Latest news with #ELEVATE
Yahoo
2 days ago
- Business
- Yahoo
ABM Stock Surges 7%: Transformation, Strategic Moves Drive Gains
ABM ABM climbed 7% over the past month, outperforming the Zacks S&P 500 composite's 6% rally. This performance is partly due to a disciplined transformation strategy that's reshaped the company from the inside out. In 2015, ABM launched its bold transformation blueprint — dubbed the 2020 Vision — with a clear mission: to drive long-term, profitable growth through a streamlined, industry-focused operating model. The company centralized functions, built out sales infrastructure and standardized service delivery across high-demand verticals, including janitorial, engineering, HVAC, energy, and mission-critical services, becoming a more agile operator. In 2021, it launched ELEVATE, a next-gen strategic plan focused on digitization, data, and workforce development. The impact is stronger client traction and operational scalability. ABM Industries Incorporated price | ABM Industries Incorporated Quote ABM's 2024 acquisition of Quality Uptime marked a significant shift in the rapidly growing data center space. As AI demand spikes, so does the need for reliable, mission-critical infrastructure. Quality Uptime brings with it capabilities in electrical testing, UPS and breaker maintenance, and power distribution, critical systems for AI-driven facilities. This move elevates ABM to a full-suite provider for data centers, unlocking high-margin growth potential in one of the fastest-expanding segments of the tech industry. ABM is not just growing, it's rewarding. In fiscal years 2022, 2023, and 2024, the company distributed dividends of $51.9 million, $57.5 million, and $56.5 million, respectively. Additionally, it returned $97.5 million, $138.1 million, and $56.1 million through share repurchases in fiscal 2022, 2023, and 2024, respectively. These actions reflect ABM's dedication to enhancing shareholder value and its confidence in the business's long-term potential. With a current ratio of 1.52 versus the industry average of 1.31, ABM maintains a solid financial footing. Its strong liquidity ensures operational agility and reinforces investor confidence, especially in volatile market conditions. ABM has a Zacks Rank #2 (Buy) at present. Some other top-ranked stocks from the broader Zacks Business Services sector are Marqeta MQ and SPX Technologies SPXC, carrying a Zacks Rank #2. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Marqeta has a long-term earnings growth expectation of 28%. MQ delivered a trailing four-quarter earnings surprise of 24.4% on average. SPX Technologies has a long-term earnings growth expectation of 18%. SPXC delivered a trailing four-quarter earnings surprise of 8.3% on average. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ABM Industries Incorporated (ABM) : Free Stock Analysis Report SPX Technologies, Inc. (SPXC) : Free Stock Analysis Report Marqeta, Inc. (MQ) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
3 days ago
- Business
- Yahoo
CPRS REVEALS AWARDS OF EXCELLENCE WINNERS SHOWCASING THE BEST IN CANADIAN PUBLIC RELATIONS AND COMMUNICATIONS
BANFF, AB, May 28, 2025 /CNW/ - The Canadian Public Relations Society (CPRS) is proud to announce sixty-three winners of the 2025 CPRS National Awards of Excellence, celebrating the exceptional work of public relations and communications professionals across the country. "On behalf of the Board of Directors of CPRS, I extend our heartfelt congratulations to all the recipients of this year's Awards of Excellence," said Claire Ryan, MCM, APR, National President of CPRS. "Each year, we are inspired by the calibre of submissions from across Canada and across sectors, which demonstrates the vital role strategic communications plays in our society. Our winners exemplify professionalism, creativity, and purpose," added Ms. Ryan. "We hope these awards serve not only as recognition of their achievements, but as lasting reminders of the impact that thoughtful, ethical communications can have." Presented during a gala ceremony at the ELEVATE 2025 CPRS National Conference, this year's awards recognize outstanding achievements in strategic communications, innovation, and leadership. "Not all submissions receive an award here at CPRS National Awards of Excellence, so the competition is intense," said Lisa Covens, MA, CAIP, board liaison to the CPRS National Major Awards and the Awards of Excellence Committee. "Presenting so many awards in person at the Awards Gala is a highlight of the conference for me." From bold campaigns which sparked national conversations to behind-the-scenes efforts building lasting trust, this year's winners are setting the pace for the future of public relations and communications in Canada. "Those who submit entries, and those who evaluate them, are helping define the very standards that shape excellence in public relations," said Julien Baudry, APR, MBA, Presiding Officer of the CPRS National Awards Committee. "Our profession has long been focused on managing the reputations of others, and too often we've neglected our own. Yet there is so much talent here, so many storytellers," added Baudry. "Building Trust in a Shifting World" was this year's conference theme, and attendees explored the evolving role of communicators in a time of complexity and change. From AI to activism, misinformation to media relations, ELEVATE 2025 brought together the profession's leading voices to tackle today's toughest communication challenges. The 2025 conference and awards gala were made possible with the generous support of our sponsors and partners: ChangeMakers, Notified, Leger, Cision, McMaster University's Masters of Communications Management Program, Royal Roads University, The Canadian Press and Aspen Films. CPRS National is pleased to announce the full list of winners of the 2025 Awards of Excellence: Best Corporate Social Responsibility Campaign SILVER – Simon Falardeau, Strategic Communications Consultant, "The April 8, 2024 Eclipse: Protect Your Eyes and Enjoy." BRONZE – IKEA Canada with Edelman Canada, "SHT" Best Influencer Campaign GOLD – Paradigm, Edgewell Personal Care, "Mighty o.b. Makes a Comeback with Gen Z" SILVER – McDonald's Canada x Weber Shandwick Canada, "It's a McDonald's Thing" BRONZE – GSK + Porter Novelli, "AsktoBsure" Best Integrated Communications GOLD – Town of Whitby Communications and Creative Services, "Whitby's 'Care Closer to Home' Campaign" SILVER – Proof Strategies & Electrical Safety Authority, "Your EV Deserves Better" BRONZE – University of Toronto, "U of T Communications for celebrating Geoffrey Hinton's Nobel Prize in Physics" Best non-profit/NGO Campaign GOLD – Proof Strategies & Electrical Safety Authority, "Your EV Deserves Better" SILVER – Movember Canada x Weber Shandwick Canada, "Moustache Mission" BRONZE – Lung Health Foundation and Edelman, "Our Lungs Make Our Lives" Best Use of Media Relations – Large Budget (More than $50,000 CAD) GOLD – Rethink PR and Molson, "See My Name" SILVER – IKEA Canada, "SHT" BRONZE – Zeno Group Canada, "Philadelphia Bagel Wholes" Best Use of Media Relations – Medium Budget ($10,000 – $50,000 CAD) GOLD – Mila and TACT, "Pause Giant AI Experiments" BRONZE – Securian Canada and Kaiser & Partners, "Behind the Gig: Securian Canada Insights" Best Use of Media Relations – Small Budget (less than $10,000 CAD) SILVER – CAA & CAA Insurance "Auto-Theft Strategy 2024" Brand Development Campaign of the Year GOLD – Craft Public Relations, "Atypique's Sober Dance Party, Featuring AJ McLean" SILVER – Craft Public Relations & Tim Hortons, "The Last Timbit, A Tim Hortons 60th Anniversary Musical" SILVER – Paradigm, Edgewell Personal Care, "Mighty o.b. Makes a Comeback with Gen Z" Canadian Advocacy and Social Marketing Campaign of the Year SILVER – ChangeMakers & Government of Nunavut, "Escape the Vape" Canadian Digital Communications Campaign of the Year GOLD – Zeno Group Canada, "Love Your Lunch Day" SILVER – Proof Strategies & Electrical Safety Authority, "Your EV Deserves Better" BRONZE – Novartis Canada and Golin Health x Edelman Canada, "My Krew Canada" Canadian Diversity, Equity, and Inclusion Campaign of the Year BRONZE – Victoria Police Department, "Women Of VicPD" Canadian Government Relations Campaign of the Year GOLD – Town of Whitby — Communications and Creative Services, "Whitby's 'Care Closer to Home' Campaign" SILVER – Club des petits déjeuners and TACT, "L'explosion des besoins alimentaires dans les écoles du Québec" Canadian Health Care Campaign of the Year GOLD – Lung Health Foundation and Edelman, "Our Lungs Make Our Lives" SILVER – Obesity Canada, Eli Lilly Canada and GCI Canada, "Reshaping the obesity narrative: The cost of inaction and impact of stigma" SILVER – Interior Health Communications & Engagement, "Give your kids their best shot" BRONZE – GSK + Porter Novelli, "AsktoBsure" Canadian Issues / Crisis Management Campaign of the Year SILVER – Munro/Thompson & Yuułuʔiłʔatḥ Government, "Cold Chain Incident Issue Management" BRONZE – The City of Red Deer, "Canada Post Strike" Canadian Marketing Communications Campaign of the Year SILVER – Proof Strategies & Electrical Safety Authority, "Powerline Safety" BRONZE – Craft Public Relations, "Nintendo Switch x Maitreyi Ramakrishnan" Employee Engagement / Internal Communications Campaign of the Year GOLD – Northland Power, "Transforming Internal Communications with The Pulse" SILVER – British Columbia Institute of Technology, "BCIT Don't Get Hooked Campaign" BRONZE – Alberta Blue Cross, "2024 Employee Giving Campaign" External Communications SILVER – Town of Whitby — Communications and Creative Services, "Whitby's 'Care Closer to Home' Campaign" BRONZE – Apostrophe, "Community-Led Collaboration Project" New Product or Service Launch GOLD – Craft Public Relations & Rakuten Kobo, "The Canadian Launch of Kobo Colour eReaders" SILVER – Mondelez x Weber Shandwick Canada, "OREO Space Dunk" BRONZE – Craft Public Relations, DDMG & Tim Hortons, "The Launch of Flatbread Pizza" Best Publication GOLD – Cooke Inc., "Cooke Newsletter - Spring 2024" SILVER – City of Welland, "Wonders of Welland" BRONZE – Town of Okotoks, "Town of Okotoks 2023 Annual Report" BRONZE – University of Toronto, "University of Toronto Magazine" Best Special Events Projects GOLD – Craft Public Relations & Tim Hortons, "Tim Hortons Pet Merch Collection Event" SILVER – Paradigm, Edgewell Personal Care, "Come Alive with Hawaiian Tropic" BRONZE – McDonald's Canada x Weber Shandwick Canada, "Toronto Raptors: Power of 3's" In House Team of the Year GOLD – City of Leduc: Communications and Marketing Services SILVER – Alberta Energy Regulator: Engagement and Communication Branch BRONZE – British Columbia College of Nurses & Midwives: BCCNM Communications Team Agency Team of the Year – Small GOLD – Monogram Communications SILVER – Apostrophe BRONZE – Coldwater Communications Agency Team of the Year – Medium GOLD – Casacom SILVER – Zeno Group Canada Agency Team of the Year – Large BRONZE – ChangeMakers BRONZE – Proof Strategies Inc. Best Sustainable Development Initiative Cooke Inc., "Cooke Newsletter - Spring 2024" Best Creativity and Innovation Zeno Group Canada, "Love Your Lunch Day" Best In Show Zeno Group Canada, "Love Your Lunch Day" About CPRS Founded in 1948, the Canadian Public Relations Society is a not-for-profit association of professionals dedicated to the practice, management, and teaching of public relations and communications. Comprising 13 local societies, CPRS' mission is to build a national public relations and communications management community through professional development, accreditation, collaboration with thought leaders, a commitment to ethics and a code of professional standards, advocacy for the profession, and support to members at every stage of their careers. SOURCE Canadian Public Relations Society View original content to download multimedia: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
3 days ago
- Business
- Cision Canada
CPRS REVEALS AWARDS OF EXCELLENCE WINNERS SHOWCASING THE BEST IN CANADIAN PUBLIC RELATIONS AND COMMUNICATIONS
BANFF, AB, May 28, 2025 /CNW/ - The Canadian Public Relations Society (CPRS) is proud to announce sixty-three winners of the 2025 CPRS National Awards of Excellence, celebrating the exceptional work of public relations and communications professionals across the country. "On behalf of the Board of Directors of CPRS, I extend our heartfelt congratulations to all the recipients of this year's Awards of Excellence," said Claire Ryan, MCM, APR, National President of CPRS. "Each year, we are inspired by the calibre of submissions from across Canada and across sectors, which demonstrates the vital role strategic communications plays in our society. Our winners exemplify professionalism, creativity, and purpose," added Ms. Ryan. "We hope these awards serve not only as recognition of their achievements, but as lasting reminders of the impact that thoughtful, ethical communications can have." Presented during a gala ceremony at the ELEVATE 2025 CPRS National Conference, this year's awards recognize outstanding achievements in strategic communications, innovation, and leadership. "Not all submissions receive an award here at CPRS National Awards of Excellence, so the competition is intense," said Lisa Covens, MA, CAIP, board liaison to the CPRS National Major Awards and the Awards of Excellence Committee. "Presenting so many awards in person at the Awards Gala is a highlight of the conference for me." From bold campaigns which sparked national conversations to behind-the-scenes efforts building lasting trust, this year's winners are setting the pace for the future of public relations and communications in Canada. "Those who submit entries, and those who evaluate them, are helping define the very standards that shape excellence in public relations," said Julien Baudry, APR, MBA, Presiding Officer of the CPRS National Awards Committee. "Our profession has long been focused on managing the reputations of others, and too often we've neglected our own. Yet there is so much talent here, so many storytellers," added Baudry. "Building Trust in a Shifting World" was this year's conference theme, and attendees explored the evolving role of communicators in a time of complexity and change. From AI to activism, misinformation to media relations, ELEVATE 2025 brought together the profession's leading voices to tackle today's toughest communication challenges. The 2025 conference and awards gala were made possible with the generous support of our sponsors and partners: ChangeMakers, Notified, Leger, Cision, McMaster University's Masters of Communications Management Program, Royal Roads University, The Canadian Press and Aspen Films. CPRS National is pleased to announce the full list of winners of the 2025 Awards of Excellence: Best Corporate Social Responsibility Campaign SILVER – Simon Falardeau, Strategic Communications Consultant, "The April 8, 2024 Eclipse: Protect Your Eyes and Enjoy." BRONZE – IKEA Canada with Edelman Canada, "SHT" Best Influencer Campaign GOLD – Paradigm, Edgewell Personal Care, "Mighty o.b. Makes a Comeback with Gen Z" SILVER – McDonald's Canada x Weber Shandwick Canada, "It's a McDonald's Thing" BRONZE – GSK + Porter Novelli, "AsktoBsure" Best Integrated Communications GOLD – Town of Whitby Communications and Creative Services, "Whitby's 'Care Closer to Home' Campaign" SILVER – Proof Strategies & Electrical Safety Authority, "Your EV Deserves Better" BRONZE – University of Toronto, "U of T Communications for celebrating Geoffrey Hinton's Nobel Prize in Physics" Best non-profit/NGO Campaign GOLD – Proof Strategies & Electrical Safety Authority, "Your EV Deserves Better" SILVER – Movember Canada x Weber Shandwick Canada, "Moustache Mission" BRONZE – Lung Health Foundation and Edelman, "Our Lungs Make Our Lives" Best Use of Media Relations – Large Budget (More than $50,000 CAD) GOLD – Rethink PR and Molson, "See My Name" SILVER – IKEA Canada, "SHT" BRONZE – Zeno Group Canada, "Philadelphia Bagel Wholes" Best Use of Media Relations – Medium Budget ($10,000 – $50,000 CAD) GOLD – Mila and TACT, "Pause Giant AI Experiments" BRONZE – Securian Canada and Kaiser & Partners, "Behind the Gig: Securian Canada Insights" Best Use of Media Relations – Small Budget (less than $10,000 CAD) SILVER – CAA & CAA Insurance "Auto-Theft Strategy 2024" Brand Development Campaign of the Year GOLD – Craft Public Relations, "Atypique's Sober Dance Party, Featuring AJ McLean" SILVER – Craft Public Relations & Tim Hortons, "The Last Timbit, A Tim Hortons 60th Anniversary Musical" SILVER – Paradigm, Edgewell Personal Care, "Mighty o.b. Makes a Comeback with Gen Z" Canadian Advocacy and Social Marketing Campaign of the Year SILVER – ChangeMakers & Government of Nunavut, "Escape the Vape" Canadian Digital Communications Campaign of the Year GOLD – Zeno Group Canada, "Love Your Lunch Day" SILVER – Proof Strategies & Electrical Safety Authority, "Your EV Deserves Better" BRONZE – Novartis Canada and Golin Health x Edelman Canada, "My Krew Canada" Canadian Diversity, Equity, and Inclusion Campaign of the Year BRONZE – Victoria Police Department, "Women Of VicPD" Canadian Government Relations Campaign of the Year GOLD – Town of Whitby — Communications and Creative Services, "Whitby's 'Care Closer to Home' Campaign" SILVER – Club des petits déjeuners and TACT, "L'explosion des besoins alimentaires dans les écoles du Québec" Canadian Health Care Campaign of the Year GOLD – Lung Health Foundation and Edelman, "Our Lungs Make Our Lives" SILVER – Obesity Canada, Eli Lilly Canada and GCI Canada, "Reshaping the obesity narrative: The cost of inaction and impact of stigma" SILVER – Interior Health Communications & Engagement, "Give your kids their best shot" BRONZE – GSK + Porter Novelli, "AsktoBsure" Canadian Issues / Crisis Management Campaign of the Year SILVER – Munro/Thompson & Yuułuʔiłʔatḥ Government, "Cold Chain Incident Issue Management" BRONZE – The City of Red Deer, "Canada Post Strike" Canadian Marketing Communications Campaign of the Year SILVER – Proof Strategies & Electrical Safety Authority, "Powerline Safety" BRONZE – Craft Public Relations, "Nintendo Switch x Maitreyi Ramakrishnan" Employee Engagement / Internal Communications Campaign of the Year GOLD – Northland Power, "Transforming Internal Communications with The Pulse" SILVER – British Columbia Institute of Technology, "BCIT Don't Get Hooked Campaign" BRONZE – Alberta Blue Cross, "2024 Employee Giving Campaign" External Communications SILVER – Town of Whitby — Communications and Creative Services, "Whitby's 'Care Closer to Home' Campaign" BRONZE – Apostrophe, "Community-Led Collaboration Project" New Product or Service Launch GOLD – Craft Public Relations & Rakuten Kobo, "The Canadian Launch of Kobo Colour eReaders" SILVER – Mondelez x Weber Shandwick Canada, "OREO Space Dunk" BRONZE – Craft Public Relations, DDMG & Tim Hortons, "The Launch of Flatbread Pizza" Best Publication GOLD – Cooke Inc., "Cooke Newsletter - Spring 2024" SILVER – City of Welland, "Wonders of Welland" BRONZE – Town of Okotoks, "Town of Okotoks 2023 Annual Report" BRONZE – University of Toronto, "University of Toronto Magazine" Best Special Events Projects GOLD – Craft Public Relations & Tim Hortons, "Tim Hortons Pet Merch Collection Event" SILVER – Paradigm, Edgewell Personal Care, "Come Alive with Hawaiian Tropic" BRONZE – McDonald's Canada x Weber Shandwick Canada, "Toronto Raptors: Power of 3's" In House Team of the Year GOLD – City of Leduc: Communications and Marketing Services SILVER – Alberta Energy Regulator: Engagement and Communication Branch BRONZE – British Columbia College of Nurses & Midwives: BCCNM Communications Team Agency Team of the Year – Small GOLD – Monogram Communications SILVER – Apostrophe BRONZE – Coldwater Communications Agency Team of the Year – Medium GOLD – Casacom SILVER – Zeno Group Canada Agency Team of the Year – Large BRONZE – ChangeMakers BRONZE – Proof Strategies Inc. Best Sustainable Development Initiative Cooke Inc., "Cooke Newsletter - Spring 2024" Best Creativity and Innovation Zeno Group Canada, "Love Your Lunch Day" Best In Show Zeno Group Canada, "Love Your Lunch Day" About CPRS Founded in 1948, the Canadian Public Relations Society is a not-for-profit association of professionals dedicated to the practice, management, and teaching of public relations and communications. Comprising 13 local societies, CPRS' mission is to build a national public relations and communications management community through professional development, accreditation, collaboration with thought leaders, a commitment to ethics and a code of professional standards, advocacy for the profession, and support to members at every stage of their careers.
Korea Herald
23-05-2025
- Business
- Korea Herald
Menarini Group Presents Updated Data Underscoring the Combinability of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2025 Annual Meeting
FLORENCE, Italy and NEW YORK, May 23, 2025 /PRNewswire/ -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, will present updated preliminary efficacy and safety results from the Phase 1b/2 ELEVATE study in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). The ELEVATE study was designed to evaluate the safety and efficacy of oral-oral combination treatment options to overcome different resistance mechanisms observed in ER+/HER2- mBC and improve patient outcomes. Additionally, various other trial-in-progress updates will be presented, investigating elacestrant's potential to become an endocrine therapy (ET) backbone across the spectrum of breast cancer. These data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The ELEVATE study is comprised of six treatment regimens evaluating elacestrant in combination with CDK4/6 inhibitors (palbociclib, abemaciclib and ribociclib) and with inhibitors of the PI3K/AKT/mTOR pathway (everolimus, alpelisib and capivasertib). ELEVATE results reported at ASCO 2025 (abstract 1070/49) include updated efficacy data which demonstrate favorable preliminary progression-free survival (PFS) from the elacestrant plus ribociclib and the elacestrant plus everolimus cohorts. A recommended phase 2 dose (RP2D) was determined to be elacestrant 345 mg plus ribociclib 400 mg. The RP2D of elacestrant 345 mg plus everolimus 7.5 mg was previously reported. "It is encouraging to see the positive preliminary efficacy and safety results when everolimus and ribocilib, respectively, are combined with elacestrant. These findings are consistent with the promising elacestrant plus abemaciclib cohort data from the same study that was presented last December, which also demonstrated favorable preliminary efficacy and safety in this setting," said Hope S. Rugo, MD, Director, Women's Cancers Program and Division Chief, Breast Medical Oncology, City of Hope Comprehensive Cancer Center. "As the progression-free survival data and safety data continue to mature across the various cohorts of the ELEVATE study, we are encouraged by elacestrant's potential to become an endocrine therapy backbone in combination regimens for the treatment of metastatic breast cancer." Additional data reported separately (abstract 1079/58) provided updated Phase 1b/2 safety results from four cohorts of the ELEVATE study, including elacestrant plus ribociclib, everolimus, alpelisib, and capivasertib. These updated preliminary results show that the combinations are consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy. "These data continue to underscore the potential value of elacestrant as a combination partner in the ER+/HER2- metastatic breast cancer treatment landscape," said Elcin Barker Ergun, CEO of the Menarini Group. "We are also exploring the potential of elacestrant in other patient populations, including our currently enrolling ELEGANT study, which is designed to assess its potential benefit in early breast cancer patients with high risk of recurrence." In addition, the company will be presenting other data at the ASCO Annual Meeting. See below for a complete list of Menarini Stemline abstracts. Menarini Stemline Abstracts: Presentation Title: Elacestrant (Ela) combinations with ribociclib (Ribo) and everolimus (Eve) in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella study. Abstract Number: 1070 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 49 Presenting Author: Hope S. Rugo Presentation Title: Elacestrant combinations in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Safety update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella study. Abstract Number: 1079 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 58 Presenting Author: Nancy Chan Presentation Title: ADELA: a double-blind, placebo-controlled, randomized phase 3 trial of Elacestrant (ELA) + everolimus (EVE) versus ELA + placebo (PBO) in ER+/HER2- advanced breast cancer (aBC) patients with ESR1-mutated tumors progressing on endocrine therapy (ET) + CDK4/6i. Abstract Number: TPS1129 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 103b Presenting Author: Antonio Llombart-Cussac Presentation Title: ELCIN: Elacestrant in women and men with CDK4/6 Inhibitor (CDK4/6i)-naïve estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC): an open-label multicenter phase 2 study. Abstract Number: TPS1127 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 102b Presenting Author: Virginia G. Kaklamani Presentation Title: ELEGANT: Elacestrant versus standard endocrine therapy (ET) in women and men with node-positive, estrogen Receptor-positive (ER+), HER2-negative (HER2-), early breast cancer (eBC) with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study. Abstract Number: TPS619 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 210a Presenting Author: Aditya Bardia Presentation Title: EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA) Abstract Number: TPS620 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 210b Presenting Author: Michail Ignatiadis About The Elacestrant Clinical Development Program Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. ADELA (NCT06382948) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease. About ORSERDU (elacestrant) U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is indicated 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. Full prescribing information for the U.S. can be found at Important Safety Information Warning 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 final 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 FDA at 1-800-FDA-1088 or About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated 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, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers.
Yahoo
23-05-2025
- Business
- Yahoo
Menarini Group Presents Updated Data Underscoring the Combinability of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2025 Annual Meeting
Preliminary efficacy analysis from the elacestrant plus everolimus and ribociclib cohorts of the ELEVATE study, along with updated safety data from additional cohorts of elacestrant plus targeted therapy combination arms, will be presented. These data highlight elacestrant's potential role as an endocrine therapy backbone in combination with various targeted agents for patients with ER+/HER2- mBC. The robust elacestrant clinical development program across wide-ranging studies further solidifies its potential in monotherapy and combination settings, in mBC and in early breast cancer. FLORENCE, Italy and NEW YORK, May 23, 2025 /CNW/ -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, will present updated preliminary efficacy and safety results from the Phase 1b/2 ELEVATE study in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). The ELEVATE study was designed to evaluate the safety and efficacy of oral-oral combination treatment options to overcome different resistance mechanisms observed in ER+/HER2- mBC and improve patient outcomes. Additionally, various other trial-in-progress updates will be presented, investigating elacestrant's potential to become an endocrine therapy (ET) backbone across the spectrum of breast cancer. These data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The ELEVATE study is comprised of six treatment regimens evaluating elacestrant in combination with CDK4/6 inhibitors (palbociclib, abemaciclib and ribociclib) and with inhibitors of the PI3K/AKT/mTOR pathway (everolimus, alpelisib and capivasertib). ELEVATE results reported at ASCO 2025 (abstract 1070/49) include updated efficacy data which demonstrate favorable preliminary progression-free survival (PFS) from the elacestrant plus ribociclib and the elacestrant plus everolimus cohorts. A recommended phase 2 dose (RP2D) was determined to be elacestrant 345 mg plus ribociclib 400 mg. The RP2D of elacestrant 345 mg plus everolimus 7.5 mg was previously reported. "It is encouraging to see the positive preliminary efficacy and safety results when everolimus and ribocilib, respectively, are combined with elacestrant. These findings are consistent with the promising elacestrant plus abemaciclib cohort data from the same study that was presented last December, which also demonstrated favorable preliminary efficacy and safety in this setting," said Hope S. Rugo, MD, Director, Women's Cancers Program and Division Chief, Breast Medical Oncology, City of Hope Comprehensive Cancer Center. "As the progression-free survival data and safety data continue to mature across the various cohorts of the ELEVATE study, we are encouraged by elacestrant's potential to become an endocrine therapy backbone in combination regimens for the treatment of metastatic breast cancer." Additional data reported separately (abstract 1079/58) provided updated Phase 1b/2 safety results from four cohorts of the ELEVATE study, including elacestrant plus ribociclib, everolimus, alpelisib, and capivasertib. These updated preliminary results show that the combinations are consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy. "These data continue to underscore the potential value of elacestrant as a combination partner in the ER+/HER2- metastatic breast cancer treatment landscape," said Elcin Barker Ergun, CEO of the Menarini Group. "We are also exploring the potential of elacestrant in other patient populations, including our currently enrolling ELEGANT study, which is designed to assess its potential benefit in early breast cancer patients with high risk of recurrence." In addition, the company will be presenting other data at the ASCO Annual Meeting. See below for a complete list of Menarini Stemline abstracts. Menarini Stemline Abstracts: Presentation Title: Elacestrant (Ela) combinations with ribociclib (Ribo) and everolimus (Eve) in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella Number: 1070Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CTLocation: Poster Bd 49Presenting Author: Hope S. Rugo Presentation Title: Elacestrant combinations in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Safety update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella Number: 1079Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CTLocation: Poster Bd 58Presenting Author: Nancy Chan Presentation Title: ADELA: a double-blind, placebo-controlled, randomized phase 3 trial of Elacestrant (ELA) + everolimus (EVE) versus ELA + placebo (PBO) in ER+/HER2- advanced breast cancer (aBC) patients with ESR1-mutated tumors progressing on endocrine therapy (ET) + CDK4/ Number: TPS1129Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CTLocation: Poster Bd 103bPresenting Author: Antonio Llombart-Cussac Presentation Title: ELCIN: Elacestrant in women and men with CDK4/6 Inhibitor (CDK4/6i)-naïve estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC): an open-label multicenter phase 2 Number: TPS1127Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CTLocation: Poster Bd 102bPresenting Author: Virginia G. Kaklamani Presentation Title: ELEGANT: Elacestrant versus standard endocrine therapy (ET) in women and men with node-positive, estrogen Receptor-positive (ER+), HER2-negative (HER2-), early breast cancer (eBC) with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 Number: TPS619Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CTLocation: Poster Bd 210aPresenting Author: Aditya Bardia Presentation Title: EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA)Abstract Number: TPS620Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CTLocation: Poster Bd 210bPresenting Author: Michail Ignatiadis About The Elacestrant Clinical Development Program Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. ADELA (NCT06382948) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease. About ORSERDU (elacestrant) U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is indicated 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. Full prescribing information for the U.S. can be found at Important Safety Information Warning 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 final 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 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 FDA at 1-800-FDA-1088 or About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated 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, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers. Logo: View original content: SOURCE Menarini Industrie Farmaceutiche Riunite View original content: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
