1stOncology™: Cancer Intelligence Service – Page 123 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

PharmaEssentia to Present New Clinical Data Supporting the Use of Ropeginterferon Alfa-2b in Essential Thrombocythemia at ASCO and EHA 2026

On May 22, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported five upcoming presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress. The ASCO (Free ASCO Whitepaper) annual meeting will be held May 29-June 2 in Chicago, and the EHA (Free EHA Whitepaper)2026 Congress will be held June 11-14 in Stockholm, Sweden.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

PharmaEssentia will present new analyses from the Phase 3 SURPASS-ET study (NCT04285086) of ropeginterferon alfa-2b in patients with essential thrombocythemia (ET), including two-year outcomes comparing early versus delayed initiation (continuous treatment from baseline vs. initiation following prior anagrelide therapy) and post-hoc analyses of patients who transitioned from anagrelide. Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi for the treatment of adults with polycythemia vera (PV). The use of ropeginterferon alfa-2b-njft for ET is currently still investigational, but it is currently under review by FDA with a PDUFA goal date of August 30, 2026.

Findings from SURPASS-ET demonstrate sustained hematologic control and progressive molecular improvement with longer interferon exposure, with deeper molecular responses and improved long-term disease control observed with earlier initiation. Patients who transitioned from anagrelide showed improved hematologic parameters over 12 weeks, supporting the feasibility of treatment transition. Importantly, estimated progression-free survival (PFS) at 24 months was 76.9% in patients who received ropeginterferon alfa-2b from baseline compared to 43.1% in those with delayed initiation. Together, these data support consideration of earlier ropeginterferon alfa-2b use in high-risk ET following hydroxyurea intolerance or resistance.

PharmaEssentia will also present an integrated analysis of the SURPASS-ET and Phase 2b EXCEED-ET (NCT05482971) trials. The analysis includes 182 patients across both studies and evaluates the consistency of clinical benefit across treatment lines, including treatment-naïve and previously treated populations, as well as across molecular subtypes and ethnicities. Results demonstrated clinically meaningful hematologic and molecular responses in both treatment-naïve and pretreated patients. Efficacy was consistent across driver mutation subtypes, and the presence of additional non-driver mutations did not adversely impact outcomes.

"These findings represent an important step forward in understanding the potential use of interferon-based approaches in essential thrombocythemia," said Ruben Mesa, M.D., co-principal investigator, presenting author, and President of Advocate Health Cancer National Service Line. "Together, these data continue to build on the growing body of evidence supporting the use of ropeginterferon alfa-2b in ET and reinforce its potential role as a meaningful treatment option for patients."

In addition, PharmaEssentia will present real-world data evaluating the association between neutrophil-to-lymphocyte ratio (NLR) and thrombotic risk in 11,809 U.S. veterans with PV. An online-only abstract will also report findings from a meta-analysis evaluating dosing strategies for ropeginterferon alfa-2b in PV, suggesting that a higher initial dose with accelerated titration (HIDAT) may lead to improved early hematologic and molecular response rates compared to lower-dose currently approved regimens.

ASCO
Poster Presentations

Title: Integrated Analysis of the Ropeginterferon alfa-2b Clinical Program in Essential Thrombocythemia to Demonstrate Molecular and Hematologic Responses with Safety Profile Across Treatment Lines, Ethnicities, and Driver Mutation Types
Abstract Number: 6576
Poster: 369
Presenter: Ruben Mesa, M.D.
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: June 1st
Time: 9-12 pm CDT

Title: Association of neutrophil‑to‑lymphocyte ratio and thrombotic events in US Veterans with Polycythemia vera
Abstract Number: 6578
Poster: 371
Presenter: Ying Wang, PhD
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: June 1st
Time: 9-12 pm CDT

Published Abstract

Title: Effect of Higher Initial Dose and Accelerated Titration of Ropeginterferon Alfa-2b on Early Hematologic and Molecular Responses in Polycythemia Vera: A Meta-Analysis
Abstract Number: e18592

EHA
Oral Presentation
Title: Early versus Delayed Initiation of Ropeginterferon Alfa-2b in High-Risk Essential Thrombocythaemia: Two-Year Results from the Phase 3 SURPASS-ET Study
Abstract Number: S219
Presenter: Harry Gill, M.D.
Session: Myeloproliferative neoplasms – Clinical
Date: June 13th
Time: 5:15 – 6:30 pm CEST

Poster Presentations

Title: Ropeginterferon alfa-2b Demonstrates Molecular and Hematologic Responses with a Favorable Safety Profile in Essential Thrombocythemia
Abstract Number: PS1986
Presenter: Harry Gill, M.D.
Session: Myeloproliferative neoplasms – Clinical
Date: June 13th
Time: 6:45 – 7:45 pm CEST

Title: Hematologic Control and Improved Safety Following Switch from Anagrelide to Ropeginterferon Alfa-2b in Patients with Essential Thrombocythemia: 12-Week Pre-/Post-Switch Analysis from the SURPASS-ET study
Abstract Number: PF912
Presenter: Lucia Masarova, M.D.
Session: Myeloproliferative neoplasms – Clinical
Date: June 12th
Time: 6:45 – 7:45 pm CEST

(Press release, PharmaEssentia, MAY 22, 2026, View Source [SID1234666022])

Inocras Announces ASCO 2026 Online Publication: Whole-genome HRD phenotyping as a predictor of PARP inhibitor benefit in first-line maintenance high-grade serous ovarian cancer

On May 22, 2026 Inocras, a bioinformatics-led company harnessing the power of whole-genome data and proprietary analytics to deliver curated insights, reported that new real-world evidence evaluating whole-genome sequencing-based homologous recombination deficiency phenotyping has been accepted for online publication at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

The abstract, titled "Whole-genome HRD phenotyping as a predictor of PARP inhibitor benefit in first-line maintenance high-grade serous ovarian cancer," reports findings from a collaborative study between Inocras and the Severance Hospital gynecologic oncology team, one of Inocras’s major clinical partners in Korea.

Using matched tumor-normal whole-genome sequencing through CancerVision, investigators evaluated 84 patients with high-grade serous ovarian cancer who received PARP inhibitor maintenance therapy in either the first-line or second-line maintenance setting. The study assessed whether WGS-based HRD indicators, or CancerVision’s WGS-HRD, correlated with clinical outcomes following PARP inhibitor therapy.

Patients classified as WGS-HRD-positive had a longer median progression-free survival than those classified as WGS-HRD-negative, with an overall mPFS of 27.5 months versus 12.0 months. The association was most pronounced in the first-line maintenance setting, where WGS-HRD positive patients had an mPFS of 44.2 months versus 10.0 months. In the second-line maintenance setting, no significant difference in survival was observed based on HRD status, suggesting the predictive value of WGS-HRD may be strongest in earlier treatment settings.

The study also found that 21.4% of patients were WGS-HRD positive despite lacking BRCA mutations, underscoring the potential of WGS-HRD to identify patients who may not be captured by BRCA testing alone. Compared with the conventional scarHRD method, WGS-HRD demonstrated higher predictive value in clinical prognosis and PARP inhibitor responsiveness. The study adds to Inocras’ growing body of evidence supporting CancerVision as a comprehensive whole-genome sequencing platform for precision oncology.

"These findings provide important real-world evidence that whole-genome HRD scoring can advance how we identify ovarian cancer patients most likely to benefit from PARP inhibitor maintenance therapy," said Jehee Suh, CEO of Inocras. "CancerVision is a comprehensive WGS-based clinical analysis platform, and these data highlight its potential to enhance clinical decision-making."

"The first-line maintenance findings are particularly encouraging because they suggest that WGS-based HRD assessment may refine current BRCA- and genomic-scar–based approaches for identifying patients most likely to derive durable benefit from PARP inhibitor maintenance therapy," said Joonoh Lim, Physician Scientist at Inocras, who led the study in collaboration with Severance Hospital. "These findings add to the growing evidence base for whole-genome HRD assessment, and we look forward to prospective validation."

Abstract Details

Title: Whole-genome HRD phenotyping as a predictor of PARP inhibitor benefit in first-line maintenance high-grade serous ovarian cancer.
Format: Online publication / Online-only abstract
Abstract Number: e17608
Publication Date/Time: May 21 at 05:00 PM ET
Authors: Joonoh Lim, MD, PhD, Inocras Inc., San Diego, CA
Session/Category: Gynecologic Cancer

(Press release, Inocras, MAY 22, 2026, View Source [SID1234666021])

2026 ASCO Abstract Highlights | Innovent Announces Preliminary PoC data of IBI363 (PD-1/IL-2α-bias bispecific fusion protein) in Combination with Chemotherapy as First-line Treatment for Advanced NSCLC, Showing Encouraging Efficacy Signals and Favorable Safety

On May 22, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported the preliminary PoC clinical study results for its global first-in-class PD-1/IL-2α-bias bispecific fusion protein IBI363 (Takeda R&D code: TAK-928) in the first-line treatment of advanced non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. An overview of the abstract information is provided below, and the full abstract is available here. More detailed results will be presented during the conference.

This study is the first stage of a PoC clinical study conducted in China, to evaluate the safety, efficacy, and dose optimization strategy of IBI363 in combination with platinum-based doublet chemotherapy (PDC) in previously untreated patients with locally advanced or metastatic NSCLC. During dose optimization, patients with NSCLC expressing PD-L1 TPS < 50% (including TPS 1-49% and TPS < 1%) were enrolled to explore the potential of IBI363 in PD-L1 negative and low-expressing NSCLC, an area with significant unmet clinical need.

The preliminary results showed that IBI363 combined with PDC demonstrated encouraging efficacy signals in the first-line treatment of NSCLC with PD-L1 negative or low expression. The 3→1.5 mg/kg dosing regimen brought comprehensive benefits with strong objective response rate (ORR), disease control rate (DCR), and manageable safety and tolerability. Meanwhile, the approach supports continuous dosing, which has the potential to translate into durable efficacy benefits with ongoing follow-up. The second stage of this study is currently ongoing, designed as a randomized head-to-head trial comparing this dose regimen vs. pembrolizumab plus chemotherapy in the first-line treatment of advanced NSCLC (all PD-L1 expression levels).

1) Mechanistic Rationale for Dosing Regimen Design and Dose Selection in Immunotherapy-naïve Population

Multiple studies have indicated that in immunotherapy (IO)-naive populations, the tumor microenvironment exhibits lower immunosuppression, which allows an immune activation strategy that ignites immunity and then maintains stability. Meanwhile, combination with chemotherapy can facilitate antigen release and activate the immune system.

Therefore, the first cycle of 3 mg/kg IBI363 could initiate the immune system to expand effector T cells rapidly, enhance T cell infiltration, and form an IO-sensitive immune microenvironment. Subsequently, a 1.5 mg/kg every three weeks (Q3W) regimen is adopted for the maintenance treatment, which could maintain the IO-sensitive tumor microenvironment, prolong the possible treatment cycles, and further enhance the efficacy. This strategy is common in the study design of other immunological treatments.

Based on this mechanism, three IBI363 combination dosing regimens were compared in the study:

3→1.5 mg/kg dose group (3 mg/kg + PDC in cycle 1, followed by 1.5 mg/kg Q3W + PDC);
1.5 mg/kg dose group (1.5 mg/kg Q3W + PDC);
3 mg/kg dose group (3 mg/kg Q3W + PDC).
2) Study Design and Baseline Characteristics: Focusing on Dose Exploration in PD-L1 Negative or Low Expression NSCLC

Previously untreated patients with locally advanced or metastatic NSCLC, without sensitizing EGFR, ALK, or ROS1 alterations were enrolled in this study. The aim of the study is to evaluate the efficacy and safety of different doses of IBI363 combined with PDC in patients with PD-L1 negative or low expression NSCLC.

As of the data cutoff date, Dec 22, 2025, a total of 80 patients had been enrolled in this Phase 1 study, including 11 patients enrolled in the safety lead-in phase and 69 patients in the dose optimization phase. The median follow-up time was 5.8 months (range: 0.9–9.5 months).

The median age was 64 years, 88.8% were male, 81.3% had an ECOG PS score of 1, and 66.3% were squamous NSCLC. The baseline characteristics of patients in the three dose groups were balanced and comparable.
In the dose optimization part, NSCLC patients with PD-L1 TPS < 50% were enrolled, of which 65.2% had PD-L1 TPS < 1% and 34.8% had TPS 1–49%.
3) IBI363 Showed Encouraging Response in First-line Treatment of PD-L1 Negative or Low Expression NSCLC

In the dose optimization stage, the 3→1.5 mg/kg dose group (n=22) showed ORR of 86.4% and confirmed ORR (cORR) of 81.8% (95% CI: 59.7-94.8) and DCR of 100%. The efficacy was consistent in the squamous (ORR 85.7%, n=14) and non-squamous (ORR 87.5%, n=8) subgroups. Additionally, durable efficacy signals were observed in the 3→1.5 mg/kg groups with ongoing follow-up. For the 1.5mg/kg (N = 19) and 3 mg/kg cohorts (N = 21), ORR was 57.9% (cORR: 42.1%) and 66.7% (cORR: 57.1%), respectively.

For NSCLC patients with negative or low PD‑L1 expression, the benefit from current immunotherapies is limited. In the Keynote‑407 study, in first‑line squamous NSCLC patients treated with PD‑1 combined with chemotherapy, the ORRs were 54.5% and 67.4% for the PD‑L1 1–49% and PD‑L1 <1% subgroups, respectively. In the Keynote‑189 study, in first‑line non‑squamous NSCLC patients treated with PD‑1 combined with chemotherapy, the ORRs were 50.0% and 33.1% for the PD‑L1 1–49% and PD‑L1 <1% subgroups, respectively.

Previous studies have shown that, regardless of PD‑L1 expression status, IBI363 demonstrates potent anti‑tumor activity in immunotherapy‑resistant NSCLC, suggesting that its unique mechanism of action may not depend on PD‑L1 expression. Preliminary efficacy data in this study showed impressive response rate of IBI363 in combination with PDC in first-line treatment of NSCLC with PD-L1 negative or low expression. This further validates IBI363 as a PD-1/IL-2α-bias bispecific fusion protein capable of exerting potent anti-tumor effects regardless of PD-L1 expression status, underscoring the powerful immune-activating effects of IL-2.

4) Favorable Safety Supports Continuous Administration with Potential to Translate into Long-term Efficacy Benefits

Good safety and tolerability were observed in 3→1.5 mg/kg dose groups. Among all patients, grade ≥3 treatment-related adverse events (G3+ TEAEs) were occurred in 65.2% of patients in the 3→1.5 mg/kg dose group, which was lower than the 3 mg/kg dose group (93.1%) and the 1.5 mg/kg dose group (82.1%). This favorable safety supports 3→1.5 mg/kg as the recommended dose regimen for further clinical investigation of IBI363 in combination therapies as a first-line treatment of NSCLC, which has the potential to translate into durable efficacy benefits.

The most common treatment emergent adverse events (TEAEs) among all patients were anemia (any grade: 78.8%; grade ≥3: 18.8%), neutrophil count decrease (75.0%; 42.5%), white blood cell count decrease (63.8%; 20.0%), arthralgia (51.3%; 2.5%), and platelet count decrease (45.0%; 17.5%).

5) Conclusion and follow-up:

Based on the comprehensive evaluation of preliminary efficacy and safety data, dose regimen of 3→1.5 mg/kg is the recommended dose for further clinical investigation of IBI363 combined with chemotherapy as a first-line treatment for advanced NSCLC. Currently, as the second part of the PoC study, a randomized head-to-head study of 3→1.5 mg/kg IBI363 combined with chemotherapy vs. pembrolizumab combined with chemotherapy as first-line treatment for advanced NSCLC (all PD-L1 expression levels) is ongoing.

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "IBI363 is designed to break through the bottleneck of current immunotherapy. Data from this study demonstrate that by designing a dosing strategy consistent with its immune mechanism, IBI363 achieved an encouraging response rate, leveraging its strong advantages in effectively activating the IL-2 pathway in first-line NSCLC patients with PD-L1 negative or low expression. At the same time, its favorable safety and tolerability holds the potential to translate into long term efficacy benefits. This not only further validates the mechanism but also represents a significant step in its clinical application. We look forward to continued evaluation of IBI363 in first-line treatment of NSCLC and the accumulation of data from the ongoing head-to-head PoC study to provide further evidence for the development of IBI363."

About IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein)

IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm blocks PD-1 and selectively delivers IL-2 to the tumor.

IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China.

(Press release, Innovent Biologics, MAY 22, 2026, View Source;innovent-announces-preliminary-poc-data-of-ibi363-pd-1il-2-bias-bispecific-fusion-protein-in-combination-with-chemotherapy-as-first-line-treatment-for-advanced-nsclc-showing-encouraging-efficac-302779649.html [SID1234666020])

Parker Institute for Cancer Immunotherapy Brings the Power of Its Integrated Network to ASCO 2026

On May 22, 2026 The Parker Institute for Cancer Immunotherapy (PICI) reported that research and expertise from across its network will be on prominent display throughout the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 29 – June 2. PICI leaders, investigators, and collaborators are contributing to more than 50 oral sessions, posters, and publications — a presence that reflects the breadth, urgency, and clinical momentum of the network’s contributions to cancer immunotherapy.

The work spans from foundational discovery to practice-changing trials, including new data in glioblastoma, melanoma, prostate, breast, lung, and urothelial cancers; updated readouts on CAR T-cell and TIL-based therapies; personalized neoantigen vaccine strategies; and immune profiling platforms that aim to predict who will benefit from checkpoint inhibition.

Adding to this strong presence, PICI will unveil the latest results from its RADIOHEAD pan-cancer cohort, with new multimodal immunoprofiling data leveraging foundation models of the immune system to predict immunotherapy response and toxicity — building on the data that PICI featured at AACR (Free AACR Whitepaper) earlier this year.

PICI will also announce the inaugural recipient of the Conquer Cancer PICI Endowed Young Investigator Award this year, to recognize an outstanding early-career clinical oncology investigator as they transition from fellowship training to faculty appointments.

"Cancer continues to demand urgency, and the PICI Network is designed to meet that challenge through coordinated, collaborative science," said Dr. Karen Knudsen, CEO of PICI. "Our participation at ASCO (Free ASCO Whitepaper) 2026 reflects the strength of this model, bringing together researchers and investigators to translate discoveries into meaningful progress for patients."

Presentation Highlights from the Network

Gliobastoma

Glioblastoma remains one of oncology’s most difficult challenges, and the PICI Network is bringing data this year that build directly on the encouraging signals shared at ASCO (Free ASCO Whitepaper) 2025.

University of Pennsylvania (Carl June, MD, Director of the PICI Center at Penn; Donald O’Rourke, MD): Updated overall survival, safety, and neurologic function outcomes from a Phase 1 trial of a bivalent CAR T-cell therapy in recurrent glioblastoma (Abstract 2013, oral session).
Dana-Farber Cancer Institute (Catherine J. Wu, MD; Patrick Ott, MD, PhD): A personalized neoantigen vaccine designed to reprogram the immune landscape of glioblastoma (Abstract 2006, oral session) — a continuation of PICI’s long-standing commitment to neoantigen-based strategies in CNS cancers.
Massachusetts General Hospital (Marcela Maus, MD, PhD): Rituximab pre-conditioning in the Phase 1 INCIPIENT trial of CARv3-TEAM-E for recurrent glioblastoma (Abstract 2059) — extending the CARv3-TEAM-E program that PICI has supported through earlier readouts.
Melanoma

TrioMBM (Allison Betof, MD, PhD — Stanford): A multicenter Phase 2 trial of relatlimab, nivolumab, and ipilimumab in patients with asymptomatic and symptomatic melanoma brain metastases (Abstract TPS9604, lead author).
OBX-115 TIL Therapy (Allison Betof, MD, PhD — Stanford): Phase 2 results of engineered tumor-infiltrating lymphocyte cell therapy with regulatable membrane-bound IL-15 in advanced melanoma after ICI progression (Abstract 9507, oral session).
STAMP (Jedd Wolchok, MD, PhD — Weill Cornell Medicine): Updated outcomes from ECOG-ACRIN EA6174 evaluating adjuvant pembrolizumab in surgically treated Merkel cell carcinoma (Abstract LBA9505, late-breaking oral co-author).
RELATIVITY-047 (F. Stephen Hodi, MD — Dana-Farber): A five-year update of nivolumab plus relatlimab in advanced melanoma (Abstract 9532), alongside a long-term indirect treatment comparison versus nivolumab plus ipilimumab (Abstract 9530).
Botensilimab ± Balstilimab (Patrick Ott, MD, PhD — Dana-Farber): Phase 2 results in patients with advanced cutaneous melanoma refractory or resistant to anti–PD-(L)1 ± CTLA-4 (Abstract 9543).
Prostate Cancer

RiboX (Karen Knudsen, MBA, PhD — PICI): A randomized Phase Ib/II study of enzalutamide with and without ribociclib in patients with RB-retaining metastatic castration-resistant prostate cancer (Abstract 5057).
CHAMP (Ana Aparicio, MD — MD Anderson): A Phase 2 multicenter trial of chemoimmunotherapy for patients with neuroendocrine or aggressive-variant metastatic prostate cancer (Abstract 5016, oral co-author).
ENZAMET Correlatives (Eli Van Allen, MD — Dana-Farber): Germline genetic correlates in metastatic hormone-sensitive prostate cancer treated with ADT plus a non-steroidal anti-androgen or enzalutamide (Abstract 5099).
C3NIRA (Padmanee Sharma, MD, PhD; Sangeeta Goswami, MD, PhD; Ana Aparicio, MD — MD Anderson): Single-cell data on early chemo-induced tumor microenvironment alterations as a predictor of response to PD-1 blockade in aggressive-variant prostate cancer (Abstract 5065).
Breast Cancer

P-RAD (TBCRC-053) (Elizabeth Mittendorf, MD, PhD — Dana-Farber): Primary results from the triple-negative cohort of a randomized trial of no-, low-, or high-dose preoperative radiation with pembrolizumab and chemotherapy in node-positive breast cancer (Abstract 1011, oral co-author).
Post-NCIT Outcomes (Elizabeth Mittendorf, MD, PhD — Dana-Farber): Outcomes after recurrence on neoadjuvant chemo-immunotherapy in patients with high-risk early-stage triple-negative breast cancer (Abstract 601, oral co-author).
ASPRIA (Elizabeth Mittendorf, MD, PhD — Dana-Farber): A single-arm Phase 2 trial of atezolizumab with sacituzumab govitecan to prevent recurrence in triple-negative breast cancer (Abstract TPS644).
Lung & Urothelial Cancers

RICHIS (Jonathan Villena-Vargas, MD — Weill Cornell Medicine): A randomized multicenter Phase 2 trial of radioimmunotherapy versus chemoimmunotherapy followed by surgery for c-stage IB–III non–small cell lung cancer (Abstract TPW8132, lead author).
Urothelial ctDNA Dynamics (Sangeeta Goswami, MD, PhD — MD Anderson): Circulating tumor DNA dynamics as an early biomarker of response to enfortumab vedotin plus pembrolizumab in advanced urothelial carcinoma (Abstract 4582).
Macrophage Polarization in Urothelial Cancer (Nina Bhardwaj, MD, PhD — Icahn Mount Sinai): The CXCL9:SPP1 ratio as a predictor of outcomes with pembrolizumab or enfortumab vedotin plus pembrolizumab in metastatic urothelial cancer (Abstract 4573).
Translational Platforms & Immune Profiling

RADIOHEAD (John Connolly, PhD — PICI): Multimodal immunoprofiling of peripheral blood using foundation models of the immune system for predicting immunotherapy response and toxicity in the RADIOHEAD pan-cancer cohort (Abstract 2533).
CTX-8371 (Patrick Ott, MD, PhD — Dana-Farber): Phase 1 dose escalation of a novel PD-1 × PD-L1 bispecific antibody in patients with advanced malignancies post checkpoint inhibition (Abstract 2629).
Axi-Cel Real-World Outcomes (David Miklos, MD, PhD — Stanford): Long-term real-world outcomes of axicabtagene ciloleucel in relapsed/refractory large B-cell lymphoma (Abstract 7028).

(Press release, Parker Institute for Cancer Immunotherapy, MAY 22, 2026, View Source [SID1234666019])

Caris Life Sciences to Present 32 Studies at ASCO 2026 Highlighting Advances in Multi-omic Biomarker Research and Real-World Evidence

On May 22, 2026 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported that Caris, the Caris Precision Oncology Alliance (Caris POA) and collaborators from more than 60 institutions will collectively present 32 studies at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including one rapid oral presentation and multiple posters across 10 tumor types as well as pan-cancer analyses. These studies reflect the use of multi-omic biomarker research and real-world data to advance understanding of tumor biology and help inform precision oncology approaches.

Highlighted research being presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting includes breast, colorectal, lung, endometrial and renal cell carcinoma studies, in addition to pan-cancer analyses. These studies are retrospective, real-world analyses and multi-omic biomarker investigations focused on immuno-oncology, tumor microenvironment characterization, and predicting treatment response and resistance.

"Caris is proud to collaborate with leading academic and clinical institutions to advance large-scale, multi-omic research and real-world evidence generation," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "The breadth of research being presented at ASCO (Free ASCO Whitepaper) reflects the importance of comprehensive molecular profiling and data-driven discovery to support continued progress in precision oncology."

Among the data to be presented are two Caris-led studies evaluating novel biomarker insights. One study examines how genetic ancestry influences ultraviolet (UV)-related mutational signatures in melanoma and their association with immunotherapy response. A second study evaluates ESR1 amplification in breast cancer, identifying it as a distinct genomic subtype associated with reduced survival and decreased benefit from CDK4/6 inhibitor therapies.

The 32 studies represent collaborations with cancer centers, academic institutions and research organizations across the United States, Europe, Asia and the Middle East, including Dana-Farber Cancer Institute, Mayo Clinic, Memorial Sloan Kettering Cancer Center and the National Cancer Institute.

Rapid Oral

Clinical impact of MSH3 loss-of-function alterations in patients treated with immune checkpoint blockade across cancer types. (Abstract 10516) Session: Prevention, Risk Reduction, and Genetics. Date/Time: Sunday, May 31, 2026 — 10:51 AM–10:57 AM CDT. Location: S403.

Posters with Merit Award

Mitochondrial DNA (mtDNA) expression as used to define metabolic and immune states in colorectal cancer (CRC). (Abstract 2647) Session: Developmental Therapeutics—Immunotherapy. Date/Time: Saturday, May 30, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 437.

Distinct late recurrence patterns and immune landscape of HER2-positive invasive lobular carcinoma (ILC): Analysis of NCCTG N9831 (Alliance) trial and real-world cohort. (Abstract 564) Session: Breast Cancer—Local/Regional/Adjuvant. Date/Time: Monday, June 1, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 49.

Organ- and histology-specific molecular and immune landscape of metastatic breast cancer. (Abstract 1024) Session: Breast Cancer—Metastatic. Date/Time: Monday, June 1, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 138.

TP53 status and licensing complex/IFNγ transcriptional profiles to stratify endocrine-related outcomes with CDK4/6i exposure in 10,833 real-world ER+/HER2- breast cancers and a treatment-naïve subset. (Abstract 1032) Session: Breast Cancer—Metastatic. Date/Time: Monday, June 1, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 146.

Posters

Survival outcomes of human epidermal growth factor receptor 2 (HER2)-amplified and HER2-mutated left-sided colorectal cancer (CRC) patients treated with anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs). (Abstract 3543) Session: Gastrointestinal Cancer—Colorectal and Anal. Date/Time: Saturday, May 30, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 297.

Association of FBXW7 mutation with prolonged survival in microsatellite instability-high colorectal cancer treated with immune checkpoint blockade. (Abstract 3657) Session: Gastrointestinal Cancer—Colorectal and Anal. Date/Time: Saturday, May 30, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 424.

Immune microenvironment signatures as prognostic biomarkers in gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC). (Abstract 4180) Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary. Date/Time: Saturday, May 30, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 163.

Influence of genetic ancestry on UV mutational signatures linked to immunotherapy response in melanoma, beyond TMB. (Abstract 3087) Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology. Date/Time: Saturday, May 30, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 224.

Identification of high-grade neuroendocrine carcinoma (HGNEC) biology across tumor types through transcriptomic profiling and validation in lung cancer. (Abstract 3121) Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology. Date/Time: Saturday, May 30, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 258.

Clinical utility of whole transcriptome sequencing for fusion detection in advanced solid tumors: SCRUM-Japan MONSTAR-SCREEN-2. (Abstract 3127) Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology. Date/Time: Saturday, May 30, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 264.

Association of treatment-induced decrease of tumor chromosome Y and prognosis. (Abstract 3136) Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology. Date/Time: Saturday, May 30, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 273.

Validation of SNHG11 as a prognostic and predictive biomarker for anti-EGFR benefit in colorectal cancer using real-world data. (Abstract 3138) Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology. Date/Time: Saturday, May 30, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 275.

Genomic and transcriptomic correlates of HER3 expression in prostate cancer. (Abstract 3142) Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology. Date/Time: Saturday, May 30, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 279.

Genomic and clinical correlates of belzutifan treatment in renal cell carcinoma (RCC): A retrospective analysis of 150 RCC patients. (Abstract 4541) Session: Genitourinary Cancer—Kidney and Bladder. Date/Time: Sunday, May 31, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 20.

Comprehensive characterization of HIF-2α and carbonic anhydrase IX expression and the genomic landscape in clear cell and VHL-altered renal cell carcinoma. (Abstract 4543) Session: Genitourinary Cancer—Kidney and Bladder. Date/Time: Sunday, May 31, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 22.

CXCL9:SPP1 ratio: Macrophage polarization and outcomes with pembrolizumab or enfortumab vedotin plus pembrolizumab in metastatic urothelial cancer. (Abstract 4573) Session: Genitourinary Cancer—Kidney and Bladder. Date/Time: Sunday, May 31, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 52.

Antigen presentation suppression as a hallmark of immune evasion and poor outcomes in small cell lung cancer. (Abstract 8084) Session: Lung Cancer—Non–Small Cell Local-Regional/Small Cell/Other Thoracic Cancers. Date/Time: Sunday, May 31, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 558.

Smoking signature as used to define a genomically distinct subset of class I BRAF-mutant NSCLC. (Abstract 8538) Session: Lung Cancer—Non-Small Cell Metastatic. Date/Time: Sunday, May 31, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 328.

Use of LIF and LIFR expression to characterize survival and tumor microenvironment composition in lung adenocarcinoma. (Abstract 8553) Session: Lung Cancer—Non-Small Cell Metastatic. Date/Time: Sunday, May 31, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 343.

Molecular and immune profiling of BRAF-mutated (BRAFMUT) non-small cell lung cancer (NSCLC). (Abstract 8653) Session: Lung Cancer—Non-Small Cell Metastatic. Date/Time: Sunday, May 31, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 443.

HPV-stratified tissue factor expression and multi-omic correlates of overall survival after tisotumab vedotin in cervical cancer. (Abstract 5537) Session: Gynecologic Cancer. Date/Time: Monday, June 1, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 203.

The role of combined T cell and NK cell activity in immune checkpoint inhibitor (ICI) therapy in endometrial cancer (EC). (Abstract 5609) Session: Gynecologic Cancer. Date/Time: Monday, June 1, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 275.

Antibody drug conjugate (ADC) biomarker targets in endometrial cancer (EC): Molecular characterization and implications for therapeutic decision-making. (Abstract 5616) Session: Gynecologic Cancer. Date/Time: Monday, June 1, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 282.

Racial disparities in endometrial cancer (EC) survival persist after molecular classification (MC). (Abstract 5620) Session: Gynecologic Cancer. Date/Time: Monday, June 1, 2026, 9:00 AM–12:00 PM CDT. Location: Hall A, Poster: 286.

Association of patient-reported stress and depression symptoms with ER-specific tumor transcriptional signatures in breast cancer (BC). (Abstract 565) Session: Breast Cancer—Local/Regional/Adjuvant. Date/Time: Monday, June 1, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 50.

Association of ESR1 amplification with survival and benefit from CDK4/6 inhibition in breast cancer. (Abstract 1093) Session: Breast Cancer—Metastatic. Date/Time: Monday, June 1, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 207.

Time on treatment for systemic therapies for patients with hormone receptor-positive breast cancer and BRCA1, BRCA2, or PALB2 pathogenic variants. (Abstract 1096) Session: Breast Cancer—Metastatic. Date/Time: Monday, June 1, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 210.

Influence of TONSL on tumor suppressor function of RAD51 and resistance to CDK4/6 inhibitors in ER+ breast cancer. (Abstract 1097) Session: Breast Cancer—Metastatic. Date/Time: Monday, June 1, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 211.

Real-world evaluation of CXCL9/10 with PD-L1 and TMB as predictors of pembrolizumab benefit in triple-negative breast cancer (TNBC). (Abstract 1125) Session: Breast Cancer—Metastatic. Date/Time: Monday, June 1, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 239.

Distinct genomic and microenvironmental profiles of brain metastases in renal cell carcinoma: Insights into hypoxia-driven adaptation and therapeutic vulnerabilities. (Abstract 2033) Session: Central Nervous System Tumors. Date/Time: Monday, June 1, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 398.

Distinct immunogenomic features of cancers arising in solid organ transplant recipients. (Abstract 10587) Session: Prevention, Risk Reduction, and Genetics. Date/Time: Monday, June 1, 2026, 1:30 PM–4:30 PM CDT. Location: Hall A, Poster: 548.

The 2026 ASCO (Free ASCO Whitepaper) Annual Meeting will take place May 29–June 2, 2026, in Chicago, IL, at the McCormick Place Convention Center. Poster and abstract summaries highlighting this research will be available onsite at Caris’ booth #27059. The full abstracts will be available on the Caris website following the meeting.

The Caris Precision Oncology Alliance (Caris POA) is a community of investigators that includes cancer centers, academic institutions, research consortia and healthcare systems collaborating to advance precision oncology and biomarker-driven research. Caris and Caris POA members work together to establish and optimize standards of care for molecular testing through innovative research to improve clinical outcomes for cancer patients.

(Press release, Caris Life Sciences, MAY 22, 2026, View Source [SID1234666018])