On March 16, 2026 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune and inflammatory diseases, reported fourth quarter and full year 2025 financial results.

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"During the fourth quarter and throughout the full year 2025, the Company successfully met its strategic development goals and objectives that demonstrated significant progress towards establishing potential first-in-class and best-in-class assets for patients suffering with autoimmune diseases," said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. "With these strategic deliverables and continued progress to date, we believe we are well positioned to further advance our differentiating Immuno-STAT platform and lead autoimmune asset, CUE-401, toward the clinic to address major unmet needs in autoimmune disease treatment."

Business Highlights

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Advanced research and development of CUE-401 for IND (Investigational New Drug) readiness
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Conducted toxicology and pharmacology studies and announced preclinical safety and tolerability data
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In two non-GLP studies, CUE-401 was well tolerated with no adverse events observed
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Proof-of concept studies reinforce promising preclinical profile and therapeutic potential of CUE-401
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Presented in vivo and in vitro data that demonstrate the therapeutic potential of CUE-401 to restore immune balance for the treatment of autoimmune and inflammatory diseases at the World Immune Regulation Meeting (WIRM) held March 11-14, 2026

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Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors
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Entitled to upfront payments totaling $15 million. Of these payments, received $9.5 million, net of withholding taxes in the fourth quarter of 2025, and entitled to receive an additional $5 million in November 2026
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Received a 40% equity stake in ImmunoScape, and the Company is eligible for high-single digit royalties
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Company plans to announce Virtual R&D Day event highlighting CUE-401, the company’s lead autoimmune asset, within the next couple of weeks. CUE-401 is designed to act mechanistically both as a regulator of proinflammatory mechanisms and as a master switch for regulatory T cell (Treg) differentiation to induce tolerance.

Fourth Quarter 2025 Financial Results

The Company reported collaboration revenue of $21.9 million and $1.6 million for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily due to revenue recognized from the collaboration and license agreement with ImmunoScape in the fourth quarter of 2025.

Research and development expenses were $16.5 million and $7.2 million for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily due to an increase in drug substance manufacturing and lab costs for CUE-401, an increase from one-time acquired acquired in-process research and development costs in connection with our collaboration and license agreement with ImmunoScape, and an increase in license fees payable to Einstein in connection with the collaboration and license agreement with ImmunoScape. These increases were partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, as well as a decrease in clinical trial costs as a result of licensing molecules from the CUE-100 series to ImmunoScape.

General and administrative expenses were $3.5 million and $4.0 million for the three months ended December 31, 2025 and 2024, respectively. The decrease was primarily due to a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, partially offset by an increase in severance expense paid to our former chief executive officer as well as an increase in professional fees related to the review, negotiation, and preparation of the collaboration and license agreement with ImmunoScape.

Full Year 2025 Financial Results

The Company reported collaboration revenue of $27.5 million and $9.3 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to revenue earned from our collaboration and license agreement entered into with ImmunoScape in the fourth quarter of 2025.

Research and development expenses were $37.7 million and $36.3 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to one-time acquired in-process research and development costs in connection with our collaboration and license agreement with ImmunoScape, an increase in drug substance manufacturing and lab costs for CUE-401, and an increase in license fees payable to Einstein in connection with the collaboration and license agreement with ImmunoScape. These increases were partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, as well as a decrease in clinical trial costs as a result of licensing molecules from the CUE-100 series to ImmunoScape.

General and administrative expenses were $16.2 million and $14.6 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to an increase in professional fees, which included fees incurred for the review, negotiation, and preparation of our 2025 collaboration and license agreements and an increase in severance paid to our former chief executive officer, partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount.

As of December 31, 2025, the Company had $27.1 million in cash and cash equivalents.

(Press release, Cue Biopharma, MAR 16, 2026, View Source [SID1234663562])

On March 16, 2026 CRISPR Therapeutics AG (the "Company") completed its previously announced private offering (the "Offering") of $600.0 million aggregate principal amount of its Convertible Senior Notes due 2031 (the "Notes"), including the exercise in full of the initial purchasers’ option to purchase up to an additional $50.0 million principal amount of Notes. The Notes were issued pursuant to an indenture, dated as of March 16, 2026 (the "Indenture"), between the Company and U.S. Bank Trust Company, National Association, as trustee. The investors in the Notes agreed to an effective coupon of 1.125%. Because of
anticipated 35% withholding on interest payments on the Notes under Swiss tax law, the Company agreed to increase the
coupon by 0.6058% to 1.7308% to effectively eliminate the impact of such anticipated withholding on any holders who are not
eligible to receive a refund.

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The Company’s net proceeds from the Offering were approximately $585.2 million, after deducting the initial purchasers’ discounts and commissions and the estimated Offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for general corporate purposes.

The Notes are senior, unsecured obligations of the Company and will mature on March 1, 2031, unless earlier converted, redeemed or repurchased. The Notes will accrue interest payable semiannually in arrears on March 1 and September 1 of each year, beginning on September 1, 2026. Holders may convert all or any portion of their Notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date, other than during a "conversion freeze period" (as defined in the Indenture). Upon conversion, the Company will deliver for each $1,000 principal amount of converted Notes a number of its common shares, nominal value CHF 0.03 per share (the "Common Shares"), equal to the conversion rate (together with a cash payment in lieu of delivering any fractional Common Share).

The conversion rate for the Notes will initially be 13.0617 Common Shares per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $76.56 per Common Share). The initial conversion price of the Notes represents a premium of approximately 45.0% to the last reported sale price of $52.80 per Common Share on the Nasdaq Global Market on March 10, 2026. The conversion rate for the Notes will be subject to adjustment in some events in accordance with the terms of the Indenture but will not be adjusted for any accrued and unpaid interest. In addition, if certain corporate events occur or are anticipated to occur prior to the maturity date of the Notes or if the Company delivers a notice of optional redemption, the Company will, in certain circumstances, increase the conversion rate of the Notes for a holder who elects to convert its Notes in connection with such a corporate event or convert its Notes called (or deemed called) for redemption in connection with such notice of optional redemption. Initially, a maximum of 11,363,580 Common Shares may be delivered upon conversion of the Notes, based on the initial maximum conversion rate of 18.9393 Common Shares per $1,000 principal amount of Notes, which is subject to customary conversion rate adjustment provisions.

The Company may not redeem the Notes prior to March 6, 2029. The Company may redeem for cash all or any portion of the Notes (subject to the partial redemption limitation described in the Indenture), at its option, on an optional redemption date occurring on or after March 6, 2029 if the last reported sale price of the Common Shares has been at least 130% of the conversion price for the Notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of optional redemption, at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the optional redemption date. No sinking fund is provided for the Notes.

If the Company undergoes a fundamental change (as defined in the Indenture), then, subject to certain conditions and except as described in the Indenture, holders may require the Company to repurchase for cash all or any portion of their Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

The Indenture includes customary covenants and sets forth certain events of default after which the Notes may be declared immediately due and payable and sets forth certain types of bankruptcy or insolvency events of default involving the Company after which the Notes become automatically due and payable. The following events are considered "events of default" under the Indenture:

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default in any payment of interest on any Note when due and payable and the default continues for a period of 30 days;
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default in the payment of principal of any Note when due and payable at its stated maturity, upon any optional redemption, upon any required repurchase, upon declaration of acceleration or otherwise;
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the Company’s failure to comply with its obligation to convert the Notes in accordance with the Indenture upon exercise of a holder’s conversion right and such failure continues for three business days;
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the Company’s failure to give a (A) make-whole fundamental change notice for any anticipated make-whole fundamental change when due and such failure continues for one business day or (B) fundamental change notice or a make-whole fundamental change notice not otherwise described in (A), in each case when due and such failure continues for four business days;
•
the Company’s failure to comply with its obligations in respect of any consolidation, merger or sale of assets;
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the Company’s failure to comply with any of the Company’s other agreements contained in the Notes or the Indenture for 60 days after its receipt of written notice of such failure from the trustee or the holders of at least 25% in principal amount of the Notes then outstanding;
•
default by the Company or any of the Company’s significant subsidiaries (as defined in the Indenture) with respect to any mortgage, agreement or other instrument under which there may be outstanding, or by which there may be secured or evidenced, any indebtedness for money borrowed with a principal amount in excess of $60.0 million (or its foreign currency equivalent) in the aggregate of the Company and/or any such significant subsidiary, whether such indebtedness now exists or shall hereafter be created (i) resulting in such indebtedness becoming or being declared due and payable prior to its stated maturity date or (ii) constituting a failure to pay the principal of any such debt when due and payable (after the expiration of all applicable grace periods) at its stated maturity, upon required repurchase, upon declaration of acceleration or otherwise, and in the cases of clauses (i) and (ii), such acceleration shall not have been rescinded or annulled or such failure to pay or default shall not have been cured or waived, or such indebtedness is not paid or discharged, as the case may be, within 30 days after written notice to the Company by the trustee (at the direction of any holder of Notes) or to the Company and the trustee by holders of at least 25% in aggregate principal amount of the Notes then outstanding in accordance with the Indenture; or
•
certain events of bankruptcy, insolvency, or reorganization of the Company or any of the Company’s significant subsidiaries.
If certain bankruptcy and insolvency-related events of default involving the Company (and not just any of its significant subsidiaries) occur, 100% of the principal of and accrued and unpaid interest on the Notes will automatically become due and payable. If an event of default other than certain bankruptcy and insolvency-related events of default involving the Company occurs and is continuing, the trustee, by notice to the Company, or the holders of at least 25% in principal amount of the outstanding Notes by notice to the Company and the trustee, may, and the trustee at the request of such holders shall, declare 100% of the principal of and accrued and unpaid interest, if any, on all the Notes to be due and payable. Notwithstanding the foregoing, the Indenture provides that, to the extent the Company so elects, the sole remedy for an event of default relating to certain failures by the Company to comply with certain reporting covenants in the Indenture will, for the first 365 days after the occurrence of such an event of default, consist exclusively of the right to receive additional interest on the Notes as set forth in the Indenture.

The Indenture provides that the Company shall not consolidate with or merge with or into, or sell, convey, transfer or lease the consolidated properties and assets of the Company and its subsidiaries substantially as an entirety to another person (other than any such sale, conveyance, transfer or lease to one or more of the Company’s direct or indirect wholly owned subsidiaries), unless: (i) the resulting, surviving or transferee person (if not the Company) is a "qualified successor entity" (as defined in the Indenture) organized and existing under the laws of Switzerland or of the United States of America, any State thereof or the District of Columbia, and such successor entity (if not the Company) expressly assumes by supplemental indenture all of the Company’s obligations under the Notes and the Indenture; and (ii) immediately after giving effect to such transaction, no default or event of default has occurred and is continuing under the Indenture.

A copy of the Indenture is attached hereto as Exhibit 4.1 (including the global form of the Notes attached hereto as Exhibit 4.2) and this description is qualified in its entirety by reference to such document.

(Filing, CRISPR Therapeutics, MAR 16, 2026, View Source [SID1234663561])

On March 16, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update.

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"We continue to focus on advancing silevertinib for the treatment of patients with EGFRm NSCLC and EGFR altered GBM," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We look forward to presenting updated results from the Phase 2 NSCLC trial in both the frontline and recurrent settings, including preliminary DOR and PFS data for frontline patients, at a medical meeting in the second quarter of 2026. We also expect to initiate our randomized Phase 2 trial in newly diagnosed GBM in the second quarter this year."

Recent Developments & Upcoming Milestones:

In December 2025 the Company disclosed initial data from the Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients harboring a broad spectrum of non-classical epidermal growth factor receptor (EGFR) mutations which demonstrated a 60% Objective Response Rate (ORR by RECIST 1.1), 86% CNS ORR (by RANO-BM) and 91% disease control rate (DCR) as of a November 3, 2025 data cutoff. No new safety signals were observed. Black Diamond continues to explore potential partnership opportunities to advance silevertinib into pivotal development.
Black Diamond anticipates the following upcoming key milestones for silevertinib:
Presentation of updated clinical data from our Phase 2 trial in patients with non-classical EGFR NSCLC in both the recurrent setting and the frontline setting, including preliminary duration of response (DOR) and progression-free survival (PFS) data for frontline EGFRm patients, at a medical meeting in the second quarter of 2026 (NCT05256290).
Initiation of a randomized Phase 2 trial in patients with newly diagnosed EGFR-altered GBM in the second quarter of 2026 (NCT07326566).
Financial Highlights

Cash Position: Black Diamond ended 2025 with approximately $128.7 million in cash, cash equivalents, and investments compared to $98.6 million as of December 31, 2024. Net cash provided by operations was $29.6 million for the year ended December 31, 2025 compared to net cash used in operations of $62.3 million for the year ended December 31, 2024.
Research and Development Expenses: Research and development (R&D) expenses were $6.3 million for the fourth quarter of 2025, compared to $12.3 million for the same period in 2024. R&D expenses were $33.6 million for the year ended December 31, 2025, compared to $51.3 million for the year ended December 31, 2024. The decrease in R&D expenses was primarily due to workforce efficiencies and outlicensing of BDTX-4933 to increase focus on the development of silevertinib.
General and Administrative Expenses: General and administrative (G&A) expenses were $4.0 million for the fourth quarter of 2025, compared to $6.0 million for the same period in 2024, and $16.6 million for the year ended December 31, 2025, compared to $27.5 million for the year ended December 31, 2024. The decrease in G&A expenses was primarily due operational and workforce efficiencies from the restructuring announced in October 2024.
Net Loss: Net loss for the fourth quarter of 2025 was $15.1 million, as compared to $16.0 million for the same period in 2024. Net income for the year ended December 31, 2025 was $22.4 million compared to a net loss of $69.7 million for the year ended December 31, 2024.
Financial Guidance

Black Diamond ended 2025 with approximately $128.7 million in cash, cash equivalents and investments which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.

(Press release, Black Diamond Therapeutics, MAR 16, 2026, View Source [SID1234663560])

On March 16, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the fourth quarter and full year 2025 and business updates.

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"We continue to focus on streamlining our costs and liabilities, allowing us to be a nimbler, fit for purpose organization," said Cokey Nguyen Ph.D., President and Chief Executive Officer of Atara. "With the adjustments we have made we are able to focus on supporting our partner, Pierre Fabre Pharmaceuticals, as they work towards addressing the concerns in the latest Complete Response Letter with the agency. We strongly believe that tabelecleucel can bring substantial benefit to post-transplant lymphoproliferative disease patients and we are committed to supporting Pierre Fabre Pharmaceuticals as they get this life-saving drug to the finish line in the U.S."

Tabelecleucel (tab-cel or Ebvallo) for Post-Transplant Lymphoproliferative Disease (PTLD)

A Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled for our partner Pierre Fabre Pharmaceuticals to discuss the issues raised by the FDA in the Complete Response Letter received in January 2026. We anticipate providing a regulatory update in the second quarter.

Corporate Updates

As previously communicated, Atara entered into an amendment (Amendment) to the Purchase and Sale Agreement dated as of December 20, 2022 with a fund managed by HealthCare Royalty ("HCRx"). Under the terms of the Amendment, HCRx agreed to amend the due date of the one-time $9.0 million cash payment associated with the achievement of a certain milestone from June 30, 2026 to January 1, 2028 in exchange for the issuance of a warrant to purchase up to 400,000 shares of Atara common stock.

Financial Update:

Fourth Quarter and Full Year 2025 Financial Results:

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Cash, cash equivalents and short-term investments as of December 31, 2025 totaled $8.5 million, as compared to $42.5 million as of December 31, 2024.
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Net cash used in operating activities was $5.7 million and $50.9 million for the fourth quarter and fiscal year 2025, as compared to $24.5 million and $68.7 million for the same periods in 2024.
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Atara reported a net loss of ($3.4) million, or ($0.25) per share, and a net income of $32.7 million, or $2.61 per share, for the fourth quarter and fiscal year 2025, respectively, as compared to a net loss of ($12.7) million, or ($1.19) per share, and ($85.4) million, or ($11.41) per share, for the same periods in 2024.
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Commercialization revenues were $120.8 million in 2025 as compared to $128.9 million in 2024.
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Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $1.6 million and $11.9 million for the fourth quarter and fiscal year 2025, respectively, as compared to $6.9 million and $32.1 million for the same periods in 2024.
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Research and development expenses were ($0.2) million and $37.4 million for the fourth quarter and fiscal year 2025, respectively, compared to $28.7 million and $151.5 million for the same periods in 2024. The 2025 results include a $2.6 million non-cash gain from an ARC facility lease amendment, resulting in a fourth-quarter credit rather than an expense.
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Research and development expenses include $0.4 million and $2.9 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2025, respectively, compared to $2.6 million and $13.5 million for the same periods in 2024.
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General and administrative expenses were $4.3 million and $26.3 million for the fourth quarter and fiscal year 2025, respectively, as compared to $9.4 million and $39.9 million for the same periods in 2024.
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General and administrative expenses include $1.1 million and $6.9 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2025, respectively, compared to $3.3 million and $13.5 million for the same periods in 2024.

2026 Outlook and Cash Runway:

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Operating expenses are expected to continue to decline significantly year-over-year as a result of the comprehensive cost-reduction initiatives completed in 2025.

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Atara expects that cash, cash equivalents and short-term investments as of December 31, 2025, combined with recent ATM proceeds of $3.0 million and the operating efficiencies realized in 2025, will be sufficient to fund planned operations through year-end 2026.

(Press release, Atara Biotherapeutics, MAR 16, 2026, View Source [SID1234663559])

On March 16, 2026 AstraZeneca reported that Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the European Union (EU) for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The regimen includes two cycles of Imfinzi in combination with chemotherapy before and after surgery, followed by Imfinzi monotherapy.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the positive results from the MATTERHORN Phase III trial, which were published in The New England Journal of Medicine.

Gastric cancer is the fifth leading cause of cancer death globally, with nearly one million people diagnosed each year.1 In 2024, there were roughly 15,500 drug-treated patients in the EU with early-stage and locally advanced gastric or GEJ cancer.2

Josep Tabernero, MD, PhD, head of the Medical Oncology Department at Vall d’Hebron University Hospital and director of the Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, Spain, and principal investigator in the trial, said: "Despite curative-intent surgery and chemotherapy, patients with resectable gastric and gastroesophageal cancers still face high recurrence rates and an urgent need for improved long-term survival. In MATTERHORN, nearly 70 per cent of patients were still alive three years after treatment with the durvalumab-based perioperative regimen. This EU approval brings patients the first immunotherapy regimen to extend survival in this early setting and is poised to become the new standard of care."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "This approval marks our third perioperative approval in Europe for an Imfinzi-based regimen, underscoring AstraZeneca’s commitment to transforming outcomes in early-stage disease, where cure is possible. For patients with early gastric and gastroesophageal cancers, this immunotherapy-based regimen delivers a durable survival benefit that increases over time."

In a planned interim analysis, patients treated with the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone (based on an event-free survival [EFS] hazard ratio [HR] of 0.71; 95% confidence interval [CI] 0.58-0.86; p<0.001). Estimated median EFS was not yet reached for the Imfinzi arm versus 32.8 months for the comparator arm. An estimated 78.2% of patients treated with the Imfinzi-based perioperative regimen were event-free at one year, compared to 74.0% in the comparator arm; the estimated 24-month EFS rate was 67.4% versus 58.5%, respectively.

In the final overall survival (OS) analysis, results showed the Imfinzi and FLOT perioperative regimen demonstrated a statistically significant and clinically meaningful survival improvement, reducing the risk of death by 22% compared to chemotherapy alone (based on a HR of 0.78; 95% CI 0.63-0.96; p=0.021). An estimated 69% of patients treated with the Imfinzi-based regimen were alive at three years compared with 62% in the comparator arm. At each subsequent prespecified OS landmark, the survival curves indicated increasing separation, signaling a greater magnitude of benefit over time for the Imfinzi-based regimen. An OS benefit was observed regardless of tumour PD-L1 status. OS results from MATTERHORN were presented in a Proffered Paper session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

The safety profile for Imfinzi and FLOT chemotherapy was consistent with the known profiles of each medicine, and the percentage of patients that completed surgery was similar compared to chemotherapy alone. Grade 3 or higher adverse events due to any cause were similar between the two arms (71.6% for Imfinzi and FLOT arm; 71.2% for comparator arm).

Imfinzi and FLOT chemotherapy is approved in the US and other countries based on the MATTERHORN results. Regulatory applications are currently under review in Japan and several other countries for this indication.

Notes

Gastric and gastroesophageal junction cancers
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-highest leading cause of cancer mortality.1 Nearly one million new patients were diagnosed with gastric cancer in 2022, with approximately 660,000 deaths reported globally.1 In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.3

GEJ cancer is a type of gastric cancer that arises from and spans the area where the oesophagus connects to the stomach.4

Disease recurrence is common in patients with resectable gastric cancer despite undergoing surgery with curative intent and treatment with neoadjuvant/adjuvant chemotherapy.5 Approximately one in four patients with gastric cancer who undergo surgery develop recurrent disease within one year, and the five-year survival rate remains poor, with less than half of patients alive at five years.5-6

MATTERHORN
MATTERHORN is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial evaluating Imfinzi as perioperative treatment for patients with resectable Stage II-IVA gastric and GEJ cancers. Perioperative therapy includes treatment before and after surgery, also known as neoadjuvant/adjuvant therapy. In the trial, 948 patients were randomised to receive a 1500mg fixed dose of Imfinzi plus FLOT chemotherapy or placebo plus FLOT chemotherapy every four weeks for two cycles prior to surgery. This was followed by Imfinzi or placebo every four weeks, for a maximum of 12 cycles after surgery (including two cycles of Imfinzi or placebo plus FLOT chemotherapy and 10 additional cycles of Imfinzi or placebo monotherapy).

In the MATTERHORN trial, the primary endpoint is EFS, defined as time from randomisation until the date of one of the following events (whichever occurred first): RECIST (version 1.1, per blinded independent central review assessment) progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period; RECIST progression/recurrence during the adjuvant period; non-RECIST progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period or discovered during surgery; progression/recurrence confirmed by biopsy post-surgery; or death due to any cause. Key secondary endpoints include pathologic complete response rate, defined as the proportion of patients who have no detectable cancer cells in resected tumour tissue following neoadjuvant therapy, and OS. The trial enrolled participants in 176 centres in 20 countries, including in the US, Canada, Europe, South America and Asia.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In GI cancer, Imfinzi is approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo (tremelimumab) in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU.

In addition to its indications in GI cancers, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC.

Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved in the US, EU, Japan and other countries for patients with muscle-invasive bladder cancer based on results from the NIAGARA Phase III trial. Additionally, in May 2025, Imfinzi added to Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.

Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several GI cancers.

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(Press release, AstraZeneca, MAR 16, 2026, View Source [SID1234663558])