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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 /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 www.orserdu.com.

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 www.fda.gov/medwatch.

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 www.menarini.com.

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.

Bybit Card Rolls Out New Lucky Draw for Guaranteed Wins Including a Tesla

DUBAI, UAE, May 23, 2025 /PRNewswire/ — Bybit, the world’s second-largest cryptocurrency exchange by trading volume, is excited to celebrate the high crypto life with the Bybit Card community in a new lucky draw that guarantees rewards for all, including the ultimate prize of a Tesla Model 3.

Starting now until June 22, 2025, eligible users may simply sign up for the event, swipe ot tap to pay with their Bybit Card to receive a lucky draw ticket, and receive a reward for each ticket. The promotion is available to all eligible Bybit Card through everyday spending, with entry thresholds as low as $10 and exclusive rewards from BTC airdrop to the crypto community’s most iconic dream car.

The event features a tiered rewards structure that will reward every participant:

  • Every $10 spent with a Bybit Card earns one ticket in the lucky draw.
  • One grand prize winner will receive 35,000 USDT, equivalent to the price of a Tesla Model 3 in most markets.
  • All participants are guaranteed to win prizes from a USDT pool valued at 40,000 USDT in BTC, USDT, and PEPE
  • New cardholders can receive 50% cashback (up to 2.5 USDT) on their first $5 spend.

New users may seize the opportunity to enjoy a host of Bybit Card privileges by applying for the card right now. Once approved, they will receive an instant virtual card ready for all their crypto payment needs, and unlock access to the lucky draw with just a few clicks.

Bybit Card Rolls Out New Lucky Draw for Guaranteed Wins Including a Tesla
Bybit Card Rolls Out New Lucky Draw for Guaranteed Wins Including a Tesla

Key Features of Bybit Card:

  • Crypto convenience: spending in crypto, and cash withdrawals from any ATM worldwide that supports Mastercard for added convenience with the physical card.
  • No annual fees, up to 10% cashback and up to 8% APR.
  • Year-round perks: 100% rebates on selected partners including Netflix and Spotify, plus airport lounge access, early-bird access to Tomorrowland Brasil 2025, and seasonal benefits
  • Multi-asset support: USDC, USDT, BTC, ETH, AVAX, and more.

The promotion is on a first-come, first served basis. Terms and conditions apply. For full benefits and on-going campaigns, users may explore: Bybit Crypto Card: Your Ultimate Crypto Debit Card.

#Bybit / #TheCryptoArk / #TheBybitCard

About Bybit

Bybit is the world’s second-largest cryptocurrency exchange by trading volume, serving a global community of over 70 million users. Founded in 2018, Bybit is redefining openness in the decentralized world by creating a simpler, open and equal ecosystem for everyone. With a strong focus on Web3, Bybit partners strategically with leading blockchain protocols to provide robust infrastructure and drive on-chain innovation. Renowned for its secure custody, diverse marketplaces, intuitive user experience, and advanced blockchain tools, Bybit bridges the gap between TradFi and DeFi, empowering builders, creators, and enthusiasts to unlock the full potential of Web3. Discover the future of decentralized finance at Bybit.com.

For more details about Bybit, please visit Bybit Press
For media inquiries, please contact: media@bybit.com
For updates, please follow: Bybit’s Communities and Social Media

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Let There Be Light: Vivid Sydney 2025 Kicks Off

SYDNEY, May 23, 2025 /PRNewswire/ — The Harbour City has awakened in colour and creativity tonight as Vivid Sydney 2025, Australia’s largest event, has officially begun for its 15th year. Under this year’s theme of Dream, a world class curation of Light, Ideas, Music and Food await festivalgoers over 23 nights, until Saturday, 14 June.

Vivid Sydney 2025, Sydney Opera House Lighting Of The Sails. Kiss Of Light by David McDiarmid. Credit - Destination NSW
Vivid Sydney 2025, Sydney Opera House Lighting Of The Sails. Kiss Of Light by David McDiarmid. Credit – Destination NSW

This year, the festival comprises over 200 events across five unique zones around the city’s CBD, all designed to inspire wonder, expand thinking and give each visitor the opportunity to see Sydney in a new light.

Making Vivid Sydney more accessible than ever, over 75 per cent of this year’s program is free to enjoy, including the entire Vivid Light Walk, Martin Place also makes a welcome return to the festival footprint after a seven-year absence.

This year, the world’s biggest names in entertainment, food, and pop culture will feature, including, Martha Stewart, Nigella Lawson, Nick Offerman and Megan Mullally, plus Portishead’s Beth Gibbons.

Minister for Jobs and Tourism Steve Kamper said, “Sydney is ready to shine! As we mark 15 years, this world-class event continues to showcase the very best destinations and creative talent our city has to offer.

“Vivid Sydney continues to grow in scale and impact, drawing millions of visitors and reinforcing Sydney’s position as the premier destination in the Asia Pacific.

“With over 75 per cent of the program free to attend and the entire Vivid Light Walk open to everyone, it is one of the most accessible events in the country, and this year’s program has something for everyone.

“It’s a festival that unites communities, supports local businesses and boosts our visitor and night-time economies. We can’t wait to see the city light up tonight!”

Vivid Sydney 2025 kicked off at Overseas Passenger Terminal in Circular Quay for the annual First Light ceremony, featuring performances by NAISDA dancers that honoured Yolngu culture in Arnhem Land. The ceremony culminated at 6pm as Sydney Harbour burst to life with pyrotechnics, projections and installations illuminating the city’s world-famous buildings and landmarks followed by First Light Live, a free concert honouring the power and pride of First Nations music.   

Vivid Sydney runs from Friday 23 May to Saturday 14 June. For more information visit vividsydney.com.

Photo – https://laotiantimes.com/wp-content/uploads/2025/05/vividsydney2025_soh_lightingofthesails_kissoflight_davidmcdiarmid_creditdestinationnsw_hl_036-1.jpg

TCL Launches TCL 60 NXTPAPER Smartphone in Vietnam

Equipped with the Innovative NXTPAPER Key it Redefines 
the Way You See Your World

HO CHI MINH CITY, Vietnam, May 23, 2025 /PRNewswire/ — TCL, a pioneer in display across feature-rich smartphones, tablets, and connected devices, today unveiled the TCL 60 NXTPAPER smartphone in Vietnam. This latest model features TCL’s cutting-edge NXTPAPER technology, along with the innovative NXTPAPER Key, to redefine reading and viewing experiences with unparalleled eye comfort.

TCL 60 Smartphone
TCL 60 Smartphone

Immersive Reading with a switch of a Button
The new TCL 60 NXTPAPER phone allows users to smoothly transition between everyday mobile use and comfortable, immersive reading – optimized for their needs. With a switch of the new NXTPAPER Key, users can effortlessly activate Max Ink Mode, turning the display into an e-ink format designed to reduce eye strain and ensure maximum eye comfort.

Under Max Ink Mode, users can fully immerse themselves in gripping novels or concentrate on important documents with zero distractions as it automatically mutes notifications, creating a conducive environment for focus. This mode offers a distinctive visual and tactile experience that allows users to feel like they are reading and writing on traditional paper. It also boasts outstanding battery life, supporting up to 7 days of reading and 26 days on standby facilitating deep engagement with different reading materials without running out of charge.

Equipped with a 6.8” FHD+ display and 90Hz refresh rate, the TCL 60 NXTPAPER streamlines all digital interactions, making scrolling through pages, switching between apps, browsing websites, and playing games remarkably smooth and fluid – all while guaranteeing enhanced comfort and clarity.

Enhanced Everyday Eye Care
With users’ wellbeing and eye health as a key priority, the TCL 60 NXTPAPER phone is crafted to ensure every digital interaction is strain-free. Backed by the advanced NXTPAPER technology, it minimizes harmful blue light and reduces glare significantly to prevent eye fatigue. In addition, the highly adaptive display automatically adjusts the brightness and color temperature to match the environment, making it perfect for both indoor and outdoor use.

To further safeguard vision, the model features a built-in Eye Care Assistant, which sends you reminders to take breaks and gentle alerts to keep your eyes healthy, empowering safer and healthier screen time. In low-light conditions, the advanced Night Light Mode on the TCL 60 NXTPAPER automatically activates a gentle, eye-friendly glow to illuminate your reading without disturbing others. Furthermore, the intelligent Night-Friendly Screen adapts to ambient light, protecting your eyes and ensuring comfortable viewing even in dim conditions.

High Capacity Meets Diverse Functionality
Despite superior display technology and competitive pricing, the TCL 60 NXTPAPER doesn’t skimp on quality and functionality. For photography lovers, the phone boasts a powerful triple camera system that includes a 108MP ultra pixel main camera and a 32MP front camera to capture picture-perfect selfies.

To allow users to make the most out of its robust features, the smartphone comes with a large 5200mAh battery to provide up to two full days of seamless support on a single charge. In addition, it features 256GB of internal storage and 8GB of RAM, expandable by an additional 10GB, ensuring optimal performance and superb stability. Users can store their precious photos and videos, documents, and reading materials without the fear of insufficient storage, making the TCL 60 NXTPAPER a reliable digital companion.

In addition to the TCL 60 NXTPAPER, TCL has also simultaneously launched two smartphones in Vietnam: TCL 60R 5G and TCL 605. The TCL 60R 5G features a 6.7-inch 120Hz high-refresh-rate display and a 5G octa-core processor, making it suitable for users with higher performance demands. TCL 605 is designed for everyday use, equipped with a 6.7-inch HD+ screen, a 50MP dual-function main camera, and a 5200mAh battery to meet basic needs.

Through the diversified combination of these three models, the TCL 60 series are designed to meet the demands of modern users with various lifestyles and preferences, showcasing TCL’s technological expertise and user care in the smartphone industry.

Pricing
TCL 60 NXTPAPER: RRP 4,490,000VND
TCL 60R 5G: RRP 3,990,000VND
TCL 605 (256GB): RRP 3,590,000VND
TCL 605 (128GB): RRP 2,490,000VND

Please visit https://www.tcl.com/vn/vi for additional product information.

Media Contact: 
tclpress@tcl.com 

About TCL Mobile 
TCL Mobile specializes in the research, development and manufacturing of smartphones, tablets and connected devices. On a mission to deliver 5G for all, TCL Mobile helps its customers ‘Inspire Greatness’ in their lives through industry leading technology and solutions.  

For more information on TCL mobile devices, please visit: https://www.tcl.com/global/en/mobile  

About TCL  
TCL Electronics specializes in the research, development and manufacturing of consumer electronics including TVs, mobile phones, audio devices, smart home products and appliances. Combining thoughtful design and innovative technology to inspire greatness, our lineup delivers must-have features and meaningful experiences. As one of the world’s largest consumer electronics brands, our vertically integrated supply chain, and state-of-the-art display panel factory help TCL deliver innovation for all. For more information, please visit: https://www.tcl.com  

TCL is a registered trademark of TCL Corporation. All other trademarks are the property of their respective owners. 

Let There Be Light: Vivid Sydney 2025 Kicks Off

SYDNEY, May 23, 2025 /PRNewswire/ — The Harbour City has awakened in colour and creativity tonight as Vivid Sydney 2025, Australia’s largest event, has officially begun for its 15th year. Under this year’s theme of Dream, a world class curation of Light, Ideas, Music and Food await festivalgoers over 23 nights, until Saturday, 14 June.

Vivid Sydney 2025, Sydney Opera House Lighting Of The Sails. Kiss Of Light by David McDiarmid. Credit - Destination NSW
Vivid Sydney 2025, Sydney Opera House Lighting Of The Sails. Kiss Of Light by David McDiarmid. Credit – Destination NSW

This year, the festival comprises over 200 events across five unique zones around the city’s CBD, all designed to inspire wonder, expand thinking and give each visitor the opportunity to see Sydney in a new light.

Making Vivid Sydney more accessible than ever, over 75 per cent of this year’s program is free to enjoy, including the entire Vivid Light Walk, Martin Place also makes a welcome return to the festival footprint after a seven-year absence.

This year, the world’s biggest names in entertainment, food, and pop culture will feature, including, Martha Stewart, Nigella Lawson, Nick Offerman and Megan Mullally, plus Portishead’s Beth Gibbons.

Minister for Jobs and Tourism Steve Kamper said, “Sydney is ready to shine! As we mark 15 years, this world-class event continues to showcase the very best destinations and creative talent our city has to offer.

“Vivid Sydney continues to grow in scale and impact, drawing millions of visitors and reinforcing Sydney’s position as the premier destination in the Asia Pacific.

“With over 75 per cent of the program free to attend and the entire Vivid Light Walk open to everyone, it is one of the most accessible events in the country, and this year’s program has something for everyone.

“It’s a festival that unites communities, supports local businesses and boosts our visitor and night-time economies. We can’t wait to see the city light up tonight!”

Vivid Sydney 2025 kicked off at Overseas Passenger Terminal in Circular Quay for the annual First Light ceremony, featuring performances by NAISDA dancers that honoured Yolngu culture in Arnhem Land. The ceremony culminated at 6pm as Sydney Harbour burst to life with pyrotechnics, projections and installations illuminating the city’s world-famous buildings and landmarks followed by First Light Live, a free concert honouring the power and pride of First Nations music.   

Vivid Sydney runs from Friday 23 May to Saturday 14 June. For more information visit vividsydney.com.

Japan’s Princess Aiko to Visit Laos in First Official Overseas Trip

Aiko, Princess Toshi, the only daughter of Emperor Naruhito and Empress Masako. (Photo: Yuichi Yamazaki/Getty Images)

Princess Aiko of Japan will visit Laos in November, marking her first official overseas engagement. The visit commemorates the 70th anniversary of diplomatic relations between Japan and Laos, which were established in 1955.

During her trip, Princess Aiko is expected to meet with Lao President Thongloun Sisoulith and attend a commemorative ceremony. The exact date of her visit has not yet been announced.

The daughter of Emperor Naruhito and Empress Masako, Princess Aiko, currently works at the Japanese Red Cross Society and has been gradually taking on more public duties.

While this will be her first official diplomatic trip abroad, she has previously traveled overseas for personal and educational purposes. These include a family trip to the Netherlands in 2006 and a summer study program in the United Kingdom in 2018.

The Japanese Imperial Family has made three previous visits to Laos.

In 1999, Prince and Princess Akishino visited on a goodwill mission. In 2010, Prince Akishino returned with Princess Mako for a cultural and research-focused visit. In 2012, then-Crown Prince Naruhito (now Emperor) visited to observe development projects and meet with Lao leaders.

Six Abstracts of Kelun-Biotech’s Clinical Studies Published at the 2025 ASCO Annual Meeting

CHENGDU, China, May 23, 2025 /PRNewswire/ — The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting is scheduled to take place in Chicago, Illinois, USA from May 30 to June 3. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, the “Company”) will present results from six clinical studies, including data on its TROP2 ADC sac-TMT, anti-PD-L1 mAb tagitanlimab, and RET inhibitor KL590586 (A400/EP0031) during the meeting.

The study abstracts were published on the ASCO website on May 22, 2025 (CDT), with key highlights summarized below:

1. Sac-TMT in patients with previously treated advanced epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study

Oral Presentation: June 1, 10:12-10:24 CDT (Abstract #8507: Lung Cancer – Non-Small Cell Metastatic)

A total of 137 patients with advanced EGFR-mutant NSCLC who had progressed after EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy were randomized (2:1) to receive sac-TMT (5 mg/kg once every 2 weeks (Q2W)) or docetaxel (75 mg/m2 once every 3 weeks (Q3W)).  The median follow-up of 12.2 months (data cutoff: December 31, 2024).

Sac-TMT achieved statistically significant and clinically meaningful outcomes compare d to docetaxel: confirmed objective response rate (ORR) (blinded independent review committee (BIRC): 45.1% vs 15.6%, one-sided p=0.0004), progression-free survival (PFS) (BIRC: median 6.9 vs 2.8 months, hazard ratio (HR)= 0.30, one-sided p<0.0001; investigator (INV): median 7.9 vs 2.8 months, HR=0.23). With 36.4% of patients in docetaxel group crossing over to receive sac-TMT, median overall survival (OS) was not reached (NR) for both groups (HR 0.49, one-sided p=0.007). The median OS analysed by pre-specified rank-preserving structural failure time (RPSFT) model adjusted for crossover was 9.3 months for docetaxel and NR for sac-TMT (HR=0.36).

Grade ≥ 3 treatment-related adverse events (TRAEs) occurred in 56.0% of patients in sac-TMT group vs 71.7% in docetaxel group. No cases of interstitial lung disease (ILD) were reported in sac-TMT group.

These results led to the approval of sac-TMT in EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy in China, which marks the first approval for a TROP2 ADC in lung cancer globally.

2. Sac-TMT as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC): Initial results from the Phase 2 OptiTROP-Breast05 study

Rapid Oral Presentation: May 30, 15:45-15:51 CDT (Abstract #1019: Breast Cancer – Metastatic)

As of November 18, 2024, a total of 41 patients with a/m TNBC who had not received prior treatment for advanced disease (median age 55 years; 43.9% Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 1; 78.0% PD-L1 combined positive score (CPS)<10) were enrolled to receive sac-TMT monotherapy at 5 mg/kg Q2W until disease progression or unacceptable toxicity. The median follow-up was 18.6 months.

The ORR was 70.7% and the disease control rate (DCR) was 92.7%. Median duration of response (DoR) was 12.2 months, while the median PFS was 13.4 months. Among the 32 patients with PD-L1 CPS <10, the ORR was 71.9% and the DCR was 93.8%. The median PFS in this subgroup was 13.1 months.

TRAEs of grade 3 or higher occurred in 63.4% of patients. No treatment-related deaths occurred, and there were no reports of neuropathy or ILD/pneumonitis.

3. Sac-TMT in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced NSCLC: Non-squamous cohort from the Phase 2 OptiTROP-Lung01 study

Poster Presentation: May 31, 13:30-16:30 CDT (Abstract #8529: Lung Cancer – Non-Small Cell Metastatic)

Advanced NSCLC patients with no prior systemic therapy and no actionable genomic alterations were enrolled to receive sac-TMT (5 mg/kg Q3W or Q2W) plus tagitanlimab (1,200 mg Q3W or 900 mg Q2W) until disease progression or unacceptable toxicity. As of December 30, 2024, 81 patients with non-squamous histology were enrolled.

After median follow-up of 17.1 months, confirmed ORR was 59.3%; Median DoR was 16.5 months; Median PFS was 15.0 months. Among patients with PD-L1 tumor proportion score (TPS)≥50%, the confirmed ORR was 77.8%; median PFS was 17.8 months; while for patients with PD-L1 TPS≥1%, the confirmed ORR was 68.1%; median PFS was 17.8 months. Among patients with PD-L1 TPS< 1%, confirmed ORR was 47.1%; median PFS was 12.4 months. Most common Grade≥3 TRAEs were neutrophil count decreased (45.7%), anemia (16.0%), white blood cell count decreased (14.8%) and stomatitis (11.1%). No TRAE led to treatment discontinuation or death.

4. Sac-TMT in patients with previously treated locally advanced or metastatic (LA/M) NSCLC harboring uncommon EGFR mutations: Preliminary results from a Phase 2 Study

Poster Presentation: May 31, 13:30-16:30 CDT (Abstract #8615: Lung Cancer – Non-Small Cell Metastatic)

As of December 1, 2024, 42 advanced NSCLC patients who had progressed on or after systemic therapy were enrolled, including 23 patients with EGFR G719X in exon 18, S768I in exon 20, or L861Q in exon 21 and 19 patients with EGFR ex20ins. Patients received sac-TMT 5 mg/kg Q2W until disease progression or unacceptable toxicity.

After a median follow-up of 9.2 months, the ORR was 35.7% and the DCR was 85.7%. Responses were durable with the median DoR not yet reached. The median PFS was 9.5 months. In the subset of patients with uncommon non-ex20ins, the ORR was 34.8%; the median PFS was 10.9 months. In the subset of patients with ex20ins, the ORR was 36.8% and the median PFS was 9.0 months.

Grade ≥3 TRAEs occurred in 52.4% of patients. No TRAEs led to treatment discontinuation or death. No cases of ILD/pneumonitis were reported.

5. Tagitanlimab versus placebo in combination with gemcitabine and cisplatin (GP) as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase Phase 3 study

Oral Presentation: May 31, 14:27-14:39 CDT (Abstract #6004: Head and Neck Cancer).

Eligible R/M NPC patients who have not previously received systemic therapy were in 2:1 ratio randomly assigned to receive tagitanlimab or placebo (1200 mg, D1) in combination with cisplatin (80 mg/m2, D1) and gemcitabine (1000 mg/m2, D1 and D8) Q3W for up to 6 cycles followed by tagitanlimab or placebo monotherapy Q3W until disease progression, unacceptable toxicity, or withdrawal of consent. The median follow-up time was 11.7 months.

The PFS per blinded independent central review (BICR) was met with a 53% reduction in risk of progression or death (HR=0.47, one-sided P <0.0001). The median PFS was not reached in tagitanlimab plus GP arm and 7.9 months in placebo plus GP arm. The ORR per BICR was 81.7% in tagitanlimab plus GP arm and 74.5% in placebo plus GP arm, with a median DoR of 11.7 months and 5.8 months (HR=0.48), respectively. The OS benefit was observed in tagitanlimab plus GP arm vs placebo plus GP arm (median OS not reached for either arm; HR=0.62). Tagitanlimab also showed a manageable safety profile.

6. Results from a Phase 1 study of KL590586 in patients with advanced RET-mutant medullary thyroid cancer (MTC)

Poster Presentation: June 2, 9:00-12:00 CDT (Abstract #6098: Head and Neck Cancer)

As of September 20, 2024, 27 advanced RET-mutant MTC patients without prior selective RET inhibitors were enrolled and treated in the phase 1 part across 4 dose levels (20 to 90 mg once a day (QD)). The median follow-up was 19.0 months.

As of September 20, 2024, the confirmed ORR was 63.0% and the DCR was 100% for overall population. The confirmed ORR was 56.3% (9/16) and 62.5% (5/8) in patients with prior multikinase inhibitor (MKI) or treatment naïve, respectively. Median DoR was not reached, with the longest duration still ongoing at 25.8 months. Similarly, median PFS was not reached, with the 24-month PFS rate of 77.8%.

All patients experienced TRAEs, with grade ≥3 TRAEs occurred in 22.2% of patients. No TRAEs led to treatment discontinuation or death.

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestically developed and fully approved for marketing ADC in China with global intellectual property rights. It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the National Medical Products Administration (NMPA), and were (to be) reviewed via the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab[1] or other agents for several types of cancer. These studies are sponsored and led by MSD.

About Tagitanlimab

Tagitanlimab is the first PD-L1 mAb to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.

About KL590586 ( A400/EP0031)

KL590586(A400/EP0031) is a novel next-generation selective RET inhibitor for NSCLC, MTC and other solid tumors with a high prevalence of RET alterations. The Company are currently conducting pivotal clinical studies for both 1L and 2L+ advanced RET+ NSCLC as well as a phase 1b/2 clinical study for RET+ MTC and solid tumor in China.

In March 2021, The Company granted Ellipses Pharma Limited, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031.

In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the Food and Drug Administration (FDA) for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the US, UK, EU and UAE.

About Kelun-Biotech

Kelun-Biotech(6990.HK)is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.

Media: klbio_pr@kelun.com

[1] Pembrolizumab (KEYTRUDA®) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

 

Vientiane Discusses Restoration Plan of Historic Black Stupa

That Dam sign (Photo: Oulayvanh Sisounonth)

The iconic That Dam, or Black Stupa, one of Vientiane’s most culturally significant landmarks, is set to undergo a major restoration as part of a new preservation initiative led by the Lao government.