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.

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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.

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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])

China approves HERNEXEOS® as first targeted oral treatment option for HER2-mutant advanced NSCLC at initial diagnosis

On May 22, 2026 Boehringer Ingelheim reported HERNEXEOS (zongertinib tablets) has been conditionally approved as monotherapy by China’s National Medical Products Administration (NMPA) as an initial treatment for adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) tyrosine kinase domain (TKD) mutations.1 The approval is based on data demonstrating a 75.7% objective response rate, with full approval contingent on confirmation of clinical benefit in an ongoing trial. It represents another major milestone following the Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China’s NMPA for first-line treatment.4 The therapy is also approved for patients in China who have received prior treatment.

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"In the past, patients with HER2‑mutant advanced non-small cell lung cancer faced significant diagnostic and treatment challenges in clinical practice. These challenges not only placed considerable physical and psychological burdens on patients but also limited the delivery of precise lung cancer treatment," said Professor Yi-Long Wu from Guangdong Provincial People’s Hospital, Chairman of the Chinese Thoracic Oncology Group (CTONG). "This advancement directly addresses patients’ core clinical needs for quality care."

The approval is based on data from a cohort of treatment-naïve patients (N=74) in the Phase Ib Beamion LUNG-1 trial, which demonstrated an objective response rate (ORR) of 75.7%, including 10.8% achieving complete response (CR) and 64.9% achieving partial response (PR). The median duration of response (mDoR) was 15.2 months. Treatment-related adverse events (AEs) were predominantly low-grade. In a pooled safety population, which included 177 patients with HER2 (ERBB2)-mutant NSCLC in Beamion LUNG-1, AEs led to dose reductions in 9% of patients and dose discontinuations in 6% of patients. Data for treatment-naive patients were presented at the European Lung Cancer Congress 2026 (ELCC 2026) and published in The New England Journal of Medicine.

"The first-line approval of HERNEXEOS in China marks an important step forward in our ambition to redefine the treatment of HER2-driven cancers," said Shashank Deshpande, Chairman of the Board of Managing Directors at Boehringer Ingelheim. "Building on strong global momentum, including approvals in the U.S., and supported by compelling clinical evidence, we are advancing this therapy across various stages of disease and tumor types. This milestone reflects not only the progress we have made, but the broader opportunity ahead – to deliver unprecedented impact for people living with cancer, now and for generations to come."

About HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type7 and the incidence is set to increase to over 3 million cases worldwide by 2040.8 NSCLC is the most common type of lung cancer.7 The condition is often diagnosed at a late stage9, and fewer than 3 in 10 patients are alive five years after diagnosis.9,10 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.8,11,12

Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).7 Mutations in HER2 can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.13

About HERNEXEOS (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby minimizing associated toxicities. HERNEXEOS is approved in the U.S., China, Hong Kong and Japan as the first orally administered targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer. Zongertinib is not approved in other markets.

The treatment is being evaluated in ongoing trials across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as an initial treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574). Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).

(Press release, Boehringer Ingelheim, MAY 22, 2026, View Source [SID1234666017])

Oncolytics Biotech® to Present Data at ASCO 2026 Reinforcing Pelareorep’s Potential Across Gastrointestinal Tumors

On May 22, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, reported translational data from the GOBLET and AWARE-1 trials will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting at McCormick Place, Chicago, Illinois, from May 29-June 2, 2026. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes.

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"These findings demonstrate that pelareorep works by expanding preexisting tumor-reactive immune cells rather than introducing new antigens," said Dr. Richard Vile, Ph.D., Professor of Immunology at the Mayo Clinic and Oncolytics Scientific Advisory Board Member. "This further underscores Oncolytics’ continued commitment to define the mechanisms by which pelareorep engages the immune system and illustrates the progress being made in developing a differentiated immunotherapy to improve treatment options for difficult-to-treat cancers."

"KRAS-mutant tumors remain among the most challenging to treat with immunotherapy," said Jared Kelly, Chief Executive Officer of Oncolytics. "These data reflect important progress in bridging translational and clinical data and help us better understand how immune responses are activated by pelareorep. When we can point to translational and mechanistic data as the reason for clinical efficacy, it gives us confidence that our development plans are more likely to succeed."

Abstract: Influence of pelareorep on mutant KRAS-specific blood TIL clonal expansion.
Author: Richard Trauger, PhD
Date: May 30, 2026, 1:30-4:30 p.m. Central Time
Abstract Number: 2664
Poster Board Number: 454

Translational analyses from the Phase 1/2 GOBLET study in advanced pancreatic cancer and the AWARE-1 window-of-opportunity study in early-stage breast cancer illustrate a multi‑step immune activation process following treatment with pelareorep. Results demonstrate that pelareorep induces an antiviral immune response within the tumor via double-stranded RNA signaling, leading to expansion of virus‑specific T cells and subsequent activation of tumor‑specific T cells associated with tumor regression.

In pancreatic cancer, serial blood analyses demonstrated expansion of anti‑viral T cells by ELISPOT and clonal expansion of tumor‑specific T cells after one cycle of therapy. Notably, the expansion of pre‑existing tumor‑infiltrating lymphocyte ("TIL") clones in blood correlated with reductions in tumor volume in pancreatic cancer. T‑cell receptor sequencing with antigen specificity assessment confirmed expansion of mutant KRAS-specific T‑cell clones, supporting a model in which pelareorep engages both innate and adaptive immunity and may help drive tumor‑directed immune responses in difficult‑to‑treat, KRAS‑driven disease.

In serial breast tumor biopsies, gene expression profiling demonstrated significant increases in antiviral and immune gene expression, consistent with activation of toll‑like receptor 3 (TLR3), alongside induction of CXCL13, a chemokine linked to the formation of tertiary lymphoid structures (TLS). TLS formation in the tumor microenvironment was further supported by imaging mass cytometry following treatment. Across studies, evidence of the expansion of TILs was observed in the tumor and the blood.

A copy of the ASCO (Free ASCO Whitepaper) presentation will be available on the Media page of the Oncolytics’ website following the conclusion of the meeting.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

Pelareorep in combination with atezolizumab (Tecentriq), gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
About AIO
AIO-Studien-gGmbH ("AIO") emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. The combination of pelareorep, letrozole, and atezolizumab resulted in 60% of patients experiencing 30% or greater increases in their CelTIL score.

(Press release, Oncolytics Biotech, MAY 22, 2026, View Source [SID1234666016])

Veracyte to Host Investor Call on June 1, 2026 to Discuss ASCO Findings

On May 22, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that it will host a conference call and webcast on Monday, June 1, 2026 at 8:30 a.m. ET to discuss data from two significant phase III clinical trials using its Prosigna Breast and Decipher Prostate tests that will be presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. This includes results from the OPTIMA and ENZAMET trials.

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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

                  Schedule Your 30 min Free Demo!

Professor Iain Macpherson, one of the principal investigators of OPTIMA, Professor of Breast Oncology at the University of Glasgow and Honorary Consultant Medical Oncologist at the Beatson West of Scotland Cancer Centre, will join for the discussion.

The conference call will be webcast live from the company’s website and will be available via the following link: View Source A webcast replay will be available following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-ins can be accessed by registering via this link.

(Press release, Veracyte, MAY 22, 2026, View Source [SID1234666015])