On January 27, 2021 Shasqi, a clinical-stage biotechnology company developing precision oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPACTM) platform, reported the publication of two preclinical studies highlighting the potential of the company’s click chemistry-based approach to the development of treatments for a range of solid cancers (Press release, Shasqi, JAN 27, 2021, View Source [SID1234574359]). The paper, "Click activated protodrugs against cancer increase the therapeutic potential of chemotherapy through local capture and activation" was published in the journal Chemical Science on January 5, 2021 and the paper, "SQ3370 Activates Cytotoxic Drug via Click Chemistry at Tumor and Elicits Sustained Responses in Injected and Non–Injected Lesions” was published in the journal Advanced Therapeutics on January 20, 2021. Shasqi is currently advancing its lead clinical candidate, SQ3370, a click-activated protodrug therapy, in a phase 1 clinical trial.

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"A goal of targeted cancer treatments is to achieve high tumor specificity with minimal side effects. The limitations of targeted therapies, which benefit only a small subset of patients, make this goal difficult to achieve in practice," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "We believe our platform has the potential to overcome these limitations and benefit patients regardless of biomarker status or genetics. The published evidence reinforces the ability of our lead candidate, SQ3370, to do that in preclinical models. We are now in the process of evaluating this approach in our first clinical trial and look forward to sharing data later this year."

Click Activated Protodrugs Against Cancer Increase the Therapeutic Potential of Chemotherapy through Local Capture and Activation. Wu, K., et. al., Chemical Science. January 5, 2021

Protodrugs of various chemotherapy agents were tested in vitro to evaluate cytotoxicity, solubility, stability and activation. These studies rendered the protodrug of doxorubicin, SQP33, as the most promising candidate for in vivo studies. In mice, the maximum tolerated dose of SQP33 in combination with locally injected tetrazine-modified biopolymer (SQL70) was 19.1-times the maximum-tolerated dose of conventional doxorubicin. Pharmacokinetics studies in rats show that a single injection of SQL70 efficiently captures multiple SQP33 protodrug doses given cumulatively at 10.8-times the maximum-tolerated dose of conventional doxorubicin with greatly reduced systemic toxicity. Combined treatment with SQL70 and SQP33 (together called SQ3370) showed antitumor activity in a syngeneic tumor model in mice.

SQ3370 Activates Cytotoxic Drug via Click Chemistry at Tumor and Elicits Sustained Responses in Injected and Non–Injected Lesions. Srinivasan, S., et. al.. Advanced Therapeutics. January 20, 2021

This study found that the Shasqi’s Click Activated Protodrugs Against Cancer (CAPAC) platform is capable of developing medicines to treat a range of tumor types and that SQ3370 is tolerated well above the maximum dose of conventional doxorubicin. In preclinical models, SQ3370 increased survival by 63 percent over conventional doxorubicin and induced a potent systemic anti–tumor response against injected as well as non–injected lesions. The sustained anti–tumor response correlated with activation of the immune system which was measured at both lesions.

SQ3370 is the first click chemistry-based treatment to be tested in humans. This study, SQ3370-001, is currently enrolling patients with advanced sarcomas and other solid tumors in the United States and Australia (ClinicalTrials.gov NCT04106492). The company presented preclinical and trial-in-progress data from the SQ3370 program in late 2020.

CAPAC and SQ3370
SQ3370 utilizes Shasqi’s proprietary Click Activated Protodrugs Against Cancer (CAPAC) platform, a click chemistry-based approach that activates cancer drugs at a specific tumor with minimal systemic toxicity. The platform utilizes the biocompatible chemical reaction between an attenuated trans-cyclooctene-modified protodrug and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely captures and activates an infused protodrug. Unlike traditional targeted therapies, the CAPAC platform is agnostic to tumor characteristics that can vary from patient to patient, such as biomarker expression and enzymatic activity. CAPAC is highly modular and can be applied to a wide variety of cancer therapeutics.

On January 27, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS") reported that it intends to effectuate an exchange offer (the "Exchange") pursuant to which Scopus BioPharma common stock would become exchangeable for units (the "X Units") of the company (Press release, Scopus BioPharma, JAN 27, 2021, View Source [SID1234574358]).

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The Exchange is being designed to reward existing holders of common stock and to provide incentives for long-term ownership of our securities by existing and prospective new investors.

Each X Unit issuable pursuant to the Exchange would be comprised of one share of common stock, identical to the company’s currently outstanding common stock, and one newly-issuable warrant (the "X Warrant"). Holders of common stock would be entitled to receive one X Unit for each share of common stock tendered.

Holders of common stock would be able to tender all, some or none of their common stock. Shares of common stock not tendered would remain outstanding and unmodified.

There would be no cash or other consideration payable to participate in the Exchange.

It is the company’s intention to apply to Nasdaq for listing of both the X Units and the X Warrants.

The securities contained within each X Unit would become separable and separately tradable and transferable on January 3, 2022. The company would be permitted to allow for such separate trading at an earlier date in its sole discretion.

Each newly-issuable X Warrant would be exercisable for one share of the company’s common stock at an exercise price of $9.00 per share. The X Warrants would become exercisable, subject to any applicable regulatory and/or Nasdaq approval, on January 2, 2023 through and including January 3, 2028. On or after January 2, 2024, the company would, at its sole option, be able to redeem the X Warrants if the common stock trades at or above $27.00 per share, subject to an applicable number of qualifying trading days and other conditions.

Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. The company’s lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. This drug candidate is highly distinctive, encompassing both gene therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment.

On January 27, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, reported that the National Medical Products Administration (NMPA) accepted its New Drug Application (NDA) for ATG-010 (Selinexor, XPOVIO), a first-in-class oral selective inhibitor of nuclear export (SINE) compound, for the treatment of patients with relapsed/refractory multiple myeloma (rrMM) (Press release, Antengene, JAN 27, 2021, View Source [SID1234574357]). This is the fifth NDA for ATG-010 submitted by Antengene, after the four NDAs recently submitted in Australia, South Korea, Singapore and Hong Kong in the Asia Pacific region, and also the first NDA of SINE compounds in mainland China, a step closer to providing a novel option to Chinese patients diagnosed with hematological malignancies.

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Antengene has recently submitted NDAs in multiple markets for ATG-010 across three indications for multiple myeloma and diffuse large B-cell lymphoma. Recently, the National Comprehensive Cancer Network (NCCN) has also added five ATG-010 regimens to its guidelines for multiple myeloma or diffuse large B-cell lymphoma. ATG-010 is the first approved SINE compound in the world. It induces the apoptosis of cancer cells in vitro and in vivo by causing the nuclear storage and activation of tumor suppressor proteins and other growth-regulating proteins, and by down-regulating the intracytoplasmic levels of various oncogenic proteins while normal cells are not affected. Clinical studies have demonstrated that ATG-010 has clinical effects in multiple types of hematological and solid tumors with manageable safety profile.

"We are delighted to see the acceptance of the NDA submission in China for ATG-010 in rrMM, which marks another important milestone and one step closer to bringing ATG-010 to patients in China." said Dr. Jay Mei, M.D., Ph.D., Founder, Chairman and CEO of Antengene. "In addition to its effectiveness in hematological malignancies, there are several clinical trials in multiple solid tumor indications with ATG-010 including a global Phase 3 trial in endometrial cancer (SIENDO) and a Phase 3 trial in liposarcoma (SEAL) which have shown encouraging results. We continue to prepare to commercialize ATG-010 in China and across the APAC region so that cancer patients can benefit from this novel cancer medicine."

About ATG-010 (selinexor, XPOVIO)

ATG-010 (selinexor, XPOVIO), a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

In July 2019, the US Food and Drug Administration (FDA) approved selinexor (XPOVIO) in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor (XPOVIO) as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). In December 2020, selinexor (XPOVIO) also received FDA approval as a combination treatment for multiple myeloma after at least one prior therapy. A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same rrMM indication. Selinexor (XPOVIO) is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor (XPOVIO) is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase 3 randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor (XPOVIO) versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase 3 SIENDO trial of selinexor (XPOVIO) in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

On January 27, 2021 Orexo reported that Q4 2020, incl. Full Year Report (Press release, Orexo, JAN 27, 2021, View Source [SID1234574355])

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Q4 2020 highlights

Total net revenues of SEK 159.2 m (238.1 last year, 196.2 m excl. Abstral EU and US)
Net earnings of SEK -49.6 m (38.9)
EBITDA of SEK 1.0 m (85.8)
US Pharma segment (ZUBSOLV US) net revenues of SEK 143.1 m (190.5), EBIT of SEK 94.4 m (95.5)
Cash flow from operating activities of SEK -11.2 m (60.2), cash balance of SEK 505.3 m (816.8)
Secured a preferred position for ZUBSOLV as the only branded product on national commercial and Medicare Part D formularies of the largest PBM in the commercial segment in the US, Express Script, from January 1, 2021
Finalized the technical development of modia, a digital therapy for opioid use disorder, for which Orexo owns the exclusive global rights
Entered an exclusive license and supply agreement with Accord Healthcare for ZUBSOLV covering 29 European countries
A new patent for ZUBSOLV, with protection until 2032, was issued by the US Patent and Trademark Office (USPTO)
Financial outlook provided for 2021, see page 14
Important events after the period

A new patent for OX124, overdose rescue medication, was issued by the USPTO protecting the technology until 2039
SEK m, unless otherwise stated

Progress while adjusting to new market dynamics

From a management perspective, the most important factor for success is to be an agile company, ready to accelerate development and to capture opportunities when they arise, but also be prepared to shift priorities when the market requires it. The quarter has seen progress on many fronts, with US Pharma showing net revenue growth in local currency comparing to last quarter and improved EBIT margin, Digital Therapeutics (DTx) testing new reimbursement routes and launching new commercialization concepts. Our lead pipeline project, a rescue medication for opioid overdose, OX124, received positive feedback from the FDA on the IND application enabling a request for Fast Track Designation of the product and we also reported an exclusive license and supply agreement for ZUBSOLV in Europe.

Strong financial base to enable investments in DTx and launch of OX124

Our full year OPEX was SEK 617 million, which is significantly less than the guidance of SEK 750-800 million communicated in our Q2 report. The guidance in Q2 was based on the significant interest in DTx in the beginning of the Covid-19 pandemic and our expectation that payers and healthcare providers would follow the FDA’s decision to include digital therapies under the Public Health Emergency Policy and find pragmatic routes for reimbursement. While the interest in Orexo’s digital therapies remains high, building a new market requires patience. We start to see concrete and promising development with regards to DTx reimbursement, which is a cornerstone to accelerate growth.

Looking ahead, we expect to increase the investment in DTx as we see a progression in sales and a clearer picture emerges regarding the multiple routes to reimbursement. 2021 will also require significant investments in OX124, as we enter the pivotal trial starting in the summer this year. To ensure we have financial headroom to invest in opportunities when they arise, both internally in our products and our pipeline and through business development, we intend to refinance our existing corporate bond during Q1 2021 with a new corporate bond issue.

Expanding the commercialization model in DTx

The expectations of our DTx portfolio in 2020 were boosted by the FDA’s decision to implement a Public Health Emergency Policy allowing commercialization of digital therapies within the CNS space without the ordinary approval process. We anticipated that the payers would adopt similar pragmatism to the reimbursement processes as a response to the Public Health Emergency Policy, but the reimbursement process is following the pattern we anticipated before Covid-19, i.e. a new disruptive treatment will take time to review and implement. As a result, we are testing several new concepts for reimbursement of our digital therapies in parallel, while making the DTx available through direct purchase for patients. The lead concept is a treatment program where we, in collaboration with selected healthcare providers, offer patients treatment under the supervision of a physician. Provided the physicians and the patients follow certain guidelines, this treatment program is currently available for reimbursement for a large portion of the US population. The program is being tested in Pennsylvania to a limited number of patients to ensure the reimbursement will follow the expected path before we launch nationwide. The same program will also be available for individual physicians to treat patients under a direct contract with Orexo. In addition to this program, we are finalizing a program for employers, working with patient to patient communication, and continue our work with payers to drive reimbursement.

ZUBSOLV decline diminishing while impact of Covid-19 continues

With bipartisan support for the ongoing opioid crisis in the US, I am pleased to see politicians returning their attention to the opioid crisis. The former US administration recently paved the way for all US physicians to prescribe medical-assisted treatment (MAT) for opioid dependence, and we are confident that in the event of changes under the new administration, addressing the opioid crisis will remain a key priority. With the ongoing Covid-19 pandemic having significantly worsened this crisis, there is a pressing need increase access to treatment. Such a change will likely drive a sustained strong market growth, which will benefit Orexo and ZUBSOLV.

This quarter we had a small net sales increase compared to Q3 and a strong EBIT margin of 66 percent. Apart from some one-time adjustments, this result is explained by minimal decline from former exclusive contracts and stable development in the open segment. When Covid-19 is behind us, we expect a stabilization of the business and growth. ZUBSOLV is the only promoted daily treatment in opioid dependence in the US, and Covid-19 restrictions have had a severe impact on our ability to promote the product. In combination with our core market segment, the commercial segment, being stagnant due to the unemployment caused by Covid-19, it is a challenging market place during the pandemic. However, the Covid-19 challenges also provides learning of how to be more efficient in the sales process, which will benefit us long term. We expect ZUBSOLV will continue to be an important EBIT contributor in the years to come and with the broad launch of modia, our digital therapy for opioid use disorder, in the second half of 2021 we will see increased commercial synergies between our digital therapies and ZUBSOLV, both from a cost and revenue perspective.

OX124 development progressing to plan

As the US death tolls associated with overdose of fentanyl continue, we are confident OX124 is urgently needed, with the promise of being the most powerful nasal delivery of naloxone in the market. I am very pleased with the progress we have made during the quarter. With continued progress according to plan, in Q1 2021 we will receive a decision on the Fast Track application, continue to establish a commercial supply chain, improve the IP protection and register the brand name for OX124. In Q2 2021 we will manufacture the batches required for regulatory stability data and we will start the pivotal clinical trial. If the Fast Track application is approved we will be ready to submit an application for approval in Q1 2022. Without Fast Track the process will be delayed as we expect the FDA will require additional stability data to support proposed shelf life of the commercial product.

Summary and Outlook

In the last quarterly report I highlighted the pressing need for Orexo’s products as a result of the Covid-19 pandemic. The Covid-19 pandemic has unfortunately escalated, and the need for our products is even greater than before. The delays to get the DTx products reimbursement is certainly frustrating, especially given the clear demand for such products in the current climate. However, I also have to respect that Covid-19 has had a severe impact on many organizations and their ability to operate as normal. This aside, we are encouraged by the positive feedback we receive from customers and the steady progression we see in the number of patients testing and buying our DTx products in January. I remain confident that 2021 will show the commercial potential of these products, while we continue to enjoy strong and stable EBIT contribution from ZUBSOLV and prepare the new drug application for OX124.Uppsala, Sweden,

Presentation

At 2.00 pm CET, the same day as the announcement of the report, Orexo invites analysts, investors and media to attend an audiocast with a web presentation where Nikolaj Sørensen, CEO, and Joseph DeFeo, CFO, will present the report. After the presentation a Q&A will be held. Questions can also be sent in advance to [email protected], no later than 11.00 am CET. Please view the instructions below on how to participate.Internet: View Source SE +46 8 50 558 358 UK +44 333 300 9267 US +1 833 249 8403 The presentation material will be available on Orexo’s website prior to the audiocast, view Investors/Reports, presentations and audicastsThis information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 am CET on January 28, 2021.

On January 27, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that the global Phase 3 RATIONALE 302 trial of its anti-PD-1 antibody tislelizumab versus investigator’s choice chemotherapy in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior systemic treatment met its primary endpoint of overall survival (OS) (Press release, BeiGene, JAN 27, 2021, View Source [SID1234574354]). In the trial results, tislelizumab demonstrated a statistically significant and clinically meaningful improvement in OS in the intention-to-treat (ITT) population, when compared to chemotherapy. The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified.

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"With our ongoing evaluation of tislelizumab across multiple tumor types, we are working to provide clinical evidence and bring this potentially differentiated anti-PD-1 antibody to far more patients around the world."

"We are excited to announce the improved overall survival observed in another Phase 3 trial for tislelizumab when compared to chemotherapy standard of care. This is our fourth positive Phase 3 readout for tislelizumab and the first from our large Phase 3 program in gastrointestinal cancers that also include liver, stomach cancers as well as esophageal cancer," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "With our ongoing evaluation of tislelizumab across multiple tumor types, we are working to provide clinical evidence and bring this potentially differentiated anti-PD-1 antibody to far more patients around the world."

BeiGene plans to discuss the RATIONALE 302 data with health authorities globally and present data at an upcoming medical conference.

"Esophageal cancer represents a significant unmet medical need with rapid progression and high mortality. Recent years have seen a paradigm-shift in advanced ESCC treatment from chemotherapy and radiation to immunotherapy. The positive topline results from the RATIONALE 302 trial demonstrated that tislelizumab may offer a new treatment option for those living with this devastating disease and bring hope to patients and their families," said Lin Shen, M.D., Vice President of Clinical Oncology at Beijing Cancer Hospital and lead investigator for the trial.

RATIONALE 302 Trial of Tislelizumab Versus Chemotherapy in Advanced ESCC

RATIONALE 302 is 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 in patients with advanced unresectable or metastatic ESCC who have received prior systemic treatment.

The primary endpoint of the trial is OS in the ITT population. A total of 512 patients enrolled in the trial in 11 countries across Asia, Europe, and North America, randomized 1:1 to either the tislelizumab arm or the chemotherapy arm (investigator’s choice of paclitaxel, docetaxel, or irinotecan).

About Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal squamous cell carcinoma (ESCC) is the most common subtype of esophageal cancer globally, the sixth leading cause of cancer-related death in the world.i In 2020, there were more than 600,000 new cases of esophageal cancer and approximately 550,000 deaths worldwide.ii Esophageal cancer is a rapidly fatal disease and more than two-thirds of the patients have advanced or metastatic disease at the time of diagnosis, with a median survival of eight to 10 months and an expected five-year survival rate of less than five percent.iii

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 granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for the treatment of patients with locally advanced or metastatic urothelial carcinoma 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. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, two supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 13 Phase 3 trials and two pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan, and the transaction is expected to close in the first quarter of 2021, subject to expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Tislelizumab is not approved for use outside of China.

About Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed/refractory classical Hodgkin Lymphoma (NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
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 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 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).