On May 27, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present clinical trial data from select pipeline candidates across the Company’s diversified oncology portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, to be held in Chicago, IL, from May 30 to June 3, 2025 (Press release, BioNTech, MAY 27, 2025, View Source [SID1234653389]). The data highlight continued progress of the Company’s clinical programs consisting of complementary therapeutic modalities, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, including antibody-drug conjugates ("ADCs").

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"We believe that the next era of cancer medicine will be defined by the interplay of complementary mechanisms and innovative molecules, unlocking their full potential through synergy. Our data presentations at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting show how we aim to help shape this era," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "We will present clinical progress with two of our therapeutic modalities: our next generation immunomodulators, most notably our investigational anti-PD-L1xVEGF-A antibody BNT327, and for one of our ADC programs, which are an important pillar of our combination strategy. These data underline the potential of our assets to improve outcomes for patients."

Highlights of BioNTech’s oncology programs to be presented at ASCO (Free ASCO Whitepaper) 2025:

•Three presentations on BNT3271, an investigational anti-PD-L1xVEGF-A antibody, will detail data from ongoing later-stage and potentially registrational clinical trials: An oral presentation will feature the first data from a Phase 2 clinical trial (NCT05918107) of BNT327 in combination with chemotherapy as first-line treatment for patients with unresectable malignant mesothelioma. Malignant mesothelioma is a type of cancer that develops in the tissue that covers the lung or the abdomen. The preliminary data indicated anti-tumor activity and a manageable safety profile. Two posters will detail the ongoing global Phase 3 and Phase 2/3 clinical trials, ROSETTA Lung-01 (NCT06712355) in extensive-stage small cell lung cancer ("ES-SCLC") and ROSETTA Lung-02 (NCT06712316) in non-small cell lung cancer ("NSCLC"). BNT327 combines the two complementary anti-tumor mechanisms of PD-L1 checkpoint and VEGF-A signaling blockade in the tumor microenvironment, thereby aiming to enhance anti-tumor activity.

•Data on BNT324/DB-1311, a B7H3-targeted ADC candidate, from an ongoing Phase 1/2 clinical trial (NCT05914116) in patients with heavily pre-treated castration-resistant prostate cancer ("CRPC") will be presented during an oral session. The data indicated early clinical activity and a manageable safety profile. BNT324/DB-1311 received Fast Track Designation by the U.S. Food & Drug Administration ("FDA") for this patient population in 2024 and is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio").

•Preliminary data on BNT316/ONC-392 (gotistobart), an investigational anti-CTLA-4 antibody, from two ongoing Phase 1/2 clinical trials evaluating the antibody candidate in combination with current standard of care treatments will be presented. Data from the PRESERVE-001 clinical trial (NCT04140526) in patients with advanced melanoma indicated a manageable safety profile and early signs of anti-tumor activity. The data included an analysis of overall survival ("OS") and an ad-hoc analysis of next-treatment free survival ("NTFS"), a measure for potential long-lasting benefit after initial treatment. Data from the PRESERVE-006 clinical trial (NCT05682443) in patients with metastatic CRPC indicated a manageable safety profile and preliminary efficacy. BNT316/ONC-392 is being developed in collaboration with OncoC4, Inc. ("OncoC4").

•Data on BNT142 from an exploratory Phase 1/2 dose finding trial (NCT05262530) in patients with CLDN6-positive advanced solid tumors will be featured in an oral presentation. BNT142 is an investigational lipid nanoparticle-formulated mRNA immunotherapy that encodes a CD3xCDLN6 T cell engager antibody. Preliminary data indicated a manageable safety profile and early signs of clinical activity, supporting scientific proof-of-concept and underscoring the potential of mRNA-encoded bispecific antibodies.

BioNTech has established a diversified oncology portfolio to develop novel treatment approaches for patients living with cancer. The Company is advancing its oncology pipeline across multiple solid tumor indications, including more than 20 active Phase 2 and 3 clinical trials with a strategic focus on two pan-tumor priority programs: investigational mRNA cancer immunotherapies and the next-generation immunomodulator candidate BNT327. BioNTech expects multiple data readouts in 2025 and 2026 aimed at supporting its strategy and advancing the Company towards becoming a diversified multi-product oncology company.

The full abstracts are available on the ASCO (Free ASCO Whitepaper) Annual Meeting website. Click here for further information on BioNTech’s pipeline assets.

Full presentation details:

Oral presentations

Asset: BNT327
Session Title: Clinical Science Symposium | Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies
Abstract Title: First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line (1L) treatment in unresectable malignant mesothelioma 
Location: E451
Abstract Number: 8511
Date: June 3, 2025
Time: 9:45 AM – 11:15 AM CDT

Asset: BNT324/DB-1311
Session Title: Rapid Oral Abstract Session | Genitourinary Cancer—Prostate, Testicular, and Penile
Abstract Title: DB-1311/BNT324 (a novel B7H3 ADC) in patients with castrate-resistant prostate cancer (CRPC)
Location: Hall D2
Abstract Number: 5015
Date: June 1, 2025
Time: 4:30 PM – 6:00 PM CDT

Asset: BNT142
Session Title: Oral Abstract Session | Developmental Therapeutics—Immunotherapy
Abstract Title: First-in-human phase I/II trial evaluating BNT142, a first-in-class mRNA encoded, bispecific antibody targeting Claudin 6 (CLDN6) and CD3, in patients (pts) with CLDN6-positive advanced solid tumors.
Location: Hall D2
Abstract Number: 2501
Date: May 31, 2025
Time: 3:00 PM – 6:00 PM CDT

Poster Presentations

Asset: BNT327
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Abstract Title: A global Phase 3 double-blind, randomized trial of BNT327/PM8002 plus chemotherapy (chemo) compared to atezolizumab plus chemo in patients (pts) with first-line (1L) extensive-stage small cell lung cancer (ES-SCLC)
Poster Board: #242a
Abstract Number: TPS8129
Date: May 31, 2025
Time: 1:30 PM – 4:30 PM CDT

Asset: BNT327
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Abstract Title: Phase 2/3, global, multisite, randomized, open-label trial of BNT327/PM8002 in combination with chemotherapy (chemo) in first-line (1L) non-small cell lung cancer (NSCLC)
Poster Board: #138b
Abstract Number: TPS8670
Date: May 31, 2025
Time: 1:30 PM – 4:30 PM CDT

Asset: BNT316/ONC-392 (gotistobart)
Session Title: Melanoma/Skin Cancers
Abstract Title: Gotistobart in combination with pembrolizumab in patients with advanced melanoma who have progressed on PD-1 inhibitors with or without CTLA-4 inhibitors
Poster Board: #34
Abstract Number: 9551
Date: June 1, 2025
Time: 9:00 AM – 12:00 PM CDT

Asset: BNT316/ONC-392 (gotistobart)
Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile
Abstract Title: Phase 1 study of gotistobart (BNT316/ONC-392) in combination with lutetium Lu 177 vipivotide tetraxetan (Lu 177) in patients with metastatic castration-resistant prostate cancer (mCRPC)
Poster Board: #266
Abstract Number: 5067
Date: June 2, 2025
Time: 9:00 AM – 12:00 PM CDT

On May 27, 2025 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update (Press release, BioLineRx, MAY 27, 2025, View Source [SID1234653388]).

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"Following our announcement last November that we out-licensed APHEXDA, our FDA-approved stem cell mobilization agent, to Ayrmid Ltd., we have been actively evaluating new assets in the areas of oncology and rare disease where we can leverage our drug development and regulatory expertise to bring new medicines to market," said Philip Serlin, Chief Executive Officer of BioLineRx. "I remain optimistic that we will announce a meaningful transaction this year."

"At the same time, APHEXDA is performing well under the stewardship of Ayrmid, and I believe this license agreement will contribute significant long-term value to our company," Mr. Serlin concluded.

Financial Updates

Completed financing in January 2025 raising gross proceeds of $10 million.
Successfully reduced operating expense run rate by over 70% beginning January 1, 2025, through the APHEXDA program transfer to Ayrmid and the resulting shutdown of the Company’s U.S. commercial operations in Q4 2024, as well as additional headcount and other operating expense reductions.
Reaffirms cash runway through the second half of 2026.
APHEXDA Performance Update

APHEXDA generated sales of $1.4 million in the first quarter of 2025, providing royalty revenues to the Company of $0.3 million.
Clinical Updates

Motixafortide

Pancreatic Ductal Adenocarcinoma (mPDAC)

Additional trial sites were activated for the CheMo4METPANC Phase 2b clinical trial, which is expected to have a positive impact on patient recruitment. Full enrollment in the randomized trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx, is planned for completion in 2027, with a prespecified interim analysis planned when 40% of progression free survival (PFS) events are observed.
An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial has been accepted for a poster presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting on Saturday, May 31st. Key highlights include:
Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response.
An analysis of pre- and on-treatment biopsies revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination.
Sickle Cell Disease (SCD) & Gene Therapy

Enrollment is continuing into the multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD). The trial is sponsored by St. Jude Children’s Research Hospital.
Reported continued progress of a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. The trial is sponsored by Washington University School of Medicine in St. Louis.
Financial Results for the Quarter Ended March 31, 2025

Revenues for the three-month period ended March 31, 2025 were $0.3 million, a decrease of $6.6 million, compared to revenues of $6.9 million for the three-month period ended March 31, 2024. The significant decrease in revenues from 2024 to 2025 reflects the one-time revenues recorded in 2024 relating to the out-licensing transaction with Gloria during the fourth quarter of 2023, as well as the change in the Company’s operations following the out-licensing of APHEXDA to Ayrmid during the fourth quarter of 2024. The revenues in 2025 reflect the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The revenues in 2024 primarily reflect a portion of the up-front payment received by the Company and a milestone payment achieved under the license agreement with Gloria, which collectively amounted to $5.9 million, as well as $0.9 million of net revenues from product sales of APHEXDA in the U.S.
Cost of revenues for the three-month period ended March 31, 2025 was immaterial, compared to cost of revenues of $1.5 million for the three-month period ended March 31, 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects sub-license fees on a milestone payment received under the Gloria license agreement and royalties on net product sales of APHEXDA in the U.S., as well as amortization of intangible assets and cost of goods sold on product sales.
Research and development expenses for the three months ended March 31, 2025 were $1.6 million, a decrease of $0.9 million, or 34.9%, compared to $2.5 million for the three months ended March 31, 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount.
There were no sales and marketing expenses for the three months ended March 31, 2025, compared to $6.3 million for the three months ended March 31, 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction.
General and administrative expenses for the three months ended March 31, 2025 were $1.0 million, a decrease of $0.4 million, or 28.6%, compared to $1.4 million for the three months ended March 31, 2024. The decrease resulted primarily from a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses.
Net non-operating income for the three months ended March 31, 2025 was $7.6 million, compared to net non-operating income of $4.5 million for the three months ended March 31, 2024. Non-operating income for both periods primarily relates to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company’s share price.
Net financial expenses for the three months ended March 31, 2025 were $0.1 million, compared to net financial expenses of $0.4 million for the three months ended March 31, 2024. Net financial expenses for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits.
Net income for the quarter ended March 31, 2025 was $5.1 million, compared to $0.7 million for the quarter ended March 31, 2024.
As of March 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $26.4 million
Conference Call and Webcast Information

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until May 29, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On May 27, 2025 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company plans to present at the following conferences (Press release, BioCryst Pharmaceuticals, MAY 27, 2025, View Source [SID1234653386]):

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Jefferies Global Healthcare Conference in New York on Wednesday, June 4, 2025, at 4:55 p.m. ET.

Goldman Sachs 46th Annual Global Healthcare Conference in Miami on Monday, June 9, 2025, at 8:40 a.m. ET.
Links to the live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst’s website at www.biocryst.com.

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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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