On May 26, 2026 Investigators from Hackensack Meridian John Theurer Cancer Center (JTCC)—part of the National Cancer Institute-designated Lombardi Comprehensive Cancer Center at Georgetown University—and Hackensack University Medical Center reported research findings at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The meeting is the premier event for cancer professionals and takes place in Chicago from May 29 to June 2.

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"The future of cancer treatment begins with translating today’s pioneering exploration into tomorrow’s standard of care, a theme that resonates strongly at this year’s ASCO (Free ASCO Whitepaper) meeting. For patients who do not respond to standard treatments, it is critical that they have access to a world-class research program. At the John Theurer Cancer Center, our globally recognized investigators are committed to this translation, driving the latest advances in cellular therapy, immunotherapy, and other innovative areas to improve outcomes for patients across the Hackensack Meridian Health network and beyond," said Dr. Andre Goy, chair, vice president, physician-in-chief of oncology, at Hackensack Meridian John Theurer Cancer Center.

Many of the studies focus on innovative therapies for blood cancers and novel immunotherapies. These are areas of expertise for John Theurer Cancer Center, New Jersey’s largest cancer center. The findings of these investigations have the potential to change the treatment and understanding of hematologic, solid tumors, melanoma and other cancers.

ASCO posters/presentations/publications that include authors from John Theurer Cancer Center:

Solid Tumors

Dominant chromosomal abnormalities in breast cancer metastasis to CNS as compared with systemic metastasis demonstrated by liquid biopsy.
Hypercalcemia as a marker of in-hospital mortality and resource utilization in breast cancer: A national analysis.
Baseline biomarker analysis and clinical outcomes of the PD-1/TGFβR2 bispecific antibody INCA33890 in patients with non-MSI-H metastatic colorectal cancer (mCRC).
Phase 1 study of LB1908, an autologous claudin 18.2-targeted CAR-T cell product, in subjects with advanced gastroesophageal adenocarcinoma.
Phase I, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug conjugate (ADC) in patients with advanced solid tumors.
BXCL701 plus pembrolizumab in second-line advanced pancreatic ductal adenocarcinoma: Final outcomes of the EXPEL PANC trial.
A phase 1, first-in-human, multicenter study of ZW251, a novel glypican-3 (GPC3)–targeted antibody-drug conjugate (ADC), in participants with hepatocellular carcinoma (HCC).
Real-world outcomes of amivantamab monotherapy in advanced EGFR-mutant non-small cell lung cancer.
Real-world efficacy and safety of tarlatamab in small cell lung cancer (SCLC) and extrapulmonary small cell carcinoma (EPSCC): A single-center experience.
Phase Ib results from the phase Ib/II study of [177Lu]Lu-DOTA-TATE in combination with standard of care as a first-line treatment for pts with extensive-stage small cell lung cancer.
Final analysis of the biomarker-directed, randomized, phase 2 KEYNOTE-495/KeyImPaCT study of pembrolizumab (P)–based combination therapy for non–small cell lung cancer (NSCLC).
Hematologic Malignancies

Efficacy and hematopoietic recovery of high-dose melphalan with stem cell rescue as bridging to CAR-T compared with non-intensive bridging in relapsed/refractory multiple myeloma.
Distinction of FLT3-ITD transcriptomic signature from FLT3-TKD and the frequency of this signature in acute myeloid leukemia without FLT3 mutation.
Defining APOBEC-like signature in diffuse large B-cell lymphoma and demonstration of distinct transcriptomic profile.
KITE-753: A phase 2 study of an autologous anti-CD19/CD20 CAR T-cell therapy in CAR-naive patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL).
Outcomes of lisocabtagene maraleucel (liso-cel) in patients (pt) with relapsed or refractory (R/R) mantle cell lymphoma (MCL): First real-world data from the CIBMTR.
Carfilzomib-based combinations for Waldenström macroglobulinemia: Real-world experience from a single center.
MACROD2 and CDKN2A in multiple myeloma: Insights to germline susceptibility and cytogenetic risk from long-read Nanopore sequencing.
Real-world outcomes and subsequent treatment utilization following anti-B-cell maturation antigen antibody-drug conjugate exposure in patients with multiple myeloma.
Immunotherapy

ASP2998, a trophoblast cell-surface antigen 2 (TROP2)–targeted immunostimulatory antibody-drug conjugate with dual payloads, in patients with locally advanced unresectable or metastatic solid tumors: A phase 1b/2 study.
A phase 1 study of BGB-A3055 (anti-CCR8) with or without tislelizumab (anti–PD-1) in patients with solid tumors.
Melanoma

Individualized neoantigen therapy intismeran autogene (intismeran) plus pembrolizumab (pembro) in resected melanoma: 5-year update of the KEYNOTE-942 study.
Models of Care

Are socio-economic status indicators barriers for enrollment in phase 1 clinical trials?
Enrollment outcomes after screening in phase 1 oncology clinical trials: Real-world evidence from a NCI-designated cancer center.
Rethinking risk: Disparities and genetic testing outcomes from a novel public-facing cancer prevention program.
Risk stratification in systemic AL amyloidosis with cardiac involvement using a multiparametric echocardiography score.

(Press release, John Theurer Cancer Center, MAY 26, 2026, View Source [SID1234666063])

On May 26, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that an abstract from a pharmacokinetic (PK) and pharmacodynamic sub-study of its ongoing Phase III TIGeR-PaC clinical trial has been published online in connection with the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 29 – June 2, 2026.

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The abstract, entitled "The TIGeR-PaC Phase 3 Clinical Trial Examining Intra-Arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic and Pharmacodynamic Sub-Study," is a sub-study of the Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer. The abstract evaluates the TAMP (Trans-Arterial Micro-Perfusion) platform for targeted intra-arterial delivery of gemcitabine via RenovoCath, (the Company’s lead investigational product candidate, known as IAG) and its potential to reduce systemic levels of gemcitabine and increase levels of its inactive metabolite compared with IV gemcitabine.

Results showed that IAG administration was associated with a direct correlation between increased metabolite levels and reduced CA 19-9, a biomarker commonly used to assess potential chemotherapy response. By decreasing systemic levels of gemcitabine, through limited systemic exposure and rapid conversion to an inactive metabolite, this drug-delivery approach may both increase local drug potency and reduce the negative side effects common to patients receiving gemcitabine via IV delivery for the treatment of pancreatic cancer. The PK and pharmacodynamic analyses were performed from a total of 16 patients across six TIGeR-PaC trial sites.

"This study suggests that enhancing local drug potency while reducing systemic exposure with IAG may increase efficacy while minimizing toxicity, addressing a key limitation of many therapies," said co-author Dr. Reza Nazemzadeh of Atrium Health Levine Cancer Institute, Charlotte, NC. "By lowering circulating drug levels, the approach has the potential to reduce side effects and improve patient tolerability, representing a promising step toward more precise and patient-centered cancer care."

The 2026 ASCO (Free ASCO Whitepaper) Annual Meeting is being held May 29 – June 2, 2026, in Chicago, Illinois.

Abstract Details:
Online Publication Date & Time: May 21, 2026, at 5:00 P.M. ET
Location: Online
Number for Publication: E16463
Title: The TIGeR-PaC Phase 3 Clinical Trial Examining Intra-Arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic and Pharmacodynamic Sub-Study

(Press release, Renovorx, MAY 26, 2026, View Source [SID1234666081])

On May 26, 2026 AstraZeneca and Daiichi Sankyo reported Datroway (datopotamab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

The approval follows Priority Review by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.

Tiffany A. Traina, MD, FASCO, Section Head, Triple-Negative Breast Cancer Clinical Research Programme, Memorial Sloan Kettering Cancer Centre and investigator for TROPION-Breast02, said: "Datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the 1st-line setting compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy. This approval will bring a much-needed treatment option for these patients."

Arlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation, said: "For seven out of 10 patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy, chemotherapy has remained the only treatment option. Today’s approval of Datroway means that for the first time, these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Triple-negative breast cancer is notoriously difficult to treat. Patients with metastatic disease, especially those who are unable to receive immunotherapy, urgently need more effective, durable and tolerable treatment options, which extend survival. With today’s approval, we are proud to bring Datroway to a broad population of advanced triple-negative breast cancer patients and we continue to study its promise as a mainstay treatment across tumours, stages and settings."

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., said: "As the first antibody drug conjugate to demonstrate a median overall survival of two years in the 1st-line metastatic setting of triple-negative breast cancer, Datroway has the potential to redefine the treatment landscape for these patients. With this approval, Datroway is now approved for three indications in the US, including two for breast cancer, underscoring its potential to play an important role across tumour types."

In the trial, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0290) and a 43% reduction in patients’ risk of disease progression or death (HR 0.57; 95% CI 0.47-0.69; p<0.0001) compared to chemotherapy as 1st-line treatment in this patient population. Datroway was also associated with more robust treatment responses, including an objective response rate (ORR) of 64% compared to an ORR of 30% with chemotherapy.1

The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer.

This application was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, reviews are ongoing in Australia, Canada, Singapore and Switzerland. This initiative is designed to bring effective cancer treatments to patients as early as possible. Additional reviews are underway in the EU, China and Japan.

Based on the results of TROPION-Breast02, datopotamab deruxtecan (Datroway) has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 1 Preferred 1st-line treatment option for patients with metastatic TNBC who are not candidates for immunotherapy. See NCCN Guidelines for detailed recommendations.2

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

Triple-negative breast cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4 In the US, an estimated 32,000 to 48,000 cases of TNBC were diagnosed in 2025, and approximately 11,000 patients with TNBC receive treatment in the 1st-line setting each year.5-7 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.8-10 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.8,11,12

While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.8 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.8 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.13,14 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, prior to the approval of Datroway, chemotherapy was the only approved 1st-line treatment.15

TROP2 is a protein broadly expressed in several solid tumours, including TNBC.16 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.17,18

TROPION-Breast02
TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrolment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are progression-free survival (PFS) as assessed by blinded independent central review and OS. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov.

Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is also approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.

Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Datroway clinical development programme
A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer, and one Phase III trial and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings.

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(Press release, AstraZeneca, MAY 26, 2026, View Source [SID1234666048])

On May 26, 2026 Mercy BioAnalytics, Inc., a pioneer in blood-based early cancer detection, reported that it will present two abstracts at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting highlighting results from studies using biospecimens from the National Lung Screening Trial (NLST) repository.

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The NLST was an NCI-sponsored randomized controlled trial that demonstrated a significant mortality benefit associated with annual low-dose CT-based screening. NLST established a biospecimen repository for the purpose of enabling the validation of early detection lung cancer biomarkers that might augment or replace low-dose CT (LDCT).1 To date, nearly 900 requests for NLST data or biospecimens have been approved.2 To our knowledge, Mercy’s ASCO (Free ASCO Whitepaper) presentation will be the first use of blood specimens from NLST subjects for preliminary validation of early detection lung cancer biomarkers. This work represents an important milestone in advancing blood-based approaches for lung cancer screening and lung nodule triage in elevated-risk subjects.

The first study reports results from a blinded evaluation of a novel blood-based lung cancer screening assay in elevated-risk subjects from the NLST. In this dataset, the blood-based screening assay showed similar sensitivity to low-dose CT across two annual screening encounters and detected lung cancers that were missed by low-dose CT, supporting further evaluation of the assay for lung cancer screening in the elevated-risk population.

The second study reports results from a blinded evaluation of a novel blood-based pulmonary nodule triage assay in elevated-risk subjects from the NLST. Six percent of LDCT-screened subjects in NLST were scored as 3 or 4A using the Lung-RADS framework. Despite a 4% prevalence of cancer in this population, immediate diagnostic workup is not recommended. Mercy’s blood-based assay exhibited 43% sensitivity for the detection of lung cancer in these subjects, supporting further evaluation as a reflex approach for LDCT-detected pulmonary nodules.

"The results of the National Lung Screening Trial documenting a 20% decrease in lung cancer mortality with low-dose CT has led to practice changing recommendations with screening now recommended in high-risk groups. Mercy’s encouraging preliminary results are exactly why the NCI set up the NLST biospecimen repository: to enable validation of promising blood biomarkers. A blood test like Mercy’s could increase lung cancer screening uptake and make evaluation of pulmonary nodules more precise, potentially leading to more lives saved," said Dr. Christine Berg, M.D. the now retired NCI lead investigator on the NLST. "I am excited about these results. I have the good fortune to serve on the Clinical Advisory Board at Mercy and observed the meticulous care with which this work was done."

These results support further evaluation which is now underway of Mercy’s blood-based approaches to lung cancer screening and risk stratification of LDCT-detected pulmonary nodules.

Mercy is continuing to advance blood-based approaches designed to expand access to earlier detection and improve decision-making in lung cancer screening and follow-up.

Presentation details for the two accepted abstracts will be available through the ASCO (Free ASCO Whitepaper) Annual Meeting program and Mercy’s communications channels as the meeting approaches.

(Press release, Mercy BioAnalytics, MAY 26, 2026, View Source [SID1234666064])

On May 26, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or "the Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported that two abstracts showcasing the Company’s RedTail platform have been accepted for online publication at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held from May 29 to June 2, 2026 in Chicago, IL. The Company’s proprietary RedTail platform is a systemically delivered virotherapy platform engineered to selectively target tumors, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetic payloads directly within tumors.

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The Company will present preclinical data on its lead program, CLD-401. CLD-401 is a systemically delivered virotherapy designed to selectively target tumors and enable high-level expression of IL-15 superagonist ("IL-15 SA"), a known T- and NK-cell activator, driving profound immune changes in the tumor microenvironment ("TME"), including the recruitment and activation of NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic response in immunocompetent animal models. The Company expects to file an IND for CLD-401 by the end of 2026.

The Company will also present preclinical data on CLD-501, the lead compound from its in situ T-cell engager ("TCE") approach. CLD-501 is a systemically delivered virotherapy designed to selectively target tumors and simultaneously enable the high-level in situ expression of a TROP-2 TCE and IL-15 SA.

"The data presented at ASCO (Free ASCO Whitepaper) demonstrate the potential for the RedTail platform as systemic virotherapy that can deliver genetic medicine to metastatic sites after systemic administration," said Antonio F. Santidrian, PhD, Chief Scientific Officer of Calidi. "The ability of CLD-401 to induce high levels of IL15-SA expression in the TME may drive activity in patients that have progressed on current IO therapies while the tandem expression of a TCE and a T-cell activator as seen with CLD-501 may overcome the barriers to TCE efficacy in solid tumors."

The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, MAY 26, 2026, View Source [SID1234666082])