Monday, March 18, 2024

Kymeta Begins Fulfilling Customer Orders of its First Multi-Orbit, On-the-Move Flat-Panel Antenna for Military Users

 

 


REDMOND, Wash. - Monday, 18. March 2024


Kymeta Osprey™ u8 HGL, a hybrid GEO-LEO-cellular terminal is now shipping after successful field trials


 


(BUSINESS WIRE)--World-leading flat-panel satellite antenna company, Kymeta (www.kymetacorp.com), announced today at SATELLITE 2024 that the Osprey u8 HGL, a hybrid geostationary/low Earth orbit (GEO/LEO/LTE) terminal purpose-built for military users, is shipping out of their facility in Woodinville, Washington. This marks the first commercially available multi-orbit terminal and the first multi-orbit terminal on Eutelsat OneWeb’s LEO network. Kymeta announced the official launch in October last year and is fulfilling a backlog of orders.


In February, the Kymeta team demonstrated in the field the capabilities of the new Osprey u8 HGL delivering resilient, auto-PACE ready communications for the armed forces to meet the demands of challenging and rugged military environments. The multi-orbit, multi-network capabilities of the Osprey u8 HGL terminal will offer even greater availability, while being durable, low power consuming, having low visibility, and easy to use.


The Osprey u8 HGL includes a field swappable modem cartridge and a OneWeb modem to enable connectivity with the Eutelsat OneWeb LEO network. At launch an iDirect 950mp cartridge is available enabling TRANSEC services over GEO. Other cartridge configurations will be available soon enabling end users to customize their terminal configuration based on their mission needs.


Initial feedback was overwhelmingly positive, with one military member stating: “This is everything we’ve been looking for in a terminal, form function and features. The LEO to GEO switching far exceeded our expectations. It’s amazing that Kymeta is already delivering on the community’s urgent need for multi-orbit SATCOM.”


Others in attendance at Army field demonstrations commented, “I cannot wait to get started with these!” and “Wow! It tracks satellites over some very difficult terrain.”


“The Kymeta Osprey HGL has a unique capability to address government requirements in support of government PACE plans,” said Ian Canning, Chief Operating Officer, OneWeb Technologies. “The Osprey supports multi-network/orbit requirements through the concurrent LTE/satellite configuration with the added benefit of now being able to add OneWeb LEO capabilities.”


Jon Osler, Senior Vice President Global Sales and Services of Kymeta, commented: “In the contemporary military landscape, mobile connectivity has become indispensable for achieving success. Unlike any other sector, the military relies heavily on dependable, adaptable, and resilient on-the-go communication systems to fulfill its operational and training needs. We take pride in our longstanding partnership with the military, delivering cutting-edge solutions that meet and exceed expectations.”


This milestone further establishes Kymeta as the leader in the multi-X revolution. Attendees of SATELLITE 2024 in Washington, DC, March 18– 20 are encouraged to visit Kymeta’s meeting room 156 to see the Osprey u8 HGL in person and to speak with a member of the Kymeta team.


About Kymeta


Kymeta is the industry leader in flat panel satellite antennas, providing purpose-built solutions across a variety of enterprise and military applications and unlocking the commercial value of space to address the vast, unmet demand for ubiquitous broadband and truly mobile connectivity for customers around the world. Its innovative metasurface technology, coupled with a software-first approach, delivers the first commercially available, metamaterial-based and electronically steered flat panel satellite antenna. Kymeta’s low-cost, low power and high throughput solutions make it easy to connect on the move or while stationary – for any vehicle, vessel, aircraft, or fixed platform – enabling industries on earth to transform their operations by harnessing capacity in space.


Kymeta is a privately held company based in Redmond, Washington.


For more information, visit kymetacorp.com.


 


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Contacts


Brenda Kuhns

Senior Director of Marketing

Kymeta Corporation

bkuhns@kymetacorp.com


Experience the Spirit of Ramadan with LG's Exciting Promotions

 Elevate your Ramadan Celebrations with LG's Seasonal Promotions - The Perfect Gifts Await!

 

Celebrate Ramadan with ease and efficiency, courtesy of LG's exclusive promotions on a wide range of innovative products! LG Electronics (LG) is committed to making this holy month more enjoyable for families across the region. With special offers on stylish TVs and advanced home appliances, including air purifiers, washing machines, refrigerators, and more, LG ensures that your home is equipped to handle all your needs during Ramadan. Focus on family gatherings and spiritual activities by treating yourself and your loved ones with the best Ramadan gift from LG.

 

Experience The Best Indoor Air Quality This Ramadan

From purifying the air in LGs PuriCare™ air purifiers to creating a comfortable indoor environment with the Dual Inverter Dehumidifier, LG has everything you need to make your home the perfect gathering place this Ramadan.

With smart features and remote control capabilities, LGs appliances ensure convenience and peace of mind during this special time of year. Celebrate Ramadan with LG and enjoy a healthier, happier home environment for you and your loved ones.

Don’t miss out on the great offers!



Valid till March 31st.

 

LG's Exclusive Offers on Washing Machines and Refrigerators

Revolutionize your home this Ramadan with LG's special promotions on washing machines and refrigerators! LG's washing machines are designed to handle your laundry efficiently, giving you more time to focus on family and spirituality. With LG's innovative refrigerators, storing your favorite meals during Ramadan is hassle-free, ensuring you have everything you need for memorable iftar gatherings. Don't miss out on these amazing promotions – upgrade your home with LG today and experience convenience like never before!

Check out the promotions for washing machines and refrigerators HERE.

 

Enjoy Effortless Cleaning this Ramadan with LGs Vacuums:

Keep your home clean and tidy this Ramadan with LG's cordless and wireless vacuums, offering unparalleled convenience and efficiency. As the season of Ramadan approaches, families are busy preparing meals, hosting gatherings, and focusing on spiritual activities. With LG's cordless and wireless vacuums, cleaning becomes a breeze, allowing you to maintain a clean home environment without the hassle of cords or wires. Whether it's quickly tidying up before guests arrive for iftar or keeping the house spotless during Ramadan gatherings.

Don't miss out on LGs vacuums promotions and enjoy a clean home throughout Ramadan!


About LG Electronics, Inc.

LG Electronics is a global innovator in technology and consumer electronics with a presence in almost every country and an international workforce of more than 74,000. LG's four companies - Home Appliance & Air Solution, Home Entertainment, Vehicle component Solutions and Business Solutions - combined for global revenue of over KRW 84 trillion in 2023. LG is a leading manufacturer of consumer and commercial products ranging from TVs, home appliances, air solutions, monitors, service robots, automotive components and its premium LG SIGNATURE and intelligent LG ThinQ brands are familiar names world over. Visit www.LGnewsroom.com  for the latest news.

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Contacts

LG-One      

Nora Nassar

Email: Nora.Nassar@lg-one.com  

Sama Announces Key Events to Support Women in 2024

 With women comprising more than half its workforce, Sama reaffirms its commitment to gender equality and removing barriers for women in the digital economy

(BUSINESS WIRE) -- Sama, the leader in providing data annotation and model validation solutions, today reaffirmed its commitment to investing in women in technology as part across its operations in Kenya, Uganda, North America and Europe. In celebration of International Women’s Day (IWD), and as part of an ongoing effort to pursue gender equality, the company announced plans to foster the development of women at all stages of their careers throughout 2024. This includes hosting lectures at secondary schools, spearheading thought leadership and tech roundtables with influential women in tech and sharing stories of inspiring women both from within the company and the industry across social media.

“The gender poverty gap remains a pressing, growing problem, and the lack of female representation continues to plague AI as an industry. From the beginning, Sama has believed in fostering an environment where every individual, regardless of their gender, can thrive,” said Wendy Gonzalez, CEO of Sama. “It is an honor to play a part in creating the next generation of female leaders and building an inclusive future for AI that benefits everyone.”

Sama is one of the few companies in AI and in tech with large numbers of women on its teams. 53% of the company’s workforce identifies as female; 48% of senior managers identify as female; and 50% of the executive team identifies as female. The company continuously assesses its practices, policies and culture to identify areas for improvement and implement necessary changes, including via third-party, unbiased evaluation where appropriate.

To encourage women to join the formal digital economy, Sama has a number of programs in place. This includes launching a public lecture series intended to educate youth on the opportunities in the tech industry. Sama intends to hold the first lecture at a secondary school for financially disadvantaged girls in Kenya this spring. Sama VP of Marketing Lisa Avvocato will give this inaugural lecture.

Sama’s commitment to gender equality across the company includes the following:

    Starting with IWD events on March 17 at Sama’s East Africa offices, Sama will host fireside chats and other talks by and for women regularly throughout the year.

    Female employees have the opportunity to participate in mentorship programs, leadership development opportunities and skill-building workshops. Sama intends to expand these programs.

    Throughout the month of March, the company will encourage employees to create their own #InspireInclusion image and statement to join in the global conversation.

    Sama will be sharing stories of women’s success at all levels of the company and the industry across social media platforms in 2024, to inspire young women and champion those who are breaking barriers, starting with the Delight video magazine every Monday in March.

    Sama also incorporates gender balance, equal opportunities and pay policies from hiring onward.

Sama’s successes as a company support the Leila Janah Foundation (LJF), its primary shareholder, and its efforts to give work, not aid to underserved women and youth in East Africa. The LJF recently launched its Women Founders Award to provide mentorship and funding to female entrepreneurs in rural western Kenya.

Liliosa Mbirimi, Program Director at the LJF, added: “Women are still more likely to live in poverty than men around the world, and 600 million women are also in insecure, informal jobs. This discrepancy begins in childhood, with more girls living in poverty than boys, and women globally still earn approximately 24% less than men over their lifetimes. Gender inequality in developing countries costs women $9 trillion every year. These sobering statistics are a reminder why the efforts of the LJF, Sama and other companies around the world are vital to ensuring women have an independent path out of poverty and into the formal economy.”

For more information on the LJF’s efforts to support social entrepreneurship in Kenya and Uganda, please visit its website.

About Sama

Sama is a global leader in data annotation solutions for computer vision that power AI and machine learning models. Our solutions minimize the risk of model failure and lower the total cost of ownership through an enterprise ready ML-powered platform and SamaIQ™, actionable data insights uncovered by proprietary algorithms and a highly skilled on-staff team of over 5,000 data experts. 25% of Fortune 50 companies, including GM, Ford, Microsoft, and Google, trust Sama to help deliver industry-leading ML models.

Driven by a mission to expand opportunities for underserved individuals through the digital economy, Sama is a certified B-Corp and has helped more than 65,000 people lift themselves out of poverty. An MIT-led Randomized Controlled Trial has validated its training and employment program. For more information, visit www.sama.com.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240307422125/en/

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Contacts

press@samasource.org

Hikma’s Executive Vice Chairman and President of MENA Joins Rakuten Medical’s Board of Directors

 Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces that its Executive Vice Chairman and President of MENA, Mazen Darwazah, has been appointed as a Board Director to Rakuten Medical, Inc. a global biotechnology company specialised in developing and commercialising precision, cell targeting therapies based on its Alluminox™ technology platform.

In August of last year, Hikma announced signing an exclusive licensing agreement with Rakuten Medical, to commercialise products in Rakuten Medical’s pipeline using its photo immunotherapy Alluminox™ technology platform, in all Hikma’s MENA markets. The agreement strengthened Hikma’s growing portfolio in oncology and biotechnology bringing a potentially innovative technology to cancer patients in the region.

“We are very pleased to welcome Mazen, highly experienced global leader, to our board,” said Mickey Mikitani, Co-CEO of Rakuten Medical, Inc. “With his strong operational direction and experience in driving strategic business decisions that grow healthcare businesses in the MENA region and globally, I'm sure that Mazen will add value as a solid guide for Rakuten Medical as it moves to a new stage of uncovering more potential as a global biotechnology company.”

 

Commenting on joining Rakuten Medical’s Board of Directors, Mazen Darwazah Hikma’s Executive Vice Chairman and President of MENA, said: “I’m honoured to join Rakuten Medical’s Board of Directors. We’re at an important crossroad at Hikma and well positioned to shape the next chapter of our growth in line with our strategy of moving to provide broader healthcare solutions in MENA. My board appointment will drive synergies and facilitate a closer working relationship with an important partner that shares Hikma’s vision of shaping a healthier world.”

About Hikma

Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, MENA and Europe. For more information, please visit: www.hikma.com

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Contacts

Hikma Pharmaceuticals PLC

Mona Abdallah

Senior Director, MENA Communications

+ 96265802900

MBAbdallah@Hikma.com

Sunday, March 17, 2024

Mobil 1 Marks 50th Anniversary with Celebratory Racing Liveries Throughout 2024 Motorsports Season


 Mobil 1 will showcase specially designed full-car wraps and icons, created in collaboration with teams in IMSA, WEC, Formula 1, NASCAR, NHRA, MotoGP and more


(BUSINESS WIRE) -- To celebrate the 50th anniversary of Mobil 1™ motor oil, this year the brand will showcase more than 40 iconic, specially-designed liveries and paint schemes on the track throughout the 2024 motorsports season.


These liveries – which will be seen within IMSA, WEC, Formula 1, NASCAR, NHRA, MotoGP and more – use distinct design elements, including anniversary gold, both signifying 50 years of the Mobil 1 brand and embodying the dynamic relationships between Mobil 1 and its collaborators. Each paint scheme reflects the spirit of the Mobil 1 brand and an ongoing commitment to growing and maintaining meaningful track-to-road relationships, which is at the heart and soul of the brand.


Mobil 1 motor oils have long been the choice for preeminent race teams competing in the most demanding and popular motorsports series around the globe. Today, Mobil 1 synthetic motor oil continues to be relied upon for its ability to deliver exceptional engine performance and protection under some of the most extreme conditions. Automotive technicians, race car drivers, team owners, and some of the world’s leading automotive manufacturers can speak to the advanced technology of Mobil 1 lubricants.


“We are thrilled to bring these special paint schemes to life for such a historic anniversary of the Mobil 1 brand,” said Robert Shearer, Director of Global Sponsorships on behalf of Mobil 1. “These liveries exemplify our collaborations in lubricant innovation in the world of motorsports. Together, we’ve crafted livery designs that not only pay homage to the 50-year legacy of the Mobil 1 brand, but also capture the essence of speed, performance and teamwork. We can’t wait for fans to join us in the love of racing and witness the culmination of our collaborative efforts on the racetrack throughout the rest of the year.”


At Mobil 1 Twelve Hours of Sebring Presented by Cadillac, golden liveries will hit the track for teams and OEMs, including Vasser Sullivan Racing (Lexus Racing), Cadillac Racing, Corvette Racing by Pratt Miller Motorsports, Kellymoss with Riley (Porsche Motorsport North America), and Porsche Penske Motorsport.


With more added throughout the season, initial 50th anniversary liveries and iconography will be seen at the following upcoming race series on sponsored teams:


  • Oracle Red Bull Racing (Formula 1)
  • Stewart-Haas Racing (NASCAR Cup Series)
  • 23XI Racing (NASCAR Cup Series)
  • Tony Stewart Racing (NHRA)
  • Red Bull KTM (MotoGP)
  • Porsche Penske Motorsport (WEC and IMSA)
  • TAG Heuer Porsche Formula E Team (Formula E)
  • Mobil 1 Porsche SuperCup
  • At the Pikes Peak International Hill Climb with BBI Autosport


In continuing to commemorate the 50th anniversary, fans should also look for a short film featuring former Formula 1 racer & Oracle Red Bull Racing ambassador, David Coulthard, who guides the audience through the Mobil 1 brand’s evolution, collaborations, and achievements. The video is available for viewing here.


Additional initiatives across partnerships, motorsports, and events will be shared through the year as the brand continues to celebrate its legacy and what's next. For coverage of Mobil 1 Twelve Hours of Sebring Presented by Cadillac as well as upcoming gold liveries and paint schemes, visit @mobil1racing on Instagram and X all year-long.


About Mobil 1

For 50 years, Mobil 1 has been trusted by drivers to keep their engines running longer. Our products combine the latest technology and innovation to exceed the toughest standards of vehicle manufacturers and tuning shops—so consumers can get the most out of their time behind the wheel, both on the road and on the track. Turn every day into an adventure with Mobil 1, the world’s leading synthetic motor oil brand. Learn more at www.mobil1.us or and follow @Mobil1Racing on Instagram and X. Join us. For the love of driving.



View source version on businesswire.com: https://www.businesswire.com/news/home/20240315781564/en/


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Contacts

Sean Hixson

shixson@webershandwick.com

Saturday, March 16, 2024

DCAS Accepting Non-Dealer Committee Membership Applications for 2024

 NEW YORK - Friday, 15. March 2024

(BUSINESS WIRE) -- DC Administration Services, Inc. (DCAS) would like to invite all interested Members of ISDA to apply for a position as a Non-dealer Committee Member of the Determinations Committee for the relevant region.


Parties wishing to apply for such a position should carefully review and submit an executed Non-dealer Committee Participation Letter by 5pm (New York time) on Wednesday, March 20, 2024.


For more information on the process and to download the form of the Non-dealer Committee Participation Letter, please visit https://www.cdsdeterminationscommittees.org/about-dc-committees/constitution-of-the-determinations-committees/.


 


View source version on businesswire.com: https://www.businesswire.com/news/home/20240315301830/en/



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Contacts

Press Inquiries:

orlando.figueroa@citadelspv.com


 

Friday, March 15, 2024

BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy

 Results from the global, Phase 3 RATIONALE 302 trial showed TEVIMBRA prolonged the survival of patients who received prior systemic treatment compared to chemotherapy


Approval represents the first indication in the U.S. for TEVIMBRA


 


(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. TEVIMBRA will be available in the U.S. in the second half of 2024.


“Today’s FDA approval of TEVIMBRA for patients with ESCC who have previously received chemotherapy, along with its ongoing review of our BLA for first-line ESCC patients, represents a significant step in our commitment to bringing this therapy to more patients around the world,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “As BeiGene’s first drug candidate produced through our immuno-oncology program and second approved medicine in the U.S., TEVIMBRA is poised to be a critical pillar of our solid tumor development program, which spans more than 17 registration-enabling clinical trials in more than 30 countries across regions globally.”


The approval is based on the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population with a statistically significant and clinically meaningful survival benefit for TEVIMBRA compared with chemotherapy. In the ITT population, the median overall survival (OS) in the TEVIMBRA arm was 8.6 months (95% CI: 7.5, 10.4) compared to 6.3 months (95% CI: 5.3, 7.0) in the chemotherapy arm (p=0.0001; hazard ratio [HR]=0.70 [95% CI: 0.57, 0.85]). The safety profile of TEVIMBRA was favorable over chemotherapy.i The most common (≥20%) adverse reactions for TEVIMBRA, including laboratory abnormalities, were increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, increased AST, musculoskeletal pain, decreased weight, increased ALT and cough.i


“Patients diagnosed with advanced or metastasized ESCC, the most common histologic subtype of esophageal cancer, often progress following initial therapy and are in need of new options,” Syma Iqbal, M.D., Associate Professor of Clinical Medicine, Section Chief Gastrointestinal Oncology, Division of Medical Oncology and Cancer Physician in Chief, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California. “The RATIONALE 302 trial showed that patients with previously treated ESCC who received TEVIMBRA saw a clinically meaningful survival benefit, highlighting its potential as an important treatment option for these patients.”


Tislelizumab received approval by the European Commission for advanced or metastatic ESCC after prior chemotherapy in 2023 and a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) in February 2024 as a treatment for non-small cell lung cancer across three indications.


The FDA is also reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The target action dates are July and December 2024, respectively.


BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts. Through these trials, TEVIMBRA has demonstrated its potential to deliver clinically meaningful improvements in survival benefits and quality of life for hundreds of thousands of cancer patients across a range of tumor types – in many cases, regardless of PD-(L)1 status – both as monotherapy and in combination with other regimens. More than 900,000 patients have been prescribed TEVIMBRA globally to date.


About RATIONALE 302


RATIONALE 302 is a global, randomized, open-label, Phase 3 study (NCT03430843) designed to investigate the efficacy and safety of TEVIMBRA when compared with investigator’s choice of chemotherapy as a second-line treatment for patients with unresectable, locally advanced or metastatic ESCC. The study randomized 512 patients from 132 research sites in 11 countries in Europe, Asia and North America.


About ESCC


Globally, esophageal cancer (EC) is the sixth most common cause of cancer-related deaths, and ESCC is the most common histologic subtype, accounting for nearly 90% of ECs.ii An estimated 957,000 new EC cases are projected in 2040, an increase of nearly 60% from 2020, underscoring the need for additional effective treatments.ii EC is a rapidly fatal disease, and more than two-thirds of patients have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases.iii


About TEVIMBRA® (tislelizumab-jsgr)


Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.


U.S. Indication and Important Safety Information for TEVIMBRA (tislelizumab-jsgr)


INDICATION


TEVIMBRA (tislelizumab-jsgr), as a single agent, is indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.


WARNINGS AND PRECAUTIONS


Severe and Fatal Immune-Mediated Adverse Reactions


TEVIMBRA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions.


Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment with a PD-1/PD-L1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated reactions.


Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.


Withhold or permanently discontinue TEVIMBRA depending on severity. In general, if TEVIMBRA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroids.


Immune-Mediated Pneumonitis


TEVIMBRA can cause immune-mediated pneumonitis, which can be fatal. In patients treated with other PD-1/PD-L1 blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation.


Immune-mediated pneumonitis occurred in 3.8% (75/1972) of patients receiving TEVIMBRA, including fatal (0.2%), Grade 4 (0.3%), Grade 3 (1.4%), and Grade 2 (1.7%) adverse reactions. Pneumonitis led to permanent discontinuation of TEVIMBRA in 35 (1.8%) patients and withholding of TEVIMBRA in 27 (1.4%) patients.


Systemic corticosteroids were required in all patients with pneumonitis. Immune-mediated pneumonitis resolved in 47% of the 75 patients. Of the 27 patients in whom TEVIMBRA was withheld for pneumonitis, 18 reinitiated TEVIMBRA after symptom improvement; of these, 3 (17%) patients had recurrence of pneumonitis.


Immune-Mediated Colitis


TEVIMBRA can cause immune-mediated colitis, which can be fatal. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1 blocking antibodies. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.


Immune-mediated colitis occurred in 0.9% (17/1972) of patients receiving TEVIMBRA, including Grade 3 (0.4%), and Grade 2 (0.5%) adverse reactions. Colitis led to permanent discontinuation of TEVIMBRA in 2 (0.1%) patients and withholding of TEVIMBRA in 10 (0.5%) patients. All 17 patients received systemic corticosteroids. Twelve (71%) of the 17 patients received high-dose systemic corticosteroids. Two (12%) of the 17 patients received immunosuppressive treatment. Immune-mediated colitis resolved in 88% of the 17 patients. Of the 10 patients in whom TEVIMBRA was withheld for colitis, 8 reinitiated TEVIMBRA after symptom improvement; of these, 1 (13%) patient had recurrence of colitis.


Immune-Mediated Hepatitis


TEVIMBRA can cause immune-mediated hepatitis, which can be fatal.


Immune-mediated hepatitis occurred in 1.7% (34/1972) of patients receiving TEVIMBRA, including fatal (0.1%), Grade 4 (0.1%), Grade 3 (1%), and Grade 2 (0.6%) adverse reactions. Immune-mediated hepatitis led to permanent discontinuation in 9 (0.5%) patients and withholding of TEVIMBRA in 20 (1%) patients. All patients received systemic corticosteroids. Twenty-nine (85%) of the 34 patients received high-dose systemic corticosteroids. One patient (2.9%) of the 34 patients received immunosuppressive treatment. Immune-mediated hepatitis resolved in 59% of the 34 patients. Of the 20 patients in whom TEVIMBRA was withheld for hepatitis, 12 reinitiated TEVIMBRA after symptom improvement; of these, 2 (17%) patients had recurrence of hepatitis.


Immune-Mediated Endocrinopathies


Adrenal Insufficiency


TEVIMBRA can cause immune-mediated adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold TEVIMBRA depending on severity.


Immune-mediated adrenal insufficiency occurred in 0.3% (6/1972) of patients receiving TEVIMBRA, including Grade 4 (0.1%), Grade 3 (0.1%), and Grade 2 (0.2%) adverse reactions. Adrenal insufficiency did not lead to permanent discontinuation of TEVIMBRA. TEVIMBRA was withheld in 5 out of the 6 patients. All 6 patients received systemic corticosteroids. Two (33%) of the 6 patients received high-dose systemic corticosteroids. Adrenal insufficiency resolved in 17% of the 6 patients.


Hypophysitis


TEVIMBRA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue TEVIMBRA depending on severity.


Hypophysitis/hypopituitarism occurred in 0.1% (1/1972) of patients receiving TEVIMBRA, including a Grade 2 (0.1%) adverse reaction. No TEVIMBRA treatment discontinuation or withholding was required.


Thyroid Disorders


TEVIMBRA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue TEVIMBRA depending on severity.


Thyroiditis: Immune-mediated thyroiditis occurred in 0.4% (7/1972) of patients receiving TEVIMBRA, including Grade 2 (0.3%) adverse reactions. Thyroiditis did not lead to permanent discontinuation of TEVIMBRA. TEVIMBRA was withheld in 1 (0.1%) patient. One (14%) of the 7 patients received systemic corticosteroids. Thyroiditis resolved in 29% of the 7 patients.


Hyperthyroidism: Immune-mediated hyperthyroidism occurred in 0.6% (12/1972) of patients receiving TEVIMBRA, including Grade 3 (0.1%), and Grade 2 (0.5%) adverse reactions. Hyperthyroidism led to the permanent discontinuation of TEVIMBRA in 1 (0.1%) patient and withholding of TEVIMBRA in 1 (0.1%) patient. One (8%) of the 12 patients received systemic corticosteroids. Hyperthyroidism resolved in 92% of the 12 patients.


Hypothyroidism: Immune-mediated hypothyroidism occurred in 7% (132/1972) of patients receiving TEVIMBRA, including Grade 4 (0.1%) and Grade 2 (5%) adverse reactions. TEVIMBRA was not permanently discontinued in any patient, while treatment was withheld in 6 (0.3%) patients. Two (1.5%) of the 132 patients received systemic corticosteroids. All 132 patients received hormone replacement therapy. Hypothyroidism resolved in 27% of the 132 patients. The majority (86%) of patients with hypothyroidism required long-term thyroid hormone replacement.


Type 1 Diabetes Mellitus, which can present with Diabetic Ketoacidosis


Type 1 diabetes mellitus has been reported with PD-1/PD-L1 blocking antibodies. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue TEVIMBRA depending on severity.


Immune-Mediated Nephritis with Renal Dysfunction


TEVIMBRA can cause immune-mediated nephritis, which can be fatal.


Immune-mediated nephritis with renal dysfunction occurred in 0.4% (7/1972) of patients receiving TEVIMBRA, including Grade 4 (0.1%), Grade 3 (0.1%), and Grade 2 (0.2%) adverse reactions. TEVIMBRA was permanently discontinued in 3 (0.2%) patients and treatment was withheld in 3 (0.2%) patients. All patients received systemic corticosteroids. Nephritis with renal dysfunction resolved in 57% of the 7 patients. Of the 3 patients in whom TEVIMBRA was withheld for nephritis, 2 reinitiated TEVIMBRA after symptom improvement and one patient had recurrence of nephritis.


Immune-Mediated Dermatologic Adverse Reactions


TEVIMBRA can cause immune-mediated rash or dermatitis. Cases of severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported, some with fatal outcome. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold or permanently discontinue TEVIMBRA depending on severity.


Immune-mediated dermatologic adverse reactions occurred in 1.2% (24/1972) of patients receiving TEVIMBRA, including Grade 4 (0.2%), Grade 3 (0.4%), and Grade 2 (0.4%) adverse reactions. Dermatologic adverse reactions led to permanent discontinuation of TEVIMBRA in 3 (0.2%) patients and withholding of TEVIMBRA in 9 (0.5%) patients. Twenty-three (96%) of the 24 patients received systemic corticosteroids. Immune-mediated skin reactions resolved in 58% of the 24 patients. Of the 9 patients in whom TEVIMBRA was withheld for dermatologic adverse reactions, 8 reinitiated TEVIMBRA after symptom improvement; of these, 2 (25%) patients had recurrence of immune-mediated rash.


Other Immune-Mediated Adverse Reactions


The following clinically significant immune-mediated adverse reactions occurred at an incidence of less than 1% each in 1972 patients who received TEVIMBRA: myositis, myocarditis, arthritis, polymyalgia rheumatica, and pericarditis.


The following additional clinically significant immune-mediated adverse reactions have been reported with other PD-1/PD-L1 blocking antibodies, including severe or fatal cases.


Cardiac/Vascular: Vasculitis


Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy.


Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.­­


Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis


Musculoskeletal and Connective Tissue: Polymyositis, rhabdomyolysis and associated sequelae including renal failure


Endocrine: Hypoparathyroidism


Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection.


Infusion-Related Reactions


TEVIMBRA can cause severe or life-threatening infusion-related reactions. Infusion-related reactions occurred in 4.2% (83/1972) patients receiving TEVIMBRA, including Grade 3 or higher (0.3%) reactions. Monitor patients for signs and symptoms of infusion-related reactions.


Slow the rate of infusion for mild (Grade 1) and interrupt the infusion for moderate (Grade 2) infusion-related reactions. For severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions, stop infusion and permanently discontinue TEVIMBRA.


Complications of Allogeneic HSCT


Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT.


Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT.


Embryo-Fetal Toxicity


Based on its mechanism of action, TEVIMBRA can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TEVIMBRA and for 4 months after the last dose.


ADVERSE REACTIONS


Permanent discontinuation of TEVIMBRA due to an adverse reaction occurred in 19% of patients. Adverse reactions which resulted in permanent discontinuation in ≥ 1% of patients were hemorrhage, pneumonitis (including pneumonitis and immune-mediated pneumonitis), and pneumonia.


Dosage interruptions of TEVIMBRA due to an adverse reaction occurred in 23% of patients. Adverse reactions which required dosage interruptions in ≥ 2% of patients were pneumonia, pneumonitis, and fatigue.


The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, increased AST, musculoskeletal pain, decreased weight, increased ALT, and cough.


Please see full U.S. Prescribing Information including Medication Guide.


About BeiGene


BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).


Forward-Looking Statements


This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s ability to bring TEVIMBRA to more patients around the world; the future significance of TEVIMBRA in BeiGene’s solid tumor development program; the potential of TEVIMBRA to be an important treatment for ESCC; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.


To access BeiGene media resources, please visit our News & Media site.


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i Shen, L., Kato, K., Kim, S. B., Ajani, J. A., Zhao, K., He, Z., ... & Van Cutsem, E. (2022). Tislelizumab versus chemotherapy as second-line treatment for advanced or metastatic esophageal squamous cell carcinoma (RATIONALE-302): A randomized phase III study. Journal of Clinical Oncology. 40(26), 3065-3076. DOI: 10.1200/JCO.21.01926

ii Morgan E, et al. The Global Landscape of Esophageal Squamous Cell Carcinoma and Esophageal Adenocarcinoma Incidence and Mortality in 2020 and Projections to 2040: New Estimates From GLOBOCAN 2020. Gastroenterology. 2022 Sep;163(3):649-658.e2. doi: 10.1053/j.gastro.2022.05.054. Epub 2022 Jun 4. PMID: 35671803.

iii National Cancer Institute. Cancer stat facts: esophageal cancer. https://seer.cancer.gov/statfacts/html/esoph.html.


 


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