2021 – Page 1719 – 1stOncology™: Cancer Intelligence Service

Libtayo® (cemiplimab-rwlc) Presentations at ASCO Highlight Expanding Clinical Data in Diverse Cancers

On May 19, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the company will share a range of presentations for its PD-1 inhibitor Libtayo (cemiplimab-rwlc) and broader oncology portfolio at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, taking place virtually (Press release, Regeneron, MAY 19, 2021, View Source [SID1234580258]). Presentations include new clinical data and in-depth analyses on the impact of Libtayo in several advanced cancers, including non-small cell lung cancer (NSCLC), cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC) and melanoma.

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"Following our presentation of updated, positive cervical data at the ESMO (Free ESMO Whitepaper) Virtual Plenary, we look forward to providing an overview of the maturing experience with Libtayo across a range of cancers at ASCO (Free ASCO Whitepaper)," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology, at Regeneron. "Presentations include a new post-hoc analysis of our pivotal Libtayo trial for advanced non-small cell lung cancer in a subset of patients with brain metastases, as well as new data from a prospective real-world trial in immunocompromised or immunosuppressed patients with advanced cutaneous squamous cell carcinoma. We will also share presentations showing the impact of Libtayo on quality of life in multiple cancers, and for the first time, positive results for Libtayo in combination with our investigational LAG-3 inhibitor fianlimab in advanced melanoma."

Investigator-assessed results from two expansion cohorts of a Phase 1 trial investigating fianlimab (REGN3767) and Libtayo in advanced melanoma were published by ASCO (Free ASCO Whitepaper) today. Efficacy was greatest in PD-1 inhibitor naïve patients, who experienced a 64% objective response rate (21 of 33 patients; 3 complete responses, 18 partial responses), and the median progression-free survival and median duration of response had not yet been reached.

Among 48 patients receiving the fianlimab and Libtayo combination, the most common adverse events (AEs) were fatigue (n=15; 31%) and rash (n=11; 23%). Grade 3 or higher AEs occurred in 35% (n=17) of patients, with 23% (n=11) of these events classified as serious. Treatment discontinuations due to an AE occurred in 8% (n=4) of patients. Updated efficacy and safety data will be presented during a poster discussion session available on-demand starting Friday, June 4 at 9:00 a.m. ET (Abstract 9515).

Earlier this year, Libtayo monotherapy was approved in the U.S. for certain patients with NSCLC whose tumors have high PD-L1 expression and no EGFR, ALK or ROS1 aberrations. The FDA also recently approved the use of Libtayo as the first immunotherapy indicated for patients with BCC previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, whose cancer is either locally-advanced (full approval) or metastatic (accelerated approval). In 2018, Libtayo was approved as the first systemic treatment for certain patients with advanced CSCC. Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

Investor Webcast Information
Regeneron will host a conference call and simultaneous webcast to share updates on the Company’s oncology portfolio on Monday, June 7 at 4:30 p.m. ET. To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 7569618. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

Libtayo joint presentations with Sanofi at ASCO (Free ASCO Whitepaper)
NSCLC

Cemiplimab monotherapy as first-line (1L) treatment of patients with brain metastases from advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%; EMPOWER-Lung 1 subgroup analysis (Abstract 9085; Mustafa Özgüroğlu, M.D.; Poster Session)
Patient-reported symptoms, functioning, and quality of life (QoL) in patients treated with cemiplimab monotherapy for first-line treatment of advanced NSCLC with PD-L1 ≥50%: Results from EMPOWER-Lung 1 study (Abstract 9078; Mahmut Gümüş, M.D.; Poster Session)
Network meta-analysis (NMA) of immuno-oncology (IO) monotherapy (mono) as first-line (1L) treatments (txs) for advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥50% (Abstract e21091; Nick Freemantle, Ph.D.; Online Publication)
Budget impact (BI) analysis of cemiplimab for first-line (1L) advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50% in the United States (Abstract e18817; Andreas Kuznik, Ph.D.; Online Publication)
BCC

Health-related quality of life (HRQoL) in patients (pts) with locally advanced basal cell carcinoma (laBCC) treated with cemiplimab: analysis of a phase II, open-label clinical trial (Abstract 9566; Alexander J. Stratigos, M.D.; Poster Session)
Frequency, characteristics, and subsequent treatment (Tx) of real-world patients (pts) who discontinue hedgehog inhibitors (HHI) as first-line (1L) systemic Tx for advanced basal cell carcinoma (aBCC) (Abstract e18740; C. Lance Cowey, M.D.; Online Publication)
Outcomes in patients (pts) with advanced basal cell carcinoma (aBCC) who discontinued hedgehog inhibitors (HHI) as first-line (1L) systemic treatment (Tx) in a US community oncology setting: A retrospective observational study (Abstract e18742; C. Lance Cowey, M.D.; Online Publication)
Budget impact (BI) analysis of cemiplimab-rwlc for advanced basal cell carcinoma (BCC) after hedgehog inhibitor (HHI) therapy in the United States (Abstract e18830; Eleanor Paul; Online Publication)
CSCC

Checkpoint inhibition in immunosuppressed or immunocompromised patients with advanced cutaneous squamous cell carcinoma (CSCC): Data from prospective CemiplimAb-rwlc Survivorship and Epidemiology (C.A.S.E.) study (Abstract 9547; Guilherme Rabinowits, M.D.; Poster Session)
Additional Regeneron presentations at ASCO (Free ASCO Whitepaper)
Libtayo in combination with fianlimab

Clinical activity of fianlimab (REGN3767), a human anti-LAG-3 monoclonal antibody, combined with cemiplimab (anti-PD-1) in patients (pts) with advanced melanoma (Abstract 9515; Omid Hamid, M.D.; Poster Discussion)
REGN5668 (MUC16xCD28)

A Phase I/II, multicenter, open-label study of REGN5668 (mucin [MUC]16 x CD28 bispecific antibody [bsAb]) with cemiplimab (programmed death [PD]-1 Ab) or REGN4018 (MUC16 x CD3 bsAb) in recurrent ovarian cancer (rOVCA) (Abstract TPS5602; Ira Winer, M.D., Ph.D.; Trial-in-progress Poster)
The use of fianlimab in combination with Libtayo for advanced melanoma is investigational, and its safety and efficacy have not been evaluated by any regulatory authority.

About Regeneron in Oncology
At Regeneron, we’re applying more than three decades of scientific innovation to develop paradigm-changing therapies for patients with cancer. Fusing our deep expertise in biology with our proprietary VelociSuite technologies, we have contributed landmark cancer research to the field and are pioneering first-in-class investigational treatments through a growing pipeline of more than 10 cancer therapies.

Our oncology portfolio is built around two foundational approaches – our approved PD-1 inhibitor Libtayo and bispecific antibodies – which are being investigated both as monotherapies and in combination with emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic treatments for a wide range of solid tumors and blood cancers.

For more information on our clinical programs, visit www.regeneron.com/pipeline.

About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

Libtayo is currently approved as the first systemic treatment in the U.S., EU and other countries for adults with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In the U.S., Libtayo is also approved as the first immunotherapy indicated for patients with advanced BCC previously treated with an HHI or for whom an HHI is not appropriate, and for the first-line treatment of certain patients with advanced NSCLC with ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.

The generic name for Libtayo in its approved U.S. indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Current clinical development programs include Libtayo in combination with chemotherapy for advanced NSCLC irrespective of PD-L1 expression and Libtayo monotherapy for advanced cervical cancer. Libtayo is also being investigated in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN-COV (casirivimab with imdevimab), Dupixent (dupilumab), Libtayo (cemiplimab-rwlc), Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb) and Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn).

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is Libtayo?
Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

Libtayo is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that cannot be removed by surgery (locally advanced BCC) and have received treatment with an HHI, or cannot receive treatment with an HHI.

Libtayo is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with an HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.

Libtayo is a prescription medicine used to treat people with a type of lung cancer called non-small cell lung cancer (NSCLC). Libtayo may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1" and your tumor does not have an abnormal "EGFR", "ALK "or "ROS1" gene.

It is not known if Libtayo is safe and effective in children.

What is the most important information I should know about Libtayo?
Libtayo is a medicine that may treat certain cancers by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, or chest pain
Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness
Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Libtayo. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling
Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Libtayo. Your healthcare provider will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Libtayo if you have severe side effects.

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. Libtayo can harm your unborn baby
Females who are able to become pregnant:

Your healthcare provider will give you a pregnancy test before you start treatment.
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.
Tell your healthcare provider about all the medicines you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Libtayo include muscle or bone pain, tiredness, rash, and diarrhea. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals and Sanofi at 1-877-542-8296.

Veracyte Announces New Pivotal Clinical Validation Data at ASCO Showing Noninvasive Nasal Swab Test Can Significantly Improve Early Lung Cancer Detection

On May 19, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported pivotal clinical validation data showing that the company’s noninvasive nasal swab test can significantly improve the early assessment of lung cancer (Press release, Veracyte, MAY 19, 2021, View Source [SID1234580257]). The new findings show that the Percepta Nasal Swab, a first-of-its-kind genomic test, accurately classifies lung cancer risk in current or former smokers with lung nodules so that those with benign nodules may safely avoid unnecessary additional procedures, while those with likely cancerous nodules may receive more timely diagnosis and treatment. The findings will be presented June 4, 2021 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"Lung nodules are often the first sign of lung cancer and cannot be ignored, yet most of them are benign," said Carla R. Lamb, M.D., interventional pulmonologist at Lahey Hospital & Medical Center in Burlington, Mass., who was an investigator on the nasal classifier study. "Today, physicians have limited objective tools to determine which patients with lung nodules found on CT scans have cancer and which don’t. Our findings showed that the nasal swab test can determine, with a high level of accuracy, which patients are at low risk of cancer and can avoid invasive procedures. Similarly, it can identify which patients are at high risk and may be confidently directed to further work-up and, potentially, to the treatment they need. An objective tool that can accurately inform these decisions could be a game-changer for early lung cancer assessment."

For the study, researchers evaluated the performance of the nasal swab test on a blinded, independent validation set of 249 patients from multiple cohorts of prospectively collected nasal samples of current or former smokers undergoing evaluation for lung nodules found on computed tomography (CT). All were followed for up to one year or until physicians made a final, adjudicated diagnosis. The cancer prevalence in the validation cohort was 54% — higher than the 25% cancer prevalence expected in the broad population of patients with suspicious nodules, on which the test is expected to be used.

Results of the validation study demonstrate that the test identifies patients as low risk for cancer with a sensitivity of 96.3% (CI: 91.6%-98.4%) and specificity of 41.7% (CI: 33.1%-50.9%). At the same time, the test identifies patients as high risk for cancer with a specificity of 90.4% (CI: 83.68%-94.57%) and sensitivity of 58.2% (CI: 49.74%-66.22%). These findings show the test classifies more than 40% of patients with confirmed benign nodules as low risk, allowing them to avoid further procedures, and it classifies nearly 60% with confirmed malignant nodules as high risk, enabling them to be directed to more timely diagnosis and potential treatment. The remaining patients were classified as intermediate risk for cancer.

When the test’s performance was applied to a population with 25% cancer prevalence, it showed that the test’s negative predictive value (NPV) is 97.1%, which means that a patient classified as low risk has only a 2.9% risk of malignancy. Similarly, the positive predictive value (PPV) is 67%, meaning that nearly 70% of patients classified as high risk will have lung cancer. The American College of Chest Physicians’ current guidelines recommend diagnostic biopsy for patients with more than 65% cancer risk.

"What is really exciting about these data is that doctors will be able to tell their patients with suspicious lung nodules that they are low risk for cancer and can likely avoid further work-up, with very high certainty that they have not missed a cancer," said Giulia C. Kennedy, Ph.D., Veracyte’s chief scientific officer and chief medical officer. "At the same time, they can be confident in guiding patients who are high risk to further diagnostic procedures, in line with current guidelines. These findings suggest that the Percepta Nasal Swab test will be able to objectively and accurately stratify approximately half of the patients with lung nodules found on CT scans to low or high risk, while those not classified will remain a candidate for current standard of care. We are excited about the opportunity to transform the early assessment of lung nodules with a simple nasal swab test."

The Percepta Nasal Swab test uses advanced genomic and established "field of injury" technology to detect smoking-related damage associated with lung cancer in current or former smokers using a sample collected from the nasal passage. Veracyte developed the final classifier using RNA whole-transcriptome sequencing and machine learning on a rich training set of nasal samples from more than 1,100 patients representing a wide range of lung and tumor biology.

Veracyte expects to begin making the Percepta Nasal Swab test available to a select number of sites in the second half of 2021. The company aims to adapt the test on the nCounter Analysis System in 2022, enabling its expansion to physicians and their patients in global markets in 2023.

The Percepta Nasal Swab test is a key part of Veracyte’s comprehensive lung cancer portfolio, which aims to transform care at every step of the patient journey. Collectively, the company’s tests are leveraging cutting-edge genomic science and technology to provide answers and insights that enable physicians and patients to make better, faster and more confident care decisions. The lung cancer portfolio includes the Percepta Genomic Sequencing Classifier, which helps improve lung cancer diagnosis when bronchoscopy results are inconclusive, and the in-development Percepta Genomic Atlas, which is intended to detect gene alterations that may inform lung cancer treatment decisions, using the same small biopsy that was collected for diagnosis.

Development and validation of the Percepta Nasal Swab test is part of Veracyte’s ongoing collaboration with the Lung Cancer Initiative at Johnson & Johnson.*

Conference Call and Webcast Details

Veracyte will host a conference call and webcast on Thursday, May 20, at 10:00 a.m. Eastern Time to discuss the Percepta Nasal Swab test data. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call can be accessed as follows:

About Lung Cancer

Lung cancer kills more than 1.8 million people worldwide each year.i Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to 6 percent when it is found at a later stage.ii Lung nodules are typically the first sign of lung cancer, but most lung nodules are benign. Each year in the U.S., an estimated 1.6 million lung nodules are found incidentally on CT scans and, with recently expanded recommendations from the U.S. Preventive Services Task Force, an estimated 15 million Americans are eligible for annual lung cancer CT screening. Physicians currently lack objective tools to determine which lung nodules found on CT are benign and which are cancerous.

BeiGene to Showcase Broad Clinical Portfolio at 2021 ASCO Annual Meeting

On May 19, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that clinical results and updates from its broad portfolio will be presented at the 2021 Annual Meeting of the American Society of Cancer Oncology (ASCO) (Free ASCO Whitepaper) being held June 4 – 8, 2021 (Press release, BeiGene, MAY 19, 2021, View Source [SID1234580256]).

"We are pleased to share updates from our growing clinical portfolio across solid tumors and hematologic malignancies at this year’s ASCO (Free ASCO Whitepaper), including multiple novel combinations of tislelizumab with our investigational Fc-competent anti-TIGIT-antibody ociperlimab and other therapeutic agents, and the ongoing evaluation of our next-generation BTK inhibitor zanubrutinib," commented Lai Wang, Ph.D., Global Head of R&D at BeiGene. "We believe that these presentations underscore the breadth and diversity, as well as the remarkable progress and momentum, in BeiGene’s integrated global clinical development program, which we hope will lead to innovative new medicines that offer expanded access and improved affordability for patients worldwide. Through our R&D approach, we share ASCO (Free ASCO Whitepaper)’s ambition of promoting greater health equity for all patients regardless of where they live."

To learn more about BeiGene’s research and development and activities around ASCO (Free ASCO Whitepaper), please visit View Source All presentations will be available on Friday, June 4 at 9:00 a.m. ET on ASCO (Free ASCO Whitepaper) Digital Program.

BeiGene’s Diverse Research and Development Program Designed to Address Unmet Patient Needs

BeiGene takes a diverse approach in its research and development efforts by evaluating different mechanisms of action in prevalent cancer types by biomarker, histology, and line of therapy in a broad, global clinical program. At ASCO (Free ASCO Whitepaper) 2021, some of the highlights include:

Initial report from the Phase 3 RATIONALE 302 trial (NCT03430843) of tislelizumab in second-line advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC);
Initial report from the Phase 2 trial (NCT03736889) of tislelizumab in patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors; and
Long-term follow-up efficacy and safety results from the pivotal Phase 2 trial (NCT03209973) in patients with relapsed or refractory classical Hodgkin’s lymphoma (cHL).
Novel Combination Trials with Tislelizumab Designed to Improve the Clinical Benefit of Checkpoint Inhibition

Although checkpoint inhibition has revolutionized cancer treatment over the past decade, tumor immune escape induced by many mechanisms and factors presents limitations in clinical benefit. To address this issue, BeiGene has been evaluating its potentially differentiated anti-PD-1 antibody tislelizumab in a broad program combining tislelizumab with over 14 therapies or therapeutic candidates, from chemotherapies and targeted therapies to other immunotherapies, and will be presenting results or trial design details on three of these combinations – with BeiGene’s investigational anti-TIGIT-antibody ociperlimab, with chemotherapy, and with investigational anti-HER2 bispecific antibody zanidatamab (ZW25), licensed from Zymeworks, at ASCO (Free ASCO Whitepaper) 2021.

Ongoing Evaluation of Next-Generation BTK Inhibitor BRUKINSA

BTK inhibition has become an emerging standard of care in B-cell malignancies, but not all patients respond to treatment with BTK inhibitors and adverse events are the most common reason for treatment discontinuation. BeiGene’s next-generation BTK inhibitor BRUKINSA (zanubrutinib) was designed to maximize BTK occupancy and minimize off-target binding for improved efficacy and decreased side effects compared to the first-generation BTK inhibitor.

At ASCO (Free ASCO Whitepaper) 2021, updated data from the Phase 2 trial (NCT04116437) of zanubrutinib in patients with previously treated B-cell malignancies who were intolerant to prior BTK inhibitors will be available in an abstract. Results from this trial at a prior data cutoff were presented in a poster at the 62nd ASH (Free ASH Whitepaper) Annual Meeting in December 2020, including that most intolerable adverse events patients experienced on the other BTK inhibitors ibrutinib and/or acalabrutinib did not recur with BRUKINSA treatment, and that the vast majority of patients who were evaluable for response at the time of data cutoff maintained or improved their responses on zanubrutinib. Updated results will also be available in a poster at the upcoming EHA (Free EHA Whitepaper)2021 Virtual Congress.

BeiGene recently announced positive results from a planned interim analysis in the Phase 3 ALPINE trial comparing BRUKINSA against ibrutinib in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). BRUKINSA demonstrated superiority in objective response rate per investigator assessment and non-inferiority in ORR per both investigator assessment and independent review committee (IRC). Data pertaining to progression-free survival (PFS), a secondary endpoint of the trial, were immature at the data cutoff for the interim analysis; however, the descriptive summaries of PFS showed an early trend favoring BRUKINSA. In addition, BRUKINSA demonstrated a statistically significant lower risk of atrial fibrillation or flutter compared to ibrutinib, and the overall safety profile of BRUKINSA was consistent with the previously seen profile in its clinical development program.

BeiGene’s Presentations at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract #

Title

Session

Time

Lead Author

4012

RATIONALE 302: Randomized, Phase 3 study of tislelizumab vs chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma.

Poster Discussion Session, Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary