Latest news with #Menarini
Yahoo
02-07-2025
- Sport
- Yahoo
FAIR PLAY MENARINI INTERNATIONAL AWARD: THE 29TH EDITION OFFICIALLY BEGINS
FLORENCE, Italy, July 2, 2025 /PRNewswire/ -- Medals and records alone are not enough to make history and actions, choices, and the way one conducts oneself, can speak louder than any achievement. With this spirit, the 29th edition of the Fair Play Menarini International Award officially kicks off today, one of the most awaited moments of the Italian summer, dedicated to those sportsmen and women who have turned their careers into powerful lessons in ethics, loyalty, and respect. Florence and Fiesole open their doors to two days of celebrations of the truest values in sport. The opening event takes place this evening in the spectacular setting of Piazzale Michelangelo, where the gala dinner will welcome the awardees to a thrilling atmosphere and share the values and principles that have always inspired the Fair Play Menarini International Award. "This edition, of the Fair Play Menarini Award will again celebrate the values of sport and its champions - said the Mayor of Florence, Sara Funaro - Values that are not only about athletic ability but also include commitment, tenacity, empathy, and team spirit. These are the same values that we promote every day to build an increasingly attentive and respectful society. The Fair Play Menarini Award reminds us every time that sport is a fundamental driver of growth and inclusion." Meanwhile, a sense of anticipation is building up for the Award Ceremony due to take place tomorrow evening, Thursday, July 3rd, at the Roman Theatre of Fiesole where the audience will applaud the winners and listen to their stories which will bring back the true meaning of sport. The protagonists of the 29th edition come from a range of different backgrounds and sporting disciplines, yet they are united by their commitment to embody the values of fair play through their actions. The Fair Play Menarini Award is proud to confirm the presence of another Ballon d'Or winner: Portuguese champion Luis Figo, star of the Barcelona, Real Madrid and Inter teams. To represent football, "Billy" Costacurta and Demetrio Albertini shall also be on stage, paragons of style, discipline, and sporting integrity, as well as unforgettable members of the AC Milan and Italian National teams. Athletics will be represented by Gianmarco Tamberi, high jump world champion in Budapest 2023 and Olympic gold medallist in Tokyo 2021; Andy Diaz, triple jump specialist and indoor world champion; Nadia Battocletti, silver medallist in the 10,000 metres at the Paris 2024 Games; and Blanka Vlasic, high jump legend and two-time world champion. Representing fencing will be Arianna Errigo, one of the most decorated foil fencers of all time. Judo will celebrate Alice Bellandi, newly crowned world champion and Olympic gold medallist in Paris. Basketball will see the spotlight on Sasha Vujacic, two-time NBA champion with the Los Angeles Lakers. Paralympic sport will be represented by Rigivan Ganeshamoorthy, gold medallist in the discus throw at the 2024 Paralympic Games whilst in the field of sports journalism, acknowledgment will be given to Guido Meda, the legendary voice of MotoGP and passionate storyteller of the two-wheeled world. Standing beside this year's awardees will be three Fair Play Menarini Ambassadors, sports legends who have already written unforgettable chapters in the history of sport: five-time Olympic swimming champion, Ian Thorpe, Giancarlo Antognoni, icon of the Fiorentina football team and 1982 World Cup winner, and Fabrizio Donato, winner of the triple jump bronze medal at the 2012 London Olympic Games. This year also sees the continued partnership with Sky TG24, accompanying viewers over the two days of the Awards and hosting the final ceremony will be Rachele Sangiuliano, Michele Cagiano, and Omar Schillaci, joined by fellow journalist Federico Buffa, ready to give voice to the athletes' stories of ethics, passion, and extraordinary sporting achievements. "With the 2025 edition of the Fair Play Menarini International Award, we aim to continue showcasing the highest values of sport and a side of sport that is not only heartwarming but also an example to society," stated Valeria Speroni Cardi and Filippo Paganelli, Board Members of the Fair Play Menarini Foundation. "It is a chance to pay tribute to those sportsmen and women who, through their gestures of fair play, have chosen to become role models for others - both in sport and in life." Participation at the award ceremony is free of charge and open to the public but only after registration on TicketOne (link). The 29th edition of the Fair Play Menarini International Award is supported by the Istituto per il Credito Sportivo e Culturale as Institutional Partner, and by Sustenium, Frecciarossa, Estra, and Adiacent as initiative partners. To keep up to date on the protagonists, relive the most exciting moments, and find out all the latest news, visit the official website and the Award's social media channels on Instagram, Facebook, and YouTube. Photo: View original content to download multimedia: SOURCE Menarini Industrie Farmaceutiche Riunite 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
Malaysian Reserve
26-05-2025
- Sport
- Malaysian Reserve
FAIR PLAY MENARINI INTERNATIONAL AWARD, THE COUNTDOWN TOWARDS A MEMORABLE 29TH EDITION BEGINS
FLORENCE, Italy, May 26, 2025 /CNW/ — The Fair Play Menarini International Award is gearing up for its 29th edition. This annual event, dedicated to champions of ethics, loyalty, and respect, is once again set to captivate audiences with a stellar line up of international sports legends. The partnership with Sky TG24 has been renewed for the year 2025 and the broadcaster will be covering all the highlights leading up to the Award ceremony, starting with the gala dinner on Wednesday 2 July. The unique setting of Piazzale Michelangelo in Florence shall indeed be welcoming those sports legends who the day after, on Thursday 3 July, will be given a very warm reception by the public at the award ceremony at the Roman Theatre in Fiesole. Once again, this year's event shall be acknowledging some of the world's top-tier athletes who are also ready to become Ambassadors of the Fair Play Menarini International Award and commit to endorsing the values of fairness and sportsmanship, both in sport and in life. The names of this edition's awardees shall be announced on Wednesday 11 June, during a press conference set to take place at the Hall of Honour at the Italian Olympic Games Committee headquarters, CONI, in Rome. On this occasion, the touching stories of fair play shown by three young athletes will be showcased and the Fair Play Menarini 'Young Athletes' award conferred. On Thursday 26 June, the spotlight will shine on the Special Fiamme Gialle 'Study and Sport' Award which acknowledges those young athletes who excel not only in competitive sports but also at school. This prize, founded in collaboration with the Sports Group of the Guardia di Finanza and the Tuscan branch of CONI, will be awarded during a press conference at Palazzo Guadagni Strozzi Sacrati, the headquarters of the Tuscany Region, in Florence. 'We're putting the finishing touches to what promises to be a thrilling 29th edition, full of extraordinary guests,' declared Valeria Speroni Cardi and Filippo Paganelli, members of the Board of the Fair Play Menarini Foundation. 'As we move forward, our passion for this journey grows even stronger. We approach each edition with the same enthusiasm as the first, eager to reunite with the audiences of the Fair Play Menarini International Award and share some of the magic of sport.' Photo:
Yahoo
26-05-2025
- Sport
- Yahoo
FAIR PLAY MENARINI INTERNATIONAL AWARD, THE COUNTDOWN TOWARDS A MEMORABLE 29TH EDITION BEGINS
FLORENCE, Italy, May 26, 2025 /PRNewswire/ -- The Fair Play Menarini International Award is gearing up for its 29th edition. This annual event, dedicated to champions of ethics, loyalty, and respect, is once again set to captivate audiences with a stellar line up of international sports legends. The partnership with Sky TG24 has been renewed for the year 2025 and the broadcaster will be covering all the highlights leading up to the Award ceremony, starting with the gala dinner on Wednesday 2 July. The unique setting of Piazzale Michelangelo in Florence shall indeed be welcoming those sports legends who the day after, on Thursday 3 July, will be given a very warm reception by the public at the award ceremony at the Roman Theatre in Fiesole. Once again, this year's event shall be acknowledging some of the world's top-tier athletes who are also ready to become Ambassadors of the Fair Play Menarini International Award and commit to endorsing the values of fairness and sportsmanship, both in sport and in life. The names of this edition's awardees shall be announced on Wednesday 11 June, during a press conference set to take place at the Hall of Honour at the Italian Olympic Games Committee headquarters, CONI, in Rome. On this occasion, the touching stories of fair play shown by three young athletes will be showcased and the Fair Play Menarini 'Young Athletes' award conferred. On Thursday 26 June, the spotlight will shine on the Special Fiamme Gialle 'Study and Sport' Award which acknowledges those young athletes who excel not only in competitive sports but also at school. This prize, founded in collaboration with the Sports Group of the Guardia di Finanza and the Tuscan branch of CONI, will be awarded during a press conference at Palazzo Guadagni Strozzi Sacrati, the headquarters of the Tuscany Region, in Florence. "We're putting the finishing touches to what promises to be a thrilling 29th edition, full of extraordinary guests," declared Valeria Speroni Cardi and Filippo Paganelli, members of the Board of the Fair Play Menarini Foundation. "As we move forward, our passion for this journey grows even stronger. We approach each edition with the same enthusiasm as the first, eager to reunite with the audiences of the Fair Play Menarini International Award and share some of the magic of sport." Photo: View original content to download multimedia: SOURCE Menarini Industrie Farmaceutiche Riunite Sign in to access your portfolio
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
