Imfinzi recommended for approval in the EU by CHMP as first and only perioperative immunotherapy for muscle-invasive bladder cancer

On May 27, 2025 AstraZeneca reported Imfinzi (durvalumab) has been recommended for approval in the European Union (EU) for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder) (Press release, AstraZeneca, MAY 27, 2025, View Source [SID1234653385]).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the NIAGARA Phase III trial, which were presented during a Presidential Symposium at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and simultaneously published in The New England Journal of Medicine.

In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm (based on event-free survival [EFS] hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001). Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event free at two years compared to 59.8% in the comparator arm.

Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy alone (based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.0106). Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm.

Dr Michiel Van der Heijden, medical oncologist and Group Leader at the Netherlands Cancer Institute, and investigator in the NIAGARA trial, said: "Approximately half of patients with muscle-invasive bladder cancer will experience disease recurrence despite curative-intent treatment with neoadjuvant chemotherapy and surgery to remove the bladder. This recommendation for the durvalumab-based perioperative regimen brings us closer to providing an important new treatment option that has demonstrated a significant survival benefit, with the potential to transform the treatment approach for patients across Europe."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "The Imfinzi-based perioperative regimen in the NIAGARA Phase III trial enabled survival of more than 80 per cent of patients at two years after treatment. This supports our strategy of moving our innovative medicines into the earlier stages of disease where the opportunity for treatment with curative intent is greatest. If approved, this novel approach will become a much-needed new treatment option for patients in Europe and could become the new standard of care in this setting."

In 2024, over 35,000 people in the five major European countries were treated for MIBC.1 Bladder cancer is considered muscle-invasive when there is evidence of the tumour invading the muscle wall of the bladder but no distant metastases.2 Despite this representing a curative-intent setting, where the current standard-of-care is neoadjuvant chemotherapy and radical cystectomy, many patients experience disease recurrence after surgery and have a poor prognosis.3

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients’ ability to complete surgery compared to neoadjuvant chemotherapy alone. Immune-mediated adverse events were consistent with the known profile of Imfinzi, manageable and mostly low-grade.

Imfinzi is approved in the US and other countries in this setting based on the NIAGARA results. Regulatory applications are currently under review in Japan and several other countries.

Notes

Muscle-invasive bladder cancer
Bladder cancer is the 9th most common cancer in the world, with more than 614,000 patients diagnosed each year.4 The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.2 In MIBC, approximately 50% of patients who undergo bladder removal surgery experience disease recurrence.3 Treatment options that prevent disease recurrence after surgery are critically needed in this curative-intent setting.

NIAGARA
NIAGARA is a randomised, open-label, multi-centre, global Phase III trial evaluating perioperative Imfinzi as treatment for patients with MIBC before and after radical cystectomy. In the trial, 1,063 patients were randomised to receive four cycles of Imfinzi plus neoadjuvant chemotherapy prior to cystectomy followed by eight cycles of Imfinzi monotherapy, or neoadjuvant chemotherapy alone prior to cystectomy with no further treatment after surgery. NIAGARA is the largest global Phase III trial in this setting.

The trial is being conducted at 192 centres across 22 countries including in North America, South America, Europe, Australia and Asia. Its dual primary endpoints are EFS and pathologic complete response at the time of cystectomy. Key secondary endpoints are OS and safety.

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 May 2025, Imfinzi plus standard-of-care Bacillus Calmette-Guérin induction and maintenance therapy demonstrated a statistically significant and clinically meaningful improvement in disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.

In lung cancer, 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 (tremelimumab) 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.

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

In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met the primary endpoint of EFS in the MATTERHORN Phase III trial in resectable gastric and gastroesophageal junction cancers.

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 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 EU and Japan.

Since the first approval in May 2017, more than 374,000 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 gastrointestinal cancers.

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Lunit Highlights AI’s Role in Advancing Precision Oncology at ASCO 2025 with 12 Studies

On May 26, 2025 Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeutics, reported that 12 studies featuring its AI-powered digital pathology solution will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30–June 3 in Chicago, IL (Press release, Lunit, MAY 26, 2025, View Source [SID1234653382]). Of these, 11 studies will be presented as posters and one as an online publication.

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One of the featured studies, conducted with Japan’s National Cancer Center Hospital East (NCCE), evaluated HER2 expression in biliary tract cancer (BTC) patients using Lunit’s AI-powered analyzer. The resulting AI scores showed strong agreement with pathologist-assigned IHC scores in a 288-patient screening cohort. Among 29 patients treated with trastuzumab deruxtecan (T-DXd), those with higher levels of HER2-intense tumor cells achieved a higher objective response rate (ORR) of 50%, along with significantly longer progression-free survival and overall survival. The study also found that AI-derived "membrane specificity" helped identify additional responders who achieved a 50% ORR and improved survival. This group included not only HER2-intense patients but also some traditionally classified as HER2-low, suggesting that the metric may expand the pool of patients who can benefit from T-DXd. These findings suggest that AI-powered HER2 analysis – especially when incorporating membrane specificity – could expand access to targeted treatment and enable more precise therapy selection in BTC.

A separate prospective study conducted with NCCE evaluated the concordance between pathologist- and AI-assessed PD-L1 expression in lung cancer patients enrolled in LC-SCRUM, one of Japan’s largest nationwide observational cohorts, using Lunit SCOPE PD-L1. The study included 847 non-small cell lung cancer (NSCLC) and 102 small cell lung cancer (SCLC) patients. The overall concordance between the AI model and three expert pathologists was 70%. Concordance was particularly high in key subgroups: 84% for TPS ≥50% and 94% for TPS 1–49%. Of the 416 patients initially classified as TPS <1% by pathologists, the AI identified 231 with higher PD-L1 expression. Since PD-L1 scoring is widely used to guide treatment eligibility, these results highlight the potential of AI-powered PD-L1 evaluation to uncover additional candidates for immunotherapy who may have been previously excluded based on low TPS. The high concordance with expert pathologists also reinforces the reliability of the AI model as a clinical decision-support tool.

A third highlighted study introduced an AI model to predict CLDN18.2 expression in gastric cancer. CLDN18.2 is a therapeutic target for zolbetuximab. It is typically assessed using immunohistochemistry (IHC), which is often limited by tissue quantity, cost, and time. To address this, researchers trained the AI on H&E slides and validated it in the external cohort. The model achieved AUROCs over 0.751, suggesting the potential to efficiently pre-screen CLDN18.2-positive patients using only H&E slides. The study also analyzed immune phenotypes using AI-powered whole-slide image analysis to explore treatment implications. Among patients predicted to be CLDN18.2-negative, those with an "inflamed" phenotype—marked by high tumor-infiltrating lymphocyte (TIL) density—showed significantly better outcomes when treated with immune checkpoint inhibitor plus chemotherapy compared to chemotherapy alone. These findings suggest that combining AI-based CLDN18.2 prediction with immune phenotype analysis could guide first-line treatment decisions without additional IHC tests.

"Our ASCO (Free ASCO Whitepaper) 2025 presentations build on years of work to turn AI into a clinically dependable tool—not just for reading pathology images, but for improving how we select the right treatments. From HER2 scoring in biliary tract cancer to PD-L1 evaluation in lung cancer, our models are helping uncover treatment opportunities for patients who might otherwise be overlooked. This level of precision and reproducibility is exactly what AI needs to deliver real clinical value," said Brandon Suh, CEO of Lunit.

In addition to these three featured studies, Lunit will present 9 additional abstracts covering a wide range of research topics. These include AI-based subcellular profiling to assess the drug-targetability of 74 membrane proteins across 34 cancer types, and deep learning analysis of endothelial cells to understand how the tumor vascular environment influences immunotherapy response.

Lunit will be exhibiting at Booth #26149, where attendees can learn more about the studies and AI solutions featured at this year’s ASCO (Free ASCO Whitepaper).

Lunit’s featured presentations at ASCO (Free ASCO Whitepaper) 2025 include:

[Poster #4047/337] Artificial intelligence-based prediction of claudin 18.2 expression and immune phenotype to guide treatment decisions in patients with gastric cancer, May 31, 9:00 AM – 12:00 PM CDT, Hall A – Posters and Exhibits
[Poster #3084/399] Artificial intelligence (AI)-powered evaluation of protein drug-targetability through subcellular-level expression profiling from immunohistochemistry (IHC) images, June 2, 1:30 PM – 4:30 PM CDT, Hall A – Posters and Exhibits
[Poster #4097/387] Membrane-specific HER2 expression by artificial intelligence-based quantitative scoring for prediction of efficacy of trastuzumab deruxtecan in biliary tract cancer (HERB trial): Exploratory analysis of a multicenter, single arm, phase II trial, May 31, 9:00 AM – 12:00 PM CDT, Hall A – Posters and Exhibits
[e13628] Deep learning to predict treatment response of immune checkpoint inhibitors from pretreatment chest X-rays in non–small-cell lung cancer, Online
[Poster #593/186] Use of artificial intelligence (AI)–powered spatial analysis to predict pathologic complete response (pCR) in HR+ HER2- breast cancer (BC) patients treated with neoadjuvant chemotherapy (NAC), June 2, 9:00 AM – 12:00 PM CDT, Hall A – Posters and Exhibits
[Poster #2578/225] Deep learning–powered H&E whole-slide image analysis of endothelial cells to characterize tumor vascular environment and correlate treatment outcome to immunotherapy, June 2, 1:30 PM – 4:30 PM CDT, Hall A – Posters and Exhibits
[Poster #8572/52] Artificial intelligence-powered spatial analysis of tumor infiltrating lymphocytes and tertiary lymphoid structures in non-small cell lung cancer patients treated with immune-checkpoint inhibitors±chemotherapy, May 31, 1:30 PM – 4:30 PM CDT, Hall A – Posters and Exhibits
[Poster #8536/16] Artificial intelligence-powered spatial analysis of tumor microenvironment in non-small cell lung cancer patients who acquired resistance after EGFR tyrosine kinase inhibitors, May 31, 1:30 PM – 4:30 PM CDT, Hall A – Posters and Exhibits
[Poster #8535/15] A large validation study of AI-powered PD-L1 analyzer compared to pathologists’ assessment of PD-L1 expression in lung cancer, May 31, 1:30 PM – 4:30 PM CDT, Hall A – Posters and Exhibits
[Poster #1110/89] Artificial Intelligence-based tumor microenvironment and PD-L1 analysis using digital pathology to predict pembrolizumab response in metastatic triple-negative breast cancer, June 2, 9:00 AM – 12:00 PM CDT, Hall A – Posters and Exhibits
[Poster #4137/427] Use of artificial intelligence-powered spatial analysis of tumor microenvironment to predict the prognosis in resected gallbladder cancer, May 31, 9:00 AM – 12:00 PM CDT, Hall A – Posters and Exhibits

Dizal to Highlight its Portfolio Advances in Hematologic Malignancies and Lung Cancer at ASCO 2025

On May 26, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that it will present latest clinical study results of its investigational drugs DZD8586 and DZD6008 at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Dizal Pharma, MAY 26, 2025, View Source [SID1234653381]). The studies focus on B-cell non-Hodgkin lymphomas (B-NHLs) and non-small cell lung cancer (NSCLC) two disease areas Dizal has approved drugs and strong clinical pipeline.

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DZD8586: A Potential Novel Therapeutic Option for Patients with B-NHL

A pooled analysis of two phase I/II studies of DZD8586 in CLL/SLL patients after treatment with covalent or non-covalent BTK inhibitors and BTK degraders (Abstract #7010) was selected for an oral presentation:

An objective response rate (ORR) of 84.2% was achieved. Tumor response was observed in patients previously treated with BTK inhibitors and BCL-2 inhibitors, with response rates of 82.4% and 83.3%, respectively.
Tumor response was observed irrespective of prior covalent/non-covalent BTK inhibitor, BTK degrader, or BCL-2 inhibitor treatment, and in patients with classic BTK resistance mutations (C481X) as well as other BTK mutations, including kinase-dead mutations.
Response was durable, with an estimated 9-month duration of response (DOR) rate of 83.3%.
Prof. Jianyong Li, MD, PhD at Jiangsu Province Hospital, and the leading principal investigator of the study, said, "DZD8586 has shown promising antitumor activity in patients with relapsed/refractory CLL/SLL. By targeting both BTK-dependent and -independent signaling pathways, it could overcome resistance driven by target depletion or bypass activation, addressing significant limitations of current BTK inhibitors. We look forward to continued data readout from ongoing clinical studies."

In addition, a Phase II study of DZD8586 as monotherapy in relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) (Abstract # e19050) will also be presented at the conference. Patients recruited in the trial had received 1-4 prior lines of therapy, and all were treated with anthracycline-and CD20-antibody based chemoimmunotherapy. At the doses of 50 mg and 75 mg QD, DZD8586 demonstrated promising antitumor activity and a manageable safety profile. Tumor responses were observed in both germinal center B-cell-like (GCB) and non-GCB subtypes. Updated results from this study will be disclosed at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress.

Prof. Lugui Qiu, MD, PhD at Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, the leading principal investigator of this study, said, "Treatment resistance in relapsed/refractory DLBCL remains a major clinical challenge. DZD8586, a non-covalent dual LYN/BTK inhibitor, has shown activity in both GCB and non-GCG subtypes, an important feature. With full BBB penetration and a favorable safety profile, it also shows promise in patients with CNS involvement, who typically confront a poor prognosis."

DZD6008: A 4th generation EGFR TKI Poised to Address Unmet Needs in NSCLC

The presentation at ASCO (Free ASCO Whitepaper) 2025 will feature promising pre-clinical and early clinical data from an ongoing Phase I/II TIAN-SHAN2 study of DZD6008 in patients with EGFRm NSCLC (Abstract #8616). Preclinical studies showed that DZD6008 was potent against EGFR mutations, including single (L858R/19del), double (T790M and L858R/19del), and triple mutations (C797X, T790M and 19del), with good selectivity (> 50-fold) over wild-type EGFR.

As of March 31, 2025, a total of 12 EGFRm NSCLC patients were enrolled in the study during the dose escalation phase. The median number of prior lines of therapy was 4.5 (range 2-8). DZD6008 monotherapy demonstrated encouraging and durable antitumor activity with good tolerability in this heavily pre-treated population. Ten patients (83.3%) showed target lesion shrinkage with DZD6008 treatment. Partial response (PR) was observed at ≥20 mg. In line with preclinical findings, DZD6008 exhibited excellent BBB penetration, as well as sustained efficacy in patients with brain metastases. The ratio of measured free drug concentrations in CSF over plasma is over 1.0.

Prof. Mengzhao Wang, MD, PhD at Peking Union Medical College Hospital, the leading principal investigator of the study said, "DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI with broad-spectrum of activity against different EGFR mutations. The clinical data revealed at ASCO (Free ASCO Whitepaper) 2025 suggested that DZD6008 has good antitumor activity and tolerability in EGFRm NSCLC patients who were resistant to EGFR TKIs, especially their durable remission effect on metastatic brain lesions. The ongoing TIAN-SHAN2 study aims to further validate these findings in a broader patient population."

"The clinical data on DZD8586 and DZD6008 presented at this year’s ASCO (Free ASCO Whitepaper) further highlight our strong R&D capabilities and competitive edge in tackling difficult-to-treat hematologic malignancies and lung cancer. The significant efficacy data and encouraging safety profile give us confidence to push forward to accelerate its clinical development programs," said Xiaolin Zhang, PhD, CEO of Dizal.

About DZD8586
DZD8586 is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

While Bruton’s Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application.

DZD8586 has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. Phase I clinical trial suggests that DZD8586 exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL.

About DZD6008
DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC.

Non-small cell lung cancer is the leading cause of cancer death in the world. Epidermal growth factor receptor (EGFR) gene is one of the most common driver genes for NSCLC. Multiple agents can be used to treat patients with EGFR mutated NSCLC who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory. Brain metastases (BM) are a leading cause of death and disease progression for NSCLC. Approximately 23%-30% of NSCLC patients are synchronous BM at their initial diagnosis. Previous studies reported that the 3-year cumulative rate of BMs ranges from 29.4% to 60.3% in patients with mutated EGFR.

Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and DZD6008 is expected to fill the unmet medical needs. DZD6008 effectively inhibits EGFR-mutated tumor growth in cell lines and in animal models. Previous clinical studies have validated the design concept of the molecule and suggest that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed third-generation EGFR TKI therapy or multiple lines of pre-treatments.

mAbxience and Abiogen Pharma Announce Strategic Licensing Agreement for Biosimilar Candidate in Italy

On May 26, 2025 mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, and Abiogen Pharma reported a new strategic licensing agreement to develop and commercialize a biosimilar candidate in Italy (Press release, mAbxience, MAY 26, 2025, View Source [SID1234653380]).

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Under the terms of this agreement, mAbxience will hold the marketing authorization for the biosimilar candidate, while Abiogen Pharma will be responsible for all commercialization and marketing activities in Italy. This collaboration combines mAbxience’s expertise in biosimilar development with Abiogen Pharma’s strong presence and commercial capabilities in the Italian market.

"We are thrilled to partner with Abiogen Pharma to bring this biosimilar candidate to patients in Italy. Our collaboration reflects mAbxience’s commitment to delivering high-quality, accessible therapies across various geographies," said José Ramón Millán, Global Partnering & Portfolio Director at mAbxience.

"This agreement is part of a broader, long-term strategic path for us," said Prisca Di Martino, Chief Commercial Officer at Abiogen Pharma. "It reflects our dedication to therapeutic areas where we bring deep expertise. Partnering with mAbxience supports our goal to expand access to advanced biologic therapies in Italy. This is another step towards innovative, sustainable solutions for patients and healthcare systems."

This agreement marks another milestone in mAbxience’s strategy to provide affordable, life-saving therapies worldwide. Both mAbxience and Abiogen Pharma expect that this partnership will enhance patient access to advanced treatments, while also helping healthcare systems manage the rising costs of biologic therapies.

Lupin Announces Presentation of Phase 1 Data on LNP7457 (PRMT5 inhibitor) at the American Society of Clinical Oncology – Annual Meeting 2025

On May 26, 2025 Lupin Limited (Lupin) reported it will present data from its Phase 1a clinical trial evaluating LNP7457, a PRMT5 inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois, from May 30 to June 3, 2025 (Press release, Lupin, MAY 26, 2025, View Source [SID1234653379]). The presentation titled "A phase 1 dose escalation study of LNP7457 (PRMT5 inhibitor) in patients with advanced or metastatic solid tumors," will be featured in the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology session. It can be viewed at Poster Board #422 on June 2, 2025, from 1.30 to 4.30 pm (CDT).

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Key findings from the study include:

LNP7457 is generally safe and well tolerated in patients with advanced or metastatic solid tumors, with desirable PK/PD profile and no impact of food on the pharmacokinetics.
The maximum tolerated dose, recommended phase 2 dose was determined based on safety, efficacy, PK/PD data, aligning with preclinical findings and the known safety profile of PRMT5 inhibitors.
"We are delighted to share the initial results from Phase I study of our PRMT5 Inhibitor, a novel epigenetic onco-therapeutic targeted for monotherapy. We are committed to innovation and advancing cutting-edge science to offer meaningful therapeutic options for patients with difficult-to- treat cancers," said Vinita Gupta, CEO.

Current data from Lupin indicates that LNP7457 is unique within its field and appears to be safe and well-tolerated as a SAM-competitive PRMT5 inhibitor. Lupin will continue to study the efficacy of LNP7457 in its phase 1b trial in India and explore its potential for treatment of cancers with significant unmet medical needs.

Details of the Presentation:

Date and time: June 2, 2025, 1:30 pm – 4:30 pm (CDT)
Location: Hall A – Posters and Exhibits | McCormick Place, Chicago, IL
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Sub Track: Small Molecules
Clinical Trial Registration Number: CTRI/2023/07/054753
Doi: 10.1200/JCO.2025.43.16_suppl.3107
Abstract Number: 3107
Poster Board Number: 422
Abstract link: View Source