On September 13, 2021 Novartis reported that the US Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for anti-PD-1 immune checkpoint inhibitor tislelizumab for the treatment of unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in people who had received prior systemic therapy (Press release, Novartis, SEP 13, 2021, View Source [SID1234587579]).

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"This is an encouraging step forward in our mission to deliver transformative therapies for people living with cancer, and especially for people with esophageal cancer, an aggressive disease with limited treatment options," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development. "We are advancing tislelizumab as a key cornerstone of our immunotherapy program and PD-1 backbone for combination therapy. We will work with regulatory authorities to ensure it is available for people with esophageal cancer as soon as possible."

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody being developed both as a monotherapy and in combination with other therapies.4 The BLA submission was based on data from the Phase III RATIONALE 302 trial, which demonstrated a 30% reduction in the risk of death (HR=0.70, 95% CI: 0.57-0.85, p=0.0001) and extended median overall survival by 2.3 months compared to chemotherapy in people with unresectable recurrent locally advanced or metastatic ESCC who had received prior systemic therapy.1

About Esophageal Cancer
ESCC is the most common type of esophageal cancer globally and the sixth leading cause of cancer-related death worldwide.2 There are approximately 17,000 people living with ESCC in the United States and in 2021, and it is estimated that there will be 19,000 new esophageal cancer cases diagnosed and more than 15,000 deaths from esophageal cancer.3,5 Globally, in 2020, there were more than 604,000 new cases of esophageal cancer and 544,000 deaths from esophageal cancer.2 More than two-thirds of people with ESCC have advanced or metastatic disease at the time of diagnosis.6 The five-year survival rate for esophageal cancer is 19.9%, and the five-year survival rate for metastatic disease is even lower at 5.2%.3

About Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. The clinical impact of these features is not yet known.4

BeiGene filed the BLA on behalf of Novartis in the United States for tislelizumab for the treatment of unresectable recurrent locally advanced or metastatic ESCC in people who had received prior systemic therapy. In an agreement finalized earlier this year, BeiGene granted Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan through a collaboration and license agreement.

On September 13, 2021 Boehringer Ingelheim, a global leader in animal health, reported that its FRONTLINE brand was named global Brand of the Year 2021-2022 in the Animalis Edition of the World Branding Awards (Press release, Boehringer Ingelheim, SEP 13, 2021, View Source [SID1234587571]).

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The organizer of the World Branding Awards, World Branding Forum, headquartered in London, UK, is a global non-profit organization dedicated to advancing branding standards for the good of the branding community as well as consumers. It organizes and sponsors a range of educational programs, including collaborations with leading universities and museums.

The winners are judged through three streams: brand valuation, consumer market research and public online voting. Over 115,000 pet and animal lovers from around the world voted for their favorite brands, in 41 countries, across six continents. This year, more than 1,100 brands were nominated by the public but only 150 were named "Brand of the Year".

"This is a celebration of the best marketers of pet and animal brands from across the globe. As consumer votes constitute 70 percent of the final score, winners of the Awards must have strong brand recall amongst their consumers," explains Richard Rowles, Chairman, World Branding Forum.

Michael Horn, Global Head of Pet Parasiticides, shares: "We are absolutely delighted to have won this global Award again. It recognizes our teams who work tirelessly ensuring brand awareness is high and consumers know what our brands stand for in the ever-changing pet segment and animal health industry."

Brand of the Year logo

World Branding Forum

The World Branding Forum (WBF) is a global, non-profit organization dedicated to advancing branding standards for the good of the branding community as well as consumers. This includes those who work in the branding, design, marketing, advertising, public relations and communications disciplines worldwide. The WBF produces, manages and supports a wide range of programs covering research, development, education, recognition, networking and outreach. For more information visit www.brandingforum.org

Boehringer Ingelheim Animal Health

The lives of animals and humans are interconnected in deep and complex ways. We know that when animals are healthy, humans are healthier too. Across the globe, our 9,700 employees are dedicated to delivering value through innovation, thus enhancing the well-being of both.

Respect for animals, humans and the environment is at the heart of what we do. We develop solutions and provide services to protect animals from disease and pain. We support our customers in taking care of the health of their animals and protect our communities against life- and society-threatening diseases.

Boehringer Ingelheim Animal Health is the second largest animal health business in the world, with net sales of 4.1 billion euros in 2020 and presence in more than 150 countries. For more information visit: www.boehringer-ingelheim.com/animal-health/overview

On September 13, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy (Press release, BeiGene, SEP 13, 2021, View Source [SID1234587561]). The Prescription Drug User Fee Act (PDUFA) target action date is July 12, 2022.

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"Tislelizumab is already approved in five indications in China and has the potential to become a preferred immunotherapy option there. We look forward to continued collaboration with Novartis to work to bring access to tislelizumab to patients around the world."

"Our uniquely designed anti-PD-1 antibody tislelizumab has been shown to significantly improve survival compared to chemotherapy for people with a variety of solid tumors and hematologic malignancies. We previously shared the compelling results at ASCO (Free ASCO Whitepaper) 2021 with tislelizumab significantly prolonging survival and demonstrating a favorable safety profile over chemotherapy in patients with locally advanced or metastatic ESCC, a devastating disease with an average five-year survival rate of just five percent. This BLA acceptance brings us closer to potentially providing tislelizumab as a treatment for these patients in the United States," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "Tislelizumab is already approved in five indications in China and has the potential to become a preferred immunotherapy option there. We look forward to continued collaboration with Novartis to work to bring access to tislelizumab to patients around the world."

The BLA submission is based on results from RATIONALE 302, a randomized, open-label, multicenter global Phase 3 trial (NCT03430843) designed to evaluate the efficacy and safety of tislelizumab when compared to investigator’s choice chemotherapy as a second-line treatment for patients with advanced or metastatic ESCC. Results of this trial were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2021). The submission also included safety data on 1,972 patients who received tislelizumab as a monotherapy from seven clinical trials.

In addition to the United States, tislelizumab is also under regulatory review in China as a treatment for patients with locally advanced or metastatic ESCC who have disease progression following or are intolerant to first-line standard chemotherapy.

About Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal cancer is one of the most common malignant tumors in the digestive tract, with more than 18,400 new cases diagnosed each year in the United States.1 There are two main types of esophageal cancer, based on the cells where cancer develop: squamous cell carcinoma (ESCC) and adenocarcinoma (EAC).2 ESCC accounts for up to 30% of esophageal cancer cases in the United States, and is the most common form of esophageal cancer worldwide.2,3,4 Because many patients are diagnosed at later stages of disease, management of ESCC is challenging and the overall prognosis remains poor.3,4

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has approved tislelizumab in five indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy. NMPA also granted conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three supplemental Biologics License Applications for tislelizumab are under review by the Center for Drug Evaluation (CDE) of the NMPA, including as second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors and for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy.

In the U.S., a Biologics License Application for tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy is currently under review by the U.S. Food and Drug Administration with a PDUFA target action date of July 12, 2022.

BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.

About the Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL; NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial of tislelizumab in patients with relapsed or refractory cHL (NCT03209973);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).
BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy volunteers. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

On September 12, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the publication of an abstract highlighting new clinical data for zanidatamab, a HER2-targeted bispecific antibody, in first-line HER2-expressing GEA. An updated and expanded data set will be presented at the ESMO (Free ESMO Whitepaper) Annual Congress taking place virtually on September 16-21, 2021 (Press release, Zymeworks, SEP 12, 2021, View Source [SID1234587560]).

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Abstract highlights from March 18, 2021 data cut:

Thirty patients had been treated with zanidatamab in combination with standard of care chemotherapy (either mFOLFOX6, CAPOX, or FP), and 14 patients remained on treatment.
The confirmed objective response rate was 68.2% and the disease control rate was 90.9% in 22 HER2-positive response-evaluable patients.
Treatment related adverse events were generally consistent with previous reports of zanidatamab and/or the chemotherapy regimens, with the majority reported as Grade 1 or 2 in severity.
"The initial data from the abstract highlight an encouraging objective response rate for zanidatamab combined with standard of care chemotherapy in patients with metastatic HER2-positive GEA," said Neil Josephson, M.D., Zymeworks’ Interim Chief Medical Officer. "We’re looking forward to presenting at the Congress the full updated data, which further support zanidatamab’s potential as the new foundational HER2-targeted therapy."

ESMO Presentation
The abstract is available on the ESMO (Free ESMO Whitepaper) conference website. The presentation will be available on Thursday, September 16 at 8:30 am CEST, 2:30 am ET, to conference registrants on the ESMO (Free ESMO Whitepaper) conference website as well as to the general public on the Zymeworks website at View Source

Title: Phase (Ph) 2 Study of Zanidatamab + Chemotherapy (chemo) in First Line (1L) HER2-expressing Gastroesophageal Adenocarcinoma (GEA)
Lead Author: Geoffrey Ku, M.D., Memorial Sloan Kettering Cancer Center, New York, NY, US
Abstract: 3678
E-poster: 1380P

Conference Call and Webcast
The company will host a conference call and webcast to discuss the updated data after it is published on September 16. The event will be led by Ali Tehrani, Ph.D., Zymeworks’ President and CEO and Neil Josephson, M.D., Zymeworks’ Interim Chief Medical Officer, and will include a presentation by medical oncologist and principal investigator, Geoffrey Ku, M.D., Memorial Sloan Kettering Cancer Center. Dr. Ku and members of Zymeworks’ executive team will be available to answer questions at the conclusion of the call.

Date: Thursday, September 16th
Time: 7:30 am ET

Interested parties can access the live webcast via the Zymeworks’ website at View Source A recorded replay will be accessible after the event through the Zymeworks website.

About Zanidatamab
Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers from the FDA, as well as Orphan Drug designation for the treatment of biliary tract and gastric cancer from the European Medicines Agency.

On September 12, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that clinical results and subgroup analyses from the Company’s robust lung cancer program will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, BeiGene, SEP 12, 2021, View Source [SID1234587558]).

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"We continue to make meaningful progress with our deep immuno-oncology portfolio, including our lung cancer program of seven Phase 3 trials in NSCLC. Driven by growing clinical insights, we are working to accelerate the development of tislelizumab in novel combinations in lung cancer, including with our internally discovered potent investigational anti-TIGIT antibody ociperlimab and therapeutic agents from collaborations, such as sitravatinib," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "In addition, our scientists are exploring new modalities for potential combinations with tislelizumab in lung cancer and other solid tumors, and with the ongoing Novartis collaboration, tislelizumab can be leveraged with their oncology pipeline for more combination opportunities. We plan to work to realize the therapeutic potential of this differentiated checkpoint inhibitor through combinations in various tumor types for patients worldwide."

To learn more about BeiGene’s research and development and activities around ESMO (Free ESMO Whitepaper), please visit View Source

Broad Lung Cancer Program Focused on Tislelizumab Combination Treatments

BeiGene is pursuing diverse mechanisms of action in combination with tislelizumab to complement targeting of the PD-1 pathway for potentially improved clinical outcomes or to overcome resistance associated with disease progression.

In NSCLC, many patients who have achieved a response to front-line anti-PD-1 antibody treatment eventually relapse due to resistance. Through its collaboration with Mirati Therapeutics, BeiGene is investigating the combination of tislelizumab and sitravatinib, a spectrum-selective tyrosine kinase inhibitor potentially capable of reversing immunosuppressive tumor microenvironment to overcome immune resistance. BeiGene is conducting a Phase 3 trial of this novel combination in NSCLC, and clinical results from an ongoing Phase 1b trial in patients with metastatic NSCLC, both naïve and refractory or resistance to anti-PD-(L)1 treatment, will be presented at ESMO (Free ESMO Whitepaper) Congress 2021.

Another novel combination of tislelizumab that BeiGene is investigating in lung cancer is with ociperlimab, a potent, Fc-intact investigational anti-TIGIT-antibody in Phase 3 clinical development. TIGIT is a co-inhibitory immune checkpoint receptor expressed on multiple immune cells and has recently emerged as a new therapeutic target that in collaboration with PD-1 has the potential to further suppress antitumor immune response. Tislelizumab’s broad combination portfolio in lung cancer also includes PI3K-delta inhibitor BGB-10188, anti-TIM-3 antibody BGB-A425, and chemotherapy.

Growing NSCLC Program Driven by Scientific Excellence and Clinical Insights

To address the prevalence of NSCLC worldwide and the clinical unmet need despite treatment progress in recent years, BeiGene is currently evaluating tislelizumab in a comprehensive NSCLC program of more than 10 clinical trials covering disease settings from early to late lines.

To gain key insights into how different patient characteristics can impact treatment outcomes, BeiGene’s immuno-oncology team reviews clinical results from NSCLC trials by geography, disease stage, smoking status, and using biomarkers.

Subgroup analyses on BeiGene’s RATIONALE 307 trial recently presented at the 2021 World Conference on Lung Cancer (WCLC) showed that tislelizumab in combination with chemotherapy provided consistent survival benefits in treatment-naïve patients with squamous NSCLC, regardless of PD-L1 expression, blood tumor mutation burden (TMB), tissue TMB, and disease stage (IIIB or IV).

At the ESMO (Free ESMO Whitepaper) Congress 2021, additional analyses on smokers vs. nonsmokers in the two Phase 3 clinical trials in first-line NSCLC, RATIONALE 304 and RATIONALE 307 will be reported.

In addition, the Company is exploring tislelizumab’s potential as an early treatment option, with an ongoing global Phase 3 trial RATIONALE 315 in neoadjuvant or adjuvant settings.

BeiGene’s ePoster Presentations at ESMO (Free ESMO Whitepaper) Congress 2021

Abstract #

Title

Lead Author

3649

Sitravatinib + tislelizumab in patients with anti-PD-(L)1 refractory/resistant metastatic NSCLC

Bo Gao, M.D., Ph.D.
Blacktown Cancer and Hematology Centre (Australia)

3457

Sitravatinib + tislelizumab in patients with metastatic NSCLC

Qing Zhou, M.D., Ph.D.
Guangdong Lung Cancer Institute (China)

2562

Effects of tislelizumab monotherapy on health-related quality of life in patients with previously treated unresectable HCC

Zhenggang Ren, M.D., Ph.D.
Zhongshan Hospital (China)

3786

RATIONALE 304: Tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment for non-squamous NSCLC in patients who are smokers vs non-smokers

Shun Lu, M.D.
Shanghai Lung Cancer Center (China)

4053

Tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment for advanced squamous NSCLC in patients who were smokers vs non-smokers

Xinmin Yu, M.D.
Zhejiang Cancer Hospital (China)

1587

Association between use of antibiotics and clinical outcomes with tislelizumab monotherapy

Zhenggang Ren, M.D., Ph.D.
Zhongshan Hospital (China)

BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy volunteers. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.