On October 17, 2023 Bristol Myers Squibb (NYSE: BMY) reported three-year follow-up results from exploratory analyses of the Phase 3 CheckMate -816 trial, demonstrating sustained event-free survival (EFS) and promising overall survival (OS) trends with three cycles of Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC), regardless of PD-L1 expression levels (Press release, Bristol-Myers Squibb, OCT 17, 2023, View Source;816-Trial/default.aspx [SID1234636059]). Neoadjuvant Opdivo with chemotherapy also showed improvements in pathologic complete response (pCR) and major pathologic response (MPR) over chemotherapy alone in PD-L1 ≥1% and <1% patient populations. The safety profile of the Opdivo-based regimen was consistent across all PD-L1 subgroups. These results will be featured in a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 on October 23, 2023, from 8:45 a.m. to 9:55 a.m. EDT / 14:45 to 15:55 CEST (Abstract #LBA57).

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"The three-year results with neoadjuvant nivolumab with chemotherapy are a continuation of the statistically significant and clinically meaningful results we have seen with this regimen in the treatment of resectable non-small cell lung cancer, and they provide hope for patients that they may achieve long-term benefit," said Mariano Provencio Pulla, M.D., Ph.D., Medical Oncology, Hospital Universitario Puerta de Hierro, Madrid, Spain. "It is encouraging to see that this neoadjuvant immunotherapy combination has demonstrated improvements across efficacy measures, regardless of PD-L1 expression levels, including within the PD-L1 negative subgroup that faces high unmet needs and represents approximately 40% of the study population. The CheckMate -816 data clearly indicate the potential for better outcomes for patients with this regimen than chemotherapy alone."

With a median follow-up of 41.4 months in the CheckMate -816 trial, exploratory analyses showed:

OS: While OS remains immature at this follow-up, promising OS trends were seen in both PD-L1 ≥1% and <1% patient populations. For patients with tumor PD-L1 expression ≥1%, Opdivo with chemotherapy reduced the risk of death by 63% (Hazard Ratio [HR] 0.37; 95% Confidence Interval [CI]: 0.20 to 0.71). Three-year OS rates favored neoadjuvant Opdivo with chemotherapy over chemotherapy alone at 85% vs. 66%, respectively. In patients with PD-L1 <1%, Opdivo with chemotherapy reduced the risk of death by 19% (HR 0.81; 95% CI: 0.48 to 1.36), with three-year OS rates being 71% vs. 60%.
EFS: Among patients with tumor PD-L1 expression ≥1%, three-year EFS rates were 72% with neoadjuvant Opdivo with chemotherapy vs. 47% with chemotherapy alone (HR 0.46; 95% CI: 0.28 to 0.77). In patients with tumor PD-L1 expression <1%, EFS rates were 42% with the combination vs. 39% with chemotherapy (HR 0.87; 95% CI: 0.57 to 1.35).
pCR: In patients with PD-L1 ≥1%, pCR rates were 32.6% with neoadjuvant Opdivo with chemotherapy compared to 2.2% with chemotherapy alone. For those with PD-L1 <1%, pCR rates were 16.7% vs. 2.6%, respectively.
MPR: Among patients with PD-L1 ≥1%, MPR rates with neoadjuvant Opdivo with chemotherapy were 44.9% vs. 5.6% with chemotherapy. For patients with PD-L1 <1%, MPR rates were 29.5% with the Opdivo-based regimen and 14.3% with chemotherapy alone.
Definitive Surgery: Definitive surgery rates with Opdivo with chemotherapy vs. chemotherapy were 84% vs. 74% in patients with tumor PD-L1 expression ≥1% and 81% vs. 77% in patients with tumor PD-L1 expression <1%. Of these, complete resection was achieved in 91% vs. 82% and 79% vs. 76% of cases, respectively.
"At ESMO (Free ESMO Whitepaper) this year, we are presenting data from several trials across stages and treatment settings in non-small cell lung cancer, including two studies in resectable disease. This is an area of research that we are heavily committed to, as it presents an important opportunity to treat cancer at earlier stages when the tumor is most responsive to treatment and the patient’s immune system is most intact," said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. "We are thrilled to see consistent results with the neoadjuvant regimen of Opdivo with chemotherapy from the CheckMate -816 study, regardless of PD-L1 expression, which build on the benefits we have already seen that led to multiple approvals of this combination globally. We want to sincerely thank every patient and investigator involved in the clinical trial."

Opdivo and Opdivo-based combinations have shown improved efficacy in the neoadjuvant, adjuvant or perioperative treatment of four earlier-stage tumor types, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

About CheckMate -816

CheckMate -816 is a Phase 3 randomized, open label, multi-center trial evaluating Opdivo with chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable stage IB to IIIA non-small cell lung cancer (per the 7th edition American Joint Committee on Cancer/Union for International Cancer Control staging criteria), regardless of PD-L1 expression. For the primary analysis, 358 patients were randomized to receive either Opdivo 360 mg plus histology-based platinum doublet chemotherapy every three weeks for three cycles, or platinum doublet chemotherapy every three weeks for three cycles, followed by surgery. The primary endpoints of the trial are event-free survival and pathologic complete response. Secondary endpoints include overall survival, major pathologic response, and time to death or distant metastases.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.

On October 17, 2023 Bristol Myers Squibb (NYSE: BMY) reported the first presentation of results from the Phase 3 CheckMate -901 trial, in which Opdivo (nivolumab) in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) compared to standard-of-care cisplatin-based chemotherapy as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma who are cisplatin-eligible (Press release, Bristol-Myers Squibb, OCT 17, 2023, View Source;901-Trial/default.aspx [SID1234636058]).

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With a median follow-up of approximately 33 months, treatment with Opdivo in combination with cisplatin-based chemotherapy reduced the risk of death by 22%, demonstrating a median OS of 21.7 months vs. 18.9 months with chemotherapy alone (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63 to 0.96; p=0.0171). At the 12- and 24-month landmark analyses, patients treated with upfront Opdivo plus chemotherapy experienced OS rates of 70.2% and 46.9%, respectively, compared to 62.7% and 40.7% with chemotherapy. In patients receiving the Opdivo-based combination, the risk of death or disease progression was reduced by 28%, with median PFS at 7.9 months compared to 7.6 months with chemotherapy (HR 0.72; 95% CI: 0.59 to 0.88; p=0.0012). The landmark 12- and 24-month PFS rates were 34.2% and 23.5%, compared to 21.8% and 9.6% with chemotherapy. The combination of Opdivo with cisplatin-based chemotherapy had a tolerable safety profile consistent with the known safety profiles of the individual components of the regimen. No new safety concerns have been identified.

Additionally, in exploratory analyses, Opdivo with cisplatin-based chemotherapy resulted in an approximately 15% higher objective response rate (ORR) compared to chemotherapy alone (57.6% vs. 43.1%), and nearly doubled the number of patients who achieved a complete response (CR; 21.7% vs. 11.8%). Opdivo in combination with cisplatin-based chemotherapy was associated with longer duration of response than chemotherapy, and median duration of complete response was nearly tripled (37.1 months vs. 13.2 months).

The first disclosure of these data will be featured in a Presidential Symposium during the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 on October 22, 2023, from 10:30 a.m. to 12:15 p.m. EDT / 16:30 to 18:15 CEST (Abstract #LBA7).

"In patients with metastatic urothelial carcinoma, we often see poor durability of responses with chemotherapy alone in the first-line treatment setting. This has long been a major challenge in the treatment of patients with this hard-to-treat disease," said Michiel S. van der Hejiden, M.D., Ph.D., Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands. "This survival benefit seen with nivolumab in combination with cisplatin-based chemotherapy represents a momentous accomplishment that may provide hope for urothelial cancer patients as the first concurrent chemo-immunotherapy combination to demonstrate such an improvement compared to standard-of-care cisplatin-based combinations. The implications of these data have the potential to be practice-changing and transform the way cisplatin-eligible patients are treated."

"Historically, there have been no effective immunotherapy-based options available in the front-line setting for patients with unresectable or metastatic urothelial carcinoma who are cisplatin-eligible. We are proud to see these results demonstrating that Opdivo with cisplatin-based chemotherapy may provide patients hope and offer survival benefits with this immunotherapy approach," said Dana Walker, M.D., M.S.C.E., vice president, global program lead, genitourinary cancers, Bristol Myers Squibb. "The CheckMate -901 results bolster our existing body of research, which has shown overall survival improvements with Opdivo-based treatments across multiple tumor types, including in genitourinary cancers. We look forward to discussing these data with global health authorities in the coming months and have great hope that we may potentially provide these patients with a new and much needed treatment regimen."

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -901 clinical trial.

Opdivo and Opdivo-based combinations have shown significant improvements in OS in Phase 3 clinical trials across several tumors, including metastatic urothelial carcinoma, advanced renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, metastatic melanoma and esophageal squamous cell carcinoma.

About CheckMate -901

CheckMate -901 is a Phase 3, randomized, open-label trial evaluating Opdivo in combination with Yervoy or Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy compared to standard-of-care chemotherapy alone, in patients with untreated unresectable or metastatic urothelial cancer.

In the CheckMate -901 study, evaluating Opdivo with cisplatin-based chemotherapy vs. standard-of-care chemotherapy, a total of 608 patients eligible for cisplatin-based chemotherapy were randomized to receive either Opdivo 360 mg in combination with cisplatin-based chemotherapy every 3 weeks or chemotherapy alone followed by 480mg/Q4 Opdivo monotherapy until disease progression or death up to a maximum of two years. The primary endpoints of this study are overall survival (OS) and progression-free survival (PFS). The study is ongoing to assess Opdivo plus Yervoy vs. standard-of-care chemotherapy.

The OS and PFS outcomes for patients who are eligible for cisplatin-based chemotherapy are based on the final efficacy analyses of these endpoints.

About Urothelial Carcinoma

Bladder cancer is the 10th most common cancer in the world, with more than 573,000 new cases diagnosed annually. Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, accounts for approximately 90% of bladder cancer cases. In addition to the bladder, urothelial carcinoma can occur in other parts of the urinary tract, including the ureters and renal pelvis. The majority of urothelial carcinomas are diagnosed at an early stage, but approximately 50% of patients who undergo surgery will experience disease progression and recurrence within two-to-three years post-surgery. Approximately 20% to 25% of patients with urothelial carcinoma develop metastatic disease. The poor durability of responses seen with chemotherapy alone in the first-line setting presents a major challenge in the treatment of metastatic disease, and there are limited treatment options in the second-line setting for patients with advanced urothelial carcinoma.

On October 17, 2023 Bristol Myers Squibb (NYSE: BMY) reported the first disclosure of data from the Phase 3 CheckMate -77T trial evaluating the perioperative regimen of neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) (Press release, Bristol-Myers Squibb, OCT 17, 2023, View Source;77T-Trial/default.aspx [SID1234636057]). In the study, the perioperative regimen showed a statistically significant and clinically meaningful improvement in the primary efficacy endpoint of event-free survival (EFS) as assessed by Blinded Independent Central Review (BICR) compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.

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With a median follow-up of 25.4 months, in patients treated with neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo, the risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 97.36% Confidence Interval [CI]: 0.42 to 0.81; p=0.00025). Additionally, neoadjuvant Opdivo and chemotherapy showed improvements in the secondary efficacy endpoints of pathologic complete response (pCR; 25.3% vs. 4.7%) and major pathologic response (MPR; 35.4% vs 12.1%). The study is ongoing to assess its other secondary endpoint of overall survival (OS). Definitive surgery rates were 78% with the Opdivo-based regimen vs. 77% with chemotherapy and placebo, with complete resection achieved in 89% vs. 90% of patients, respectively. The safety profile of the Opdivo-based regimen was consistent with previously reported studies in NSCLC. No new safety signals were identified.

The first disclosure of these data will be featured in a Presidential Symposium during the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 on October 21, 2023, from 10:30 a.m. to 12:15 p.m. EDT / 16:30 to 18:15 CEST (Abstract #LBA1).

"Over the past few years, we have witnessed incredible progress in the treatment of patients with non-metastatic non-small cell lung cancer. Now, we are evaluating therapeutic strategies that expand on these advances with the goal of providing clinical benefit to a greater number of patients with resectable disease," said Tina Cascone, M.D., Ph.D., associate professor of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. "I am extremely encouraged by the findings of CheckMate -77T evaluating neoadjuvant nivolumab and chemotherapy followed by surgery and adjuvant nivolumab, and by how continuing adjuvant nivolumab after surgery may further improve outcomes and provide a potentially more durable benefit for our patients. The results from the CheckMate -77T study are promising for physicians, patients and their families alike. I look forward to seeing how the data from this ongoing trial continues to unfold, especially the secondary endpoint of overall survival."

"The results from the CheckMate -77T study add to the evidence supporting the use of Opdivo-based therapies in resectable non-small cell lung cancer and reinvigorate our commitment to treating cancer at earlier stages of the disease in the hopes of helping patients attain durable benefit," said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. "We are pleased to be presenting research from multiple trials in resectable NSCLC at ESMO (Free ESMO Whitepaper), building on our deep scientific understanding of thoracic cancer treatment. We look forward to upcoming discussions with regulatory authorities and hope that we may offer yet another option to patients with non-metastatic NSCLC that could potentially reduce their risk of disease recurrence, progression or death, and lead to better long-term outcomes."

To date, Opdivo and Opdivo-based combinations have shown improved efficacy in the neoadjuvant, adjuvant or perioperative treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -77T clinical trial.

About CheckMate -77T

CheckMate -77T is a Phase 3 randomized, double-blind, placebo-controlled, multi-center trial evaluating neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo in 452 patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The primary endpoint of the trial is event-free survival (EFS). Secondary endpoints include overall survival (OS), pathologic complete response (pCR) and major pathologic response (MPR).

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.

On October 17, 2023 Biomea Fusion, Inc. ("Biomea" or "the company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported that the first patient has been dosed in COVALENT-103, the company’s Phase I trial of BMF-500, an investigational covalent FLT3 inhibitor developed using the proprietary FUSIONTM System, in adult patients with relapsed or refractory acute leukemia (Press release, Biomea Fusion, OCT 17, 2023, View Source [SID1234636056]).

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"Despite several late stage and approved therapies targeting FLT3, the majority of patients with AML harboring FLT3 mutations have not achieved durable remissions. We believe that BMF-500, which is designed to have key attributes of covalency, potency, and selectivity, has the capacity to fully extinguish FLT3-driven disease and the potential to combine with other targeted therapies and standard-of-care agents," said Steve Morris, MD, Biomea’s Chief Development Officer.

"Today, we have taken another important step to bring novel covalent drug candidates into the clinic by exploring the potential of BMF-500, an investigational covalent FLT3 inhibitor, in treating adult patients with relapsed or refractory acute leukemia. BMF-500 is designed to be a potent molecule and is the second covalent inhibitor we have developed in-house, demonstrating the potential of the FUSIONTM platform and our team in bringing novel assets to the clinic. Beyond single agent studies of BMF-500 we are planning combination studies with various approved therapies and therapy candidates, including BMF-219, to explore the potential of this powerful dual-mechanistic approach to provide deeper and more durable treatment responses," said Thomas Butler, Biomea’s CEO and Chairman of the Board.

About COVALENT-103

COVALENT-103 is a multicenter, open-label, non-randomized trial seeking to evaluate the safety and efficacy of BMF-500, a twice daily oral treatment, in adult patients with relapsed or refractory acute leukemia with FMS-like tyrosine kinase 3 (FLT3) wild-type and FLT3 mutations. Additional information about the Phase I clinical trial of BMF-500 can be found at ClinicalTrials.gov using the identifier NCT05918692.

About BMF-500

BMF-500, an investigational, novel, orally bioavailable, highly potent and selective covalent small molecule inhibitor of FLT3, was discovered and developed in-house at Biomea using the company’s proprietary FUSION System and has demonstrated encouraging potential based on extensive preclinical studies. The kinase inhibitory profile of BMF-500 showed high target selectivity, suggesting the potential for reduced off-target liabilities. BMF-500 was designed to have a therapeutic profile to allow for combinations with standard of care and/or novel targeted agents like BMF-219, Biomea’s investigational covalent menin inhibitor currently in clinical development for solid and liquid tumors as well as diabetes.

Previous data presented at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showed BMF-500’s picomolar affinity for inhibition of activating FLT3 mutations, including FLT3-ITD and various tyrosine kinase domain (TKD) mutations. BMF-500 demonstrated multi-fold higher potency and increased cytotoxicity than the commercially available non-covalent FLT3 inhibitor gilteritinib. These data also showed complete tumor regression in mouse models of FLT3-ITD AML, with no tumor regrowth even after treatment cessation.

Data presented at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting exhibited the potential utility of combination strategies to achieve higher antileukemic cell killing with reduced concentrations of BMF-500 and BMF-219. Additionally, Biomea has shown the potential of combinatorial approaches of BMF-500 and BMF-219 with MEK and BCL2 blockade in other preclinical studies. These data provide preclinical evidence for combining pathway-specific inhibitors as a promising therapeutic strategy for further investigation in acute leukemia.

About FLT3 in AML

FLT3 is a receptor tyrosine kinase (RTK) that plays a central role in the survival, proliferation, and differentiation of immature blood cells. FLT3 gene mutations are common in patients with AML and are associated with a poor prognosis. Nearly 30% of AML patients have a FLT3 mutation, representing more than 6,000 incident patients in the U.S. each year. In addition, academic literature suggests that >50% of AML patients with an NPM1 mutation also harbor a FLT3 mutation. While FLT3-specific and pan-tyrosine kinase inhibitors are approved by the FDA across various lines of therapy in AML, these agents have produced relatively low rates of durable responses and overall survival remains an unmet need.

On October 17, 2023 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that the Phase 3 RATIONALE 315 study met its dual primary endpoints of major pathological response (MPR) by Blinded Independent Pathology Review (BIPR) and event-free survival (EFS) by Blinded Independent Central Review (BICR), demonstrating statistically significant and clinically meaningful improvements in patients with resectable Stage II or IIIA NSCLC treated with tislelizumab in combination with chemotherapy before surgery and as a single agent after surgery versus neoadjuvant chemotherapy plus placebo followed by placebo after surgery (Press release, BeiGene, OCT 17, 2023, View Source [SID1234636055]). The tislelizumab plus chemotherapy regimen also showed a statistically significant improvement in pathological complete response (pCR), the key secondary endpoint, after neoadjuvant therapy versus chemotherapy. The MPR and pCR data will be featured as a late-breaking mini oral presentation on October 23 at 2:55 p.m. CEST at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 (Abstract #LBA58).

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In the study, 56.2% of NSCLC patients treated with tislelizumab in combination with chemotherapy before surgery achieved MPR, compared to 15.0% of patients treated with chemotherapy alone (difference: 41.1%; 95% CI: 33.2-49.1, p<0.0001). MPR is defined as less than 10% residual viable tumor after neoadjuvant therapy. Additionally, 40.7% of patients on the tislelizumab-based regimen achieved pCR, defined as no viable residual tumor after neoadjuvant therapy, compared to 5.7% of patients treated with chemotherapy alone (difference: 35.0%; 95% CI: 27.9-42.1, p<0.0001). Tislelizumab plus chemotherapy was generally well tolerated, with no new safety signals identified.

Additionally, at a recent prespecified interim analysis conducted by the independent data monitoring committee (IDMC), the tislelizumab-based regimen demonstrated a statistically significant improvement in EFS per assessment by BICR. Detailed results will be submitted for presentation at an upcoming medical conference.

"Lung cancer remains the most common type of cancer and the leading cause of cancer-related death worldwide. Despite available treatment options, rates of recurrence within five years remain unacceptably high, underscoring the need for innovative new neoadjuvant and adjuvant interventions to help improve patient outcomes," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "The data from RATIONALE 315 are encouraging and demonstrate that early integration of tislelizumab into the treatment paradigm may help both improve responses at the time of surgery and reduce the recurrence risk for these patients. These results add to the growing evidence suggesting the potential benefits of tislelizumab in treating patients with NSCLC."

About RATIONALE 315 (NCT04379635)

RATIONALE 315 is a randomized, double-blind, placebo-controlled, Phase 3 trial evaluating the efficacy and safety of neoadjuvant tislelizumab plus platinum-based doublet chemotherapy, followed by surgery and subsequent adjuvant tislelizumab, compared to placebo plus neoadjuvant platinum-based doublet chemotherapy followed by surgery and subsequent adjuvant placebo in patients with resectable Stage II or IIIA NSCLC. The primary endpoints are MPR rate by BIPR and EFS by BICR. The key secondary endpoint is pCR. Other secondary endpoints included overall survival (OS), objective response rate (ORR), disease-free survival (DFS) as assessed by BICR, and investigator assessed EFS. A total of 453 patients were enrolled and randomized 1:1 to receive either tislelizumab or placebo in combination with chemotherapy.

About Tislelizumab

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody, with high affinity and binding specificity against PD-1, specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. In pre-clinical studies, binding to Fcγ receptors 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.i,ii,iii,iv

The tislelizumab development program encompasses 21 registration-enabling clinical trials in more than 30 countries and regions. To date, BeiGene has announced positive readouts from 10 Phase 3 pivotal studies across multiple tumor types and disease settings, such as NSCLC, small cell lung cancer, gastric cancer, ESCC, hepatocellular cancer, and nasopharyngeal cancer. More information on the clinical trial program for tislelizumab can be found at: View Source

Tislelizumab is currently under review by the U.S. Food and Drug Administration (FDA) and received approval by the European Commission for advanced or metastatic ESCC after prior chemotherapy. Additionally, the FDA recently accepted for review a Biologics License Application for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. The European Medicines Agency (EMA) is reviewing a marketing authorization application for tislelizumab as a treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated locally advanced or metastatic NSCLC.

Regulatory submissions for tislelizumab are also under review by authorities in Australia, Brazil, China, Korea, Israel, New Zealand, Singapore, Switzerland, and the U.K. Tislelizumab is approved for 11 indications in China and is the leading PD-1 inhibitor in the country.