On July 28, 2025 Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing breakthrough therapies, via intratumorally administration, for primary and metastatic breast cancers, reported they have successfully secured the foundational Composition-of-Matter patents and claims from the USPTO for their proprietary breast cancer platform (Press release, Zetagen Therapeutics, JUL 28, 2025, View Source [SID1234654576]).

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"Securing these allowances and composition-of-matter patents for our intratumorally administered breast cancer therapeutics represents a strategic leap forward in our mission to redefine oncologic care," said Joe C. Loy, CEO of Zetagen Therapeutics. "This latest patent protects the molecular uniqueness of our drug ZetaPrime and affirms the disruptive potential in our pursuit to minimize off target side effects of conventional chemotherapeutics. We are proud to advance precision therapies designed to target tumors directly and deliver meaningful hope to patients with limited options."

Zetagen Therapeutics has built a robust intellectual property portfolio anchored in its groundbreaking discoveries in intratumorally drug administration for both primary and metastatic breast cancer. The company’s IP estate—which now includes multiple composition-of-matter patents—focuses on proprietary and established molecules designed to be delivered directly into tumors, reducing systemic toxicity and off-target side effects. This precision method not only protects healthy tissue but also holds the potential to significantly improve survival outcomes by enhancing therapeutic efficacy at the site of disease. Zetagen’ s growing suite of patents underscores its commitment to redefining standards of care and advancing targeted oncology innovation.

"Receiving multiple composition-of-matter patents for our breast oncology candidates is a transformative milestone for our scientific and clinical mission," said Bryan S. Margulies, Ph.D., CSO of Zetagen Therapeutics. "By securing these patents, we validate the unique molecular design of our compounds and strengthen our pursuit of transformative therapies for underserved patient populations."

Zetagen has enlisted Foley & Lardner LLP as its intellectual property counsel and maintains a collaborative professional relationship with Steve Maebius, Esq. Foley & Lardner LLP is a prominent law firm with global reach and specialized expertise in Life Sciences intellectual property and strategic counsel.

About ZetaMet (Zeta-BC-003) – Lead Drug Candidate:
ZetaMet is a groundbreaking molecular pathway drug, targets metastatic breast cancer in bone, ceasing lytic activity, inhibits pain, and regenerates new bone all via locoregional administration, 30-minute outpatient procedure, without systemic limitation, minimizing skeletal related events (SRE) while increasing survival rates.

ZetaMet has been awarded 2x FDA Breakthrough Designations and has been approved in the treatment of 8x Compassionate Use stage 4 cancer patients in the US and Canada. ZetaMet has demonstrated cross-species efficacy at consistent concentrations, with findings published in several peer-reviewed journals—underscoring its translational promise from lab to clinic. Notably, these individuals had previously failed to respond to standard treatments such as chemotherapy, surgery, and radiation.

Zetagen has successfully completed enrollment of phase 2a clinical trial for the treatment of metastatic breast cancer to the spine, University of British Columbia, preliminary results available upon request and full study results anticipated November 2025.

About ZetaMast (Zeta-MBC-005)
ZetaMast is a proprietarydrug-eluting hydrogel carrier designed for locoregional administration, controlled releaseof small molecules in treatment of multifocal, unresectable, liver metastases from breast cancer with potential to increase survival rates.

Zetagen has completed preclinical studies, drug elution refinement, toxicity testing and a dose optimization study, results published in peer-review journal PLOS-One.

Zetagen plans to file an IND with the FDA this fall and upon approval conduct a Phase 1b dose escalation study early 2026.

About ZetaPrime (Zeta-PBC-007)
ZetaPrime is a neo-adjuvant treatment for primary HR+ breast cancer, engineered for a locoregional administration following diagnosis. Utilizing a proprietary hydrogel-like lipid carrier, formulation enables controlled release of two small molecules— one being our novel molecular entity, and the ability to deliver other companies CDK4 or CDK4/6 protein inhibitor and any anticancer therapeutic. Designed for solubility within adipose tissue, approach targets primary breast cancer, aiming to mitigate off-target effects, reduce necessity for lumpectomies and mastectomies, postpone radiation exposure, and enhance patient survival.

On July 28, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported it will jointly present a poster on updated data from the Phase I part of the Phase I/IIa study of BT-001 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting (Press release, Transgene, JUL 28, 2025, View Source [SID1234654577]). ESMO (Free ESMO Whitepaper) will take place in Berlin, Germany, from October 17 to 21, 2025.

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Poster details

Title: "Updated clinical results of BT-001, an oncolytic virus expressing an anti-CTLA4 mAb, administered in combination with pembrolizumab in patients with advanced solid tumors."

Abstract number: 2828

Authors: C. Lebbe, R. Bahleda, E. Ezine, B. Baroudjian, M. Sakkal, E. Rowinski, A. Vinceneux, S. Champiat, K. Bidet Huang, N. Stojkowitz, H. Makhloufi, A. Sadoun, A. Ropenga, M. Semmrich, A. McAllister, M. Chisamore, P. Cassier

The abstract will be available on ESMO (Free ESMO Whitepaper)’s website on October 13, 2025, at 00:05 CEST.

BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting recombinant human anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine. BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent. In the Phase I part of this study, as monotherapy and in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), BT-001 has been shown to be well tolerated. BT-001 also showed the first signs of efficacy with clinical response in two out of six refractory patients, thirteen patients evaluated in total, when given in combination with pembrolizumab, with shrinkage of injected and non-injected lesions. Treatment with BT-001 converted "cold" tumors into "hot" ones, and induced T-cell infiltration, as well as PD(L)-1 expression in the tumor microenvironment (See press release from September 14, 2024 here).

The ongoing Phase I/IIa study (NCT04725331) is a multicenter, open label, dose-escalation study evaluating BT-001 as a single agent and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab). The last patient in the Phase I part was enrolled in August 2024.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On July 28, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that it has secured a €37.5 million, 4-tranche financing from the European Investment Bank (EIB) (Press release, MaaT Pharma, JUL 28, 2025, View Source [SID1234654558]). The financing will support the advancement of its late-stage hemato-oncology clinical programs including the lead-asset Xervyteg, recently partnered with Clinigen in Europe, and currently under regulatory review by the European Medicines Agency (EMA) for the treatment of acute Graft-versus-Host Disease (aGvHD) and the second drug candidate, MaaT033, currently being evaluated in a Phase 2b randomized controlled trial in improving survival for patients receiving allogeneic stem cell transplants.

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With robust cGMP manufacturing, proprietary therapies, and a development platform, MaaT Pharma is a global leader in microbiome-based oncology, pioneering full-ecosystem therapies to improve survival in oncology. Since completing enrollment in the ARES trial for Xervyteg (MaaT013) in October 2024, MaaT Pharma has steadily advanced its roadmap, reporting topline results in January 2025, submitting the Marketing Authorization Application with the European Medicines Agency in June 2025, and signing an exclusive agreement for marketing and distribution in Europe with Clinigen in July 2025.

The €37.5 million financing from the EIB follows a rigorous due diligence process by the EIB and further confirms MaaT Pharma’s innovation, strategic vision and operational maturity. This funding is part of a global financial strategy to support the Company’s development that combines various non-dilutive and dilutive sources to best preserve shareholder value.

Eric Soyer, Chief Financial Officer, MaaT Pharma, said: "We are grateful for the confidence shown in MaaT Pharma and the support from the EIB, which is a further foundation towards the next phase of MaaT Pharma’s growth on bringing the potential first microbiome-based therapy to market in Europe. Each operational and financing step strengthens our track record. Following the regulatory submission to the EMA for Xervyteg(MaaT013) and our recent partnership with Clinigen for its commercialization, the EIB financing represents another step in reinforcing the Company’s financial position. As previously announced, MaaT Pharma intends to fund its plans and development programs while preserving shareholder value in the best manner possible with a mix of non-dilutive and dilutive financial sources, and the recent announcements of both partnership financing with the Clinigen agreement and debt financing with the EIB agreement, are benchmarks to reflect that strategy."

Summary of the main terms and conditions of the Loan and Warrants

The loan would be available in four (4) tranches, respectively of €3.5 million for Tranche A, €6.0 million for Tranche B, €8.0 million for Tranche C, and €20.0 million for Tranche D, each tranche with Warrants attached. Disbursement of Tranches 2 to 4 are subject to operational and financing conditions. All Tranches are redeemable after a grace period of 4 years from the date of drawing, with reimbursement over a period of 2 years (Tranche A, B and C, i.e. a maturity of 6 years) to 4 years (Tranche D, i.e. a maturity of 8 years). Each tranche will bear interests at 7%, it being provided that some interests will be deferred and paid at maturity and for Tranche C and Tranche D part of the interest will be paid quarterly.

MaaT Pharma will issue warrants to the benefit of EIB at the time of (and subject to) disbursement of each tranche in a number depending, for each relevant tranche, on the amount of the relevant tranche and the average price per share paid by investors in the context of equity injection made prior to disbursement of the relevant tranche (except for tranche A where the average price per share over the last trading days preceding the date of execution of the financing agreement). Each warrant will give right to subscribe to one share at a price per warrant equal to 99% of the average price over a period of 5 trading days preceding the issuance of each Warrant. The Warrants may be exercised at any time following maturity of Tranche A. The Warrants will have a 20-year term.

EIB and MaaT Pharma have also agreed on (i) a put option to the benefit of EIB under which MaaT Pharma undertook to acquire from EIB all or part of the Warrants upon occurrence of certain events and (ii) a call option to the benefit of MaaT Pharma under which EIB undertook to sell all its Warrants, upon occurrence of a public tender offer over the securities issued by MaaT Pharma.

The Warrants are not transferable, except to affiliates of EIB or except in case of occurrence of certain events (including maturity date of Tranche D). In case of transfer of Warrants to third party, MaaT Pharma shall benefit from a preemptive right to acquire the Warrants first.

MaaT Pharma was assisted in this transaction by Mr. Eric Briole and by Van Lanschot Kempen as Financial Advisors and McDermott Will & Emery as Legal Advisor.

On July 28, 2025 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported that it has earned a $100 million milestone payment from Sarepta Therapeutics (NASDAQ: SRPT) (Press release, Arrowhead Pharmaceuticals, JUL 28, 2025, View Source [SID1234654578]). The milestone was triggered when Arrowhead reached the first of two prespecified enrollment targets and subsequent authorization to dose escalate in a Phase 1/2 clinical study of ARO-DM1, an investigational RNA interference (RNAi) therapeutic for the treatment of type 1 myotonic dystrophy (DM1), the most common adult-onset muscular dystrophy. Arrowhead currently expects to achieve the second enrollment target by the end of 2025, which would trigger an additional $200 million milestone payment from Sarepta.

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In accordance with the license and collaboration agreement, Arrowhead expects to receive this payment within 60 days.

About the Arrowhead-Sarepta Agreement

Arrowhead and Sarepta signed a global licensing and collaboration agreement in November 2024, which closed in February 2025, whereby Sarepta received rights to multiple investigational treatments that leverage Arrowhead’s leading Targeted RNAi Molecule (TRiMTM) platform. The agreement covers multiple clinical and preclinical programs in rare, genetic diseases of the muscle, central nervous system, and the lungs, and also allows Sarepta to select up to six new targets for Arrowhead to conduct discovery and preclinical development activities in areas complementary to Sarepta’s leadership in precision genetic medicine for rare diseases.

Summary Financial Terms

Upon closing, Arrowhead received a $500 million upfront payment and $325 million through the purchase by Sarepta of Arrowhead common stock priced at $27.25 per share, representing a 35% premium to the 30-day volume weighted average price (VWAP) when the agreement was signed. Arrowhead will also receive $250 million to be paid in annual installments of $50 million over five years, and has the potential to receive an additional $300 million in near-term milestone payments associated with the continued enrollment of certain cohorts of a Phase 1/2 study of ARO-DM1, $100 million of which has now been earned.

Arrowhead is also eligible to receive further development milestone payments of between $110 million and $180 million per program, sales milestone payments of between $500 million and $700 million per program, and tiered royalties on commercial sales up to the low double digits.

Summary of Programs Under the License and Collaboration Agreement

Clinical Stage

ARO-DUX4, which is designed to target the gene that encodes the DUX4 protein as a potential treatment for patients with facioscapulohumeral muscular dystrophy type 1, currently dosing patients in a Phase 1/2 clinical study.
ARO-DM1, which is designed to reduce expression of the dystrophia myotonica protein kinase (DMPK), gene in skeletal muscle as a potential treatment for patients with type 1 myotonic dystrophy, currently dosing patients in a Phase 1/2 clinical study.
ARO-MMP7, which is designed to reduce expression of matrix metalloproteinase 7 (MMP7) in the lung as a potential treatment for idiopathic pulmonary fibrosis, currently dosing patients in a Phase 1/2 clinical study.
ARO-ATXN2, which is designed to silence expression of the toxic ATXN2 protein in the CNS as a potential treatment for spinocerebellar ataxia 2 (SCA2), currently in a Phase 1/2 study that is open for enrollment.
Preclinical Stage

ARO-HTT for patients with Huntington’s disease, expected to be CTA-ready in 2025
ARO-ATXN1 for patients with spinocerebellar ataxia 1 (SCA1) expected to be CTA-ready in 2026
ARO-ATXN3 for patients with spinocerebellar ataxia 3 (SCA3) expected to be CTA-ready in 2026
Discovery

During the five-year term, Sarepta can propose up to six new CNS or muscle targets for which Arrowhead will perform discovery and preclinical development. Sarepta would then receive an exclusive license to those programs and would be responsible for subsequent clinical development and commercialization.

Drug Manufacturing

Under the terms of the agreement, Arrowhead will manufacture clinical drug supply for all programs arising out of the license and collaboration, and commercial drug product for the four programs currently in clinical trials.

On July 28, 2025 AstraZeneca reported supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review in the US for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers (Press release, AstraZeneca, JUL 28, 2025, View Source [SID1234654559]).

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The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2025.

Imfinzi was also recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.2

Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-highest leading cause of cancer mortality.3 In 2024, there were approximately 6,500 drug-treated patients in the US with early-stage and locally advanced gastric or GEJ cancer. 4

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This Priority Review reinforces the potential for a perioperative approach with Imfinzi to transform care for patients with early gastric and gastroesophageal junction cancers, who frequently face disease recurrence or progression even after curative-intent surgery and perioperative chemotherapy. This novel treatment is the only immunotherapy-based regimen to show a statistically significant reduction in the risk of progression, recurrence or death in this setting, and if approved, is poised to change the clinical paradigm."

The sBLA is based on data from the MATTERHORN Phase III trial which was presented during the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.

In the trial, patients were treated with neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy. 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, signalling a greater magnitude of benefit over time for the Imfinzi-based regimen.

For the key secondary endpoint of overall survival (OS), a strong trend was observed in favour of the Imfinzi-based perioperative regimen (HR=0.78; 95% CI 0.62-0.97; p=0.025). The trial will continue to follow OS, which will be formally assessed at the final analysis.

The safety profile for Imfinzi and FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) 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.

Regulatory applications are currently under review in the EU, Japan and several other countries based on the MATTERHORN results.

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.3 Nearly one million new patients were diagnosed with gastric cancer in 2022, with approximately 660,000 deaths reported globally.3 In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.5 In 2024, there were approximately 43,000 drug-treated patients in the US, European Union (EU), and Japan with early-stage and locally advanced gastric or GEJ cancer.4 Approximately 62,000 patients in these regions are expected to be newly diagnosed in this setting by 2030.6

GEJ cancer is a type of gastric cancer that arises from and spans the area where the oesophagus connects to the stomach.7

Disease recurrence is common in patients with resectable gastric cancer despite undergoing surgery with curative intent and treatment with neoadjuvant/adjuvant chemotherapy. Approximately one in four patients with gastric cancer who undergo surgery develop recurrent disease within one year, and one in four patients do not survive beyond two years, reflecting a high unmet medical need.8-9 Additionally, the five-year survival rate remains poor, with less than half of patients alive at five years.10

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 up to 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 and other countries for patients with muscle-invasive bladder cancer based on results from the NIAGARA Phase III trial. Additionally, in May 2025, Imfinzi plus standard-of-care 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.