On May 9, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics, reported financial results for the quarter ended March 31, 2023 (Press release, Guardant Health, MAY 9, 2023, View Source [SID1234631312]).

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!

First Quarter 2023 Financial Highlights

Revenue of $128.7 million for the first quarter of 2023, an increase of 34% over the first quarter of 2022
Reported 39,100 tests to clinical customers and 6,150 tests to biopharmaceutical customers in the first quarter of 2023, representing an increase of 45% and 21%, respectively, over the first quarter of 2022
Recent Operating Highlights

Delivered record clinical volumes driven by the FDA approval of Guardant360 CDx for ESR1 mutations in metastatic breast cancer and expanded commercial coverage to more than 300 million lives
Received Medicare coverage for Guardant Response, the first blood-only liquid biopsy for I-O monitoring for all solid tumors

Filed premarket approval (PMA) application for Shield blood-based CRC screening, and FDA review process underway
Presented additional data from ECLIPSE trial at Digestive Disease Week (DDW)
Strengthened leadership team with the appointment of Ines Dahne-Steuber as Chief Operating Officer to drive further operating efficiency and scale, and the promotion of Darya Chudova to Chief Technology Officer to continue innovation of our market-leading technology platform
"We are off to a very strong start with robust clinical volume growth fueled by continued expansion in lung cancer and a step change in breast cancer volumes following our recent FDA approval of Guardant360 CDx in metastatic breast cancer," said Helmy Eltoukhy, co-founder and co-CEO. "With the recent coverage of Guardant Response, we now have full Medicare coverage across our Therapy Selection and MRD product portfolios. This coverage will help drive continued volume growth as we approach breakeven in our Therapy Selection core business and execute on our strategy to be the worldwide leader in precision oncology."

"Each quarter we are making more progress on our goal of developing a new patient-preferred market category in CRC screening. Shield is the first mover in this category that achieved 83% overall CRC sensitivity at 90% specificity in range with other guideline-recommended non-invasive CRC screening tests. Based on this study readout, our team has recently submitted the PMA, and the FDA review is currently underway," said AmirAli Talasaz, co-founder and co-CEO. "Today at DDW, the study investigators presented additional insights for the ECLIPSE trial. Sensitivity of our test at stage I-III was 81% where cure rates are highest, and 72% in detecting localized disease that would most likely be cured through surgical procedures. Based on our ECLIPSE results, we believe that as a longitudinal screening test, taken every three years, Shield will detect nearly all CRCs at a curable stage and will save many lives."

First Quarter 2023 Financial Results

Revenue was $128.7 million for the three months ended March 31, 2023, a 34% increase from $96.1 million for the three months ended March 31, 2022. Precision oncology revenue grew 35%, driven predominantly by an increase in clinical testing volume and biopharma sample volume, which grew 45% and 21%, respectively, over the prior year period. Development services and other revenue increased by 28%, primarily due to revenues earned from our partnership agreements during the three months ended March 31, 2022.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $75.6 million for the first quarter of 2023, an increase of $11.5 million from $64.1 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 59%, as compared to 67% for the corresponding prior year period. Precision oncology gross margin was 60% in the first quarter of 2023, as compared to 64% in the prior year period. The reduction is due to the change in mix between clinical and biopharma revenue, as well as the year over year change in blended clinical ASP due to the increased proportion of volume coming from Reveal, TissueNext and Response. Development services and other gross margin was 48% in the first quarter of 2023, as compared to 89% in the prior year period. The change is due to a one-time cost incurred in the first quarter of 2023 related to one of our partnership agreements and to the inclusion of the cost of processing Shield LDT samples as part of our screening market development activities.

Operating expenses were $209.7 million for the first quarter of 2023, as compared to $187.5 million for the corresponding prior year period, an increase of 12%. Non-GAAP operating expenses were $188.3 million for the first quarter of 2023, as compared to $158.7 million for the corresponding prior year period.

Net loss was $133.5 million for the first quarter of 2023, as compared to $123.2 million for the corresponding prior year period. Net loss per share was $1.30 for the first quarter of 2023, as compared to $1.21 for the corresponding prior year period. Non-GAAP net loss was $108.5 million for the first quarter of 2023, as compared to $93.2 million for the corresponding prior year period. Non-GAAP net loss per share was $1.06 for the first quarter of 2023, as compared to $0.91 for the corresponding prior year period.

Adjusted EBITDA loss was $101.0 million for the first quarter of 2023, as compared to a $86.6 million loss for the corresponding prior year period.

Free cash outflow for the first quarter of 2023 was $82.0 million. Cash, cash equivalents and marketable debt securities were $937.0 million as of March 31, 2023.

2023 Guidance

Guardant Health expects full year 2023 revenue to be in the range of $535 million to $545 million, representing growth of 19% to 21% compared to full year 2022. This compares to its previous guidance range of $525 million to $540 million. Guardant Health continues to expect full year 2023 operating expenses to be below full year 2022, driven by efficiency measures and continued leverage of its existing infrastructure, and free cash outflow to be approximately $350 million in 2023.

Webcast Information

Guardant Health will host a conference call to discuss the first quarter and full year 2023 financial results after market close on Tuesday, May 9, 2023 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

Non-GAAP Measures

Guardant Health has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP cost of precision oncology testing, non-GAAP cost of development services and other, non-GAAP research and development expense, non-GAAP sales and marketing expense, non-GAAP general and administrative expense, non-GAAP loss from operations, non-GAAP net loss, non-GAAP net loss per share, basic and diluted, Adjusted EBITDA, and free cash flow.

We define our non-GAAP measures as the applicable GAAP measure adjusted for the impacts of stock-based compensation and related employer payroll tax payments, changes in estimated fair value of noncontrolling interest liability, contingent consideration, acquisition related expenses, amortization of intangible assets, fair value adjustments on marketable equity securities, impairment of non-marketable securities and other assets, and other non-recurring items.

Adjusted EBITDA is defined as net loss adjusted for interest income; interest expense; other income (expense), net; provision for (benefit from) income taxes; depreciation and amortization expense; stock-based compensation expense and related employer payroll tax payments; changes in estimated fair value of noncontrolling interest liability; adjustments relating to contingent consideration; and, if applicable in a reporting period, acquisition-related expenses, and other non-recurring items. Free cash flow is defined as net cash used in operating activities in the period less purchases of property and equipment in the period.

We believe that the exclusion of certain income and expenses in calculating these non-GAAP financial measures can provide a useful measure for investors when comparing our period-to-period core operating results, and when comparing those same results to that published by our peers. We exclude certain other items because we believe that these income (expenses) do not reflect expected future operating expenses. Additionally, certain items are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance. We use these non-GAAP financial measures to evaluate ongoing operations, for internal planning and forecasting purposes, and to manage our business.

These non-GAAP financial measures are not intended to be considered in isolation from, as substitute for, or as superior to, the corresponding financial measures prepared in accordance with GAAP. There are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation, and do not present the full measure of our recorded costs against its revenue. In addition, our definition of the non-GAAP financial measures may differ from non-GAAP measures used by other companies.

On May 9, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported its financial results and operational highlights for the first quarter ended March 31, 2023 (Press release, Adicet Bio, MAY 9, 2023, View Source [SID1234631311]).

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!

"We are excited about the continued clinical progress of our lead asset ADI-001," said Chen Schor, President and Chief Executive Officer of Adicet. "In the second quarter, we plan to discuss with the FDA the path forward for a potential pivotal study for ADI-001 in post-CAR T large B-cell lymphoma patients and expect to initiate this study in the fourth quarter of 2023. We plan to report updated efficacy, durability and safety data from ADI-001’s ongoing Phase 1 trial, as well as provide an update on our meeting with the FDA in the second quarter of 2023. Additionally, Adicet is making steady advances in developing our early-stage pipeline candidates, including presenting promising data demonstrating preclinical proof-of-concept for our armored allogeneic gamma delta T cell therapy ADI-270 at ASGCT (Free ASGCT Whitepaper) later this month. Further, we are on track to submit an IND for our novel CAd gamma delta T cell product candidate ADI-925 in the second half of this year."

First Quarter 2023 and Recent Operational Highlights:

Company remains on track to report additional efficacy, durability and safety data and provide a regulatory update and plan for ADI-001 pivotal program in the second quarter of 2023. In December 2022, Adicet reported interim safety and efficacy data from its ongoing Phase 1 study of ADI-001, the Company’s investigational therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). The Company is preparing to initiate its first potential pivotal study with ADI-001 in the fourth quarter of 2023.

ADI-270 preclinical data at ASGCT (Free ASGCT Whitepaper). Adicet will present a preclinical data poster for ADI-270, an armored CD70-targeted allogeneic gamma delta chimeric antigen receptor (CAR) T cell development candidate, at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting on May 18, 2023. This encouraging data demonstrates preclinical proof-of-concept for Adicet’s first-in-class development candidate specifically designed to address the needs of solid tumor indications with the addition of TGFb dominant negative receptor armoring and additional protection against host elimination.

Continuing to advance new pipeline programs. In November 2022, Adicet presented preclinical data for four new CAR and CAd (chimeric antigen adaptor) gamma delta T cell programs targeting several hematologic and solid malignancies. The Company continues to advance these new pipeline programs and expects to submit an Investigational New Drug Application (IND) for ADI-925 in the second half of 2023.
Financial Results for First Quarter 2023:

Research and Development (R&D) Expenses: R&D expenses were $26.8 million for the three months ended March 31, 2023, compared to $13.5 million during the same period in 2022. The $13.3 million increase is primarily driven by a $5.0 million increase in contract development manufacturing organization (CDMO) and other externally conducted research and development expense and a $4.1 million increase in payroll and personnel expenses resulting from an increase in overall headcount. There was also a $3.2 million dollar increase in allocated facility expenses and a $1.0 million increase in lab expenses. Payroll and personnel expenses for the three months ended March 31, 2023, includes $2.2 million of non-cash stock-based compensation expense compared to $1.7 million during the same period in 2022.

General and Administrative (G&A) Expenses: G&A expenses were $6.6 million for the three months ended March 31, 2023, compared to $6.8 million during the same period in 2022. The $0.2 million decrease is primarily driven by a $0.9 million decrease in allocated facility and other costs, a $0.1 million decrease in stock-based compensation and a less than $0.1 million decrease in professional fees. The decrease was partially offset by a $0.7 million increase in payroll and personnel expenses. Payroll and personnel expenses for the three months ended March 31, 2023, includes $2.6 million of non-cash stock-based compensation expense compared to $2.6 million during the same period in 2022.

Net Loss/Income: Net loss for the three months ended March 31, 2023 was $30.9 million, or a net loss of $0.72 per basic and diluted share, including non-cash stock-based compensation expense of $4.8 million, as compared to a net income of $4.6 million during the same period in 2022, or a net income of $0.12 per basic share and $0.10 per diluted share, including non-cash stock-based compensation expense of $4.4 million.
Cash Position: Cash and cash equivalents were $231.6 million as of March 31, 2023, compared to $277.9 million during the same period in 2022. The Company expects that current cash and cash equivalents as of March 31, 2023, will be sufficient to fund its operating expenses into the first half of 2025.

On May 9, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported a corporate update and announced financial results for the fiscal second quarter ended March 31, 2023 (Press release, ESSA, MAY 9, 2023, View Source [SID1234631310]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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!

"ESSA is in a strong cash position as we execute our clinical strategy to advance our lead candidate, EPI-7386, with our cash runway expected to fund operations and programs through 2025," stated David Parkinson, MD, President and CEO of ESSA. "This quarter, we continued to enroll patients into our Phase 1 study of EPI-7386 in combination with Xtandi (enzalutamide), and we are working with clinical sites to prepare for initiation of the randomized Phase 2 portion of the study as soon we complete Phase 1 and select a recommended Phase 2 dose. Our Phase 1 EPI-7386 monotherapy expansion study is progressing as planned with two doses of EPI-7386 currently being tested in advanced metastatic castration-resistant prostate cancer ("mCRPC") patients. We also advanced an additional EPI-7386 combination therapy program through an agreement with Janssen, under which Janssen will supply Erleada (apalutamide) and Zytiga (abiraterone acetate) for an ESSA-sponsored and conducted Phase 1 clinical study in multiple prostate cancer patient populations including metastatic hormone-sensitive prostate cancer patients and non-metastatic castration-sensitive prostate cancer patients. We plan to begin testing these new antiandrogen combinations with EPI-7386 in the second half of 2023."

Clinical and Corporate Highlights for the Second Quarter Ended March 31, 2023

EPI-7386 Clinical Collaborations

The Company continues to enroll patients into the fourth cohort of the Phase 1/2 study of EPI-7386 in combination with enzalutamide in patients with mCRPC naïve to second generation antiandrogens. The Company expects to complete the Phase 1 portion of the study and establish the recommended Phase 2 combination doses (for both EPI-7386 and enzalutamide when used in combination) in the third quarter of 2023, followed by initiation of the Phase 2 part of the study. The open-label, randomized Phase 2 study will assess the anti-tumor activity of EPI-7386 in combination with enzalutamide at the recommended phase 2 doses versus single agent enzalutamide at the standard of care dose. The Phase 2 study is expected to enroll approximately 120 patients.
In April 2023, the Company entered into a clinical trial support agreement with Janssen Research & Development, LLC ("Janssen") under which Janssen will supply apalutamide and abiraterone acetate for a Phase 1 clinical study sponsored and conducted by ESSA evaluating EPI-7386 combination therapies in two cohorts. The two cohorts will be evaluated as additional cohorts in the Company’s ongoing Phase 1 study of EPI-7386 (Clinical Trials Identifier: NCT04421222). Cohort A will assess EPI-7386 in combination with abiraterone acetate plus prednisone in patients with mCRPC and high-risk metastatic castration-sensitive prostate cancer. Cohort B is a Window of Opportunity study in which patients with non-metastatic castration-resistant prostate cancer ("nmCRPC") will receive up to 12 weeks of single agent EPI-7386 before adding standard-of-care apalutamide. ESSA will retain all rights to EPI-7386. The Company expects enrollment to begin in the second half of 2023.
EPI-7386 Monotherapy

The Phase 1b EPI-7386 monotherapy dose expansion study is ongoing and is evaluating two doses/schedules of single agent EPI-7386 in mCRPC patients with less than three prior lines of therapy, no visceral disease and no prior chemotherapy who have progressed on at least one second-generation antiandrogen. The Company is also enrolling nmCRPC patients in the Window of Opportunity cohort of this study, in which patients will receive 12 weeks of EPI-7386 monotherapy treatment before starting standard of care therapy.
Summary Financial Results

Net Loss. ESSA recorded a comprehensive loss of $7.1 million for the first quarter ended March 31, 2023, compared to a comprehensive loss of $10.9 million for the second quarter ended March 31, 2022. For the second quarter ended March 31, 2023, this included non-cash share-based payments of $1.4 million compared to $1.9 million for the prior year, recognized for stock options granted and vesting. The decrease in the second quarter was primarily attributed to decreases in research and development expenditures and general and administration expenditures in addition to an increase of $852,347 in interest income.
Research and Development ("R&D") expenditures. R&D expenditures for the second quarter ended March 31, 2023 were $4.5 million compared to $7.6 million for the second quarter ended March 31, 2022 and include non-cash costs related to share-based payments ($750,159 for the second quarter ended 2023 compared to $1.1 million for the second quarter ended 2022). The decrease in R&D expenditures for the year ended March 31, 2023 is the result of decreased non-cash share-based payments, legal patents and license fees and manufacturing costs related to the Phase 1 clinical trial of EPI-7386.
General and administration ("G&A") expenditures. G&A expenditures for the second quarter ended March 31, 2023 were $3.7 million compared to $3.8 million for the second quarter ended March 31, 2022 and include non-cash costs related to share-based payments of $686,932 for the second quarter ended 2023 compared to $741,494 for the second quarter ended 2022. The decrease in the second quarter is the result of decreased non-cash share-based payments and professional fees.
Liquidity and Outstanding Share Capital

At March 31, 2023, the Company had available cash reserves and short-term investments of $157 million reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period. The Company’s cash position is expected to be sufficient to fund current and planned operations through 2025.

As of March 31, 2023, the Company had 44,092,374 common shares issued and outstanding.

In addition, as of March 31, 2023 there were 2,927,477 common shares issuable upon the exercise of warrants and broker warrants. This includes 2,920,000 prefunded warrants at an exercise price of $0.0001, and 7,477 warrants at a weighted average exercise price of $42.80. There were 8,045,274 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.08 per common share.

On May 9, 2023 CytoMed Therapeutics Limited (Nasdaq: GDTC) ("CytoMed" or the "Company"), a biopharmaceutical company focused on harnessing its licensed proprietary technologies to create novel allogeneic cell-based immunotherapies for the treatment of human cancers, reported it has entered into a research collaboration agreement with The University of Texas MD Anderson Cancer Center ("MD Anderson") in Houston, Texas, to use gamma-delta T cells (gdTc) for the treatment of acute myeloid leukemia (AML) and breast cancer (Press release, Cytomed Therapeutics, MAY 9, 2023, View Source [SID1234631309]). AML is the most common type of acute leukemia in adults and is likely to worsen quickly if untreated. However, there are not many treatment options available for AML. Similarly, the incidence rate of breast cancer globally is high, and patients may quickly run out of treatment options, especially if they suffer from triple-negative breast cancer. This collaboration aims to develop new treatment modalities for unmet needs of AML and breast cancer patients at an affordable cost.

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 study will be led by Venkata Lokesh Battula, Ph.D., associate professor of Leukemia at MD Anderson. Under the terms of the two-year agreement, research teams will evaluate the application of CytoMed’s allogeneic gdTc on various subtypes of AML and breast cancer in vitro and in vivo. The study is expected to use patient-derived AML cells and breast cancer cell lines for investigation. The results of the study are intended to be part of an Investigational New Drug Application with the U.S. Food and Drug Administration for the allogeneic use of gdTc for blood and solid cancers.

CytoMed received approval in January 2023 from Singapore’s Health Science Authority to conduct a first-in-human Phase I clinical trial for the use of its lead allogeneic chimeric antigen receptor T-cell (CAR-T) product candidate (CTM-N2D) against several blood and solid tumor cancers, including colorectal, lung, liver, ovarian, lymphoma and multiple myeloma [ANGELICA Trial, NCT05302037]. This is a single-site, open-label, dose-escalating trial at the National University, Hospital, Singapore, an established major public hospital.

"Interest in the potential of our allogeneic immunotherapy platform to provide additional treatment options has been strong," said Dr Tan Wee Kiat, Chief Operating Officer at CytoMed, "and international collaborations, like the current collaboration with MD Anderson Cancer Center, are a key part of our strategy to maximize our impact."

On May 9, 2023 The Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly-owned subsidiary of the Menarini Group, reported that they will present new data related to elacestrant in upcoming congresses (Press release, Menarini, MAY 9, 2023, View Source [SID1234631308]).

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!

Elacestrant has been approved by the FDA for treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. New data will be presented at the upcoming 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Congress and the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"ER+/HER2- breast cancer constitutes 70% of all breast cancers. ORSERDU (elacestrant) is the first new endocrine therapy in 20 years approved by the FDA addressing ER+, HER2-, ESR1-mutated metastatic breast cancer (mBC), a subgroup that appears in up to 40% of patients in second line mBC and beyond, and who have poor outcomes," said Elcin Barker Ergun, CEO of the Menarini Group. "We continue to generate new data for elacestrant in different subgroups, as well as quality of life data, which is important because being able to lead a normal life when under treatment is a vital goal for patients suffering from breast cancer."

See below for details of the Menarini Group/Stemline Therapeutics’ upcoming presentations on elacestrant.

ESMO Breast Cancer Congress 2023
Abstract Title: EMERALD trial analysis of patient-reported outcomes (PROs) in patients with ER+/HER2− advanced or metastatic breast cancer (mBC) comparing oral elacestrant vs standard of care (SoC) endocrine therapy
Abstract #: 1880
Session Title: Proffered Paper session 1 (ID 7)
Session Date and Time: May 11, 2023; 2:00-3:30 PM CEST, Hamburg Hall
Presentation Type: Oral (proffered paper)

2023 ASCO (Free ASCO Whitepaper) Annual Meeting
Abstract Title: Oral elacestrant vs standard-of-care in estrogen receptor-positive, HER2-negative (ER+/HER2-) advanced or metastatic breast cancer (mBC) without detectable ESR1 mutation (EMERALD): Subgroup analysis by prior duration of CDK4/6i plus endocrine therapy (ET)
Abstract #: 1070 | Poster Bd #: 291
Session Title: Breast Cancer – Metastatic
Session Date and Time: June 4, 2023; 8:00AM CDT, Hall A
Presentation Type: Poster

About the EMERALD Phase 3 Study (NCT03778931)
The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+, HER2- advanced/metastatic breast cancer patients. The study enrolled 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoints of the study were progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations.

About ORSERDU (elacestrant)

Indication
ORSERDU (elacestrant), 345 mg tablets, is approved by the U.S. Food & Drug Administration (FDA) for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

The Marketing Authorization Application (MAA) is currently under review by the European Medicines Agency (EMA).

Elacestrant is also being investigated in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108); and ELCIN (NCT05596409). Elacestrant is also planned to be evaluated in early breast cancer disease.

Full prescribing information can be found at www.orserdu.com

Important Safety Information, ORSERDU
Warnings and Precautions

Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU.
Embryo-Fetal Toxicity

Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm 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 ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose.
Adverse Reactions

Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
The most common adverse reactions (≥10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%).
Drug Interactions

Concomitant use with CYP3A4 inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.
Use in Specific Populations

Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.
Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).
The safety and effectiveness of ORSERDU in pediatric patients have not been established.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or via email at [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.