On May 22, 2026 SAGA Diagnostics, a pioneer in ultrasensitive molecular residual disease (MRD) detection and precision oncology, reported that the company and key collaborators will present data from three abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting, taking place May 29 to June 2 in Chicago.

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Key poster presentations highlight the expanding body of evidence supporting Pathlight, SAGA’s tumor-informed structural variant (SV)-based circulating tumor DNA (ctDNA) platform, across both metastatic and localized settings. Retrospective analysis of PADA-1 samples will explore ctDNA kinetics during first-line therapy in metastatic breast cancer, while the real-world CITCCA cohort will evaluate Pathlight in colon and rectal cancer, through assessment of ctDNA clearance, recurrence risk, and outcomes in localized disease.

"As MRD testing becomes increasingly important in oncology, clinicians need assays capable of detecting patient-specific molecular residual disease at the lowest possible levels across a broad range of clinical settings," said Wendy Levin, MD, MS, Chief Clinical Officer at SAGA Diagnostics. "The data being presented at ASCO (Free ASCO Whitepaper) 2026 further highlight the potential of Pathlight’s ultrasensitive tumor-informed ctDNA approach to support treatment monitoring, recurrence assessment, and longitudinal disease surveillance across both metastatic and localized cancers."

Key SAGA Diagnostics Presentations During ASCO (Free ASCO Whitepaper) 2026:

Abstract Title

Presentation Details

ctDNA kinetics throughout first-line AI and palbociclib using a tumor-informed structural variant-based ctDNA assay: retrospective analysis of PADA-1 samples

Abstract: 3050

Poster: 187

Date: May 30, 2026

Time: 1:30 – 4:30 PM

Speaker: Luc Cabel, Institut Curie

Circulating Tumor DNA Clearance of Adjuvant Chemotherapy in Localized Colorectal Cancer Using an Ultrasensitive Structural Variant–Based Assay

Abstract: 3625

Poster: 392

Date: May 30, 2026

Time: 9:00 – 12:00 PM

Speaker: Cecilia Merk, MD, Karolinska Institutet

Localized Rectal Cancer Outcomes Predicted by ctDNA Analysis Using a Novel Ultrasensitive Structural Variant (SV)-based Method

Abstract: 3619

Poster: 386

Date: May 30, 2026

Time: 9:00 – 12:00 PM

Speaker: Cecilia Merk, MD, Karolinska Institutet

The full abstracts for SAGA Diagnostics at ASCO (Free ASCO Whitepaper) 2026 can be found here.

(Press release, SAGA Diagnostics, MAY 22, 2026, View Source [SID1234666024])

On May 22, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present new clinical data and trial updates from its late-stage oncology pipeline and innovative combination programs at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting held in Chicago, from May 29 to June 02. Two oral presentations will highlight new data for key strategic assets pumitamig and gotistobart. In addition, four trial in progress poster presentations will illustrate advancement of the Company’s ongoing pivotal trials and novel-novel combination trials, including antibody-drug conjugates ("ADC").

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"Achieving more for patients with cancer through translating science into innovative therapies is our unwavering ambition at BioNTech," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "At this year’s ASCO (Free ASCO Whitepaper), our presentations underscore our oncology strategy of building a diversified portfolio of complementary modalities delivering differentiated therapeutic profiles across tumor types with high unmet medical need. We are focused on accelerating key strategic programs, both as monotherapies and combinations with standard of care treatments, to deliver our first wave of oncology innovations to patients. Simultaneously, and building on this momentum, we are advancing novel-novel combination approaches, including ADC-based regimens, to unlock the full synergistic potential of our pipeline."

Highlights of BioNTech’s late-stage oncology programs to be presented at ASCO (Free ASCO Whitepaper) 2026:
Pumitamig (BNT327/BMS986545) – an investigational bispecific immunomodulator combining PD-L1 checkpoint inhibition and VEGF-A neutralization, developed in collaboration with Bristol Myers Squibb Company ("BMS"):

1L NSCLC: Data from the interim analysis of the Phase 2 dose-optimization part of the global Phase 2/3 ROSETTA Lung-02 clinical trial (NCT06712316) showed encouraging anti-tumor activity in first-line ("1L") non-small cell lung cancer ("NSCLC"). The trial evaluated pumitamig plus chemotherapy in patients with non-squamous and squamous NSCLC without actionable genomic alterations and across PD-L1 expression levels. These data mark the third global data set to consistently show encouraging anti-tumor activity for pumitamig plus chemotherapy, adding to the reported global data in small cell lung cancer and triple-negative breast cancer. The results inform the ongoing pivotal Phase 3 part of ROSETTA Lung-02 evaluating pumitamig plus chemotherapy versus pembrolizumab plus chemotherapy. Updated data from a later cut-off date will be presented in a rapid oral presentation.
Gotistobart (BNT316/ONC-392) – an investigational tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. ("OncoC4"):

PROC: Data from the Phase 2 PRESERVE-004 clinical trial (NCT05446298) evaluating gotistobart plus pembrolizumab in heavily pre-treated patients with platinum-resistant ovarian cancer ("PROC") showed durable anti-tumor activity and clinically meaningful overall survival outcomes. Together with a manageable safety profile, the results add to the growing body of evidence supporting gotistobart’s potential as a chemotherapy-free treatment option, complementing the recently announced data in second and later line squamous non-small cell lung cancer.

BioNTech is advancing a diversified oncology pipeline spanning next-generation immunomodulators, ADCs, and mRNA cancer immunotherapies, both as monotherapies and novel treatment combination approaches. With more than 25 Phase 2 and Phase 3 clinical trials, including 13 ongoing pivotal trials as well as novel-novel combination trials, BioNTech is focused on developing innovative approaches to address the challenges of cancer treatment among the Company’s tumor focus areas from early to late-stage conditions.

All abstracts are available on the ASCO (Free ASCO Whitepaper) website. Further information on BioNTech’s late-stage oncology portfolio can be accessed here.

Full presentation details:

Medicine Abstract Title Abstract Number/Presentation Details
Pumitamig Phase 2 data from ROSETTA Lung-02, a global randomized Phase 2/3 trial of pumitamig (PDL1 × VEGF-A bsAb) + chemotherapy in 1L NSCLC Abstract #8513
Rapid Oral Abstract Session
Lung Cancer – Non-Small Cell Metastatic
May 30, 2026, 1:15 – 2:45pm CDT
Phase 2/3 trial of pumitamig (PD-L1 ×VEGF-A bsab) plus chemotherapy versus bevacizumab plus chemotherapy in previously untreated, unresectable, or metastatic colorectal cancer (ROSETTA CRC-203) Abstract #TPS3672
Poster Session
Genitourinary Cancer – Prostate, Testicular, and Penile
Poster Board: 229a
May 31, 2026: 9:00am-12:00pm CDT
Gotistobart Overall survival for patients with pre-treated platinum-resistant ovarian cancer receiving gotistobart in combination with pembrolizumab Abstract #5511
Rapid Oral Abstract session
Gynecologic Cancer
May 30, 2026: 8:00 – 9:30am CDT
BNT326/YL202 BNT326-01: A Phase 1b/2 trial of BNT326/YL202 (HER3 ADC) as monotherapy and in combination with pumitamig (anti-PD-L1 × VEGF bsAb) in patients with advanced solid tumors Abstract #TPS3160
Poster Session
Developmental Therapeutics -Molecularly Targeted Agents and Tumor Biology
Poster Board: 294b
May 30, 2026: 1:30 – 4:30pm CDT
BNT324/DB-1311 BNT324-03: A Phase 3, randomized, open-label trial of BNT324/DB-1311, a B7H3 ADC, versus docetaxel in patients with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC) Abstract #TPS5137
Poster Session
Genitourinary Cancer – Prostate, Testicular, and Penile
Poster Board: 229a
May 31, 2026: 9:00am – 12:00pm CDT
Trastuzumab pamirtecan
(BNT323/DB-1303) Fern-EC-01 (BNT323-01): A phase 3 trial of trastuzumab pamirtecan (HER2 ADC) versus investigator’s choice of chemotherapy in patients with previously treated, HER2-expressing, recurrent endometrial cancer (EC) Abstract #TPS5645
Poster Session
Gynecologic Cancer
Poster Board: 302b
June 1, 2026: 9:00am – 12:00pm CDT

(Press release, BioNTech, MAY 22, 2026, View Source [SID1234666009])

On May 22, 2026 Foundation Medicine, Inc., a global, patient-focused precision medicine company, reported it will showcase data across its portfolio of high-quality comprehensive genomic profiling tests at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held May 29-June 2 in Chicago. Data from 14 abstracts will be presented on copy number loss detection, serial circulating tumor DNA (ctDNA) genomic profiling, Foundation Medicine’s proprietary homologous recombination deficiency signature (HRDsig) and more.

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To access the abstracts being presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, please visit ASCO (Free ASCO Whitepaper).org/abstracts.

Follow Foundation Medicine on LinkedIn, X and Instagram for more updates from #ASCO26 and visit us in person at booth #19145.

Foundation Medicine’s Abstracts at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract Number

Title

Product

Saturday, May 30, 2026

6071

Inferring optimal detection of homozygous loss (homozygous deletion) in head and neck cancer: Associations with HPV status, primary disease site, and clinical outcomes.

FoundationOneCDx

3553

Detecting MTAP loss in liquid biopsies from patients with clinically advanced colorectal cancer (CRC).

FoundationOneCDx, FoundationOneLiquid CDx

4138

Homologous recombination signature (HRDsig) in clinically advanced gallbladder adenocarcinoma (CAGAC): A genomic landscape study.

FoundationOneCDx

3147

Fast-TRACKing precision oncology for rare cancers: A national decentralized trial offering comprehensive genomic profiling and a molecular tumor board.

FoundationOneCDx, FoundationOneRNA, FoundationOneHeme, FoundationOneLiquid CDx

3135

Carcinomas of unknown primary treated with molecularly guided therapies and immune checkpoint inhibitors: A subset from the I-PREDICT N-of-1 Precision Oncology study.

FoundationOneCDx, FoundationOneLiquid CDx

2628

Personalized N-of-1 combinations based on molecular profiles in advanced malignancies: Immunotherapy group analysis of the I-PREDICT N-of-1 precision oncology study.

FoundationOneCDx, FoundationOneLiquid CDx

4124

Beyond fibroblast growth factor receptor 2 (FGFR2) fusions: Mutations and amplifications in intrahepatic cholangiocarcinoma.

FoundationOneCDx

4060

Impact of molecular profile on switch maintenance to paclitaxel plus ramucirumab (PTX-RAM) versus continuation of first-line fluoropyrimidine and oxaliplatin (FOX) chemotherapy (ChT) in patients (pts) with advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer: An exploratory endpoint of the ARMANI phase 3 randomized trial.

FoundationOneCDx

Sunday, May 31, 2026

8551

Serial ctDNA genomic profiling integrated with a networked molecular tumor board in first-line advanced NSCLC: The COPE randomized phase II trial.

FoundationOneLiquid CDx

5044

Genomic landscape of TP53 Y220C–mutated clinically advanced prostate carcinoma (CAPC).

FoundationOneCDx

4619

Neoadjuvant sacituzumab govitecan in patients with muscle-invasive bladder cancer: Final results and biomarker analyses of the SURE-01 trial.

N/A

Monday, June 1, 2026

1121

Homologous recombination deficiency signature (HRDsig+) in older women with advanced breast cancer (ABC).

FoundationOneCDx

2022

Risk of developing brain/central nervous system (CNS) metastases across multiple ERBB2-altered cancer types: Genotype as shaper of phenotype.

FoundationOneCDx

1038

Characterization of genomic alterations between local breast cancers and cutaneous metastases.

FoundationOneCDx

(Press release, Foundation Medicine, MAY 22, 2026, View Source [SID1234666025])

On May 22, 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 that its Chief Executive Officer, Mark Velleca, M.D., Ph.D., will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 3, 2026, in New York, NY. In addition, the company will host one-on-one meetings with investors on the same day.

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

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Presentation details are as follows:

4:55-5:25pm ET on Wednesday, June 3

The Webcast will be available at the start of the presentation under "Events and Presentations" on the Investors section of the Company’s website, www.blackdiamondtherapeutics.com. A replay of the webcast will also be available and archived for 90 days following the event.

(Press release, Black Diamond Therapeutics, MAY 22, 2026, View Source [SID1234666010])

On May 22, 2026 Ellipses Pharma ("Ellipses"), a global oncology drug development company with a pipeline of innovative programmes, reported that its partner, Kelun-Biotech, is presenting pivotal trial data for EP0031/A400, for the potential treatment of RET-fusion positive Non-Small Cell Lung Cancer (NSCLC), at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting Chicago, May 29 to June 2.

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

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Efficacy and safety of lunbotinib (A400/EP0031), a next-generation selective RET inhibitor (SRI), from a pivotal phase Ⅱ study in patients with advanced RET-fusion positive non-small cell lung cancer (NSCLC), will be presented as an oral presentation scheduled on May 29, 2026, 14:36-14:48 local time (Abstract #8505: Lung Cancer – Non-Small Cell Metastatic).

The oral presentation of these data at the prestigious ASCO (Free ASCO Whitepaper) annual meeting, represents another major milestone in the global development of EP0031/A400 as a next generation SRI.

The data were generated in Kelun-Biotech’s Phase 2 study (NCT05265091) that evaluated the efficacy and safety of EP0031/A400 90mg orally once daily (QD) in patients with pre-treated and treatment-naïve RET-fusion positive locally advanced, or metastatic, NSCLC. EP0031/A400 demonstrated robust efficacy in both cohorts and an encouraging, manageable tolerability and safety profile. In September 2025 Kelun-Biotech submitted an NDA for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) which was accepted for review by the NMPA of China.

EP0031/A400 is being developed jointly by Ellipses and Kelun-Biotech. Ellipses has been granted an exclusive licence to develop, manufacture and commercialise this agent outside Greater China and certain Asian countries under the code EP0031.

Ellipses has an ongoing Phase 1/2 trial in US, EU, UK and UAE (EP0031-101 NCT05443126). Phase 2 cohorts are currently evaluating the combination of EP0031/A400 with platinum doublet chemotherapy in patients with RET-fusion positive NSCLC that are naïve to or have previously received 1st generation SRI. Data supporting the strong preclinical rationale for this combination strategy were recently presented at the annual European Lung Cancer Congress 2026 (ESMO Open Volume 11, Suppl 3, https://www.sciencedirect.com/science/article/pii/S2059702926007490).

Professor Sir Christopher Evans, Chairman, Ellipses Pharma, commented: "We congratulate our partners Kelun-Biotech on the tremendous progress they have made with the development of EP0031/A400 in China. The presentation of these exciting data from the pivotal trial represents a significant step in the development of this agent for patients globally. Ellipses is immensely proud to be partnering with Kelun-Biotech and continues to make significant progress with the development of EP0031/A400 for patients outside Greater China."

Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses Pharma, commented: "Congratulations to our colleagues at Kelun-Biotech on the acceptance of these data for oral presentation at ASCO (Free ASCO Whitepaper). These data further establish the credentials of EP0031/A400 as a promising next-generation SRI. We look forward to continuing to build our data in the Ellipses trial to ensure EP0031/A400 is brought to Western patients as early as possible.’

About EP0031/A400

EP0031/A400 has broad and potent activity against the spectrum of common RET fusions and mutations, as well as RET resistance mutations that have been shown to emerge on progression on 1st gen SRIs. EP0031 has a differentiated preclinical profile compared with 1st gen SRIs with greater potency and antitumour activity in SRI naïve and SRI resistant PDX models as well as greater tissue permeability, with increased exposure in the CNS and improved survival in orthotopic models.

Data from the dose finding and optimisation cohorts, which evaluated EP0031/A400 as a monotherapy, were presented at ASCO (Free ASCO Whitepaper) in June 2025, showing promising evidence of activity, including CNS responses, in patients with advanced NSCLC that had received prior 1st generation Selective RET Inhibitor (SRI), with encouraging safety and tolerability (Journal of Clinical Oncology Volume 43, Number 16_suppl View Source).

In November 2023, Ellipses announced it had secured Orphan Drug designation for EP0031/A400 from the US Food and Drug Administration (FDA) for EP0031/A400 for the treatment of RET-fusion positive tumours.

About RET altered malignancies

Activating RET mutations and rearrangements have been identified as actionable drivers of oncogenesis in numerous tumour types and are most prevalent in non-small cell lung and thyroid cancer. It is estimated that RET mutations and rearrangements may be responsible for ~2% of all solid tumours. After the successful development of first generation SRIs and an increasing understanding of escape mechanisms to these agents, there is an unmet need to develop new treatments that can address acquired resistance, including the development of next-generation SRIs.

(Press release, Ellipses Pharma, MAY 22, 2026, View Source [SID1234666026])