On May 26, 2026 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, (together with its subsidiaries and/or affiliated companies, "Sun Pharma") reported the company will share updated results from the locally advanced cutaneous squamous cell carcinoma (laCSCC) expansion cohort from the pivotal CK-301-101 trial of UNLOXCYT (cosibelimab-ipdl) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31, 2026 in Chicago.

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In the investigator-reviewed data being presented at ASCO (Free ASCO Whitepaper), 64 patients with laCSCC received ≥1 dose of UNLOXCYT. The median age of patients in the cohort was 77 years old and 66% were male. This reflects the population commonly seen in clinical practice. Patients received a median of 29 doses over a median treatment duration of 60 weeks. The objective response rate was 50%, including 17 (27%) complete responses and 15 (23%) partial responses. Over a median follow-up of 31 months, responses were durable and the median duration of response was not yet reached.

"These data support clinically meaningful efficacy within this patient population. We observed a high rate of complete responses in patients with laCSCC, which is associated with long-term clinical outcomes. The durability of these responses, a primary therapeutic objective, was achieved alongside a manageable safety profile," said Rahul Ladwa, MBChB, BSc, FRACP, MPhil, Medical Oncologist at the Princess Alexandra Hospital and Greenslopes Private Hospital; Associate Professor, The University of Queensland, Australia; and presenting study co-author at ASCO (Free ASCO Whitepaper).

The safety profile was comparable to what was observed in an earlier analysis of a smaller cohort.

The most common adverse events (AEs) were anemia and diarrhea, recorded in 17 (27%) patients each.
Immune-related adverse reactions (irAEs) were observed in 22 (34%) patients.
Grade ≥3 irAEs occurred in 1 (2%) patient and were dermatologic in nature (maculo-papular and pruritic rashes) and considered treatment-related.
Treatment-emergent AEs (TEAEs) were reported in 61 (95%) patients and considered treatment-related in 50 (78%) patients; none were fatal.
Grade ≥3 TEAEs were reported in 26 (41%) patients and considered treatment-related in 7 (11%).
"The findings from this large cohort of patients are impressive from both an efficacy and tolerability perspective. Patients with laCSCC are older and have many comorbidities, so we need treatment options that are both efficacious and well tolerated, so patients remain on therapy and experience meaningful benefit," said Emily Ruiz, MD, MPH, Associate Professor of Dermatology, Harvard Medical School, Academic Director of the Micrographic Surgery Center at Brigham and Women’s Hospital; co-founder of Skin Cancer Champions; and study co-author. "Cosibelimab seems to work differently than other checkpoint inhibitors by restoring the adaptive immune response and engaging the innate immune system while preserving the PD-1/PD-L2 pathway. We believe this may explain the results we observe in these patients."

Poster Presentation Details

Title: Efficacy and safety of cosibelimab 800 mg every 2 weeks for locally advanced cutaneous squamous cell carcinoma: Updated follow-up from a pivotal study
Poster Session: Melanoma/Skin Cancers
Abstract Number: 9585
Poster Board Number: 301
Date and Time: May 31, 2026; 9:00am-12:00pm CDT
Presenter: Dr. Rahul Ladwa
"We’re looking forward to presenting these data at ASCO (Free ASCO Whitepaper)’s Annual Meeting later this month, highlighting pivotal results from the second largest ever reported prospective study of laCSCC patients treated with PD-(L)1 monotherapy, reinforcing our commitment to the skin cancer community," said Ahmad Naim, MD, Senior Vice President, North America Chief Medical Officer, Sun Pharma. "With a median duration of response not yet reached after more than two and a half years of follow-up, UNLOXCYT continues to demonstrate the kind of clinically meaningful efficacy with durable clinical responses and well-tolerated treatment option that patients with laCSCC need."

UNLOXCYT (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. The recommended dosage of UNLOXCYT is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks.

UNLOXCYT (cosibelimab-ipdl) was approved at 1,200 mg Q3W because PK/PD modeling showed it provides similar overall exposure and PD-L1 receptor coverage as the trial regimen of 800 mg Q2W. Since checkpoint inhibitors have flat exposure-response curves, they have been utilized with more convenient dosing schedules if equivalent efficacy and safety are maintained. The safety analyses included patients who received both 800 mg Q2W and 1,200 mg Q3W.

About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (CSCC) is among the most common skin cancers worldwide. While early stages are treatable, an estimated 40,000 US patients each year progress to advanced disease, resulting in nearly 15,000 deaths.

Important risk factors for CSCC include chronic ultraviolet radiation exposure and immunosuppressive conditions. In addition to being life threatening, CSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region and that invade blood vessels, nerves, and vital organs such as the eye or ear.

(Press release, Sun Pharma, MAY 26, 2026, https://www.prnewswire.com/news-releases/at-the-asco-2026-annual-meeting-sun-pharma-to-present-pivotal-long-term-follow-up-data-on-unloxcyt-cosibelimab-ipdl-302781880.html [SID1234666065])

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])

On May 26, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the publication of two investigator-initiated trials-in-progress abstracts on May 21, 2026. These abstracts will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago. The abstracts highlight ongoing clinical investigations evaluating the use of Delcath’s percutaneous hepatic perfusion (PHP) with melphalan using the HEPZATO KIT Hepatic Delivery System (HDS) in metastatic melanoma involving the liver — a common and difficult-to-treat site of disease progression.

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One abstract, titled "Phase 2 sequential treatment of percutaneous hepatic perfusion with melphalan/hepatic delivery system followed by tebentafusp in the treatment of metastatic uveal melanoma," describes an investigator-initiated Phase 2 trial evaluating sequential treatment with HEPZATO followed by tebentafusp in patients with metastatic uveal melanoma (mUM) who are HLA-A*02:01 positive and have isolated or liver-dominant metastases. The study is designed to assess progression-free survival and additional measures including safety, objective response, overall survival, and biomarker analyses. The study opened for enrollment in November 2025.

A second abstract, titled "Phase 1b/2 trial of melphalan-percutaneous hepatic perfusion (PHP) therapy and nivolumab/relatlimab in patients with metastatic melanoma and liver metastasis," outlines a single-center Phase 1b/2 study evaluating HEPZATO in combination with nivolumab/relatlimab as a first-line treatment approach for patients with metastatic non-uveal melanoma involving the liver. The trial is intended to assess safety, tolerability, and preliminary efficacy, with secondary objectives including disease control rate, progression-free survival, overall survival, duration of response, and tumor reduction. The study opened for enrollment in January 2026.

The abstract on sequential PHP followed by tebentafusp in mUM (Abstract TPS9605) and the abstract on PHP plus nivolumab/relatlimab in metastatic melanoma with liver metastasis (Abstract TPS9600) will be presented as posters at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. Specific session details will be available on the ASCO (Free ASCO Whitepaper) website.

"We believe the publication of these two ASCO (Free ASCO Whitepaper) abstracts underscores the growing clinical interest in HEPZATO’s potential across multiple metastatic melanoma settings with liver involvement," said Gerard Michel, Chief Executive Officer of Delcath Systems. "These investigator-initiated trials will provide important insights into combining or sequencing liver-directed therapy with modern systemic treatments in patients with challenging disease. We remain committed to supporting such research to advance therapeutic options for patients with liver cancers and metastases."

(Press release, Delcath Systems, MAY 26, 2026, View Source [SID1234666050])

On May 26, 2026 Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, reported progress on its prospective observational case-control study designed to train and validate a blood test for multi-cancer early detection (MCED) at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting from May 29-June 2, 2026.

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The CAMPERR study (NCT05366881) is enrolling 6,300 participants at 15 sites with nationwide representation across the US. Approximately 98% of participants have been enrolled to date, and enrollment is expected to be complete by the end of 2026.

"CAMPERR is one of the most comprehensive prospective observational MCED studies conducted to date," said Anne-Renee Hartman, MD, Co-Founder and Chief Medical Officer at Adela. "The study’s scale, demographic diversity, and scientific rigor provide high confidence that a lab developed test (LDT) for MCED trained and validated with CAMPERR samples will be highly generalizable, performing reliably across a broad and diverse population."

CAMPERR is enrolling 2,400 participants with newly diagnosed, untreated cancer or cancer recurrence across 20 pre-selected cancer types, with blood collected prior to treatment initiation. Together, these 20 cancer types represent 93% of annual cancer incidence and 88% of annual cancer deaths in the United States. An additional 3,900 cancer-free control participants have been enrolled. A subset of participants with Stage I–III lung cancer will undergo additional blood draws and longitudinal follow-up, enabling training and validation of a test for MRD-based recurrence detection.

Adela’s genome-wide methylome enrichment platform is unique from other methylation-based MCED tests because it utilizes a high-affinity enrichment process, enabling capture and preservation of more genomic material for sequencing compared to other platforms that use enzymatic or chemical treatment (bisulfite conversion).

"The methylome carries one of the richest cancer signals in the blood, particularly for detecting early-stage disease and identifying cancer signal of origin," said Daniel De Carvalho, PhD, Co-Founder and Chief Scientific Officer at Adela. "Adela’s genome-wide methylome enrichment platform is designed to capture that signal while preserving the integrity of cfDNA, rather than relying on chemical conversion methods that can degrade limited blood-derived DNA. This allows us to access a broad, biologically informative view of cancer-associated methylation from a blood draw, with the potential to improve sensitivity, in particular for early stage and low-shedding cancers, when tumor-derived DNA is present at very low levels in the blood."

At the ASCO (Free ASCO Whitepaper) Annual Meeting, Adela is also presenting data using an updated classifier for recurrence detection for head & neck squamous cell carcinoma. Adela previously reported clinical validation results for head & neck cancer in Annals of Oncology.

Adela’s test for MRD is currently available to select providers and institutions for use to monitor for recurrence in head & neck cancer. Adela plans to expand commercialization of the test later this year for use in patients with solid tumors treated with immunotherapy to monitor response and help guide treatment decision-making. The test is also broadly available for use by biopharmaceutical companies and other investigators for recurrence monitoring and immunotherapy response monitoring, including for biomarker discovery and drug development.

Presentation Details

Abstract 6084: Evaluation of a tissue-free genome-wide methylome enrichment assay for detecting molecular residual disease (MRD) in patients with head and neck squamous cell carcinoma (HNSCC).

Dr. Geoffrey Liu1

Hall A, Poster Board: 541

Saturday, May 30, 2026: 1:30 PM-4:30 PM CDT

Abstract TPS10628: CAMPERR: A multicenter, prospective, observational study to evaluate a cfDNA-based genome-wide methylation enrichment assay for multicancer early detection (MCED), identification of molecular residual disease, and relapse prognostication.

Dr. Gregory Idos2

Hall A, Poster Board: 589a

Monday, June 1, 2026: 1:30 PM-4:30 PM CDT

(Press release, Adela, MAY 26, 2026, View Source [SID1234666066])

On May 26, 2026 Bionano Genomics, Inc. (Nasdaq: BNGO) reported publication of a peer-reviewed study in Modern Pathology showing that optical genome mapping (OGM) detected genomic abnormalities in 97.8% of T-cell acute lymphoblastic leukemia (T-ALL) cases — nearly double the 55% detection rate achieved by conventional cytogenetic analysis. Conducted by researchers at The University of Texas MD Anderson Cancer Center and Johns Hopkins University School of Medicine and representing one of the most comprehensive genomic analyses of T-ALL to date, the study underscores OGM’s potential to transform how this aggressive blood cancer is studied and understood.

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T-ALL is an aggressive form of pediatric and adult leukemia driven by a wide variety of complex genetic changes, many of which are too subtle or structurally complex to be detected by traditional methods. The disease is notoriously difficult to characterize fully, limiting the ability of researchers to study its biology, classify subtypes, and develop targeted therapies.

The 91-subject study compared OGM head-to-head against conventional karyotyping and next-generation sequencing (NGS) — the standard tools for evaluating T-ALL. Where karyotyping identified abnormalities in just 55% of cases, OGM found them in 97.8% of cases, and provided additional genomic insights beyond standard methods in approximately 70% of the cases — all from OGM’s single workflow.

Key Highlights:

91 cases: of T-ALL cases analyzed across three platforms — OGM, conventional karyotyping, and NGS — making this study the largest OGM study of T-ALL conducted to date.
High success rate for finding abnormalities: OGM identified chromosomal abnormalities in 97.8% of cases, compared to 55% by conventional karyotyping — a dramatic improvement in detection for a disease where missed findings can leave the biology incompletely understood.
Broader picture in 70% of cases: OGM delivered clinically relevant genomic information beyond karyotyping in approximately 70% of cases, uncovering abnormalities that standard methods missed — all without requiring additional testing.
24 known + 21 novel gene fusions identified: OGM detected gene rearrangements in 80% of cases, including 24 known recurrent fusions and 21 newly identified fusions, pointing to potential new targets for T-ALL research.
Comprehensive sequence variant and copy number profiling: OGM identified copy number changes in 93% of cases. NGS detected sequence variants in 92% of cases. The gene most frequently found to harbor variants was NOTCH1 (57% of cases).
Disease subtypes decoded: OGM uncovered distinct genomic patterns across T-ALL subtypes, supporting more precise biological classification of this heterogeneous disease.
OGM can streamline workflows for T-ALL. T-ALL presents particular challenges for standard genomic analysis: samples often yield poor-quality material for karyotyping, and many of the most biologically important genetic changes are subtle, small-scale, or driven by rearrangements in non-coding regions of the genome. Conventional approaches typically require multiple sequential analyses to piece together a complete picture — a process that is time-consuming, costly, and incomplete. OGM can address these limitations with a genome-wide approach that captures the full landscape of genetic variation in a single workflow.

"This publication further strengthens the growing body of evidence supporting OGM as a powerful tool for resolving the genomic complexity of challenging childhood and adult blood cancers like T-ALL, 50% of which remain unsolved by legacy methods, such as, karyotyping. This study, as one of the first and largest of its kind in T-ALL, demonstrates the complementarity that OGM and NGS can provide and shows how OGM can be particularly well-suited to T-ALL’s unique challenges — including poor sample quality, subtle rearrangements, and a wide range of genomic targets — capturing recurrent and novel alterations in a single pass that would otherwise require multiple sequential tests," said Alka Chaubey, PhD, FACMG, chief medical officer of Bionano. Dr. Chaubey continued, "the ability to uncover subtle and complex rearrangements in diseases like T-ALL can give researchers a far more complete picture of the biology — and reinforces why comprehensive structural variant analysis matters in blood cancer research."

(Press release, BioNano International Singapore Pte, MAY 26, 2026, View Source [SID1234666083])