODELVY, including 8% (9/108) of patients with mTNBC after at least 2 prior therapies. Less than 1% (1/408) of patients had febrile neutropenia leading to permanent discontinuation. The incidence of Grade 1-4 neutropenia was 64% in patients with mTNBC (n=108). In all patients treated with TRODELVY (n=408), the incidence of Grade 1-4 neutropenia was 54%; Grade 4 neutropenia occurred in 13%. Less than 1% (2/408) of patients permanently discontinued treatment due to neutropenia.
Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. Administer atropine, if not contraindicated, for early diarrhea of any severity. At the onset of late diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.

Diarrhea occurred in 63% (68/108) of patients with mTNBC and 62% (254/408) of all patients treated with TRODELVY. In each population, events of Grade 3-4 occurred in 9% (10/108) of mTNBC patients and 9% (36/408) of all patients treated with TRODELVY. Four out of 408 patients (<1%) discontinued treatment because of diarrhea. Neutropenic colitis was observed in 2% (2/108) of patients in the mTNBC cohort and 1% of all patients treated with TRODELVY.
Contraindications: Severe hypersensitivity reaction to TRODELVY.

Hypersensitivity

TRODELVY can cause severe and life-threatening hypersensitivity, including anaphylactic reactions. Hypersensitivity reactions occurred within 24 hours of dosing in 37% (151/408) and Grade 3-4 hypersensitivity occurred in 1% (6/408) of all patients treated with TRODELVY (n=408). The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 1% (3/408).
Pre-infusion medication for patients receiving TRODELVY is recommended. Observe patients closely for infusion-related reactions during each TRODELVY infusion and for at least 30 minutes after completion of each infusion. Medication to treat such reactions, as well as emergency equipment, should be available for immediate use.
Nausea and Vomiting

TRODELVY is emetogenic. Nausea occurred in 69% (74/108) of patients with mTNBC and 69% (281/408) of all patients treated with TRODELVY. Grade 3 nausea occurred in 6% (7/108) and 5% (22/408) of these populations, respectively. Vomiting occurred in 49% (53/108) of patients with mTNBC and 45% (183/408) of all patients treated with TRODELVY. Grade 3 vomiting occurred in 6% (7/108) and 4% (16/408) of these patients, respectively.
Premedicate with a 2- or 3-drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV).
Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting at the time of scheduled treatment administration and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.
Use in Patients with Reduced UGT1A1 Activity

Individuals who are homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia and may be at increased risk for other adverse events following initiation of TRODELVY treatment. Closely monitor patients with reduced UGT1A1 activity for severe neutropenia. The appropriate dose for patients who are homozygous for UGT1A1*28 is not known and should be considered based on individual patient tolerance to treatment.
In 84% (343/408) of patients who received TRODELVY (up to 10 mg/kg on Days 1 and 8 of a 21-day cycle) and had retrospective UGT1A1 genotype results available, the incidence of Grade 4 neutropenia was 26% (10/39) in patients homozygous for the UGT1A1*28 allele, 13% (20/155) in patients heterozygous for the UGT1A1*28 allele, and 11% (16/149) in patients homozygous for the wild-type allele.
Embryo-Fetal Toxicity

TRODELVY contains a genotoxic component and can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.
Lactation

Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 1 month after the last dose of TRODELVY.

Adverse Reactions

Most common adverse reactions (incidence >25%) in patients with mTNBC are nausea (69%), neutropenia (64%), diarrhea (63%), fatigue (57%), anemia (52%), vomiting (49%), alopecia (38%), constipation (34%), rash (31%), decreased appetite (30%), abdominal pain (26%), and respiratory infection (26%).

On December 10, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that new 5-year data from the NBRST trial that will be presented in a poster spotlight discussion Thursday, December 10, 2020 from 3:30pm-4:45pm CST at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020) (Press release, Agendia, DEC 10, 2020, View Source [SID1234572627]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster, entitled 5-year outcomes in the NBRST trial: Preoperative MammaPrint and BluePrint breast cancer subtype is associated with neoadjuvant treatment response and survival, contains the largest data set evaluating a genomic test in the neoadjuvant setting with long-term outcomes. These outcomes demonstrate the predictive and prognostic abilities of MammaPrint and BluePrint, and underpin both assays’ pre-operative utility.

In the 5-year results of the Neoadjuvant Breast Symphony Trial (NBRST), 22% of the tumors evaluated were reclassified from their original clinical subtype into a different molecular subtype by MammaPrint and BluePrint. This reclassification has significant implications for treatment planning, reinforcing the importance of the multi-disciplinary care team having this meaningful information at the earliest point after diagnosis to inform the decision for the timing of surgery and systemic therapy.

Importantly, the reclassification by BluePrint allowed researchers to detect more genomic diversity within pathologically ER+ and HER2 negative breast cancers than previously thought. 18% of those tumors were reclassified as Basal-Type by BluePrint (ER+/Basal) while 44% of pathologically HER2+ tumors were reclassified as Luminal- or Basal-Type by BluePrint. Of note, the response to treatment and longer term outcomes in those reclassified patients were distinctly different and aligned with the subtype identified by BluePrint.

"Genomic classification is uncovering the diversity in these pathologically-defined subsets," said Pat Whitworth, M.D., first author of the spotlight poster and a breast surgical oncologist at the Nashville Breast Center. "If a conventional HER2+ or an ER+/HER2 negative tumor is reclassified as BluePrint Basal-Type, switching to a different treatment approach, such as a HER2-targeted regimen with optimal basal coverage or different timing for surgery, may improve outcomes for those patients. With this extra layer of information, the patient and her care team are able to make important decisions at the very beginning of their journey that will be felt years down the line. Just as important, these patients should be the focus of upcoming trials."

In looking into the genomic makeup of the tumors, BluePrint could further stratify ER+ and HER2+ breast cancers as Luminal- or Basal-Type, which respond differently to treatment and could one day impact how these patients are treated. This observation echoes what was seen in a subanalysis of the APHINITY trial, also part of a spotlight poster discussion at SABCS 2020.

"The finding that a subset of ER+ HER2 negative primary breast cancers has a basal genotype on BluePrint analysis is a novel and very provocative result that compels us to study this further," said Joyce O’Shaughnessy, M.D., Director of the Breast Cancer Research Program for Texas Oncology and the US Oncology Network. "Should the ER+/basal breast cancers be treated as triple negative breast cancers, with platinum-based regimens, capecitabine post-op for residual disease and potentially with preop checkpoint inhibitors? We plan to study preop administration of platinum-based chemotherapy in patients with ER+/basal cancer to determine whether their outcomes parallel those of triple negative basal breast cancers."

Also presented at SABCS 2020 is a supporting poster on the NBRST study, "Molecular subtyping by BluePrint improves prediction of treatment responses and survival outcomes in patients with discordant clinical and genomic classification," which focused on the discordant groups within the 22% of BluePrint reclassifications displayed in the NBRST study. The data showed that molecular subtyping using MammaPrint and BluePrint is additive to pathologic assessment and thus facilitates more informed treatment decisions.

In addition, the supplemental NBRST poster reinforces the importance of genomic testing to further stratify Luminal patients. The data showed that Luminal A-Type patients have excellent outcomes on neoadjuvant endocrine therapy alone, an important consideration during the COVID-19 pandemic, while Luminal B-Type patients need additional systemic treatment.

According to James Pellicane, M.D., Director of Breast Oncology at the Bon Secours Cancer Institute, "These data confirm that BluePrint can be utilized as a tool to determine whether neoadjuvant systemic therapy or surgery followed by adjuvant therapy is the best option for a patient based on the molecular subtype of their breast cancer and its predicted response to therapy. What we’ve seen from NBRST is that certain patients, specifically the Luminal A subtypes, will respond to neoadjuvant endocrine therapy and have good long-term outcomes postoperatively with endocrine therapy alone. Others may respond to neoadjuvant endocrine therapy but because of their more aggressive biology, specifically the Luminal B subtypes, will benefit from cytotoxic chemotherapy in the adjuvant or sometimes in the neoadjuvant setting. As a surgeon, it’s comforting to know that you can triage these patients more effectively, having a better understanding of the biology of their breast cancer and how it will respond to different treatment algorithms and how that response corresponds with their long-term outcome."

These data are part of a large suite of 13 posters, spotlight sessions and an oral presentation on MammaPrint and BluePrint that were accepted to SABCS 2020, and underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.

On December 10, 2020 Creatv MicroTech, a privately-held biotechnology company reported that it has pioneered a blood test to predict treatment response in patients with newly diagnosed Stage I-III esophageal cancer (EC) treated with chemoradiation therapy (CRT) (Press release, CREATV MICROTECH, DEC 10, 2020, View Source [SID1234572626]). The results were published in the Journal of Translational Medicine. Creatv’s collaborator MD Anderson Cancer Center recruited patients for the study under standard of care CRT and IRB approved protocol. "We are delighted to present a method to stratify patients with EC who are responding to CRT using a single tube of blood," said Dr. Cha-Mei Tang, CEO of Creatv. "Now, patients who are not responding to CRT can be identified quickly for alternative therapy." Currently, no other blood test predicts treatment response for Stage I-III esophageal cancer therapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the United States, 18,440 new cases are expected in 2020 for esophageal cancer, a disease that has the sixth highest cancer mortality rate. Even localized disease has a 5-year survival rate of less than 50%, making timely treatment decisions critical to patient outcome. The ability to monitor a patient’s response to therapy throughout treatment will allow for more precise adjustment to therapeutic regimes to optimize the management of the disease. In a completely novel concept, the test analyzes patients’ immune response to the presence of cancer, isolating cells from cancer sites that have migrated into the blood stream. Creatv demonstrated that a particular subtype of cell, Cancer Associated Macrophage-Like cells (CAMLs), tracks the patient’s response to therapy in real time. CAMLs are phagocytic myeloid cells that reveal the patient’s immunological response to active malignancy. CAMLs are not found in the blood of normal, healthy individuals.

Creatv has previously shown that in solid tumors, patients with CAMLs larger than 50 µm in size have a poorer prognosis, with shorter progression free survival (PFS) and overall survival (OS). In this paper, Creatv presents the findings from a two-year single blind prospective study of 32 esophageal cancer patients with Stage I-III treated with standard CRT. A CAML size of ≥50 µm in blood drawn immediately after the completion of CRT indicates a poor prognosis compared to patients with CAMLs < 50 µm, with a Hazard Ratio (HR) =12.0 for progression free survival (PFS) 95% CI 2.7-54.1, p=.004.

The paper is available here.

About LifeTracDx Liquid Biopsy

Creatv’s liquid biopsy assays (LifeTracDx) are commercialized Research Use Only tests designed for analysis of CAMLs and Circulating Tumor Cells (CTCs). LifeTracDx tests are applicable for cancer screening, companion diagnostics, prediction of treatment response (including immunotherapy) and prognosis. LifeTracDx tests also provide unfragmented tumor DNA for sequencing and can predict minimal residual disease (MRD) and early detection of cancer recurrence. LifeTracDx tests are currently used in more than 20 clinical trials, from basic research to drug development. Creatv’s publications have shown that LifeTracDx liquid biopsy can be used for multiple solid tumor cancers as an early predictor of patient response to therapy.