On May 22, 2025 Clinicians and scientists from RWJBarnabas Health and Rutgers Cancer Institute reported that it will share new findings and lead discussions at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, showcasing advances from their cutting-edge cancer research program (Press release, Rutgers Cancer Institute of New Jersey, MAY 22, 2025, View Source [SID1234653332]). The meeting will be held in Chicago (and online) from May 30-June 3. Through 45 accepted abstracts and presentations, the institutions will highlight innovative oncology research across a range of tumor types and specialties, including two oral sessions featuring a multisite randomized trial focused on psychosocial support for young adults with cancer, and new findings from a study evaluating pathologic complete response in HER2-positive breast cancer using clinicopathologic variables and the HER2DX pCR score.

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"As New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center, Rutgers Cancer Institute and RWJBarnabas Health are advancing cancer care through the work of our world-class team of researchers and clinicians, whose groundbreaking studies and collaborative innovation continue to shape the future of oncology," said Steven K. Libutti, MD, FACS, William N. Hait Director, Rutgers Cancer Institute and Senior Vice President, Oncology Services, RWJBarnabas Health. "Our presence at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting underscores our unwavering commitment to confronting cancer on every front, from prevention and early detection to the development of novel therapies that improve outcomes for patients. With the recent opening of the Jack & Sheryl Morris Cancer Center, New Jersey’s first freestanding cancer hospital, we’re excited to mark a new chapter in our mission to transform cancer care and research, expanding our ability to deliver cutting-edge treatments and patient-centric care throughout the region and beyond."

The research accepted for presentation at ASCO (Free ASCO Whitepaper) includes four oral sessions, in addition to numerous poster sessions and publication-only abstracts, all highlighting data across a range of cancers, including breast, colorectal and gastrointestinal.

Highlights of the accepted abstracts include the following:

Results from a multisite randomized trial of Bright IDEAS-Young Adults, a problem-solving skills training intervention, showed statistically and clinically significant improvements in depression, anxiety, and health-related quality of life compared to enhanced usual care among young adults newly diagnosed with cancer. Improvements were attributed to increased problem-solving ability, particularly in reducing the tendency to view problems as significant threats and doubt one’s ability to successfully solve problems.
A national analysis, which found that living in a food desert, clinical trial desert, or area with high transportation vulnerability was independently associated with significantly lower odds of breast cancer clinical trial participation. Patients living in both a food and clinical trial desert had a 27% decreased likelihood of enrollment, highlighting the compounded impact of geographic and socioeconomic barriers such as neighborhood transportation barriers, clinical trial deserts, and food deserts.
Secondary results from the EA1181/CompassHER2 pCR trial, which showed that neoadjuvant THP led to pathologic complete response (pCR) in 64% of HER2+/ER- and 32% of HER2+/ER+ breast cancers. The HER2DX pCR score significantly predicted pCR regardless of ER status, and lower ER expression and higher grade were associated with higher pCR rates.
A single center study evaluated whether requiring tumor biopsies (Bx) in phase I cancer trials affects patient enrollment and participation. Of the 146 patients enrolled across 25 trials, 42.4% underwent at least one study-specific biopsy, most commonly of the liver and lung. Patients who had a biopsy experienced a statistically significant delay—median of 6 days—in initiating treatment and had a shorter average duration on study. Findings suggest that further review is needed to understand factors contributing to shorter study duration among patients who underwent trial-related biopsies.
A review of 283 patients with metastatic colorectal cancer (mCRC) enrolled in phase I trials across two institutions found an overall survival of 8.6 months and a clinical benefit rate of 38.1%, comparable to standard third-line therapies. No significant differences in outcomes were observed across racial or ethnic groups. Most patients had multiple sites of metastases and had received a median of three prior therapies. A non-significant trend suggested that overall survival decreased as the number of prior therapies increased.
A large analysis of over 13,000 patients with cancer of unknown primary (CUP) found that 29% had potentially targetable genetic alterations identified through liquid biopsy. Common mutations included TP53, KRAS, PIK3CA and EGFR. This study is the first to show that liquid biopsy can identify targetable mutations in nearly 30% of CUP patients at a scale comparable to tissue testing. While these findings support its use, further trials are needed to confirm the effectiveness of matched therapies.
The full list of presentations at this year’s 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting can be found here.

On May 22, 2025 Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, reported that its Trial in Progress abstract has been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, which is being held May 30 – June 3, 2025 at the McCormick Place Convention Center in Chicago, Illinois (Press release, Bantam Pharmaceutical, MAY 22, 2025, View Source [SID1234653331]). The poster will highlight the company’s ongoing Phase 1 trial evaluating its lead product candidate, BTM-3566, in patients with relapsed/refractory mature B-cell lymphomas. BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets difficult-to-treat, aggressive tumors by activating OMA1-ATF4 Integrated Stress Response (ISR), a newly described mitochondrial homeostasis pathway.

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The Phase 1 multicenter, prospective, dose-escalation study is focused on enrolling patients in the United States and Canada, with the first U.S. site activated at The University of Texas MD Anderson Cancer Center.

"Patients with relapsed or refractory B-cell lymphomas continue to face significant clinical challenges, particularly those who have progressed following cell therapy or targeted agents," said Dr. Michael Wang, global principal investigator and professor of lymphoma & myeloma at The University of Texas MD Anderson Cancer Center. "The opportunity to investigate BTM-3566 and its novel mechanism of action is especially compelling given its preclinical activity across diverse hematologic tumor models, including those with high-risk features. Advancing BTM-3566 into the clinic represents an important step toward expanding therapeutic options for patients who urgently need more effective treatments."

In the U.S., the study follows a standard 3+3 dose escalation design beginning at 0.3 mg/kg, while the Canadian sub-protocol initiates at 0.9 mg/kg using a single-patient cohort with accelerated dose titration. In both regions, patients receive BTM-3566 orally on Days 1 through 7 of a 14-day cycle. The complementary-dual-country approach accelerates the identification of clinically active doses for lymphoma patients while preserving the scientific rigor required to ensure meaningful clinical impact. It is expected to support future harmonization of U.S. and Canadian data to generate a robust, integrated dataset and inform development strategy.

Primary endpoints are safety and tolerability. Secondary and exploratory endpoints include objective response rate (ORR) by revised Lugano criteria, duration of response (DoR), progression-free survival (PFS), and pharmacokinetic and pharmacodynamic assessments. Initial clinical data from the trial are expected in the second half of 2025.

While the current trial is focused on treating lymphomas through activating the OMA1-ATF4 ISR, the mechanism represents a broader therapeutic opportunity. Recent preclinical findings have shown that BTM-3566 drives significant regressions in biomarker-selected solid tumors – particularly in difficult-to-treat tumor types. Additionally, combination data demonstrate synergy with standard-of-care agents in acute myeloid leukemia, underscoring the broad potential of this mechanism across both hematological and solid tumors. The company intends to advance these findings clinically as product development progresses.

Poster Presentation Details

Title: A phase 1 trial of BTM-3566 in relapsed/refractory mature B cell lymphomas
Presenter: Michael Wang, MD, Department of Lymphoma & Myeloma, MD Anderson Cancer Center
Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: Sunday, June 1st at 10 a.m. to 1 p.m. ET
Abstract Number: TPS7097

Additional meeting information can be found on the ASCO (Free ASCO Whitepaper) website, View Source The poster presentation will be made available under the News & Resources section of the company’s website shortly after the event.

About BTM-3566

BTM-3566 is a novel, orally available small molecule designed to target a wide range of cancers, including both hematologic and solid tumors. Its initial clinical focus is on mature B-cell lymphomas, such as mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), Burkitt’s lymphoma, and follicular lymphoma (FL). In preclinical studies, BTM-3566 demonstrated potent anti-cancer activity, driving significant tumor regression – and in many cases, complete tumor elimination – in models resistant to standard treatments, including CAR-T cell therapy. BTM-3566 works by disrupting the mitochondrial function in tumor cells, triggering their natural cell death process (apoptosis). Notably, its anti-tumor activity is independent of tumor genotype, addressing a critical need for therapies capable of delivering robust and durable responses across genetically diverse cancers. With its unique mechanism of action and strong preclinical data, Bantam also plans to expand clinical development, broadening its potential impact for patients with limited treatment options.

Currently, Bantam is conducting ongoing Phase 1 clinical trials in both the U.S. and Canada evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas. For more information about the U.S. trial, visit ClinicalTrials.gov and search NCT06792734. For more information about the Canadian trial, visit ISRCTN.com and search ISRCTN15438979.

On May 22, 2025 Cizzle Bio, Inc. reported the online publication of a new study abstract in conjunction with the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, projecting that its proprietary CIZ1B biomarker blood test for early-stage lung cancer could save the U.S. Medicare program up to $518 million annually (Press release, Cizzle Biotechnology, MAY 22, 2025, View Source [SID1234653330]). Co-authored by healthcare economist Jennifer Hinkel, M.Sc., the study models how integrating CIZ1B into lung cancer screening for high-risk Medicare populations could lower healthcare costs, reduce unnecessary procedures, and increase early-stage lung cancer detection.

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Breakthrough Blood Test Expands Access and Reduces Costs

The CIZ1B biomarker test was developed from more than 30 years of research into the CIZ1 gene at the University of York, identifying the CIZ1B protein variant and its strong association with early-stage lung cancer. With 95% sensitivity for Stage I detection and Negative Predictive Value (NPV) at 96%, the test can detect lung cancer at its earliest, most treatable stage. Cizzle Bio is preparing for the commercial launch of CIZ1B in U.S. clinical environments in the coming months.

"Our economic models project that the CIZ1B test has the potential to be not only a clinical advance but a significant economic win for the healthcare system when implemented as part of lung cancer screening in high-risk, eligible Medicare populations," said Hinkel, a researcher in health economics and oncology outcomes. "By enabling earlier diagnoses and early intervention with less costly treatment, CIZ1B has the potential to make lung cancer screening more accurate, accessible, and sustainable, especially for Medicare patients."

Improves Lung Cancer Screening with Economic Impact

While low-dose CT (LDCT) is a clinically recommended method for lung cancer screening in high-risk individuals (such as those with a significant smoking history), only 4% to 6% of eligible Medicare beneficiaries undergo the procedure. The new study demonstrates that incorporating the CIZ1B biomarker blood test into lung cancer screening protocols could significantly reduce both the financial and clinical burdens currently associated with using LDCT alone.

The model hypothesized that introduction of a blood-based biomarker test such as CIZ1B would enable a 15% increase in lung cancer screening participation among Medicare-eligible high-risk individuals by reducing access barriers associated with LDCT screening including travel, availability, and radiation exposure concerns. The study modeled that this expanded access could identify many more lung cancer cases at an earlier stage, especially in underserved populations, than screening with LDCT alone at the current participation rates.

"Greater participation in screening programs is critical to shifting lung cancer diagnoses to earlier, more treatable stages," added Hinkel. "We have been challenged to move the needle on screening rates solely through education of clinicians and patients, and we know that barriers such as travel time to reach a CT scan appointment, or fear of extra radiation exposure and the risk of a biopsy procedure, can discourage patients from participating—even when there is so much benefit to catching cancer early. Because it is a simple blood test, CIZ1B testing can reach more patients where they are. Implementing cancer screening through a blood test like this can drive a real change toward better outcomes and lower costs in Medicare patients, which is very meaningful."

As a significant component of saving costs, the model projects that CIZ1B biomarker testing can reduce the number of unnecessary biopsies by improving screening specificity, or reducing false positives. LDCT often detects nodules that are visually suspicious, requiring a follow-up biopsy procedure, even though 96% of these procedures are on nodules that are found to be non-cancerous. Avoiding these invasive procedures not only reduces direct healthcare costs but also minimizes patient anxiety and complications.

"This publication is a significant milestone for Cizzle Bio," said Bill Behnke, founder and chief executive officer of Cizzle Bio. "Our mission is to make early lung cancer detection easier, more accurate, and more widely accessible. These findings strengthen the case for CIZ1B as a cornerstone of the future lung cancer screening paradigm."

The abstract is available online in conjunction with the ASCO (Free ASCO Whitepaper) 2025 Annual Meeting and can be accessed via www.asco.org/abstracts.

On May 22, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that an abstract of the research results of the confirmatory Phase II clinical trial of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against protein Claudin18.2) for advanced gastric/gastroesophageal junction cancer (G/GEJC) in China (CT041-ST-01, NCT04581473) is available on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") website (Press release, Carsgen Therapeutics, MAY 22, 2025, View Source [SID1234653329]).

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Title

Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician’s choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01)

Abstract Number

4003

Session Type and Title

Oral Abstract Session – Gastrointestinal Cancer— Gastroesophageal, Pancreatic, and Hepatobiliary

Session Date and Time

May 31, 2025, 3:00–6:00 PM CDT

This open-label, multicenter, randomized controlled trial (RCT) was conducted in China to compare the efficacy and safety of satri-cel versus standard of care (SOC) in CLDN18.2 positive, advanced G/GEJC patients with failure to at least 2 prior lines of treatment. The primary endpoint was PFS assessed by the Independent Review Committee (IRC). Key secondary endpoint was OS. Data cutoff date was Oct 18, 2024.

Patients were randomized (2:1) to satri-cel arm or TPC arm. For satri-cel arm, satri-cel dose of 250×106 cells were infused up to 3 times. For TPC arm, one of the standard of care (SOC) drugs (apatinib, paclitaxel, docetaxel, irinotecan or nivolumab) was given per physician’s decision. Those who experienced disease progression or drug intolerance in TPC arm could receive subsequent satri-cel, if eligible.

From Mar 29, 2022 to Aug 16, 2024, a total of 156 patients were randomized to satri-cel arm (n = 104) or TPC arm (n = 52). Twenty patients in TPC arm received subsequent satri-cel. Median number of prior systemic therapies was 2 in both arms, and 26.9% vs 19.2% had received ≥3 lines. 71.2% vs 65.4% were Lauren diffuse/mixed type. 69.2% vs 59.6% had peritoneal metastasis.

In ITT population (i.e., all randomized patients), satri-cel arm showed significant improvement in mPFS by IRC (3.25m vs 1.77m; HR 0.366, 95% CI:0.241, 0.557; p < 0.0001) meeting the primary endpoint with a 63% reduction in risk of disease progression or death. Even with 15.4% (n=16) patients in satri-cel arm failing to receive infusion and nearly 40% (n=20) patients in TPC arm receiving subsequent satri-cel, satri-cel arm still demonstrated a clear trend toward OS benefit (mOS 7.92m vs 5.49m; HR 0.693, 95% CI: 0.457, 1.051; one-sided p = 0.0416) , showing over 30% reduction in mortality risk.

More importantly, in mITT population (i.e. patients who were actually treated), 136 patients received study drug (satri-cel 88 patients vs TPC 48 patients), mPFS by IRC was 4.37m vs 1.84m, HR 0.304 (95% CI: 0.195, 0.474), representing a 70% reduction in risk of disease progression or death. The mOS was 8.61m vs 5.49m, HR 0.601 (95%CI: 0.385, 0.939), corresponding to 40% reduction in mortality risk. These results demonstrate that satri-cel treatment benefits were pronounced in patients who actually received CAR-T infusion.

Of particular note, 20 TPC patients with subsequent satri-cel infusion achieved an mOS of 9.20 months. When analyzing all 108 patients who received satri-cel infusion (88 patients in satri-cel arm and 20 patients in TPC arm), the mOS reached 9.17 months, while the mOS of 28 patients in TPC arm who did not receive satri-cel treatment was only 3.98 months (HR 0.288; 95% CI: 0.169-0.492). These findings provide further evidence that satri-cel infusion can deliver substantial survival benefits for patients.

Furthermore, satri-cel demonstrated a favorable overall safety profile. Only 4 cases of Grade 3 cytokine release syndrome (CRS) were reported, and no Grade 4-5 CRS events were observed. No immune effector cell-associated neurotoxicity syndrome (ICANS) was reported.

This is the first confirmatory RCT of CAR-T therapy in solid tumors. Satri-cel demonstrated significant PFS improvement and a clinically meaningful OS benefit with a manageable safety profile in CLDN18.2 positive G/GEJC patients with failure to at least 2 prior lines of treatment, compared to standard therapy. These results support satri-cel as a potential new SOC for advanced G/GEJC.

About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2 positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation of China’s National Medical Products Administration for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of G/GEJA.

On May 22, 2025 Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox platform-based photoimmunotherapy, reported that it will present a Trial in Progress poster at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place May 30 – June 3, 2025, in Chicago, Illinois (Press release, Rakuten Medical, MAY 22, 2025, View Source [SID1234653328]).

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The poster will feature Rakuten Medical’s ongoing global Phase 3 clinical trial evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab (anti-PD-1) as a first-line therapy for patients with recurrent head and neck squamous cell carcinoma (HNSCC) (Protocol number: ASP-1929-381 / Acronym: ECLIPSE / ClinicalTrials.gov Identifier: NCT06699212). The poster will also highlight interim findings from the completed Phase 1b/2 study (ASP-1929-181 / ClinicalTrials.gov Identifier: NCT04305795) which evaluated ASP-1929 photoimmunotherapy in combination with anti-PD-1 in recurrent or metastatic HNSCC.

"We are honored that our Trial in Progress poster has been accepted for presentation at ASCO (Free ASCO Whitepaper) 2025," said Anastasios Maniakas, MD, PhD, Assistant Professor in the Department of Head and Neck Surgery and an investigator of the ASP-1929-381 study at The University of Texas MD Anderson Cancer Center. "This Phase 3 study represents a significant step forward in evaluating the potential synergistic efficacy of ASP-1929 photoimmunotherapy and pembrolizumab as a first-line treatment for patients with recurrent HNSCC. We look forward to sharing our progress with the global oncology community and advancing innovative approaches for the treatment of patients facing this challenging disease."

Rakuten Medical is also pleased to announce that it has recently initiated patient enrollment in Taiwan as part of its global expansion of the Phase 3 ASP-1929-381 study. Currently, over 10 clinical sites across the United States and Taiwan are actively enrolling patients. Additional sites are expected to be activated in both regions, with patient enrollment in Japan anticipated to begin shortly.

"We are pleased to be part of this global Phase 3 study and to contribute to the development of an innovative treatment approach like photoimmunotherapy," said Kai-Ping Chang, MD, PhD, Professor of the Department of Otolaryngology – Head & Neck Surgery and Principal Investigator of the ASP-1929-381 study at Chang Gung Memorial Hospital in Taiwan. "Head and neck cancer ranks third in male cancer incidence and fourth in male cancer mortality in Taiwan1. Local recurrence or metastasis is one of the leading causes of death in these patients2, and nearly half of those with recurrent or metastatic disease survive for less than one year3. By participating in this trial, we hope to help advance new therapeutic options that may prolong overall survival of patients with recurrent HNSCC, both in Taiwan and around the world."

ASCO attendees are invited to visit Rakuten Medical at booth #33110 to learn more about the ASP-1929-381 study and the company’s broader Alluminox platform.

Rakuten Medical’s Trial in Progress Poster Overview

Abstract Title: A phase 3 randomized study of ASP-1929 photoimmunotherapy in combination with pembrolizumab versus standard of care in locoregional recurrent head and neck squamous cell carcinoma (HNSCC)
Abstract Number: TPS6122
Abstract Link: View Source
Session: Poster Session – Head and Neck Cancer
Date: Monday, June 2, 2025
Time: 9:00 a.m. – 12:00 p.m., CDT
First Author: Anastasios Maniakas, The University of Texas MD Anderson Cancer Center, TX, the U.S.
Location: Exhibit Hall A, Poster Board # 523b
Rakuten Medical Exhibit Booth

Location: Exhibit Hall A, Booth #33110
Exhibit Date: Saturday – Monday, May 31 – June 2, 2025
About ASP-1929-381 Study
The ASP-1929-381 study is a multi-regional multi-center, randomized, open-label Phase 3 trial, designed to assess the efficacy and safety of ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for locoregional recurrent HNSCC without distant metastases. 412 patients globally will be randomized to either an experimental arm receiving ASP-1929 photoimmunotherapy in combination with pembrolizumab, or a control arm receiving the current pembrolizumab-based standard of care (SOC), where patients may receive pembrolizumab alone or in combination with chemotherapy according to the physician’s choice.
The primary endpoint is Overall Survival (OS), with key secondary endpoints including Complete Response Rate (CRR) and Overall Response Rate (ORR).