On September 20, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 1:10 p.m. EDT on Monday, October 1, at the Cantor Global Healthcare Conference (Press release, Puma Biotechnology, SEP 20, 2018, View Source [SID1234529505]). The conference will be held at the InterContinental New York Barclay Hotel.

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

On September 20, 2018 Pierre Fabre reported that the European Commission (EC) has granted marketing authorisation for the combination of BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation, as detected by a validated test (Press release, Pierre Fabre, SEP 20, 2018, View Source [SID1234529504]).1,2 The EC decision is applicable to all 28 European Union (EU) member states plus Liechtenstein, Iceland and Norway.

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"We are extremely pleased that European patients with advanced BRAF-mutant melanoma will now have the combination of BRAFTOVI and MEKTOVI as a new treatment option", said Frédéric Duchesne, President & CEO of the Pierre Fabre Pharmaceuticals Division. "All of us at Pierre Fabre are driven to make a real difference for patients. Bringing more than 30 years of oncology experience and our heritage in dermatology to our partnership with Array BioPharma, we have been able to harness our expertise in order to help men and women living with this devastating disease. Today’s news inspires us to continue pursuing new innovations that will benefit patients".

The EC decision, which follows the positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July, is based on results from the Phase 3 COLUMBUS trial.3 This trial demonstrated that the combination of BRAFTOVI 450 mg once daily and MEKTOVI 45 mg twice daily significantly improved median progression-free survival (PFS), compared with vemurafenib alone 960 mg twice daily (14.9 months versus 7.3 months, respectively: hazard ratio [HR] 0.54, 95% confidence interval [CI], 0.41–0.71; two-sided p<0.0001).3 Data published in The Lancet Oncology4 in September 2018 demonstrated that treatment with BRAFTOVI and MEKTOVI achieved a median overall survival (OS) of 33.6 months, compared with 16.9 months for patients treated with vemurafenib as a monotherapy (HR 0.61, 95% CI, 0.47–0.79; p<0.0001) in the planned analysis of OS in the COLUMBUS trial4. The most common adverse reactions (≥25%) occurring in patients treated with BRAFTOVI administered with MEKTOVI at the recommended dose (n=274 based on two Phase II trials and COLUMBUS) were fatigue, nausea, diarrhoea, vomiting, retinal detachment, abdominal pain, arthralgia, increased blood creatine kinase and myalgia.1,2 In the COLUMBUS trial, adverse events leading to discontinuation that were suspected to be related to the study treatment occurred in 6% of patients.3,4

"The European Commission’s approval is an important advance in improving the prognosis of patients with advanced BRAF-mutant melanoma", said Professor Reinhard Dummer, University of Zürich, Vice-Chairman of the Department of Dermatology in the University Hospital of Zürich, Switzerland, and investigator of the COLUMBUS study. "Physicians and patients will now have BRAFTOVI and MEKTOVI as an effective and well-tolerated treatment combination option, which has been shown to delay disease progression and potentially prolong patients’ lives".

Important safety information and recommendations for the use of BRAFTOVI and MEKTOVI are detailed in the Summary of Product Characteristics (SmPC), published in the European public assessment report (EPAR) and available in all official EU languages.
See full SmPC at: View Source

On 27 June 2018, Pierre Fabre’s partner Array BioPharma, which has exclusive rights for these medicines in the United States (US), announced that the combination of BRAFTOVI and MEKTOVI was approved by the US Food and Drug Administration (FDA) for the treatment of unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.5,6 BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma.

About BRAF-mutant Metastatic Melanoma
Melanoma develops when unrepaired DNA damage to skin cells triggers mutations that may lead them to multiply and form malignant tumours. Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates.7,8 There are a variety of gene mutations that can lead to metastatic melanoma. The most common genetic mutation in metastatic melanoma is BRAF. There are more than 100,000 new cases of melanoma diagnosed in Europe each year,9 approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma.10–11

About BRAFTOVI (encorafenib) and MEKTOVI (binimetinib)
BRAFTOVI (encorafenib) is an oral small-molecule BRAF kinase inhibitor and MEKTOVI (binimetinib) is an oral small-molecule MEK inhibitor that targets key enzymes in the MAPK signalling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, including melanoma, colorectal cancer, non-small-cell lung cancer, thyroid and others.

Pierre Fabre has exclusive rights to develop and commercialise BRAFTOVI and MEKTOVI worldwide, except in the US and Canada, where Array BioPharma retains exclusive rights; Israel, where Medison has exclusive rights; and in Japan and South Korea, where Ono Pharmaceutical has exclusive rights to commercialise both products.

BRAFTOVI + MEKTOVI Abbreviated EU Prescribing Information
▼These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of SmPC for how to report adverse reactions.

Name of the medicinal products: BRAFTOVI (encorafenib) 75 mg hard capsules and 50 mg hard capsules. MEKTOVI (binimetinib) 15 mg film-coated tablets.

Clinical particulars:
Therapeutic indications: Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Posology and method of administration: Encorafenib treatment in combination with binimetinib should be initiated and supervised under the responsibility of a physician experienced in the use of anticancer medicinal products. Posology: The recommended dose of encorafenib is 450 mg (six 75 mg capsules) once daily, when used in combination with binimetinib. The recommended dose of binimetinib is 45 mg (three 15 mg tablets) twice daily corresponding to a total daily dose of 90 mg approximately 12 hours apart. Dose modification: The management of adverse reactions may require dose reduction, temporary interruption or treatment discontinuation (for complete information, please refer to SmPC 4.2 section). Method of administration: For oral use. The capsules of encorafenib are to be swallowed whole with water. They may be taken with or without food. The concomitant administration of encorafenib with grapefruit juice should be avoided. The tablets of binimitinib are to be swallowed whole with water. They may be taken with or without food.

Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the BRAFTOVI and MEKTOVI SmPc.

Special warnings and precautions for use: Encorafenib and binimetinib have to be given in combination. Before taking encorafenib in combination with binimetinib, patients must have BRAFV600 mutation confirmed by a validated test. For complete information on the following special warnings and precautions for use: Patients who have progressed on a BRAF inhibitor, patients with brain metastases. Left ventricular dysfunction, Haemorrhage, ocular toxicities. QT Prolongation, New primary malignancies, Cutaneous and non-cutaneous malignancies, Liver laboratory abnormalities, Hepatic impairment, Renal impairment, CK elevation and rhabdomyolysis, Hypertension, Venous thromboembolism (VTE), Pneumonitis/Interstitial lung disease, Lactose intolerance, please refer to BRAFTOVI and MEKTOVI SmPC 4.4 section.

Interaction with other medicinal products and other forms of interaction: Encorafenib is primarily metabolised by CYP3A4. Therefore, concomitant administration of encorafenib with strong CYP3A4 inhibitors should be avoided. Agents that are CYP3A4 substrates (inhibitor and inducer) should be co-administered with caution. Binimetinib is primarily metabolised through UGT1A1 mediated glucuronidation. Therefore, inducers and inhibitors of UGT1A1 should be co-administered with caution. For complete information, please refer to SmPC, 4.5 section.

Undesirable effects: Summary of safety profile: At the recommended dose (n=274) in patients with metastatic melanoma, the most common adverse reactions (≥ 25%) occurring in patients treated with encorafenib administered with binimetinib were fatigue, nausea, diarrhea, vomiting, retinal detachment, abdominal pain, arthralgia, blood CK increased and myalgia. For complete information, please refer to BRAFTOVI and MEKTOVI SmPC 4.8 section.

For complete information please refer to the full SmPC which can be found at: View Source

About COLUMBUS
The COLUMBUS trial (NCT01909453) is a two-part, international, randomised, open-label, Phase 3 trial evaluating the efficacy and safety of BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) compared with vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAFV600 mutation.12 The primary endpoint of the trial was median progression-free survival (PFS); all secondary efficacy analyses, including the prospectively planned analysis overall survival (OS), are descriptive in nature. More than 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the COLUMBUS trial.

The EC decision is based on results from the Phase 3 COLUMBUS trial, which demonstrated that the combination improved median PFS, compared with vemurafenib alone (14.9 months versus 7.3 months, respectively: HR 0.54, 95% CI, 0.41–0.71; p<0.001).1–3 As presented at ASCO (Free ASCO Whitepaper) in June 2018, treatment with BRAFTOVI and MEKTOVI achieved a median OS of 33.6 months, compared with 16.9 months for patients treated with vemurafenib as a monotherapy (HR 0.61, 95% CI, 0.47–0.79; p<0.0001) in the planned analysis of OS in the COLUMBUS trial.1–2,4 Adverse events leading to discontinuation that were suspected to be related to the study treatment occurred in 6% of patients.3,4 The most common Grade 3–4 adverse events, seen in more than 5% of patients, were: increased gamma-glutamyltransferase (9%), increased creatine phosphokinase (7%) and hypertension (6%).3,4

On September 20, 2018 Exicure, Inc. (OTCQB:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional spherical nucleic acid (SNA) constructs, reported that Phase 1 results for AST-008, an SNA consisting of toll-like receptor 9 (TLR9) agonists designed for immuno-oncology applications (Press release, Exicure, SEP 20, 2018, View Source [SID1234529502]).

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"Phase 1 results for AST-008 demonstrated our desired highly potent immune system activation without serious adverse events or dose limiting toxicity. We believe this molecule could lead to better combination therapies for patients with cancer and, to that end, we expect to initiate a Phase 1b/2 trial in patients before year end," said Dr. David Giljohann, Chief Executive Officer of Exicure. "These data support the potential of our SNA platform for immuno-oncology and set the stage for ongoing development of the SNA platform into indications well beyond cancer."

Exicure’s Phase 1 Trial Results

The Phase 1 trial of AST-008 was a single ascending subcutaneous dose trial comprised of 16 healthy volunteers. AST-008 was shown to be safe and tolerable in all subjects, with no serious adverse events and no dose limiting toxicity. AST-008 was well tolerated and all AST-008-related adverse events were of short duration, reversible and consistent with TLR9 activation.

In addition to the principle safety and tolerability endpoint, the trial screened for levels of select cytokines and markers of immune cell activation. AST-008 was shown to elicit high levels of certain cytokines as well as activate important effector cells of the immune system including T cells and natural killer cells, the main drivers of anti-tumor response.

For the four subjects receiving the trial’s top dose of about 20 µg/kg of AST-008, initial analyses suggest that the average fold-increase above baseline for these cytokines is approximately as follows: IFN-gamma: 3 fold; IL-6: 57 fold; IL-12: 2 fold; IP-10: 32 fold; and MCP-1: 4 fold. At this dose, AST-008 also elicited 9.5 fold and 3.5 fold increases in the fraction of activated T cells and natural killer cells, respectively, compared to baseline.

Exicure’s Planned Phase 1b/2 Patient Trial

Exicure intends to begin an open-label Phase 1b/2 trial of intra-tumorally dosed AST-008 in combination with a checkpoint inhibitor before year end. The trial will begin with an AST-008 dose finding Phase 1b stage, followed by a Phase 2 expansion stage. In the Phase 1b, Exicure will enroll patients with superficial injectable tumors and will prioritize those with Merkel cell carcinoma, cutaneous squamous cell carcinoma, melanoma, and squamous cell carcinoma of the head and neck. Preliminary data from the Phase 1b stage are expected in late 2019.

Historical TLR9 Agonist Healthy Volunteer Data

In 2015, Mologen AG published results (European Journal of Cancer, 2015, volume 51, supplement 1, page S12) from a healthy volunteer trial. In a single cohort, 13 subjects each received one 60 mg dose (equivalent to 923 µg/kg for a 65 kg subject) of lefitolimod subcutaneously. On average, across the cohort, there was a 7 fold-increase in IP-10 expression above baseline. No cell activation data were reported. Lefitolimod is currently in a Phase 3 clinical trial.

In 2004, Coley Pharmaceutical Group (now Pfizer, Inc.) published results (Journal of Immunotherapy, 2004, Volume 27, pages 460–471) from a single ascending dose healthy volunteer trial. In that trial, their TLR9 agonist, PF-03512676, was administered subcutaneously to six subjects per dose level. For the 20 µg/kg dose level, the average fold-increase above baseline for these cytokines is as follows: IFN-gamma: no change from baseline; IL-6: 8 fold; IL-12: no change from baseline; IP-10: 9 fold; and MCP-1: 3 fold.

On September 20, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported two oral presentations and one poster presentation highlighting previously reported clinical data relating to selinexor, the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) compound at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) 2018 taking place September 19-23, 2018 in Xiamen, China (Press release, Karyopharm, SEP 20, 2018, View Source [SID1234529501]).

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"Given our recently executed strategic alliance with Antengene Corporation to develop selinexor in China, we are honored to share these key results from the STORM, STOMP and SADAL studies with the medical oncology community this year at CSCO," said Sharon Shacham, PhD, Founder, President and Chief Scientific Officer of Karyopharm. "The CSCO annual meeting is among the most prestigious oncology conferences in China and presenting these important data further our goal of advancing selinexor in this important market and across the globe."

Details for the presentations at CSCO:

Oral presentations

Title: Phase 2b Results of the STORM Study: Oral Selinexor plus Low Dose Dexamethasone (Sd) in Patients with Penta-Refractory Myeloma (penta-MM)
Date and Time: Friday, September 21, 2018, from 16:42 to 16:50

Title: Single Agent Oral Plus Selinexor Exhibits Durable Responses in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) of Both GCB and Non-GCB Subtypes: The Phase 2b SADAL Study
Date and Time: Saturday, September 22, 2018 from 8:45 to 8:55

ePoster presentation

Title: Selinexor Plus Low-Dose Bortezomib and Dexamethasone (SVd) Induces a High Response Rate in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Date and Time:Thursday, September 20 – Sunday, September 23, 2018

About Selinexor

Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,600 patients have been treated with selinexor. In April and September 2018, Karyopharm reported positive top-line data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), with a request for accelerated approval for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma. The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval. Selinexor is also being evaluated in several other mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On September 20, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported its preliminary clinical data from Chinese patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors enrolled in an ongoing Phase 1/2 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) in Xiamen, China.

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"Tislelizumab is being developed in a broad clinical program as both a monotherapy and in combination with other treatments for a number of potential clinical indications. We are encouraged by the preliminary results presented today with tislelizumab for patients with MSI-H or dMMR solid tumors and are excited about starting a Phase 2 trial in China in patients with advanced forms of these tumors to test our belief that they are sensitive to immune checkpoint inhibition. We hope this further enables the availability of new treatments options, which are urgently needed, especially in China," commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene.

"This is the first presentation of tislelizumab data in the population of patients with MSI-H or dMMR solid tumors, and we are encouraged by the objective response rate of 29 percent in a difficult-to-treat patient population. Tislelizumab was also generally well-tolerated in these patients," said Lin Shen, M.D., Vice President of Clinical Oncology at Beijing Cancer Hospital and Peking University, and study presenter. "We hope that further study of tislelizumab may lead to a new treatment for patients with these tumors."

Summary of Results from the MSI-H and dMMR Cohorts in the Phase 1/2 Trial

The multi-center, open-label Phase 1/2 trial of tislelizumab as monotherapy in advanced solid tumors in China (CTR20160872) consists of a Phase 1 dose verification component and a Phase 2 component of indication expansion in disease-specific cohorts, which includes MSI-H and dMMR solid tumors.

Data presented at CSCO today are from 22 patients enrolled in the cohort, of which 14 patients with centrally confirmed MSI-H/dMMR tumors were evaluable for antitumor activity per RECIST v1.1 criteria. Patients were treated with tislelizumab at a dose of 200 mg every three weeks. Colorectal cancer was the most common primary tumor type and 82 percent of the study population received one or more prior lines of systemic therapy. At the time of the data cutoff on May 11, 2018, median treatment duration was 2.2 months (0.69-11.1 months), median follow-up time was 4.4 months (0.10-10.7 months), and ten patients remained on treatment.

Adverse events (AEs) assessed by the investigator to be related to treatment occurred in 18 patients (82%). Of those, the most common treatment-related AEs (TRAEs) (occurring in ≥ 15% of patients) were increased bilirubin (36%), increased transaminase (27%), increased blood creatine phosphokinase (23%), anemia (23%) and decreased white blood cell and/or neutrophil count (18%). All of the TRAEs were grades 1 or 2. Immune-related AEs (irAEs) occurred in 13 patients (59%) and many were overlapping with the TRAE cases. All irAEs were grade 1 or 2 as well.

At the time of the data cutoff, the efficacy evaluation was early and 14 patients, including 12 patients with colorectal cancer, with centrally confirmed MSI-H/dMMR tumors were evaluable for response. The objective response rate was 29 percent (four patients, all with colorectal cancer), with the median duration of response still maturing. Additionally, three patients centrally confirmed as negative for MSI-H/dMMR were evaluable for response, and progressive disease was the best response in all three of these patients.

In addition to this Phase 1/2 trial, tislelizumab is being investigated in two pivotal Phase 2 clinical trials in China in relapsed/refractory (R/R) classical Hodgkin’s lymphoma and in urothelial cancer, Phase 3 trials in China and globally in a number of malignancies including non-small cell lung cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma; as well as two global Phase 2 trials in patients with previously treated hepatocellular carcinoma or with R/R mature T- and NK-cell lymphomas.

About Microsatellite Instability-High or Mismatch Repair Deficient Solid Tumors
Microsatellite instability-high (MSI-H) cancer cells have a greater than normal number of genetic markers called microsatellites, which are short, repeated sequences of DNA. Cancer cells that have large numbers of microsatellites may have defects in the ability to correct mistakes (also known as mismatch repair deficiency, or dMMR) that occur when DNA is copied in the cell. MSI-H and dMMR tumors are found most often in colorectal cancer, other types of gastrointestinal cancer and endometrial cancer, although they may also be found in cancers of the breast, prostate, bladder and thyroid.

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).