2026 ASCO | Pivotal Data of InnoCare’s Novel BCL2 Inhibitor Mesutoclax Released

On May 22, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the abstracts of two clinical studies of the Company’s novel BCL2 inhibitor mesutoclax have been published on the official website of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). The study of mesutoclax for the treatment of myeloid malignancies was selected for an oral presentation at this year’s ASCO (Free ASCO Whitepaper) annual meeting, and the research on mesutoclax for B-cell malignancies was chosen for a poster presentation.

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The following data has just been released on the ASCO (Free ASCO Whitepaper) official website, with updated oral presentation data to be announced on June 2 Central Time. The data show that mesutoclax demonstrates outstanding efficacy and safety in treating various hematologic malignancies.

Oral Presentation

Safety, tolerability, and efficacy of mesutoclax (ICP-248) in combination with azacitidine in patients with myeloid malignancies (Abstract No.: 6506)

The study enrolled patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Mesutoclax has demonstrated favorable safety and efficacy in the treatment of both MDS and AML.

Among evaluable treatment-naïve (TN) MDS patients, the overall response rate (ORR) per IWG 2006 criteria was 100%, including complete response (CR) in 20%, and marrow CR in 80%. The composite CR rate was 70% per IWG 2023 criteria including 30% CR even when most patients only received 1 cycle treatment.

Among the evaluable TN AML patients, 85.7% achieved composite CR (cCR, CR+CRi). Among those who achieved cCR, 86.7% were MRD (Minimal Residual Disease) negative per flow cytometry. cCR was 75% in adverse risk per 2017 ELN classification. The duration of response (DOR) rate at 3 months was 91.7%. The 6-month overall survival (OS) rate was 94.1%.

There were no dose-limiting toxicity (DLT) or tumor lysis syndrome (TLS) events in the study.

The updated research data, including findings from studies on relapsed or refractory (R/R) AML patients (including those with prior BCL2 inhibitor treatment failure), hematologic recovery, and data related to the TP53-mutated population, will be further disclosed following the oral presentation at the ASCO (Free ASCO Whitepaper) annual meeting.

Poster Presentation

Efficacy and safety of mesutoclax (ICP-248) in combination with orelabrutinib in patients with B-cell malignancies: A pooled analysis (Abstract No.: 7073)

The study enrolled patients with R/R mantle cell lymphoma (MCL), R/R marginal zone lymphoma (MZL), and TN chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The data demonstrated that mesutoclax combined with orelabrutinib exhibited favorable efficacy and safety in the treatment of these B-cell malignancies, suggesting that this all oral, chemo-free regimen has the potential to establish a novel therapeutic option for patients with B-cell non-Hodgkin lymphoma.

All treatment groups achieved an overall response rate (ORR) of 100% and a high complete response rate (CRR). Deep response was observed in patients receiving mesutoclax 125mg combined with orelabrutinib.

Among MCL and MZL patients who had at least one disease evaluation, the CRR was 100% and 50% respectively. 38.5% of patients achieved peripheral blood (PB) undetectable MRD (uMRD).

For TN CLL/SLL, 76.2% of patients had moderate or high TLS risk, and 14.3% had TP53 mutation or del (17p). In the CLL/SLL patients receiving mesutoclax 125 mg, the CRR was 38.1%, and the peripheral blood uMRD rate at 36-week was 65%. The 12-month progression-free survival (PFS) rate was 100%.

Mesutoclax in combination with orelabrutinib demonstrated a tolerable safety profile in all treatment groups. No treatment-related adverse events (TEAEs) leading to drug discontinuation or death reported. No clinical or laboratory TLS occurred.

Note:

1. IWG criteria refers to International Working Group (IWG) response criteria in myelodysplasia.

2. CRi refers to complete response with incomplete hematologic recovery.

(Press release, InnoCare Pharma, MAY 22, 2026, View Source [SID1234666028])

Crinetics Pharmaceuticals to Participate in Jefferies Global Healthcare Conference 2026

On May 22, 2026 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported that company management will participate in the Jefferies Global Healthcare Conference, taking place June 2-4, 2026 in New York, NY.

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Management will be available for 1×1 meetings with investors on Wednesday, June 3, 2026. If you are interested in arranging a 1×1 meeting with management, please contact your conference representative.

(Press release, Crinetics Pharmaceuticals, MAY 22, 2026, View Source [SID1234666027])

Pivotal Trial Data for EP0031 (A400), a Next-Generation Selective RET Inhibitor (SRI), in RET Positive Advanced NSCLC, to be Presented at ASCO 2026

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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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])

Foundation Medicine Showcases Innovation at 2026 ASCO® Annual Meeting

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])

SAGA Diagnostics to Present Data on Ultrasensitive Pathlight™ MRD Test in Breast, Colon, and Rectal Cancers at ASCO 2026

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])