On August 27, 2026 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas, reported its 2026 interim results and recent business highlights.

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Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented, "In the first half of 2026, CStone entered a pivotal stage of transition from innovation-driven accumulation to global value realization.

Our lead asset, CS2009, continues to advance rapidly through global clinical development. To date, we have accumulated clinical data from more than 300 patients, consistently demonstrating three key clinical validations: first, proof of safety; second, multidimensional confirmation of CTLA‑4 target activity and efficacy, evidenced by pharmacodynamic biomarkers and clinical activity in "cold tumors" and IO‑pretreated NSCLC; and third, broad‑spectrum and highly competitive antitumor efficacy across multiple tumor types. The most recent data show that CS2009’s antitumor activity continues to deepen and strengthen with longer follow-up, exhibiting particularly competitive efficacy and a well-tolerated safety profile in key patient populations, including NSCLC and mCRC. These robust data provide strong support for the upcoming global Phase III registrational trials. We look forward to presenting additional more mature clinical data on CS2009 in oral presentations at the ESMO (Free ESMO Whitepaper) Congress this October.

Beyond CS2009, other Pipeline 2.0 candidates are also progressing steadily toward clinical stage. CS5007, built on our proprietary ADC platform, has initiated a global Phase I clinical trial in both China and Australia. In addition, more than ten early-stage programs spanning next-generation ADCs, immunology & inflammation and other areas are advancing smoothly. The successive entry of these differentiated innovative assets into clinical development will serve as a critical driver for the Company’s sustained growth and global expansion.

On the commercial front, our three key products, sugemalimab, pralsetinib, and avapritinib, continued to achieve breakthroughs across domestic and international markets, contributing significant momentum to revenue growth. Notably, following pralsetinib’s first-time inclusion in the NRDL earlier this year, its in-market sales volume increased by almost 500% year-over-year during the first seven months of 2026, making it the primary driver of the Company’s revenue growth in the first half of 2026.

Looking ahead, CStone will focus on advancing the clinical value of its Pipeline 2.0 assets and actively pursue global partnerships to accelerate their development. Concurrently, the Company will continue to maximize the commercial potential of its marketed products through strategic partnerships and resource integration. Our goal is to foster a sustainable growth model where R&D and commercialization reinforce each other, creating a virtuous cycle between innovation and business operations."

Business Highlights

For the six months ended June 30, 2026 and up to the date of this results announcement, CStone made significant progress across both its proprietary Pipeline 2.0 portfolio and its commercial franchise, advancing the Company’s strategy to build a fully integrated, globally competitive biopharmaceutical company.

Clinical Stage Core Asset

CS2009, PD-1/VEGF/CTLA-4 trispecific antibody

Accelerating global clinical development toward Phase III registrational trials by year end
The ongoing global Phase I/II trial has enrolled more than 300 patients across China and Australia, with U.S. Investigational New Drug (IND) clearance obtained in February 2026.

CStone plans to initiate the first wave of global Phase III multi-regional clinical trials (MRCTs) for CS2009 by the end of 2026. Planned registrational studies include first-line non-small cell lung cancer (NSCLC) in combination with chemotherapy (versus pembrolizumab plus chemotherapy), and first-line mCRC in combination with chemotherapy (versus bevacizumab plus chemotherapy), with additional registrational studies planned for 2027 and following years.

CS2009 validates its potential as a next-generation I/O backbone
At the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, CStone presented comprehensive Phase I/II data from the ongoing global multicenter trial. As of the data cutoff date of August 2026, updated monotherapy efficacy data from the ongoing global Phase I/II trial of CS2009, reflecting a longer follow-up and larger sample size than the ASCO (Free ASCO Whitepaper) 2026 presentation continued to demonstrate robust and deepening antitumor activity across multiple tumor types. Three important key clinical validations are achieved from over 300 patient data:

Proof of safety
Across all dose levels, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. In the ASCO (Free ASCO Whitepaper) 2026, the incidence of Grade ­3 treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs) were 24.6% and 12.7%, respectively. Notably, the incidence of Grade ­3 VEGF-related TRAEs was only 5.1%. No excessive toxicities typically associated with CTLA-4/PD-(L)1 combinations were observed. As of August 2026, the safety profile of CS2009 remained consistent with that presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, with no new safety signals identified.

Proof of CTLA-4 activities and efficacy
Dose-dependent upregulation of ICOS on CD4+ T cells was observed as a pharmacodynamic biomarker of CTLA-4 blockade. Activity was also seen in "cold tumor" not sensitive to PD-(L)1 mAb:

Later-line monotherapy for mCRC (30 mg/kg): the objective response rate (ORR) was 20.0% (3/15) and the disease control rate (DCR) was 93.3% (14/15).
Later-line monotherapy for soft-tissue sarcoma (STS): the ORR was 38.5% (5/13) and the DCR was 69.2% (9/13). Later-line monotherapy for non-clear cell renal cell carcinoma (nccRCC): the ORR was 42.9% (3/7) and the DCR was 100.0% (7/7).
Promising anti-tumor activity in later-line post immuno-oncology (IO) NSCLC monotherapy: ORR was 23.8% (5/21), DCR was 61.9% (13/21). Among patients who had previously received immunotherapy plus platinum-based chemotherapy (n=13), ORR was 38.5% (5/13) and DCR was 84.6% (11/13).
Proof of broad efficacy
Monotherapy and chemo-combination activity in first-line and later-line NSCLC:

First-line NSCLC monotherapy (PD-L1 tumor proportion score [TPS]­ ≥1%; enrollment completed): ORR of 61.7% (29/47) and DCR of 93.6% (44/47), including ORR of 70.8% (17/24), DCR 91.7% (22/24) in patients treated at 30 mg/kg; in the PD-L1 TPS ≥­50% group (n=24), ORR was 83.3% (20/24) and DCR was 95.8% (23/24) (versus ORR of 81.3% [13/16] at the 2026 ASCO (Free ASCO Whitepaper) cutoff), including ORR of 100.0% (11/11) and DCR of 100.0% (11/11) in patients treated at 30 mg/kg. After median follow up of 6 months, median progression-free survival (PFS) and DOR have not been reached.
Second-line or later NSCLC monotherapy (30 mg/kg): ORR of 28.0% (7/25) and DCR of 60.0% (15/25), with a 6-month DOR rate of 83.3% (versus ORR of 24.0% and a 6-month DOR rate of 80.0% at the 2026 ASCO (Free ASCO Whitepaper) cutoff). Across all evaluated dose levels (n=54), ORR was 16.7% (9/54) and DCR was 68.5% (37/54), with a 6-month DOR rate of 87.5% (versus 85.7% at the 2026 ASCO (Free ASCO Whitepaper) cutoff).
Later-line NSCLC (second/third-line combination therapy, n=6): ORR of 66.7% (4/6), DCR of 100.0% (6/6). Data are as of the 2026 ASCO (Free ASCO Whitepaper) data cutoff and will be updated at ESMO (Free ESMO Whitepaper) 2026.
First-line squamous NSCLC combination therapy (PD-L1-low/negative, TPS ≤5%, n=8): ORR of 75.0% (6/8), DCR of 100.0% (8/8); notably, the ORR reached 100.0% (4/4) in the PD-L1-negative subgroup. Data are as of the ASCO (Free ASCO Whitepaper) 2026 data cutoff and will be updated at ESMO (Free ESMO Whitepaper) 2026.
Robust Chemo-combo efficacy in the first-line mCRC, mostly proficient mismatch repair or microsatellite stable (pMMR/MSS):

First-line mCRC (with XELOX, n=6): ORR of 66.7% (4/6), DCR of 100.0% (6/6). Data as of 2026 ASCO (Free ASCO Whitepaper) cutoff, will be updated at ESMO (Free ESMO Whitepaper) 2026.
Promising monotherapy activity observed in metastatic castration-resistant prostate cancer (mCRPC), ovarian cancer, triple-negative breast cancer, gastric cancer, esophageal cancer, as well as STS and nccRCC.

Upcoming two oral presentations of CS2009 at ESMO (Free ESMO Whitepaper) 2026
The clinical research results of CS2009 have been accepted for two Rapid Oral presentations at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The presentations will feature Phase I/II clinical data of CS2009 in patients with advanced NSCLC and mCRC.

Other Clinical Stage Asset

CS5007, EGFR/HER3 ADC

Global Phase I trial initiated in China and Australia
The Company initiated the Phase I first-in-human study in June 2026. This trial consists of dose-escalation and dose-expansion cohorts evaluating CS5007 as a monotherapy in patients with advanced solid tumors, and will be conducted concurrently in Australia and China. CStone presented preclinical data for CS5007 at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, further supporting its broad-spectrum anti-tumor potential.

Commercial Products

CEJEMLY (sugemalimab), anti-PD-L1 antibody

Global regulatory and scientific recognition
Following the initial marketing authorizations of sugemalimab in the European Union (EU) and the United Kingdom (U.K.) for Stage IV NSCLC, sugemalimab received additional approvals in the EU in November 2025 and subsequently in the U.K. in February 2026 as monotherapy for adults with unresectable Stage III NSCLC whose disease has not progressed following platinum-based chemoradiotherapy (CRT). Meanwhile, marketing authorization applications for sugemalimab have either been approved or are under active review in nearly 30 countries worldwide.

In March 2026, CEJEMLY (sugemalimab) was included in the ESMO (Free ESMO Whitepaper) Early and Locally Advanced NSCLC Living Guideline. Sugemalimab received a Level [I, A] recommendation for consolidation therapy in patients with unresectable Stage III NSCLC who have not progressed after concurrent or sequential chemoradiotherapy.

Secured fifth international commercial partnership
In June 2026, CStone entered into an exclusive commercialization agreement with Arrotex Pharmaceuticals Pty Ltd (Arrotex), Australia’s largest privately owned pharmaceutical company with established oncology commercialization capabilities and distribution infrastructure across Australia and New Zealand. This milestone expands sugemalimab’s global commercialization network to five strategic partnerships, covering more than 60 countries and regions across Europe, the Middle East and Africa, Latin America, and Oceania.

Pralsetinib capsules, RET inhibitor

NRDL inclusion and accelerated commercial growth
Following the inclusion of pralsetinib capsules (100 mg) in China’s NRDL in late 2025, effective January 1, 2026, patient access has improved significantly. In the seven‑month period ending July  2026, pralsetinib’s in-market sales volume increased by almost 500% year-over-year.

Localized manufacturing approval supporting commercial scalability
Following the approval by China’s NMPA of the manufacturing localization application for pralsetinib capsules (100 mg), the first batch of locally-manufactured pralsetinib was released in China in 2026.

Preclinical/IND-enabling Stage Programs

A balanced, differentiated early-stage portfolio spanning oncology and immunology/inflammation

CStone’s preclinical Pipeline 2.0 comprises innovative candidates across multispecific antibodies, ADCs and other next-generation modalities, with potential first-in-class (FIC) or best-in-class (BIC) opportunities spanning oncology, immunology, inflammation and other high-value therapeutic areas.

The Company’s proprietary ADC platform incorporates optimized linker technologies designed to enable tumor-selective payload release and supports multiple Pipeline 2.0 ADC candidates, including CS5007 (EGFR and HER3 bispecific ADC), CS5006 (ITGB4 ADC), CS5008 (DLL3 and SSTR2 bispecific ADC), etc. The Company is also exploring next-generation ADC technologies, including dual-payload ADCs (e.g., CS5009, a B7H3/PD-L1 bispecific dual-payload ADC, and CS5010, a HER2-targeting dual-payload ADC) and novel-payload ADCs (e.g., CS5012, a HER2-targeting novel-payload ADC). In April 2026, CStone presented preclinical data for CS5007, CS5006 and CS5008 at the 2026 AACR (Free AACR Whitepaper) Annual Meeting, highlighting the breadth and differentiation of its next-generation ADC pipeline.

Beyond oncology, CStone has expanded Pipeline 2.0 into immunology and inflammation by leveraging its proprietary multispecific antibody platform. The Company has developed CS2015 (OX40L/TSLP bispecific antibody) targeting Type 2 inflammatory diseases, CS2013 (BAFF/APRIL bispecific antibody) targeting B cell-mediated autoimmune diseases, CS2016 (TL1A/α4β7 bispecific antibody), and CS1016 (PD-1 agonist antibody).

Future and Outlook

Our mission is to deliver transformative therapies through scientific excellence and technological innovation, making high-quality treatments accessible worldwide to benefit patients and their families.

We reaffirm our commitment to advancing a robust and differentiated pipeline by prioritizing internal discovery capabilities and sustained R&D investments, while executing strategic partnerships to unlock the global value of our in-market products. Key catalysts for the second half of 2026 include:

Clinical milestones

Accelerate global development of CS2009 by advancing interactions with global regulatory authorities, including the U.S. FDA and the CDE of NMPA, on Phase III registrational trial design, with the first wave of global Phase III MRCTs planned to be initiated by the end of 2026, while continuing to pursue global partnerships.
Advance clinical development of CS5007 (EGFR/HER3 bispecific ADC), CS5006 (ITGB4 ADC), CS5008 (SSTR2/DLL3 ADC) and other early-stage candidates.
Innovation and technology

Further strengthen proprietary technology platforms, including multi-specific antibody and next-generation ADC technologies, to support sustained expansion of the preclinical pipeline.
Present key clinical data, including updated CS2009 data, at major international scientific conferences, including two Rapid Oral presentations of CS2009 Phase I/II data at the 2026 ESMO (Free ESMO Whitepaper) Congress.
Financial Highlights

International Financial Reporting Standards (IFRS) Measures:

Revenue was RMB205.1 million for the six months ended June 30, 2026. The revenue is composed of RMB183.2 million from sales of pharmaceutical products (avapritinib, pralsetinib and sugemalimab), RMB6.9 million from license fee income and RMB15.0 million from royalty income of sugemalimab. The substantial revenue growth was primarily driven by a significant increase in sales of pharmaceutical products, particularly pralsetinib, following its successful inclusion in the NRDL effective from January 2026, which led to a marked sales ramp-up.

Cost of revenue was RMB110.9 million for the six months ended June 30, 2026.

Research and development expenses were RMB205.5 million for the six months ended June 30, 2026, primarily due to increased costs for clinical trials.

Administrative expenses were RMB51.3 million for the six months ended June 30, 2026.

Selling and marketing expenses were RMB73.1 million for the six months ended June 30,2026.

Loss for the period was RMB252.3 million for the six months ended June 30, 2026.

Cash and cash equivalents and time deposits were RMB1,560.2 million as of June 30, 2026.

Non-International Financial Reporting Standards (Non-IFRS) Measures:

Research and development expenses excluding the share-based payment expenses were RMB193.4 million for the six months ended June 30, 2026, primarily due to increased costs for clinical trials.

Administrative and selling and marketing expenses excluding the share-based payment expenses were RMB115.2 million for the six months ended June 30, 2026.

Loss for the period excluding the share-based payment expenses was RMB230.9 million for the six months ended June 30, 2026.

2026 Interim Results Conference Call

The Company will host its 2026 Interim results earnings call at 9:00 a.m. (Beijing Time) on Friday August 28, 2026. Please register for the conference in advance through the link: View Source .

(Press release, CStone Pharmaceauticals, AUG 27, 2026, View Source [SID1234670393])

On August 27, 2026 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, reported that it has commenced a tranched registered public offering (the "Offering") of (i) American Depositary Shares ("ADSs"), each representing five hundred (500) ordinary shares of the Company, no par value per share, or in lieu of ADSs to certain investors, pre-funded warrants to purchase ADSs, (ii) accompanying Series A Warrants to purchase ADSs (or pre-funded warrants in lieu thereof), which are exercisable immediately at an exercise price equal to 115% of the initial public offering price per ADS and accompanying Warrants and expire upon the earlier of 30 days following the Company’s Stage IV triple-negative breast cancer (TNBC) data readout, expected in the second half of 2027, or the five-year anniversary of issuance, and (iii) accompanying Series B Warrants to purchase ADSs (or pre-funded warrants in lieu thereof), which are exercisable immediately at an exercise price equal to 125% of the initial public offering price per ADS and accompanying Warrants and expire upon the earlier of 30 days following the Company’s HR+/HER2- data readout, expected in the first half of 2028, or the five-year anniversary of issuance. All of the securities in the Offering are to be sold by Kazia.

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Leerink Partners and Guggenheim Securities are acting as joint bookrunning managers for the proposed Offering. BTIG, Needham & Company and Laidlaw & Company are acting as co-managers for the proposed Offering. The proposed Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed or as to the actual size or terms of the Offering.

Kazia intends to use the net proceeds from the Offering primarily to fund clinical development of paxalisib, including ongoing and planned studies in triple-negative breast cancer and HR+/HER2- breast cancer and other oncology indications, and for working capital and general corporate purposes.

The ADSs and warrants are being offered pursuant to a registration statement on Form F-3 (File No. 333-294392), which was previously filed with and subsequently declared effective by the Securities and Exchange Commission (the "SEC"). The Offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A copy of the preliminary prospectus supplement relating to and describing the terms of the Offering will be filed with the SEC and will be available for free on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained, when available, from Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected], or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, telephone: (212) 518-9544, email: [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the Offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Kazia Therapeutics, AUG 27, 2026, View Source [SID1234670392])

On August 27, 2026 Daiichi Sankyo reported that the first patient has been dosed in a first-in-human phase 1 trial evaluating DS1025 in adult patients with advanced or metastatic solid tumors with disease progression on or after at least one prior line of standard therapy.

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DS1025 is a specifically engineered, investigational, potential first-in-class CD25 directed antibody drug conjugate (ADC) containing an immuno-oncology optimized cytotoxic payload discovered by Daiichi Sankyo (TSE:4568).

CD25 is a cell surface protein that is highly expressed on regulatory T cells (Treg cells) which suppresses the response of the immune system against cancer, 1 making it a promising therapeutic target. Currently, there are no CD25 directed ADCs approved for any type of cancer.

"While immunotherapies have transformed cancer treatment, continued innovation in leveraging pathways that can activate the immune system is needed," said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. "The initiation of this trial evaluating DS1025 reflects continued progress in advancing our pipeline through the development of novel antibody drug conjugates in order to deliver medicines that improve outcomes for patients with cancer."

About the Phase 1 Trial

The multicenter, open-label, first-in-human, dose escalation phase 1 trial will assess the safety, tolerability, pharmacokinetics and preliminary efficacy of DS1025 in patients with advanced or metastatic solid tumors with disease progression on or after at least one prior line of standard therapy.

The trial will evaluate primary endpoints of safety and tolerability, including dose-limiting toxicities and adverse events. Secondary endpoints include pharmacokinetics and immunogenicity. Exploratory endpoints include overall response rate, duration of response and time to response.

The trial is expected to enroll up to 45 patients across multiple sites in Asia and Europe. For more information, please visit ClinicalTrials.gov.

About CD25

CD25 is a cell surface protein that is highly expressed on regulatory T cells (Treg cells). Treg cells work to suppress the immune system, helping tumors evade the body’s natural ability to destroy abnormal cells and are thought to be a key contributor to resistance that develops with currently available immunotherapies.

About DS1025

DS1025 is an investigational, potential first-in-class CD25 directed ADC that builds on the DXd ADC Technology of Daiichi Sankyo by delivering an immuno-oncology optimized cytotoxic payload that works to deplete immunosuppressive T cells (Treg cells) in the tumor microenvironment and activate the immune system to detect and destroy cancer cells.

(Press release, Daiichi Sankyo, AUG 27, 2026, View Source [SID1234670390])

On August 27, 2026 Knight Therapeutics Inc. ("Knight") (TSX: GUD), a pan-American (ex-US) pharmaceutical company, reported that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.

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"This supplemental submission to ANVISA marks an important step in our efforts to expand MINJUVI’s potential in earlier lines of therapy in Brazil," said Samira Sakhia, President and Chief Executive Officer of Knight. "Patients with previously untreated DLBCL and HGBL continue to face significant unmet medical needs. We are encouraged by the clinical data supporting the addition of tafasitamab and look forward to working with regulators under Project Orbis to bring this potential new first-line treatment option to patients as quickly as possible."

In September 2021, Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ:INCY), for the exclusive rights to distribute tafasitamab (commercialized as MONJUVI in the United States and MINJUVI ex-U.S.). Knight has launched MINJUVI in Brazil, Mexico and Argentina for use in combination with lenalidomide, followed by MINJUVI monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL, who are not eligible for autologous stem cell transplantation (ASCT). In March 2026, Knight announced the approval and launch of MINJUVI in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in Brazil.1 Also in March 2026, Knight submitted MINJUVI for the same indication in Argentina and Mexico.

This supplemental submission to ANVISA builds on those approvals, seeking a first-line indication for MINJUVI based on results from the Phase 3 frontMIND trial.

About MINJUVI

MINJUVI (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., MONJUVI is approved for use in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).2

Additionally, MONJUVI received approval in the U.S. in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).2 This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, MINJUVI received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by MINJUVImonotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, MINJUVI is approved for use in Europe in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.3

In Japan, MINJUVI is approved for use in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).4 MINJUVI is also approved for use in Japan in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL (2L+ FL).5

XmAb is a registered trademark of Xencor, Inc.

MONJUVI and MINJUVI are registered trademarks of Incyte. All other trademarks are the property of their respective owners.

About Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse Large B-Cell Lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, accounting for a third of all NHLs and ranging between 20%−50% by country.6 DLBCL commonly presents with enlarged lymph nodes or rapidly growing mass along with B symptoms, which include fever, night sweats, and weight loss. The B symptoms can be seen in 30% of patients. Bone marrow involvement is more common in indolent disease and can be seen in up to 50% of the cases.7 Each year, approximately 25,000 people in the U.S. and up to projected 28,000 people in Western Europe are diagnosed with DLBCL.8,9 In Brazil, data from The Department of Information Technology of the Brazilian Public Unified Healthcare System (DataSUS) reported DLBCL as the most frequently diagnosed NHL with 39,012 cases reported between 2008 – 2017. With about 40% of DLBCL patients not responding to initial therapy or relapsing thereafter,10,11 there is a high medical need for new, effective therapies, particularly for high-risk patients.

About High-grade B-Cell Lymphoma (HGBL)

High-grade B-Cell Lymphoma (HGBL) is a rare and aggressive category of B-cell non-Hodgkin lymphoma (NHL) defined by the World Health Organization (WHO).12 It comprises two principal subtypes based on specific genetic characteristics: DLBCL/HGBL with MYC and BCL2 rearrangements, which encompasses most lymphomas previously known as double- or triple-hit lymphoma, and HGBL, not otherwise specified (NOS), a heterogeneous subtype defined by high-grade morphology in the absence of these genetic rearrangements.12,14 HGBL shares clinical features with DLBCL, including rapidly enlarging lymph nodes and B symptoms such as fever, night sweats, and weight loss, and accurate diagnosis requires expert pathologic review incorporating cytomorphology, immunohistochemistry, and fluorescence in situ hybridization (FISH).12,15 The aggressive nature of HGBL and the failure of intensified therapy to improve overall survival underscore the significant unmet need for more effective treatment options.12,13

About frontMIND trial

The frontMIND trial (NCT04824092) is a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).16

The study enrolled 899 adults (≥18 to ≤80 years) and is evaluating the efficacy and safety of tafasitamab and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared with R-CHOP.16

The primary endpoint of the study is investigator-assessed progression-free survival (PFS) using the Lugano 2014 criteria. Key secondary endpoints include event-free survival (EFS) by investigator assessment and overall survival (OS).16

For more information about the frontMIND trial, please visit View Source

(Press release, Knight Therapeutics, AUG 27, 2026, View Source [SID1234670386])

On August 27, 2026 Biogen Inc. (Nasdaq: BIIB) reported that Christopher A. Viehbacher, President and Chief Executive Officer, will participate in a fireside chat during the Morgan Stanley 24th Annual Global Healthcare Conference. The webcast will be live on Monday, Sept 14, 2026, at 9:15 a.m. ET. To access the live webcast, please visit the Investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available for at least 30 days following the presentation.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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(Press release, Biogen, AUG 27, 2026, View Source [SID1234670385])